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05/11/2023 Audit Monroe County Clerk of circuit Court & Comptroller Internal Report 1*0 * ** V * * AW *** ** Coot! Audi t of Monroe county Fire Rescue controlled Substances 2023-001 May 11, 2023 "f''jL&� !`Ub&V&ZZ)U UC o���" IIIIIII � IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII IIIIIII IIIII 'II�IIIIIIIII�IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII � IIIII IIIII 500 Whitehead Street, Key West, FL 33040 1 (305) 292-3550 1 Monroe-Clerk.com This page is intentionally left blank. jy� aunra Kevin Madak cPA Clerk of the Circuit Court&Comptroller—Monroe County, Florida AOE cow May 11, 2023 Chief James Callahan Monroe County Fire Rescue 490 6311 Street Ocean Marathon, FL 33050 Dear Chief Callahan: It was widely reported that in late July 2022, Monroe County Fire Rescue(MCFR) Management received an anonymous tip regarding the chief flight nurse falsifying MCFR's controlled substance logs. MCFR Management took immediate steps to address this serious breach of controls including removing its chief flight nurse from duty and notifying the Monroe County Sheriffs Office that a crime may have been committed. The Sheriffs Office immediately began an investigation into the allegations. Subsequently other law enforcement agencies also began investigations and it is our understanding that their work is ongoing at the time of the release of this report. In addition, on August 11,2022, former Fire Chief Steven Hudson sent a letter to Monroe County Clerk of Circuit Court & Comptroller Kevin Madok requesting an audit be conducted of MCFR's Emergency Medical Services (EMS) system performance and controlled substance inventory records for the period June 2021 through July 2022. The audit scope included: (1)reviewing compliance with MCFR's controlled substance policy,related inventory procedures,and applicable laws and regulations;(2)evaluating methods for ordering controlled substances and related supplies; (3) evaluating efficiency and effectiveness of the receipt and storage of controlled substance inventory; (4) evaluating the internal controls and processes over storage security of controlled substances; (5) examining records, documentation, reviews and management for storage policies and procedures;(6)reviewing the disposal activities of unused and expired controlled substances; (7) reviewing the inspection and reporting requirements of controlled substance containers that have been tampered or degraded; and (8) reviewing other internal controls or procedures as they may come to our attention during the audit. We appreciate the courtesy and cooperation extended to the Clerk's Office by MCFR and other BOCC departments that met with us. Sincerely, [Yarn Radloff, CPA Interim Internal Audit Director Monroe County Clerk of Circuit Court& Comptroller Cc: Board of County Commissioners Roman Gastesi, County Administrator Bob Shillinger, County Attorney Deputy Chief R.L Colina, Fire Rescue Tammie Murray, Internal Audit KEY WEST MARATHON PLANTATION KEY 500 Whitehead Street 3117 Overseas Highway 88770 Overseas Highway Key West, Florida 33040 Marathon, Florida 33050 Plantation Key, Florida 33070 This page is intentionally left blank. Table of Contents Audit of Monroe County Fire Rescue Controlled Substances Executive Summary..................................................................................... 1 Monroe County's EMS Programs ..............................................................2 Purpose and Scope of Internal Audit.........................................................3 Management of Controlled Substwices ......................................................4 Reconciling mid Mmaging Controlled Substuices Inventory......................................................................4 Ordering, Receipting, Disposing,mid Storing of Controlled Substuices.................................................. 10 Ordering mid Receipting of Controlled Substuices .............................................................................. 11 Disposal of Controlled Substuices........................................................................................................ 13 Expired/Damaged Controlled Substuices............................................................................................. 15 Storing Controlled Substuices............................................................................................................... 16 Medical Director Role mid Responsibilities .............................................................................................. 18 County Management of EMS Programs...................................................23 Prevention wid Detection of Drug Diversion............................................................................................23 Drug-Free Workplace ProgT uii.................................................................................................................27 AppendixI ................................................................................................31 AppendixII...............................................................................................33 AppendixIII .............................................................................................68 AppendixIV..............................................................................................70 AppendixV...............................................................................................78 This page is intentionally left blank. Executive Summary In late July 2022, Monroe County Fire Rescue (MCFR) Management was alerted about an anonymous tip reporting a suspicion that the chief flight nurse was altering controlled substance logs to pilfer drugs. MCFR Management took immediate steps to investigate the authenticity of the tip. Once the tip was deemed credible, MCFR Management took action to address this serious breach of controls including taking steps to remove its chief flight nurse from duty and notifying the Sheriff's Office that a crime may have been committed. The Sheriff immediately began investigating these allegations and subsequently arrested MCFR staff suspected of illegal activity. In early August 2022, MCFR Management also formally requested the Monroe County Clerk of Circuit Court & Comptroller's Office conduct an internal audit of MCFR's emergency medical services' (EMS) system performance and controlled substance inventory records for the period June 2021 through July 2022. Our audit found that controlled substances were being diverted by MCFR staff along with a widespread lack of management oversight. Our audit procedures included verifying whether the daily physical counts for controlled substances during the audit period could be traced to either an authorized inventory change or an incident where the drug was administered to a patient. We found material discrepancies in the inventory logs that we subsequently reported to appropriate law enforcement officials so that they may conduct any further investigation that they deem necessary. Based on our audit findings, we made recommendations to MCFR to strengthen internal controls over its EMS program's handling of controlled substances. More importantly, we recommended that Monroe County conduct an immediate and comprehensive review of MCFR's Medical Director contract to determine whether the current Medical Director has been adequately fulfilling the contract terms. Our review found that a lack of oversight by MCFR's Medical Director likely was a primary reason that the chief flight nurse's alleged drug diversion activities went undetected for so long. The sloppiness of MCFR's inventory and patient care records are evidence that minimal oversight by a licensed medical professional was being performed. We also reviewed whether MCFR was provided the needed support, resources, and tools from County Administration's senior directors who serve lead roles in advising county managers on personnel and fiscal matters, and to properly react to and address the unusual situation they were facing. We found that County Administration does not have effective preventive or detection measures to ensure their employees' safety and that controlled substances are secure from drug diversion. In fact, it has been reported that there were a number of behavioral indicators that the chief flight nurse exhibited that would have raised red flags had county management been trained or educated on the best practices for detecting drug diversion. Our report includes recommendations for county management to provide its managers and employees with training, education,resources, and tools for preventing and detecting drug diversion and maintaining a drug- free workplace. Monroe County's EMS Programs Monroe County Fire Rescue (MCFR) uses ground ambulances to provide emergency medical services (EMS) to the unincorporated areas of Monroe County. MCFR employs dual-certified firefighters/emergency medical technicians(EMTs)and firefighters/paramedics to perform critical patient care. Eight of MCFR's nine fire stations provide ground ambulance services. Supplementing the critical services provided by MCFR's ground ambulances is Monroe County's air ambulance program known as Trauma Star. The Trauma Star Program has become an essential life-saving program for the County and its residents since its beginnings in 2001. Given the geographical challenges facing all residents and visitors in the Florida Keys, the Trauma Star program provides rapid air ambulance transport for those who are critically injured and/or who need to be immediately transported for medical reasons to a hospital on the mainland. Over the past two decades, Monroe County's Trauma Star Program has repeatedly proven its commitment to providing the highest quality air ambulance transport care. In 2021, the Trauma Star crew flew 1,386 flights and carried 1,458 patients to Miami hospitals while also providing advanced life support to those patients. Trauma Star's annual average is typically 1,000 flights. In comparison, according to the Federal Aviation Administration's Association of Air Medical Services, the national average for similar programs is transporting 264 patients per year. The Trauma Star Program operates two bases. Trauma Star North(TSN)is located at the Marathon Airport and Trauma Star South (TSS) is located in Key West at the Lower Keys Medical Center. Each base is staffed around-the-clock and ready to launch at a moment's notice. Each helicopter can transport up to two critically injured or ill patients at a time. Trauma Star is staffed with highly trained flight nurses, flight-trained firefighters/paramedics, and helicopter pilots. The Monroe County Board of County Commissioners (BOCC)partners with the Monroe County Sheriff (Sheriff) to provide this critical service to Monroe County. The flight nurses and paramedics are employed by the BOCC's MCFR MCFR, in turn, reports directly to the County Administrator. The helicopter pilots,mechanics,and program director are employed by the Sheriff. Trauma Star helicopters are configured with state-of-the-art medical equipment to allow an experienced and highly skilled air medical team to provide care for the patient. As required by Florida statutes,the BOCC contracts with a Medical Director. The Medical Director is responsible for supervising and accepting responsibility for the medical performance of the licensed/certified air medical team response personnel as well as MCFR's licensed/certified personnel providing medical care on its ground ambulances. — 2 — Purpose and Scope of Internal Audit In late July 2022, MCFR Management was alerted about an anonymous tip reporting a suspicion that the chief flight nurse was altering controlled substance logs to pilfer drugs. MCFR Management took immediate steps to investigate the authenticity of the tip. Once the tip was deemed credible, MCFR Management took action to address this serious breach of controls including taking steps to remove its chief flight nurse from duty and notifying the Sheriff's Office that a crime may have been committed. The Sheriff immediately began investigating these allegations and subsequently arrested MCFR staff suspected of illegal activity. Subsequently other law enforcement agencies also began investigations and it is our understanding that their work is ongoing at the time of the release of this report. In addition, in early August 2022, MCFR Management formally requested the Monroe County Clerk of Circuit Court & Comptroller's Office (Clerk) conduct an internal audit of MCFR's EMS system performance and controlled substance inventory records for the period June 2021 through July 2022. Based on MCFR's request, the scope of the Clerk's audit included: (1) Reviewing compliance with the MCFR's controlled substance policy and related inventory procedures and applicable laws and regulations; (2) Evaluating methods for ordering controlled substances and related supplies; (3) Evaluating efficiency and effectiveness of the receipt and storage of controlled substances inventory; (4) Evaluating the internal controls and processes over storage security of controlled substances; (5) Examining records, documentation, reviews, and management for storage policies and procedures; (6) Reviewing the disposal activities of unused and expired controlled substances; (7) Reviewing the inspection and reporting requirements of controlled substance containers that have been tampered or degraded; and (8) Reviewing other internal controls or procedures that come to our attention during the audit. As part of our audit procedures, we reviewed and evaluated MCFR's written standard operating procedures (SOPS); interviewed MCFR staff about the procedures they followed for ordering, storing, and handling controlled substances; and evaluated internal controls over the handling of controlled substances. In addition, MCFR's Medical Director was requested to provide evidence of compliance with the terms of her contract along with evidence of providing the required medical supervision for MCFR's EMS program. Finally, we interviewed the County Administrator's staff to evaluate the administrative support provided to MCFR in managing its EMS program. — 3 — Management of Controlled Substances To be able to perform life-saving measures when caring for patients being transported in either air or ground ambulances, licensed/certified MCFR staff(e.g., flight nurses,paramedics,EMTs)must have access to controlled substances. The ordering, receipting, storing, and handling of the narcotics that MCFR has on hand for patient care purposes must adhere to strict requirements as defined by the U.S. Department of Justice's Drug Enforcement Administration (DEA) and the State of Florida. The DEA, through the Federal Controlled Substances Act(CSA), has created a closed system of distribution for controlled substances. A licensed medical professional must register with the DEA to be authorized to handle controlled substances. The CSA requires DEA registrants to maintain complete and accurate records of all quantities of controlled substances manufactured, imported, exported, received, delivered, distributed, dispensed, or otherwise disposed. From these records, the DEA expects to be able to trace the flow of any drug from the time it is manufactured to where it is distributed (e.g., pharmacy, hospital, EMS provider, etc.) to the actual patient who received the drug. As required by Florida Statute Chapter 401 and 64J-1.004(3)(c), FAC,the BOCC contracts with a Medical Director to be a DEA registrant authorized to provide controlled substances to MCFR as an EMS provider. The Medical Director is required to formulate and ensure adherence to detailed written procedures for the purchase, storage, use, and accountability of the narcotics used by MCFR personnel as required by Florida Statute Chapter 499 and 893 and Rule 64J-1.021, FAC. As part of our audit, we reviewed the sufficiency and effectiveness of MCFR's controls over its inventory of controlled substances. What follows is the detail of our findings after performing audit procedures that: (1) evaluated MCFR's inventory reconciliation process; (2) reviewed MCFR's compliance with federal and state requirements for the receipting/storing/disposing of controlled substances; and (3) assessed the Medical Director's effectiveness in supervising and performing quality assurance for MCFR's ground and air ambulance operations. Reconciling and Managing Controlled Substances Inventory During the audit period June 2021 to July 2022,MCFR maintained Standard Operating Procedures (SOP) 703.061 Controlled Substances. The purpose of SOP 703.06 was to ensure the proper tracking and timely replacement of narcotics in MCFR's possession. Because there were allegations that the chief flight nurse pilfered drugs directly from MCFR's inventory by falsifying During the audit period,we relied on SOP 703.06 that were dated June 8,2021 and December 7,2021. — 4 — records, our primary focus was to review how the Trauma Star Program managed its controlled substance inventories. We also conducted a review of MCFR's ground ambulances handling of controlled substances. Chart 1 illustrates the flow for restocking narcotic inventories stored at MCFR's various locations at the fire stations and the Trauma Star's helicopters stations. Chart 1 Plow of Controlled Substances Inventory Trauma Star North Patient (TSN)Helicopter Trauma Star North (TSN)Supply Room Trauma Star South �"^ Patient (TSS)Helicopter Supply from DEA MCFR HQ/Logistics Authorized Vendor 'K,\\ \ Ground Ambulances located at 8 Fire - - Patient Stations During the audit period, MCFR relied on numerous paper-based inventory logs to track the drugs used at each location. Appendix I provides a list of the various logbooks maintained by each location to manage their respective controlled substances inventory. As an example of how the logbooks interplayed with each other,the TSN Supply Room maintained a log of daily physical counts of each narcotic. At each morning shift change the incoming and outgoing flight nurses would conduct the physical counts. The flight nurse on duty was expected to be in charge of the TSN Supply Room and log any movement of narcotics in or out of its inventory. To ensure narcotics that were leaving the TSN Supply Room were appropriately delivered to one of the helicopters,the Trauma Star flight crew(flight nurse and flight paramedic)maintained three paper-based inventory logbooks: (1) Log of Daily Physical Counts: logged the physical counts conducted at each morning shift change by the incoming and outgoing flight nurses. (2) Inventory Changes Log: logged the restocking or return of inventory between the TSN Supply Room and the helicopter. The flight nurse and the flight paramedic must sign for any change in inventory. (3) Administration Log: logged the administration of controlled substances during an incident. The attending flight nurse must sign as the person administering the drugs to the patient and the flight paramedic signs as the witness. — 5 — Further, the flight nurse or paramedic was required to record those drugs administered during an incident in the Patient Care Record (PCR) which is saved in MCFR's automated ESO Electronic Health Record system. The PCR should match the entries made in the Administration Log. While each inventory logbook served an important purpose for tracking and managing inventory, they also provided an unintended opportunity for misuse because of a lack of segregation of duties among staff. The staff responsible for managing the inventory at the TSN Supply Room were the same staff managing the inventory counts on each of the helicopters. This is a significant breach of controls. For the audit period,we verified whether the daily physical count for each narcotic could be traced to: (1) an authorized inventory change (e.g., restock of inventory; return of expired drugs); or (2) the administration of the narcotic by the flight crew.We also verified whether the amounts reported in an Administration Log agreed with the amounts recorded in the corresponding PCR. Our review found significant discrepancies existed between the restocking of inventory, the physical counts conducted, and the drugs recorded as administered to patients. As a result, it appears that a material amount of narcotics may have been diverted during the audit period as shown in Table 1. Table 1 Narcotics Missing From Inventory Logs Number of Estimated Narcotic Vials Volume Ativan 7 14 mg Versed 119 1190 mg Morphine 19 190 mg Dilaudid 242 484 mg Fentanyl 219 35000 mcg Ketamine 17 8500 ml Moreover, our review found that some of the discrepancies could be due to sloppiness in recordkeeping but in other instances the discrepancies appear to have been an attempt to conceal the diversion of drugs. Table 2 summarizes the discrepancies that likely involved the falsification of records. — 6 — Table 2 Summary of Discrepancies in Inventory Logs Controlled Substance Type of Discrepancy Ativan Versed Valium Morphine Dilaudid Fentanyl Ketamine Totals Administration Log Shows Drug Administered For Incident but PCR 2 21 0 0 17 37 1 78 Shows No Drugs Were Administered for Inicdent or PCR Did Not Exist Drugs Recorded as Administered on Administration Log Does Not Match 2 26 2 1 57 13 7 108 Drugs Recorded as Administered on PCR Discrepancies in Daily Physical Counts 0 49 0 10 84 91 12 246 Among Inventory Logs We reported the discrepancies we found during our review to appropriate law enforcement officials so they may conduct further investigation as deemed necessary. It is our understanding that law enforcement is continuing their investigations at the time of the release of this report. While each of the inventory logs serve an important purpose, MCFR did not have procedures in place that reconciled and reviewed the logs to ensure proper management of the controlled substance inventories. Appendix II provides four specific examples that demonstrate the sloppiness of staff's recordkeeping and the lack of review and reconciliation of the controlled substance inventory logs. The examples in Appendix II also demonstrate how existing procedures did not provide for proper separation of duties as evidenced by the following examples: • Flight crews were solely responsible for entering information into the logbooks as well as performing a cursory monthly review of those same logbooks to confirm that everything was in order. • Physical counts were conducted each morning by the incoming and outgoing flight nurses. However, because flight nurses work, at a minimum, 48-hour shifts, frequently the incoming and outgoing flight nurse was the same person. As a result,there were not always two people conducting the morning physical counts. • Flight crews were solely responsible for recording in both the Administration Log and the corresponding PCR the amount of drugs administered to a patient. There were no procedures in place requiring verification by an independent source that the information reported in the Administration Log matched the amount reported in the PCR. The lack of separation of duties provided opportunities to create confusion making it difficult to detect deficiencies in the inventory records. _ 7 — During our review of inventory records,we also found examples where the Trauma Star staff were not using older narcotics first as required by SOP 703.06. Specifically, these procedures direct the flight crew to make every attempt to rotate controlled medications according to their expiration date, "using the drug with the closest expiration date first." The lack of day-by-day reconciliation between the various MCFR controlled substances logs along with a lack of separation of duties likely created an opportunity for staff to divert drugs without detection. We recommend that MCFR require a monthly reconciliation between the logs to ensure: • Amounts of controlled substances being transferred out from Headquarters agree with the amounts of drugs being received at afield location, • Amounts listed as administered to patients agree with amounts reported as administered on the PCR; and • Controlled substance inventories are being properly rotated by using the drug with the closest expiration date first. Management Response: • Agreed. The recent addition of a chief officer to Trauma Star/EMS, along with a Firefighter/ Flight Paramedic, both now assigned to a 40-hour work week, will facilitate administrative oversight for controlled substance reconciliation of logs, and review amounts transferred and administered as recommended. • Reconciliation, audit procedures and frequency will be included on the expanded Controlled Substance SOP 703.06. • Upgrading from paper logs to an electronic platform allows real time viewing of Controlled Substance on hand, on the units as well as HQ. This has also streamlined the ordering and receiving process.Additionally,MCFR intends to continually evaluate the reconciliation and auditing procedures and enhance them as needed. • The electronic platform provides real-time viewing of expiration dates. The managing officers have the ability to easily identify and rotate expiring medications. This practice is still being evaluated from a risk-benefit standpoint. MCFR's intention is to have minimal movement of Controlled Substances as this creates a more difficult audit trail and may add more vulnerability to the system than the benefit of the cost savings. — g — Equally important, to ensure the proper segregation of duties, we recommend the reconciliation be performed by a MCFR staff person who does not have any involvement with replenishing or administering controlled substances. Management Response: • The institution of the chief officer and firefighter/flight medic assigned to manage the Trauma Star/EMS program will enable the administrative function required for reconciliation and will be an expectation outlined in the expanded Controlled Substance SOP 703.06. • Replenishment is not typically conducted by the Controlled Substance Officer, whose responsibility is reconciliation, upholding the separation of duties. • The growth of the Trauma Star/EMS division for MCFR will continue the review of additional staff positions to assist in implementing a greater separation between those performing any type of reconciliation and those replenishing or administering controlled substances. Finally,because the PCR report is key to performing a full reconciliation, it is imperative that staff be required to make it a priority to complete the PCR reports properly by the end of their 24-hour shift. This will allow the PCR reports to be finalized and approved so they can be effectively used as part of the reconciliation process. We found that sometimes it may take several days for staff to finalize and approve PCR reports. MCFR recently eliminated the TSN Supply Room and now requires any requests for restocking of inventories to be submitted directly to Headquarters. This change should significantly improve the management and tracking of the controlled substances inventories. Additionally, we recommend that Headquarters replenish the helicopters'inventories solely based on authorized and confirmable usage by requiring:(1)the replenishment request identify the specific incidents where drugs were administered, and (2) MCFR's Controlled Substances Officer confirm the request by reviewing the related PCR. Management Response: • The procedure for replenishing inventories on the helicopter is the same as the field rescue units. An administration form is completed,which requires the Firefighter/Flight Paramedic or Flight Nurse to identify the specific incident where the drugs were administered, the amount administered, and the amount wasted. • We agree that the Controlled Substance Officer will reconcile requests for replenishing inventories by reviewing each administration in relation to the PCRs through a monthly auditing process which will be included n the expanded Controlled Substance SOP 703.06. — 9 — MCFR recently transitioned from paper-based inventory logs to an automated inventory system using the Operative IQ software application. The automated inventory system is a cloud-based system which should significantly reduce intentional or unintentional errors in recordkeeping due to staff sloppiness and will also promote more prompt and accurate recording of changes to the narcotics' inventory. However, despite the recent automation of its inventory tracking capabilities, a formal and documented reconciliation should still be performed at least monthly by staff not involved in the handling of controlled substances. Ideally, MCFR should determine whether it would be possible to automate the reconciliation process between its Operative IQ system and its EOS Electronic Health Record system used for managing the PCR reports. We recommend MCFR contact its software vendors to discuss the feasibility of creating automated reports to support the reconciliation process. Management Response: • MCFR has recognized that the current electronic platform being utilized has limitations and the reporting is not as robust as expected. MCFR has identified a different electronic platform that will improve the reconciliation process and will generate the auditing reports as recommended. MCFR is in the process of procuring the management software and developing an implementation plan. Ordering, Receipting, Disposing, and Storing of Controlled Substances The CSA requires that complete and accurate records be kept of all quantities of controlled substances. From these records it should be possible to trace the flow of any drug from the time it is first imported or manufactured,through the distribution level,to the actual patient who received the drug. The mere existence of this requirement is meant to discourage diversion of drugs. It is also designed as an internal check for entities to uncover diversion,such as pilferage by employees. The CSA places all regulated controlled substances into one of five schedules as shown in A1212endix IIh. The placement in the schedule is based upon the narcotic's medical use,potential for abuse, and safety or dependence liability. To manage the movement of controlled substances, the DEA requires its registrants to maintain records showing the distribution of a controlled substance,whether the registrant is a retail supplier or a dispenser, such as MCFR. For Schedule I and 11 drugs (the highest level of control), a retail supplier must receive a completed DEA Form 222 from a DEA registrant. DEA Form 222 is issued by the DEA to individuals who are registered to handle Schedule I and II controlled substances. The form is preprinted with the name and 'As shown in Appendix III,MCFR's inventory includes Schedule II drugs(Morphine,Dilaudid,and Fentanvl); Schedule III drugs (Ketarnine);and Schedule IV drugs (Ativan,Versed,and Valium). 10 address to where the drugs must be shipped. The use of this form ensures that only authorized individuals may obtain Schedule I and II drugs. For drugs in Schedules III, IV, and V, no specific order form is needed, but both the supplier and the purchaser must still maintain records of all transactions involving these controlled substances and those records must contain specific information required by DEA regulation. The supplier is obligated to verify the authenticity of the customer. The supplier is held fully accountable for any drugs that are shipped to a purchaser who does not have a valid DEA registration. Any theft or significant loss of any controlled substance must be reported to the DEA, local law enforcement,and state regulatory agencies.Prompt notification to enforcement agencies will allow them to investigate the incident and prosecute those responsible for the diversion. If there is a question as to whether a theft has occurred or a loss is significant,the DEA expects that a registrant will err on the side of caution and report it to DEA and local law enforcement authorities. The DEA also prescribes the process for disposing of narcotics,whether the narcotic's package is damaged, the narcotic is expired, or the vial of a narcotic was not fully administered to a patient. This is to ensure the unused, unwanted, or expired controlled substance is disposed of in a secure, safe, and responsible manner. For example, the DEA has promulgated regulations that allow registrants to transfer controlled substances to authorized entities for disposal in a safe and effective manner consistent with effective controls against diversion. Ordering and Receipting of Controlled Substances. MCFR's Logistics Supervisor manages the inventory levels of narcotics kept on hand at Headquarters. If the Logistics Supervisor needs to reorder Schedule II drugs, an email is sent to the Medical Director who is the DEA registrant. The Medical Director completes the DEA 222 form which is then submitted to MCFR's retail supplier. Because the DEA does not require Schedule III and IV drugs to be ordered by the Medical Director, the Logistics Supervisor places an order directly to MCFR's retail supplier to replenish the Schedule III and IV inventories. All narcotics are shipped to MCFR Headquarters. The Logistics Supervisor is then responsible for receipting the inventory and entering the information into Headquarters' inventory records. Requests for inventory replenishments from the field (ground and air ambulances) are emailed to the MCFR's Controlled Substances Officer email group'. The Logistics Supervisor is expected to fill the request and arrange for a Logistics Assistant to transport the narcotics out to the field. Neither the Controlled Substances Officer nor the Logistics Supervisor is required to conduct a 3 The MCFR staff who receive an email that is sent to the Controlled Substances Officer email group include the Fire Chief,the Deputy Chief of Operations,the Division Chief of Fire Rescue Services,the Controlled Substances Officer, the Fire Rescue Battalion Chiefs,the Logistics Supervisor,the Logistics Assistants,and Fire Rescue Captains. 11 review of the necessity or reasonableness of the requested replenishment. Our review of the ordering and receipting of controlled substances also found that there is a lack of separation of duties for these critical steps. The Logistics Supervisor has been tasked with both ordering and receipting controlled substances especially with Schedule III and IV drugs. When we discussed our concerns with MCFR staff, they acknowledged that they were uncomfortable with the lack of segregation of duties and stated that they have repeatedly asked the Medical Director to assume responsibility for ordering all drugs needed by MCFR. According to staff, the Medical Director refused staff's request. This simple requirement would greatly strengthen internal controls over the ordering and receipting of controlled substances in addition to keeping the Medical Director directly apprised of the volume of controlled substances being used by MCFR staff. To ensure there is a proper segregation of duties in the ordering and receipting of controlled substances, we recommend. • Prior to replenishing inventory, the Controlled Substances Officer be required to review and confirm the reasonableness of the requests for replenishments of narcotic inventories by ground and air ambulances by comparing requests to the related PCRs; • The Medical Director be required to order all controlled substances needed by MCFR's EMS program, and • Two staff employees be designated to receive all ordered drugs and each staff employee confirms the receipt of the drugs by signing the packing slip. MCFR needs to ensure that staff assigned to receive delivered drugs are properly backed up in in the event of a staff employee's absence. Management Response: • Agreed. MCFR is in the process of expanding the Controlled Substance SOP 703.06. The administrative oversight for controlled substances, reconciliation of logs, and review of amounts transferred and administered would be completed in an audit. The Controlled Substance Officer will reconcile requests for replenishing inventories by reviewing each administration in relation to the PCRs through a monthly auditing process. This audit would be separate from the replenishment process (separation of duties). Replenishing an administered Controlled Substance on a field rescue unit is completed to maintain the unit's PAR levels as currently outlined in the Controlled Substance SOP 703.06. • Agreed. The Controlled Substances Officer gets approval from non-schedule II Controlled Substance orders from the Medical Director prior to the order being placed. Order confirmations are sent to the Medical Director for her records in addition to being uploaded 12 to the electronic platform. Schedule II Controlled Substances are ordered only by the Medical Director. • Controlled Substances are delivered via UPS or FED EX and are signed for by a single staff member,however the sealed box is not opened and is secured until the Controlled Substance Officer and a second staff member (witness) open the box, both sign the packing slip, the Controlled Substances are electronically received,control numbers are assigned and printed, each Controlled Substance is labeled and then placed into the biometric safe. One reason that there is not a proper separation of duties is because MCFR employees'job duties and responsibilities are not clearly defined. For example, a fire lieutenant paramedic has been given the assignment of Controlled Substances Officer but there is no detailed description on what is expected of the Controlled Substances Officer especially as it relates to managing controlled substances. Likewise, the Logistics Supervisor and the Logistics Assistant job titles do not have a detailed description of their respective responsibilities. We recommend that job descriptions be formally documented for the job titles that have responsibilities in managingMCFR's controlled substances. Management Response: • The current job descriptions for Division Chief Trauma Star/EMS, Battalion Response: Chief, Captain, Fire Rescue, Lieutenant, Fire Rescue, provide for the "management of the Controlled Substance policy, storage, orders, and records for all ALS apparatus and helicopters." MCFR agrees that the expectations need to be more detailed and expanded, and will be added to the Controlled Substance SOP 703.06. • Agreed. The job descriptions for the Logistics Supervisor and the Logistics Assistant will be updated to include similar language. • Agreed. An additional job description supplement for the Controlled Substance Officer will be created and will include specific duties and responsibilities of the primary and alternate Controlled Substance Officer positions. Disposal of Controlled Substances. MCFR's SOP 703.06 directs staff to use a red sharps container to dispose of wasted drugs, syringes, and vials as approved by the U.S. Food and Drug Administration (FDA). Red sharps containers are puncture-resistant, leak-proof, and labeled that the contents are hazardous. SOP 703.06 requires that when a controlled substance has been prepared but not administered to a patient, the quantity not administered must be drawn from any partially used vial and wasted (pushed from the syringe)into a red sharps container in the field. This procedure must be witnessed by another crew member. The emptied syringe must then be placed in the red sharps container 13 along with any empty controlled substance vial or syringe. The amount of wasted controlled substance must be recorded in the Administration Log and signed by the crew member who wasted the substance as well as the crew member who was the witness. Our review found that MCFR's logs recorded the amounts of narcotics wasted and required sign off by both the flight nurse wasting the substance and the flight paramedic witnessing the waste. However, while this documentation exists, our review also found that the logs documented an unusual and material amount of wasted drugs which should have raised suspicions among both MCFR Management and staff as well as being questioned by the Medical Director, had there been a proper review and reconciliation of the logs. For example, Table 3 shows the amount of Fentanyl administered and wasted by each Trauma Star flight crew member during the audit period as recorded in the administration logs. Table 3 Review of Administration and Waste of Fentanyl By Trauma Star Flight Crew For The Period June 2021 to July 2022 Percent of (a) (b) (c) Fentanyl Micrograms Micrograms Total Wasted to Flight of Fentanyl of Fentanyl Fentanyl Total Amount Crew Recorded As Recorded as Dispensed Dispensed Memberl Administered* Wasted* [ (a) +(b) ] [ (b) _ (c) ] 1 1,650 1,500 3,150 47.62% 2 3,275 1,825 5,100 35.78% 3 150 50 200 25.00% 4 1,675 1,125 2,800 40.18% 5 28,909 33,309 62,218 53.54% 6 1,800 1,550 3,350 46.27% 7 700 200 900 22.22% 8 3,300 3,000 6,300 47.62% 9 250 50 300 16.67 10 525 175 700 25.00% 11 2,125 750 2,875 26.09% 12 50 200 250 80.00% Totals 44,409 43,734 88,143 *The amounts recorded as administered and wasted were obtained from Trauma Star's Administration Logs 14 A substantial amount of waste may be reasonable in some situations. For example, in Table 3, Flight Crew Member 12 shows his waste was 80%of the total amount dispensed. However,taking a closer look at his situation, it appears he was attending a single incident where he administered 50 micrograms (mcg) of Fentanyl to a patient from a 250 mcg vial_ In other words, the flight crew member had to waste 200 mcg of the 250 mcg vial. Nevertheless, while there may be certain instances where substantial waste is unavoidable, a study of wasting of controlled substances has stated that, on average, 22.2% of drugs dispensed are waste.' Using the average of 22.2% of drugs dispensed are waste, Table 3 raises questions regarding the extraordinary waste by some flight crew members when compared to the amount of drugs administered. The material amount of waste suggests that the lack of oversight provided an opportunity to misuse the disposal process and created an opportunity to divert drugs for other purposes. We recommend that MCFR take the necessary steps to ensure that the Medical Director, at least on a monthly basis, conducts a review of the administration and waste of controlled substances by MCFR personnel to verify that amounts of administration and waste appear normal and consistent with the patient care being provided. Management Response: • In conjunction with the Controlled Substance Officer's audit, we agree that the Medical Director should also review narcotic administrations and confirm they are indicated and in line with current medical protocols. • The Chief of Trauma Star/EMS will conduct a Quality Assurance Process with the Medical Director on a monthly basis to address this recommendation. Expired/Damaged Controlled Substances. MCFR staff are expected to return any expired or damaged controlled substances to Headquarters. However, we found that there does not appear to be specific procedures for returning expired drugs and no strict controls over the handling of expired drugs once returned to Headquarters. Moreover, while there appears to be a general expectation that the Controlled Substances Officer should be taking the lead to manage and control expired or damaged controlled substances, this expectation is not formalized in an SOP. Staff indicated that expired drugs are returned to Headquarters but these expired drugs are kept on-hand at Headquarters for an indeterminate amount of time rather than being promptly returned to a DEA- authorized controlled substances destruction company. 4 Mankes RF, Silver CD: Quantitative study of controlled substance bedside wasting, disposal and evaluation of potential ecologic effects. Sci Total Environ.2013,444:298-310. 10.1016/j.scitotenv.2012.11.096 15 Similar to MCFR's SOP that provides guidance to staff that they should always try to first use the drugs closest to their expiration date, we recommend that MCFR develop an SOP for the handling of expired or damaged drugs including addressing how staff should: • Verify that all expired drugs that should be returned to Headquarters have been returned; • Inventory all expired or damaged drugs maintained by Headquarters on a regular basis to ensure full accountability; • Identify specific staff who should be responsible for handling and returning expired or damaged drugs; and • Establish time requirements for staff to return all expired drugs as required by the DEA. Management Response: SOP 703.06 (12/0 1/22) Controlled Substances, addresses handling of expiring medications. MCFR agrees and will include specific procedures for handling expired or damaged drugs as recommended to the additional job description supplement for the Controlled Substance Officer and alternate Controlled Substance Officer(As outlined in Response to Recommendation 46). Storing Controlled Substances. Federal regulations specify the physical security controls DEA registrants must maintain for storing narcotics. The DEA expects a registrant to maintain effective controls and procedures to guard against theft and diversion of controlled substances. At a minimum, MCFR is required to store its controlled substances in a securely locked, substantially constructed cabinet. Subsequent to the audit period, MCFR Headquarters acquired a safe with dual-controls which will improve security. The dual-control feature requires two individuals to be personally verified (e.g., enter personal identification number) before gaining access to the contents of the safe. The safe also sends emails to MCFR Management alerting them about who is accessing the safe and when. The safe is located in a room at Headquarters that also contains other sundry inventory items. The inventory room's door is solid wood and has a digital lock. However, on the two occasions when we observed the room during normal working hours we noted the door was kept unlocked and propped open. While there are cameras installed in the hallway outside the inventory room, there is no camera installed within the safe to record what the person may be taking from the safe. As a positive step for strengthening its inventory controls, MCFR Management recently changed 16 their SOP to eliminate the TSN Supply Room as a location for storing controlled substances. Now, if one of the helicopters needs a restock of controlled substances, the flight nurse must email the Controlled Substances Officer email group similar to the procedures followed by the ground ambulances. The Logistics Supervisor will then direct a Logistics Assistant to transport the needed drugs to the respective helicopter. However, no documentation is kept at Headquarters showing the successful delivery/hand-off of the drugs to the flight crew. While the elimination of the TSN Supply Room should improve controls and management of MCFR's narcotics, an audit trail is needed to document that the transfer of drugs to the helicopter occurred. The Logistics Assistant transporting the drugs should be required to have ground or air ambulance staff sign a receipt acknowledging that they physically received the controlled substances. We applaud MCFR for continuing to strengthen their security over controlled substances. In addition to the recent improvements that have been made, we recommend: • Installing a camera within the safe to monitor what is being removed from the safe; • Keeping the inventory room locked at all times and minimizing the number of staff who may access the room, and • Developing a form for the Logistics Assistant to use to formally acknowledge that the requested controlled substances were sent/received by MCFR staff. Likewise, the form should be used to acknowledge expired or damaged drugs were sent from the field to Headquarters. Management Response: • A camera has been added to the logistics room containing the safe to directly capture any individual accessing the safe. All activity on all cameras at MCFR is recorded by software managed by IT and maintained for 30 days in coordination with the Fire Chiefs Executive Administrator. Additional procedures are being established to ensure the recordings are archived for at least six months. This is a manual process completed by IT that will need to be requested each month. • The Controlled Substance Policy Section VI. Security will be updated to include language supporting a more stringent requirement that the logistics door is to be secured at all times. A sign has been placed on the room that contains the Controlled Substance safe requiring the door be closed and locked at all times. SOP 703.06 (12/01/22) Controlled Substances, VI. Inventory and Security, B.2. addresses controlled substance inventory "Check-Out Procedures" With the current electronic platform the required documentation is handwritten on the Record of Administration generated by the associated MCFR field unit, this form is then stored in the biometric safe. This manual process will be obsolete in the near future with the new and upgraded electronic platform. 17 Medical Director Role and Responsibilities To operate Monroe County's EMS operations, the BOCC must engage a Medical Director as required by Florida Statutes. Specifically, s. 401.23(16), F.S., defines Medical Director as "a physician who is employed or contracted by a licensee and who provides medical supervision, including appropriate quality assurance but not including administrative and managerial functions, for daily operations and training pursuant to this part." Since 1987,MCFR has relied on Professional Emergency Services, Inc., (PES)to provide medical direction for managing its EMS operations. Monroe County's contract with PES for Medical Director services is comprehensive and consistent with applicable statutes and administrative code. As stated in the PES contract, the Medical Director supervises and accepts "responsibility for the medical performance of all certified/licensed response personnel functioning within the scope of their official duties while on duty"with MCFR. The County's EMS operations rely heavily on the direction and supervision of its Medical Director to ensure the integrity of its EMS programs. The oversight provided by the Medical Director is an essential and statutorily-required component of the program. The Medical Director's required oversight includes,but is not limited to: (1)conducting audits of patient care reports to ensure staff are properly administering controlled substances to patients; (2) establishing a patient care quality assurance system to assess the medical performance of all certified/license MCFR response personnel including the establishment of a Quality Assurance Committee; (3) reviewing all protocol deviations and initiating or recommending corrective action including reviewing at least 40 patient care reports each month; and(4) acting as a patient advocate in the County's fire rescue system to ensure that all aspects of the EMS systems are developed to place the needs of the patient first. As part of our audit procedures, we sent a public records request to PES asking for documents to support that the Medical Director had fully complied with the terms of the contract during the audit period. While we did receive documents showing MCFR's SOPS and other work performed by the Medical Director,PES did not produce numerous requested types of substantive documentation to demonstrate that the Medical Director performed minimum levels of quality assurance as required by the contract. In response to our request, the Medical Director stated, ". . . MCFR disbanded the monthly Quality Assurance Committee meetings and the Medical Director relies on notification from MCFR personnel to open a medical quality review." In addition, we asked PES to provide patient care quality assurance audits or reviews conducted by the Medical Director or her designee during the audit period. The Medical Director could not provide any documentation showing patient care quality assurance audits were conducted. The Medical Director claimed that "such reviews are in the possession of MCFR, not the Medical 18 Director." However, when we requested this information from MCFR, we were told that the Medical Director did not provide MCFR these types of documents. We also requested PES provide us with the quarterly status reports that the Medical Director was required to prepare for the Fire Chief. Specifically, Section 4.11.8 of PES' contract requires the Medical Director to "document in a quarterly status report to the Fire Chief, evidence of issues identified with MCFR personnel, and communicating with hospital emergency department staff." The Medical Director stated that the quarterly reports were verbally provided to the Fire Chief. However, MCFR Management advised us that the Medical Director provided neither verbal nor written quarterly reports as required. During our discussions with MCFR Management, they appeared frustrated with the lack of cooperation from the Medical Director despite their repeated efforts requesting the Medical Director provide clearer and more comprehensive communication to MCFR Management. In addition, MCFR expressed concerns that it was not clear the Medical Director was adequately fulfilling all contractual requirements. Following the discovery of discrepancies in the controlled substances inventory at the end of July 2022, MCFR Management rightfully began to raise questions about the performance of the Medical Director's supervision of the medical performance of EMS staff. This is evidenced by an August 9 h letter formally notifying PES it needed to "strengthen its performance with the terms of the Contract with Monroe County BOCCBOG." The letter, as shown in Appendix IV, outlines the sections of the PES' contract with the BOCC that requires action and specific measures for compliance by the Medical Director. MCFR Management sent a follow-up letter to PES on September 15, 2022 (see At�r�er�dix Ii�) stating MCFR's expectations for requiring PES to begin to formally report the Medical Director's activities including: (1) activities the Medical Director performed on behalf of MCFR for the past month; (2) a list of patient care reports reviewed by incident number; and (3) a list of individuals the Medical Director spoke with and for what purposes over the past month. Finally, on September 20, 2022, the former Fire Chief sent a final letter to PES stating that the letter served as notice that PES "complies and is in good standing with the terms of its Contract . " (see Appendix IV). It is noteworthy that the September 20'h letter did not copy other MCFR Management team members or the County Attorney's Office like the other memos. Since this letter was in direct contradiction of the previous letters sent,we attempted to reach out to the former Fire Chief to gain an understanding as to why he sent this letter. Unfortunately, we were unable to obtain confirmation from the former Fire Chief regarding the contradictory communications. Since we were unable to conduct any follow-up with the former Fire Chief, we reviewed the documentation the Medical Director provided us and found that the documentation does not provide sufficient evidence that the Medical Director is now in compliance with the terms of the 19 contract. For example, no documentation exists to evaluate the extent of the Medical Director's involvement in reviewing patient care records nor does documentation exist to support that the Medical Director was in full compliance with the contract deliverables. Rather, the material diversion of controlled substances by MCFR staff suggests that, at a minimum, the quality assurance system set up by the Medical Director for MCFR is ineffective. It appears that the Medical Director relied heavily on staff, particularly the former Chief Flight Nurse, to perform audits of patient care records. While statutes and provisions within the contract do allow the Medical Director to delegate the quality assurance review and audit of patient care records, the Medical Director still has the overriding responsibility to provide oversight to ensure that the responsible staff were properly performing the audit function. The sloppiness of MCFR's inventory records and that these records oftentimes did not match the narcotics logged in the patient care records, are evidence that the Medical Director was not even performing minimal oversight. The letters sent on August 9 h and September 15'h to PES clearly demonstrate MCFR Management's frustration with PES' contract performance. We remain puzzled by the September 20'h letter from the former Fire Chief. Given the materiality of the apparent diversion of controlled substances that occurred under PES' medical direction and the available evidence suggesting the Medical Director has failed to meet the minimum requirements of PES' contract with the BOCC, we recommend thatMonroe County conduct an immediate and comprehensive review of PES' contract to determine whether PES has fulfilled the terms, understandings and covenants of the contract. Monroe County should consider all available options to ensure that MCFR is provided with competent, reliable, and responsive medical direction. Management Response: The Deputy Chief of Operations will be responsible to conduct the recommended review, in coordination the Chief of Trauma Star/EMS and will report the findings directly to the Fire Chief. If it is determined that it is in the best interest of Monroe County to continue the contract with PES, we strongly recommended that MCFR revise standard operating procedures to require the Medical Director to: • Lead a quality assurance committee that will provide for quality assurance review of all emergency medical technicians and paramedics operating under his or her supervision; • Conduct assessments of MCFR new employees at their nine-month evaluation period and provide MCFR Management written review of the assessment performed, 20 • Perform a review of at least 40 patient care reports each month and require a review of all trauma-related incidents and provide MCFR Management a written summary of the reviews conducted which must include a list of the patient care reports reviewed by incident number, and • Follow MCFR's established chain of command for all communications including providing prompt responses directly to MCFR Management when MCFR Management makes inquiries to the Medical Director. Management Response: • These requirements are contained in the Contract between the Monroe County Board of County Commissioners and the Board of Governors of Fire and Ambulance District 1 and Professional Emergency Services,Inc. for Medical Director for Monroe County Fire Rescue. MCFR will expand the contract to include more specific expectations to improve the quality assurance review process. • The recent addition of the chief officer and firefighter/flight medic assigned to manage the Trauma Star/EMS program will help expand and manage the Quality Assurance process, the Medical Director is a key component to this review process and will need to be directly involved in providing oversight for this expanded Quality Assurance program. PES has provided Medical Director services to Monroe County for over three decades.While there was competitive solicitation conducted for these services over a decade ago, Monroe County has opted to use a provision within its purchasing policy which does not require a competitive process for the renewal of PES' contract. In other words, because the Medical Director is providing professional medical services, County staff chose to recommend to the BOCC to simply renew the contract rather than perform a competitive solicitation to confirm that the best qualified organization is providing these critical services. The County's Purchasing Office, within the Office of Management and Budget (OMB), is responsible for governing the County's procurement process. According to OMB, if a County department needs to procure professional services, it is within the department manager's purview not to conduct a competitive solicitation. OMB indicated that they do not get involved in a department's decision-making process. However, when asked about the solicitation process they followed for acquiring medical director services, MCFR Management told us they followed the guidance provided by OMB. It appears that departments are not provided guidance on how to evaluate whether it is in the best interest of the County to perform a competitive solicitation for professional services. The County's 21 current purchasing policy is being interpreted by staff to not require an evaluation whether it is in the County's best interest to perform a competitive solicitation when procuring professional services.As a result,it is not uncommon for departments to use the same professional for numerous years without any formal evaluation of the professional's performance. When the term of a contract is nearing its end, OMB does not reach out to departments to advise them on how to evaluate whether a consultant or contractor is sufficiently meeting their contractual obligations. If County departments were trained on what they should be reviewing and what questions they should be asking,the evaluation could be used as a key determiner as to whether or not a department should or should not forego a competitive solicitation when the consultant's contract is up for renewal or re-negotiation. Because of the lack of centralized controls over contract management, MCFR was not provided the tools or resources by County Administration to critically evaluate the Medical Director's performance when MCFR is faced with entering into a new contract for these services. We recommend Monroe County's purchasing policy be revised to require departments to complete a performance evaluation of a consultant or contractor before entering into a contract renewal. Renewals must be contingent upon a satisfactory performance evaluation. Management Response: • Creating an evaluation would provide more specific expectations, clear performance benchmarks and would serve to document compliance with the outlined expectations. • MCFR will discuss recommendations with the director of Purchasing for Monroe County. — 22 — County Management of EMS Programs MCFR Management was proactive upon learning of the anonymous tip about a possible diversion of drugs. They understood the serious nature of the accusation and the potential risk to the public's safety if these allegations proved true.MCFR Management alerted County Administration because MCFR Management knew they would need to work closely with County Administration's professionals to navigate how to handle the situation in the best interest of the County and its citizens. As part of our audit procedures, we reviewed whether MCFR Management was provided the appropriate support, resources, and tools from County Administration to properly react to and address the unfortunate situation they were facing. We evaluated whether the County's current policies,procedures, and oversight were sufficient to promote the prevention of drug diversion;to encourage a drug free workplace; and to provide administrative support and resources for properly handling such difficult personnel matters. We found that County's management team was not prepared to provide the support that was needed because there were no organization-wide efforts to prevent and detect drug diversion. Prevention and Detection of Drug Diversion The illegal distribution or use of prescription drugs, also known as drug diversion, is a risk in any work environment that handles controlled substances. Employers are expected to be aware of these risks and take appropriate preventive and detective measures to keep their employees safe and the controlled substances secure. Drug diversion can happen in a variety of ways. In the case of a health care professional, such as a nurse, the scheme to divert drugs may be as simple as stealing discarded syringes or vials or illegally altering medical records documenting the administration of drugs. We studied authoritative guidance in the field for developing preventive and detective workplace measures for drug diversion. This guidance indicates that the best practice is for an employer to be proactive and have all disciplines — county management, human resources, and fire rescue professionals -work together to prevent and detect diversion. This may include such measures as: • Training and educating everyone about the scope of controlled substance diversion in healthcare and how to recognize signs and symptoms of drug diversion. • Conducting a thorough risk assessment to identify and regularly evaluate the organization's strengths and weaknesses for receipting, transporting, handling, and storing of controlled substances. 23 • Promoting a healthy workplace environment including ensuring staff are not overworked and are given appropriate outlets to deal with work-related trauma and stress. • Creating a culture that encourages staff to immediately report to management if they observe possible diversion of drugs. It is important that an interdisciplinary approach be taken for preventing and detecting drug diversion to ensure that there is a proper separation of duties. While MCFR Management is the front-line manager for the day-to-day responsibilities for handling of controlled substances,MCFR may be too close to the daily activities of responding to emergencies to objectively raise concerns at an early stage. County management's role should be to continually monitor key indicators and immediately question MCFR Management if warning flags begin appearing. As part of our audit procedures, we found that Monroe County does not have a formal program to monitor for drug diversion. Further, as evidenced by the interviews conducted by the Sheriff's investigators, staff are not trained, encouraged, or made aware of how or to whom to report if they suspect drug diversion. This is especially true if they suspect it is their supervisor who is involved in the diversion. Because County management was not familiar with the best practices for handling drug diversion, County Administration struggled to figure out what steps should have been taken to handle the situation with the chief flight nurse. Guidance is readily available that gives an organization a blueprint to monitor for diversion. For instance, the North Carolina Healthcare Association (NCHA) published a guidebook that details different types of indicators that should raise warning flags for managements As an example, the guidebook lists behavioral indicators in employees that should be monitored such as: • Frequently volunteers to work extra shifts. • Frequently spills or wastes narcotics; excessive or unexplained breakage of narcotics vials. • Excessive amounts of time spent near a drug supply. • Interpersonal relations with colleagues, staff and patients are adversely impacted. Rarely admits errors or accepts blame for errors or oversights. • Sloppy recordkeeping. • Uncharacteristic deterioration of handwriting and charting. • Wearing long sleeves when inappropriate. • Always administering the maximum amount of pain meds. The interviews of MCFR employees by the Sheriff's investigators revealed that the chief flight nurse had for months exhibited warning signs that she could be diverting drugs and possibly North Carolina Healthcare Association, "Controlled Substances Diversion Prograin Structure",July 2018,page 3. 24 experiencing a substance abuse disorder. These interviews clearly revealed that staff did not have the support structure within county government that reassured them they were safe to report their suspicions that there were signs of drug diversion. Had County Administration worked with human resources and fire rescue professionals to implement basic drug diversion preventive and detective measures, they likely would have been alerted years ago that they should have kept a close eye on the activities of the chief flight nurse. A review of the chief flight nurse's work schedule clearly shows that questions should have been raised by County Administration regarding her overtime hours and her lack of use of vacation hours especially since her job required her to work with controlled substances. Table 4 Calendar Year 2021 Gross Pay and Hours Worked By Chief Flight Nurse 2021 Pay Description Gross Pay Hours Regular Pay 67,193.13 1,972.00 Overtime 1,235.52 36.00 Premium Overtime 108,869.99 2,078.50 Holiday Pay 3,668.48 108.00 Vacation - - Sick Leave - - $ 180,967.12 4,194.50 Base Pay Annualized: $71,386 Of Gross Pay to Base Pay 253.51% As shown in Table 4 and in more detail in Appendix V, after becoming the chief flight nurse in January 2018, this employee's overtime grew to an alarming amount. The amount she earned in overtime always exceeded her base pay. By the end of calendar year 2021, she grossed 1.5 times more in overtime pay than her base pay. The hours she worked without taking vacation time also raises concerns given that the employee had responsibility for managing controlled substances. As provided in Monroe County's Personnel Policies and Procedures Manual (PPPM), as approved by the BOCC, it is the responsibility of County Administration to provide needed administrative support to County departments. County Administration, through its Department of Employee Services, should be providing regular guidance including monitoring tools and formal training and educational programs on the topic of drug diversion for all of the County's managers. 25 We recommend: • Require Employee Services to work with MCFR supervisors and staff to develop a formal training and education program on recognizing drug diversion. The program should require staff to attend drug diversion prevention and detection training on an annual basis. • Require the Medical Director to immediately conduct a thorough risk assessment of how MCFR receipts, transports, handles, and stores controlled substances. This risk assessment should establish policies and procedures that will ensure that there are proper separation of duties as well as proper security over controlled substances at all times. • Require Employee Services to work with MCFR Management and staff to develop formal policies and procedures to ensure staff are not working extensive overtime and that they are given resources to deal with work-related trauma and stress. • Require Employee Services to develop formal policies and procedures that encourage staff to immediately "say something if they see something"as it relates to the diversion of drugs. Management Response: • In addition to the current drug-free awareness program, MCFR agrees that the addition of a drug diversion prevention and detection training program would be proactive and beneficial for MCFR staff. • A risk assessment would be beneficial after the new Controlled Substance policies and job descriptions are created and implemented, with a review annually for any needed changes. • MCFR recently implemented a Peer Support Team to assist personnel with work related stress and trauma. • MCFR agrees with the establishment of a formal policy and procedure to report a drug diversion suspicion, this process should include a way to report anonymously. • MCFR will discuss these recommendations with the director of Employee Services for Monroe County. 26 Drug-Free Workplace Program Federal and state laws and regulations require public employers like Monroe County to establish a Drug-Free Workplace Program. The Florida State Legislature expects a public employer to promote a drug-free workplace and discourage drug abuse. Also, as a recipient of federal grants, Monroe County must comply with the Federal Drug-Free Workplace Act which requires Federal agency contractors and grantees to certify that they will provide a drug-free workplace as a pre- condition of receiving a contract or a federal grant as detailed by Federal regulations. Our audit included reviewing Monroe County's Drug-Free Workplace Policy and Work Rules published under Administrative Instruction 4703.111 (dated January 1, 2019) and we were able to confirm that it is consistent with federal and state requirements. Administrative Instruction 4703.111 is the guidance MCFR Management and County Administration relied on when responding to the allegations made against the MCFR's flight crew. Employee Services advised us that they were contacted by the former Fire Chief around 5 pm on July 25 h regarding MCFR's concerns about the chief flight nurse. At that time, the former Fire Chief advised Employee Services that he suspected the chief flight nurse may have been stealing narcotics and requested Employee Services approve an immediate drug test for the chief flight nurse. However, according to Employee Services,Employee Services could not find an authorized health care provider to conduct an afterhours drug test so no drug test was administered. Section D, Part 3.0 of Administrative Instruction 4703.111 states, "The County will terminate any employee who has a positive, confirmed drug test." Because County Administration failed to conduct a drug test when MCFR Management was reasonably suspicious that the chief flight nurse was using illegal drugs, she continued to serve as the chief flight nurse potentially putting the public's safety at risk. When asked if other MCFR employees were tested once the situation with the chief flight nurse was discovered, County management indicated that they did not have a reasonable suspicion that other MCFR employees had colluded with the chief flight nurse, so they had no basis under Administrative Instruction 4703.111 for conducting drug tests. It was explained to us that Administrative Instruction 4703.111 only allows the County to drug test an employee if there is a "reasonable suspicion" which requires "an objective indicator" to be present before a test can be conducted. Employee Services confirmed that they did not conduct a job-related investigation to determine the scope of the problem that MCFR could be facing. Employee Services explained that since the chief flight nurse had readily admitted to wrongdoing, County management did not believe there was anything further to investigate. However, it appears that because Employee Services did not 27 perform an internal investigation,the County was unable to assess whether there was a reasonable suspicion that other MCFR employees were involved with the chief flight nurse's inappropriate handling of drugs. This lack of follow-up is concerning. It is important for an employer to conduct an internal investigation so the employer understands the facts surrounding the alleged misconduct. A prompt and timely internal investigation is important to: • Establish the full scope of the problem; • Identify if any corrective action is needed; • Avoid problems or issues from escalating if they are not handled in a timely manner; • Conduct a risk assessment of the potential impact that the alleged allegation may have on the employer, its employees, and/or the general public; and • Evaluate if any federal or state rules or regulations were violated and/or need to be reported. Employee Services expressed concern that if they conducted an internal investigation that they could potentially be interfering with the Sheriff's investigation. However, the objective of a criminal investigation differs from the objective of an employer's internal investigation. Best practice is that even if law enforcement has been alerted to possible criminal misconduct, human resources professionals should still conduct an internal investigation to determine the facts so employers are able to address the problem and take any needed corrective action. We asked Employee Services why MCFR personnel are not subject to random drug tests under Administrative Instruction 4703.111. Section 9.0 of Monroe County's policy defines a "safety- sensitive"position as "a position in which a drug or alcohol impairment constitutes an immediate and direct threat to public health and safety, such as a position that requires the employee to carry a firearm, perform life-threatening procedures, work with confidential information or documents pertaining to criminal investigations, or work with controlled substances; a position subject to Section 110.1127, Florida Statutes; or a position in which a momentary lapse in attention could result in the injury or death to another person." A flight nurse clearly meets several of these requirements. In response, Employee Services stated that Monroe County has no formal policy or procedure requiring random drug tests for these special risk positions. Currently, the only mandatory testing is for the County's Commercial Driver License (CDL) drivers as required by the Florida Department of Transportation. The County Attorney's Office further explained that the Collective — 28 — Bargaining Agreement (CBA) between Monroe County and the International Association of Firefighters Local 3909 (IAFF) is silent on requiring random drug testing by covered employees. It is not uncommon for public employers to successfully negotiate random employee drug testing as part of the CBA. Specifically, Section D, Part 1.5 of Administrative Instruction 4703.111 states: 1.5 Random Testing for Safety-Sensitive or Special Risk Employees: Safety-sensitive and special-risk employees are subject to random testing as determined by the County.Random testing shall be conducted via an unbiased selection procedure, and in accordance with drug-testing rules adopted by the Agency for Health Care Administration and the Department of Labor and Employment Security. Random testing shall be subject to collective bargaining, and shall not be conducted for employees covered by such agreements unless expressly included in the agreement. MCFR Management has indicated that they are very supportive of entering into a memorandum of understanding with the IAFF to require random drug testing of MCFR employees. As required by s. 440.102(13)(b), F.S., drug free workplace program requirements are a mandatory topic of negotiations. We recommend: • Employee Services make arrangements with available health care providers to ensure managers are able to conduct random drug tests any day at any time if a reasonable suspicion exists. This will allow County Administration to know immediately if a reasonably suspicious employee is using illegal drugs and allow management to take swift and appropriate action. • Employee Services work with the IAFF to amend the current CBA so county employees in special-risk positions can be randomly drug tested during their employment with Monroe County. • Employee Services and MCFR Management request the Medical Director to immediately issue a Medical Directive requiring all MCFR EMS employees to be subject to random drug tests as allowed by Administrative Instruction 4703.111. • To ensure that the public's safety is placed at the highest priority,Employee Services take immediate action to conduct internal investigations when there is reasonable suspicion of drug use within a department. This will allow County Administration to gain an understanding of the scope of the problem the County is facing and take immediate corrective action. 29 • Require Employee Services provide more constructive and effective annual drug awareness training for employees. Management Response: • Employee services has contracts with health care providers for 24/7 drug testing, however geography and time to travel does present some challenges. • Collective bargaining would be required for the implementation of random drug testing, the agreement does not expire until September 30, 2024. • MCFR will discuss recommendations with the director of Employee Services for Monroe County and the executive board of IAFF Local 3909. • Employee Services does conduct internal investigations where reasonable suspicion is present, however during this occurrence, a law enforcement investigation was already underway, and the County did not want to impede the law enforcement investigation. • Agreed. An updated and more constructive and effective drug awareness training would be beneficial to employees. 30 Appendix I Listing of MCFR Controlled Substances Inventory Logs 31 List of MCFR Inventory Logbooks Location Inventory Log Description Controlled Substances Log Log of any additions or subtractions from HQ s controlled substances inventories MCFR HQ/Logistics Outdated/Damaged Log of expired or damaged controlled Controlled Substances Log substances returned to HQ/Logistics or removed for destruction Log of Daily Physical Log of physical counts conducted at each Count morning shift change by the incoming and outgoing nurses Log of inventory taken to/from TSN Inventory Change to/from Supply room to/from a helicopter. The TSN Supply Room Helicopter flight nurse and the flight paramedic must sign for any change to inventory Log of inventory taken to/from TSN Inventory Changes to/from Supply room to/from MCFR Logistics HQ/Logistics. The flight nurse and the transporter must sign for any change to inventory Log of Daily Physical Log of physical counts conducted at each Count morning shift change by the incoming and outgoing nurses Log of restocking or return of inventory between the TSN Supply Room and the Each Air and Inventory Changes Log helicopter. The flight nurse and the flight Ground Ambulance paramedic must sign for any change in inventory Log of controlled substances during an incident. The attending flight nurse must Administration Log sign as the person administering the drugs to the patient and the flight paramedic signs as the witness 32 Appendix II Examples of Inventory Record-Keeping 33 Following are four examples of the typical inventory recordkeeping of controlled substances by MCFR's Trauma Star flight crews. Example l: The Chief Flight Nurse sent the weekly Monday morning email on August 9, 2021 requesting an inventory restock of 4 vials of Dilaudid, 15 vials of Fentanyl, 5 vials of Versed, and 1 vial of Ativan for the Trauma Star North (TSN) Supply Room as shown in Illustration 1. Because of a nationwide narcotic shortage, the restock was delayed until Headquarters could replenish its on- hand inventory. After receiving a delayed shipment of drugs from its vendor on August 12'', Headquarters physically transferred inventory to the TSN Supply Room on Saturday, August 141' (see Illustration 3). Example 1—Illustration 1 Email from Chief Flight Nurse to Headquarters Request to Restock Fentanyl for TSN Supply Room From: r�.ski-�.Ynd:+ To: a ` n CC: :E;Ieaw k Subject: TSN narcotics order Date: Monday,August 9,2021 7:06:29 AM Please find the narcotic c)rder for TS N.This order is fore 2 weeks, as no narcotics were delivered. Drug On Hand Need Fentanyl (20) 5 15 Dilaudid (10) 6 4 Versed (10) 5 5 Ativan (10) g 1 Ketamine (10) 10 0 The morning physical count conducted on August 14, 2021 by the incoming and outgoing flight nurses recorded having on-hand 9 vials of Ativan, 5 vials of Versed, 2 vials of Dilaudid, 1 vial of Fentanyl, and 10 vials of Ketamine at the TSN Supply Room (see Illustration 2). 34 Example 1—Illustration 2 TSN Supply Room Monthly Controlled Substance Log August 14,2021 Morning Physical Count by Incoming and Outgoing Flight Nurse _.............. ! ........ ... . . .......... ......_ ._ ------_.-- _. Off' TKY CO T"B OT.,LE SUBS- ANCE i_OG TRAUMA s,rAR VIEMCAL SUPPLY ROOM August 2021 0AYC I rot mAT4YAN V8SA81„"p VA4adf1P aIw3ATYdINK..., CLAAflWfid .i'F',NTANYL KET Y?G.AwStl1T NUa,# WGNATVM NN O t Illustration 3 is the entry in the Headquarters' Monthly Controlled Substance Log recording that on August 14, 2021, Headquarters transferred 2 vials of Dilaudid, 18 vials of Fentanyl, and 5 vials of Versed to the TSN Supply Room. Example 1—Illustration 3 Headquarters' Monthly Controlled Substances Log August 14,2021 Entry Showing Restock Request To TSN Supply Room FRHEADQUARTERS CONTROLLED SUBSTANCE LOB Ak, —Log may not contain more than orre year— ANvm nita"d ranAMI Ketamlrm Mwphine vamum Ver"d Tlfanepal'lef 2mg, 2mg 1mg 200 mg 10M9 10mg 2mg JA# print na4e U41T§.... IN 0 .,. Iw °. .. . 43!alY9. ...CiamNroea QuaMkks IMQuaflabar. Seal# .. ....�....�.»-._...,w. e y IH., ,. _ ,. ... _.... .,. .,_.., Cbr Un Un Un r Uri Un Urt 81gn $ign IFame H Wad IN bUY Naila IH U0J1' H IN UUY Haflln auT hand 2 ..-2—..1.0 SNAmdA Aca�kt ..m room brw- -33 ROM While Headquarters' inventory records clearly show 2 vials of Dilaudid, 18 vials of Fentanyl, and 5 vials of Versed being transferred to the TSN Supply Room on August 14'', the TSN Supply Room recorded receiving 2 vials of Dilaudid, 17 vials of Fentanyl, and 6 vials of Versed on this date as shown in Illustration 4. 35 Example 1—Illustration 4 TSN Supply Room Inventory Changes—To and From Logistics August 14,2021 Entry of Drugs Received From Headquarters MONTHLY CONTROLLED SUBSTANCELOG August 2021 CU TRAUMA STAR E=AL SUN PLY ROOM INVENTORY lk-A G S - To and fiorn f.o ostics ARiv m W✓eraeti r ur 47k.rR i NG m�taaP YreU a i � Misla r rVru uataxca { ¢Pok u9a�apeliat r uk�a tln Raiaa ra tl �tCC'.va tlarauxarima�cR^ POd_..F....R@B b._RVlrIF C RGA ..Sem Cimm RP&W4C asta R0a. ......... ;V,I rq amrm l k ------------- To determine whether the discrepancies between the Headquarters' log and the TSN Supply Room's inventory change log was due to sloppiness or possible diversion, we traced the subsequent entries made in other TSN Supply Room inventory logs and the helicopters' inventory logs for the same date to verify the accuracy of the next morning's physical inventory count. Illustrations 5 and 6 show the morning physical inventory counts of drugs for both helicopters. Example 1—Illustration 5 TSN Helicopter Monthly Controlled Substance Log—August 14 Morning Physical Inventory Count by Incoming/Outgoing Flight Nurses *74 aar�arnwe arrvax �Rsea au.aurno vewr auwe Rtovwr wuRae ��. f � aY7-t-6z. N- ( 12 aFtz /0-�2Z 4 Cz) (.zz f-1-Z-2 Gi�)537 iz ( !t-zz 3. .zg tz1 5" C' S Z 21,L a Iz-i-2Z 111I C3ii ZZ Oro e cptfU (" 'F � fb '1 Z, ; t`(�LL ° z3 Zt 2 qf2 .'� 5 Z Zvi(Z as 36 Example 1—Illustration 6 TSS Helicopter Monthly Controlled Substance Log—August 14 Morning Physical Inventory Count by Incoming/Outgoing Flight Nurses PI 4rA alb Q�, I fA PY r d.f " l41 R,, . t 7 h ny {Jt l{r n _._ _. ..... ...................... rAl" ANV VENgFp VA4ANM (YdAUiU1IY PENTANYL K&'TA-0 FUGW NUN9E HAT 0, rr• ti 7 �r.,,� �. .L,. Ski' - "��`a�s`"5 aa-- 7-40 On August 14, 2021, the TSN Supply Room's Inventory Changes To and From Helicopter Log documents that 2 vials of Fentanyl were transferred to the TSN helicopter for Incident 3584 and 1 vial of Fentanyl was transferred to the TSS helicopter for Incident 3585. Illustration 7 shows the entries recorded in the TSN Supply Room's Inventory Changes Log and Illustrations 8 and 9 show corresponding entries in each helicopter's Inventory Change Log. Example 1—Illustration 7 TSN Supply Room Inventory Changes—To Helicopter August 14,2021 Entries �.. MONTHLY O TROI T ETA UBs"r N CE N,.0 G August 2021 .................. 4 4 onfinuued Page 2 ARivan . Vef,,:d••••• Valk"',... ATauvp4.,w P,[,,,adil 4'cinUarro V F UGH1 NURSE' PARA.140.k:N31iC Data Ti—1 WCezeseore _ d^C¢^Ua Awa6aAc' p"4 td 111H WITNESS is rja U '.......PN pYt U"w u,i�_� arU A r _vU r i ar.a v, ouUw 'NiG�,cewaxarbre Nw,aamCNTe ....--- ` 51 .... ilk I-- 37 Example 1—Illustration 8 TSN Helicopter Inventory Changes 2 Vials of Fentanyl Received From TSN Supply Room August 14,2021 Entries for Incident 3584 w. � 2;:r2/. INVENTORY CHANGES To atiid FI•oImt t.�l�la� �tooni • AkYwan Versed Valium Morphlav 6B¢tlauffl 1 Fentanyl PI Id IqT NUMB PARAMEDIC P I WefTinve 6 IC nn K+etamine ,H# Hii WITNESS 1fNtt} 0441'1' Ra OUr Ch oUT 6N OUT P, M i EN frYu-w tN �o-ut i 5�i,�dtad&re Signature W i 3'�SCE (2� 0 a 0 e 14 ' 4 0 c 3 - <a r 4Z r a 176 ° .. m *. ° Example 1—Illustration 9 TSS Helicopter Inventory Changes 1 Vial of Fentanyl Received From TSN Supply Room August 14,2021 Entries for Incident 3585 wPpd 6.._A _....._...LJ�___.._._.__.__.__...._......._......_..............._._._. IN VENTORY CHANGES To and Froln Supply Room Ativan Versed Valium =needid Fentanp9 F1,IC'6:YITtlVpBa"'E PARATotEIk►C,m aDGM 9N (;a. , QbtJ'N" oltP y...IN � otlT IN .�ne ,_ WITN$"1 Vtata7"A e a Kemmm ' ;,, la".P ueignatnru5 S rieatnre -AT ". ' 5 1 ,... . a cb Cr " d ... W , O > , C c' e _ 0J i 38 Next, we verified that there was a corresponding entry made in each of the helicopter's Administration Logs to ensure drugs were administered to patients for the listed incidents. Illustrations 10 and 11 show the entries made in the Administration Logs for August 14, 2021. The TSN Administration Log shows flight staff reported administering 2-250 microgram (mcg) vials of Fentanyl for incident 3584 (300 mcg administered and 200 mcg wasted). The TSS Administration Log shows flight staff reported administering 1-250 mcg vial of Fentanyl for incident 3585 (administered 50 mcg and wasting 200 mcg). Example 1—Illustration 10 TSN Helicopter Administration Log-August 14,2021 Entry for Incident 3584 L ':," 'ri, , L ,,, 1 ?i k Pacoq it Dwe ba uIi .,,. .... 4 c a n V Ple A4#an'oini pe"redl ,.. Witness Tune CKA r w_'... _,�D ZZO 0 a tfC1 R50 345 . 3 ..�_. 1W NOd 9 351 . . .. r sel> s _ Z el 39 Example 1—Illustration 11 TSS Helicopter Administration Log-August 14,2021 Entry for Incident 3585 IR M, A u cy ix,;i/1)2,1 I Kounme Adn"�inflsevzed Wkness Dare Afivm Wrscd V"�Iu": Tiznc OCA Jo g( .......... fA- MCFR Management stated that the Patient Care Report (PCR) should be considered an accurate record of drugs administered by MCFR staff for an incident. Therefore, we next reviewed the corresponding PCR for Incidents 3584 and 3585 to verify that flight staff reported the same amounts being administered in these records. Illustrations 12 and 13 show the entries in the PCR for each incident. Example 1—Illustration 12 TSN Helicopter Patient Care Record for Incident 3584 incident incident Treatment Treatment Provider Dose Measure Medical Control Number Date Unit Shift Name Time 8/14/2021 TS2 B-Shift Fentanyl 15:55:00 PUSINOWSKI, 100 Micrograms(mcg) Protocol(Standing LYNDA order) 3/14/2021 TS2 B-Shift Fentanyl 16:00:00 RUSINOWSKI, 50 Micrograms(mcg) Protocol(Standing LYNDA Order) 8/14/2021 TS2 B-Shift Fentanyl 16:25:00 RUSINOWSKI, 100 Micrograms(mcg) Protocol(Standing LYNDA order) — 40 — Example 1—Illustration 13 TSS Helicopter Patient Care Record for Incident 3585 Incident Incident Treatment Treatment Number pate Unit Shift Name TiITTe Provider (lose Pleasure Medical Control i 8/14/2021 TS3 B3-Shift Fentanyl 16:38:00 MENDEZ,ROY 50 Micrograms(mcg) Protocol(Standing Carder We did not note any issue with the information recorded for Incident 3585. However,we did note an issue for incident 3584. As Illustrations 10 and 12 show, a discrepancy exists between the TSN Administration Log and the PCR. The flight nurse recorded using 2-250 mcg vials of Fentanyl for Incident 3584 by administering 300 mcg and wasting 200 mcg. However, in the PCR the flight nurse recorded administering 1-250 mcg vial of Fentanyl to the patient for Incident 3584.We noted the discrepancy between these two records as a possible diversion of 1 vial of Fentanyl. Based on the activity on August 14'', our last step was to review the physical inventory counts on the morning of August 15'h to verify that the inventory counts match the activity that occurred. Illustrations 14, 15 and 16 show what was recorded as the physical inventory counts on the morning of August 15, 2021 by the incoming and outgoing flight nurses. Example 1—Illustration 14 Monthly Controlled Substance Log-TSN Supply Room Physical Inventory Count for Morning of August 15,2021 !�! "'W — __.... ._......_ ._....._....w_ ............._—_. .... MON'T'liLY CONTROLLED SUBSTANCE LOG august 2021 -1 DATEITIME ATIVAN VERSED VALRW MOM-HINE DLALDID FENTANYL KETAMINE FLIGHT MAM SIONATUYRE to Az5q)z - _� 41 Example 1—Illustration 15 Monthly Controlled Substance Log-TSN Helicopter Physical Inventory Count for Morning of August 15,2021 m�� I' U rvug �I% �.�Ika aIIL��� 70"rfrr,r��%lEld�,�l_;, ,�, �,V,°�, 1i fd,Yy i r, a. DArEmme ArWM VEWSEb VALIUM MOWPKINS DILAUDID I'SNTANVL KSTAMINS F41£#WT NtYN'Sfl SM14ATURP qW{ c1 �2Z3+ 27 Example 1—Illustration 16 Monthly Controlled Substance Log-TSS Helicopter Physical Inventory Count for Morning of August 15,2021 Y v�AnlnwII�� IfifrtfG�V �6mW rtirof(uw rmi(✓�a�(rtr e,r w�rF „� ....»._.. ..... ........... .......... " i r 01 EI. f,) rEI rlr �ir�,,,e( ��< Jf .'Jig f i ..ill �, lF Cho. ^U 1f ER U rdrq➢rr�rC�?f ,DgYN'�YYwYW� `ATWAN t�F.R,&SD YAUrUM MONN"WYNL' OKAUMD FSRTANYL KSTAMIWS' FUQNR NURSE IMGNA"t x x x 4rtKidpf4IMNYM9t9M :54 y x cnwxv.NN xexaxr�rnE U✓ P' 6�,�` �` '� C° � 9`+" � `�" °� k�y W}FJ 51 �,,. '�""""��' �,�,,. �f?AY�d'r{z"1 ^-�".. Table 5 summarizes the activity MCFR staff recorded for each drug on August 14, 2021 to calculate what the August 15, 2021 expected morning physical count should be. This expected inventory count was compared to the actual physical inventory count conducted and found that there was a possible diversion of 2 vials of Fentanyl and 1 vial of Dilaudid. It also looks like the recordkeeping for Versed was inaccurate which may be due to sloppiness. 42 Table 5 Tracking of Inventory Changes August 14,2021 Through August 15,2021 As Recorded in the MCFR Inventory Log Books Recorded 8/14/21 8/14/21 Calculated 8/15/21 Morning Administered 8/14/21 8/14/21 8/15/21 Morning Discrepancy Inventory Controlled Physical or Inventory Inventory Inventory Physical In Inventory Location Substance Count Wasted' In Out Count2 Count' Count Ativan: 0 N/A 0 0 0 0 0 Dilaudid: 2 N/A 0 (2) 0 0 0 Fentanyl: 103 N/A 0 (18) 85 85 0 Headquarters Ketamine: 16 N/A 0 0 16 16 0 Morphine: 0 N/A 0 0 0 0 0 Valium: 0 N/A 0 0 0 0 0 Versed: 38 N/A 0 (5) 33 33 0 Ativan: 9 N/A 0 0 9 9 0 Dilaudid: 2 N/A 2 0 4 3 (1) TSN Supply Fentanyl: 1 N/A 18 (3) 16 15 (1) Room Ketamine: 10 N/A 0 0 10 10 0 Morphine: 0 N/A 0 0 0 0 0 Valium: 0 N/A 0 0 0 0 0 Versed: 5 N/A 5 0 10 11 1 Ativan: 5 0 0 0 5 5 0 Dilaudid: 5 0 0 0 5 5 0 TSN Fentanyl: 5 (1) 2 0 6 5 (1) Helicopter Ketamine: 2 0 0 0 2 2 0 Morphine: 0 0 0 0 0 0 0 Valium: 0 0 0 0 0 0 0 Versed: 5 0 0 0 5 5 0 Ativan: 5 0 0 0 5 5 0 Dilaudid: 5 0 0 0 5 5 0 TSS Fentanyl: 5 (1) 1 0 5 5 0 Helicopter Ketamine: 2 0 0 0 2 2 0 Morphine: 0 0 0 0 0 0 0 Valium: 0 0 0 0 0 0 0 Versed: 5 0 0 0 5 5 0 NOTES: 1The amount recorded as administered or wasted is based on the information recorded by MCFR staff in the Patient Care Report 2The Calculated Inventory Count for August 15,2021 takes the August 14,2021 inventory count then adds the amount of each drug that was recorded as being transferred in and subtracts the amount of each drug being recorded as transferred out,administered or wasted on August 14,2021. 3The Recorded 8/15/2021 Morning Physical Count is the amount reported as counted as being on hand in each respective location's Monthly Controlled Substance Log.For Headquarters,this amount is the amount recorded after transferring inventory to the TSN Supply Room on August 14,2021. 43 Example 2: The morning physical inventory count conducted on March 23, 2022 at the TSN Supply Room by the incoming and outgoing flight nurses recorded on-hand supplies of 26 vials of Ativan, 19 vials of Versed, 17 vials of Dilaudid, 26 vials of Fentanyl, and 10 vials of Ketamine (see Illustration 17). Example 2—Illustration 17 TSN Supply Room Monthly Controlled Substance Log March 23,2022 Morning Physical Count by Incoming and Outgoing Flight Nurse yrr;; MONTHLY CONTROLLED SUBSTANCE LOG TRAUMA STAR MEDICAL SUPPLY ROOM Match 2tl2g DATEITOE ATIVAN VERSED VALUM NDRP'NINE MAU= FENTANYL KETAFNNE PLIGHT NURSE SIGNATURE RN 1r , �• 1' ! Gr36•: , 411 73 C! 3.3M x r a,ro.wrew,. cmagw, We reviewed the changes to the TSN Supply Room's inventory by reviewing the inventory change logs on March 23rd for the TSN Supply Room. There were no entries in the TSN Supply Room showing the receipt of any inventory from Headquarters. Illustration 18 shows the entries made for all inventory changes on March 23, 2022. As Illustration 18 shows,the TSN Supply Room transferred drugs to the TSS helicopter on March 23, 2022 for the following incidents: • Incident 1428: 1 vial of Versed, 2 vials of Dilaudid, and 3 vials of Fentanyl. • Incident 1433: 3 vials of Dilaudid and 3 vials of Fentanyl. 44 Example 2—Illustration 18 TSN Supply Room Inventory Changes Log To Helicopters March 23,2022 MONTHLY CONTROLLED SUBSTANCE LOG � TRAUMA STAR MEDICAL SUPPLY ROOM PVf_r h 0 2 Continued Page 3 Aaavaun 'Varwd A sVVnm "ad upadnour is I fd I Y n¢.prorl 4 d OG.Mk&'C [tl L'kHd:, tl'A9@A.�dl@,IdBi7 F ^/B`dma^ Rem on _ _ _ y kw..a uunu rpm 14N 8d 911 N w p h....P"4's Ctk 11f'M1` -MN VDM`P` '.m 0�+ 8FX_"0� 14 .dam I I f II Y 4 ¢nV 0 y+. Op "G .....`fiky,CYapIGd l" f ZV - � .._ ....._.. . - 2 r, 13 To confirm that staff properly updated the TSS helicopter inventory records for the March 23rd inventory activity,we first looked at the helicopter's physical inventory counts for March 23,2022. Illustration 19 shows the March 23rd morning physical inventory count of drugs for the TSS helicopter. Example 2—Illustration 19 TSS Helicopter Monthly Controlled Substance Log—March 23,2022 Morning Physical Inventory Count by Incoming/Outgoing Flight Nurses %WN DATE ITWE 0.TIVAN VENSEO -UN MPflPNUIE FW6NTNUR4E 410NATIINE NNN "3pi &i'ra_t7a z-1-Z3 �` r.a3 C.�_2� '�i-3r-22- 5 5 5 2z W Sac2 f tdsaLh f7to�oY L. oo.at3 2 `�(i zap, ,-Foltz x3 (4)0-i 27 5 r z3 S 3r z 45 We confirmed that there was no recorded activity for the TSN helicopter for March 23. Next, we reviewed the inventory changes recorded for March 23, 2022 for the TSS helicopter. Illustrations 20 and 21 show the entries recorded in the TSS Inventory Changes log for replenishing for Incident 1428 and 1433. Example 2—Illustration 20 TSS Helicopter Inventory Change Log Received From TSN Supply Room for Incidents 1428 on March 23,2022 r, INVENTORY CHANGES i17 f "cl and FrCtlrl;��� 1 I1oo A,tiwan Versed Vallam Morphine pine Dilao.udid rentangl ...... .. .......PARAMEDIC ." l FLIGHT NURSE PAII�LIv113DIC itIONIZE/ P7 mo Raw" 1Kntamum Fi# kl#I WITNESS ��� ... .. ..wa .„... ,Pm,�,. .... ._..... , __.., _. . % ONI is I IPA" dlul C,1tV1' j IJ ; 72't Otrf IN OUT IN OUT W '(7UT SM�M�141te� Signature // rq s MIMIC lo Ell AV IN l /.._. -7 i � l a� f r � er g � ' PA 46 Example 2—Illustration 21 TSS Helicopter Inventory Change Log Received From TSN Supply Room for Incidents 1433 on March 23,2022 pp L. .., ,., _..... _...._.__. ,...._. ._,.. _ ...... .... .. __ _ _._..... ___ .......... INVENTORY CHANGE,S (,'gn(k,ued Page 2 / To and.From Supply Room kMv Versed Vahum � Morphine Difaudid rer�k Byl FIICtEThJCPItwF PARAMEDIC[ �Cetemanc k#iP l i% %. "., a�„ i�a .asr yr "%.ayia ra�r uvirc ' in Guar itv:f 4trc tore 6KK pmtrare As Illustrations 20 and 21 show, the TSS helicopter shows the helicopter recorded the receipt of the following drugs form the TSN Supply Room transferred drugs for the March 23rd incidents: • Incident 1428: 1 vial of Versed, 2 vials of Dilaudid, and 3 vials of Fentanyl. • Incident 1433: 2 vials of Dilaudid and 3 vials of Fentanyl. Next, we reviewed the Administration Log for the TSS Helicopter for each March 23rd incident to identify what the flight crew reported as the drugs administered to the patients. Illustration 22 shows the entries made in the TSS helicopter's Administration log for March 23, 2022. 47 Example 2—Illustration 22 TSS Helicopter Administration Log for Incidents 1428 and 1433 on March 23,2022 I _.... ... ..... _. _..,.. _.M .M....._.. III V�f Il W.e €[ 's�al��ni v1 f r t,l :i,_ F�.I ryiri� it fiY't¢.r4ka^u°4'uf ... V✓IY11 c,s.. ,., .�... ...b .... .. .w ... ..._.., �,.. ........ &' 'i�sru,uaw+✓�° bus 4X;afiea6'w• Tim", OC,A dp �dtl ' 47J 1(4 � t � � .. _ � 2 c � (� MIX Paz �►~'�� to m I °► �Jfi We also reviewed the PCR for each incident as shown in Illustrations 23 and 24. Example 2—Illustration 23 TSS Helicopter Patient Care Record for Incident 1428 Incident Incident 7reatrraerrt Treatinerit Number pate Unit slritt Name Time Provider Dose Measure Medical Control �r Y 3/23/2022 TS2 A-Shift Fentanyl 14:49:00 RUSINOW SKI, IlCC Micrograms(m�¢�� �rataeal(�Iandirg LYNDA d�rder) fltUSINOW+US�I„ 3/23/2022 T52 A-Shift Fe Caryl I5.20:¢1¢1 75 Micrograms(mcg) Protocol(standing LYNDA Order) 3/23/2022 TS2 A-Shift Fentanyl 35;40:00 RUSINOWTMPSIKI„ 50 Micrograms(mcg) Protocol(Standing LYNDA Order) 48 Example 2—Illustration 24 TSS Helicopter Patient Care Record for Incident 1433 Incident Incident .... Name Time Unit Shaft Treatment Treatment Number Date Unit Dose Measure Medical control . Ir" 3/23/2022 TS2 A-Shrift Fentanyl 21:30:00 RUSINOWSKI, 100 Micrograms(mcg) Protocol(Standing LYNDA carder) 3/23/2022 TS2 A-Shift Dilaudid 21:43:00 RUSINOWSKI, 1 MiHigrarns(mg) Protocol(Standing LYN 6i Jrde }} We noted discrepancies between the TSS Administration Log and the PCR for both Incidents 1428 and 1433. For Incident 1428,the flight nurse recorded in the PCR that she administered 3-100 mcg vials of Fentanyl. However, her entry in the TSS Administration Log recorded she administered 3-100 mcg vials of Fentanyl and 1 vial of Versed in addition to wasting 1 vial of Dilaudid. For Incident 1433, the flight nurse recorded in the PCR that she administered 1-100 mcg vial of Fentanyl and 1 vial of Dilaudid. Her entry in the TSS Administration Log indicates she administered 1 vial of Dilaudid and 3-100 mcg vials of Fentanyl for Incident 1433. Based on the activity on March 23rd, our last step was to review the physical inventory counts on the morning of March 24,2022 to verify that the inventory counts match the activity that occurred. Illustrations 25 and 26 show what was recorded as the physical inventory counts on the morning of March 24, 2022 by the incoming and outgoing flight nurses. There was no activity on either March 23rd or March 24th to the TSN helicopter. Example 2—Illustration 25 Monthly Controlled Substance Log-TSN Supply Room Physical Inventory Count for Morning of March 24,2022 MONTHLY CONTROLLED SUBSTANCE LOG TRAUMA STAR MEDICAL SUPPLY ROOM March 2022 p DATE I-W! j ATlVAN M... 114LLI11 D14AUM FENTANYL NET..6 FLIGHT NURSE SIGNATURE RN K 000 1'7 _......_..-... .- L 5 Z ., 01� 10) c I. 3, x °1. 3 a s d lral4 23 1L>.f17 �.z1 49 Example 2—Illustration 26 Monthly Controlled Substance Log—TSS Helicopter Physical Inventory Count for Morning of March 24,2022 DATE I TIME ATIVAN VERSED VALUM MORPHINE OILAUDR) FENTANYL KETAMINE FLUGHTNURSE SIGNATURE RNO """"' uevmry 4nw xn wumnp R Nu ~I 1 Z..3 �-r-31'22- U 'c 4 -z3 !' - q3375*(. IF I owpmoanmwr rules¢ aw.+,r II[NM IC NH99 Y Y N Y i ✓f Y Y OY1%M'C ��, NS W'rtrmwq u ea NwrtiE ,d1✓ 1 1pabh'L�1 1`p4.w3o L'� L G4..t�Z3 �-l''LJ J"��`�' G- ��i Gr 2� c (04"o to-(,e3 c712 p =1 Table 6 takes all the activity MCFR staff recorded for each drug on March 23, 2022 to calculate what the March 24, 2022 expected morning physical count should be. This expected inventory count was compared to the actual physical inventory count conducted and found that there was a possible diversion of 3 vials of Dilaudid, 2 vials of Fentanyl, and 2 vials of Versed. 50 Table 6 Tracking of Inventory Changes March 23,2022 Through March 24,2022 As Recorded in the MCFR Inventory Log Books Recorded 3/23/22 3/23/22 Calculated 3/24/22 Morning Administered 3/23/22 3/23/22 3/24/22 Morning Discrepancy Inventory Controlled Physical or Inventory Inventory Inventory Physical In Inventory Location Substance Count Wasted' In Out Count2 Count Count Ativan: 26 N/A 0 0 26 26 0 Dilaudid: 17 N/A 0 (5) 12 12 0 TSN Supply Fentanyl: 26 N/A 0 (6) 20 20 0 Ketamine: 10 N/A 0 0 10 10 0 Room Morphine: 0 N/A 0 0 0 0 0 Valium: 0 N/A 0 0 0 0 0 Versed: 19 N/A 0 (1) 18 17 (1) Ativan: 5 0 0 0 5 5 0 Dilaudid: 5 0 0 0 5 5 0 TSN Fentanyl: 5 0 0 0 5 5 0 Helicopter Ketamine: 2 0 0 0 2 2 0 Morphine: 0 0 0 0 0 0 0 Valium: 0 0 0 0 0 0 0 Versed: 5 0 0 0 5 5 0 Ativan: 5 0 0 0 5 5 0 Dilaudid: 5 (1) 4 0 8 5 (3) TSS Fentanyl: 5 (4) 6 0 7 5 (2) Helicopter Ketamine: 2 0 0 0 2 2 0 Morphine: 0 0 0 0 0 0 0 Valium: 0 0 0 0 0 0 0 Versed: 5 0 1 0 6 5 (1) NOTES: 1The amount recorded as administered or wasted is based on the information recorded by MCFR staff in the Patient Care Report. 2The Calculated Inventory Count for March 24,2022 takes the March 23,2022 inventory count then adds the amount of each drug that was recorded as being transferred in and subtracts the amount of each drug being recorded as transferred out,administered or wasted on March 23,2022. - Sl ti Example 3: The morning physical count conducted on May 19, 2022, by the incoming and outgoing flight nurses recorded on-hand supplies of 19 vials of Ativan, 19 vials of Versed, 14 vials of Dilaudid, 13 vials of Fentanyl, and 10 vials of Ketamine at the TSN Supply Room (see Illustration 27). Example 3—Illustration 27 TSN Supply Room Monthly Controlled Substance Log May 19,2022 Morning Physical Count by Incoming and Outgoing Flight Nurse 77 W')NI1i T C01 TII GI� TII� ,I ST III'gUI L".CC t Offir May 2022 . ......... ......... ...... ... __. w .... ._._....__..���.____ DATE./'TIME, ATIVAN VERSED VALIUM MORRNINE DILAUDID FENTANVL KETAMINE FUGI4T NURSE: SIGNATURE RNM �.. .. �°"�"h �?'.. wdr.C�J u°nva "^'y0 �v dr" ' t•2' ���" ' !, �y" ..... �." J. r A �✓ � C a L ' r . .. 6 11 cad C "�� f� ' ... ---------------- We also reviewed the morning physical counts for May 19' for both helicopters as shown in Illustrations 28 and 29. 52 Example 3—Illustration 28 TSN Helicopter Monthly Controlled Substance Log May 19,2022 Morning Physical Count by Incoming and Outgoing Flight Nurse .... ...... __.._ ._ .... _. - ___.... ......... __.. _.._.. DAF/YII1W A7I1IF1 VII"f"sr'D VAILIIUM IAt/Itf^I{IIV I':: IfflAUDIO IflIU7 -L IIL IFlrntlW- fl lral i"I'ldUI4SE SIGNATURE ItPv if M 9 „t y .. r 50/ ... " ✓ F l fw "�110%G„ kJ Y�,`,, c r .......__ .� �@ . Example 3—Illustration 29 TSN Helicopter Monthly Controlled Substance Log May 19,2022 Morning Physical Count by Incoming and Outgoing Flight Nurse --------------------- .. DAAL/TTP11, ATIVAIV VLfx:��Lfl VAaL€UMh M()Itk rVlNf: f./rf."I.1 f111} I N'Y':: AUv k'L RI 4AIVIfp�lp'_ II..I MY IrPPI/.l p:. SIGNATURE g �a IT 3) tm 30-w 04 ,2 rayto AA rl d ,' r., 1 ,✓ ;P l,F"Y 'z,t ��p P1 R(7 F a Me ...., ' _ ._ � .� F .> ... .. e ..X,� „ ... t i �faa t r "^!> "` 1..T r .>�a� 7 r"t`, any ;• z ..m Mw � r r l x 15 53 We reviewed the changes to the TSN Supply Room's inventory by reviewing the inventory change logs on May 19th for the TSN Supply Room. There were no entries in the TSN Supply Room showing the receipt of any inventory from Headquarters. Illustration 30 shows the entries made for all inventory changes on May 19, 2022 from the TSN Supply Room. As Illustration 30 shows, the TSN Supply Room transferred 2 vials of Fentanyl to the TSN helicopter on May 19'. It is difficult to read the incident number associated with this entry but it likely is Incident 2314 given the date and other incident numbers during this time. This would also coincide with the entry made in TSN's Inventory Change Log for Incident 2314 showing the receipt of 2 vials of Fentanyl from the TSN Supply Room on May 19, 2022 (see Illustration 31). TSS helicopter did not record any inventory changes for this date. Example 3—Illustration 30 TSN Supply Room Inventory Changes Log to Helicopters May 19,2022 TWO 1"FILY CON 110U ! SU !!IS I fi t: III„.0G l Q' t'y 2 W2 L.?... iiaf if niiIIu II'kv.l.�.�::`.�llu�'� : .., Ua , , A , "I,.., '.., i o f i f ,( I f f f ., XF� / : ... r .. U�.. ... ,...� �, .... ....,w._. ...� �. v... ... .......... .wA Example 3—Illustration 31 TSN Helicopter Inventory Changes Log from TSN Supply Room May 19,2022 INVENTORY ('11ANGES ............ ................, _...., ..,...,,,.__ :d "", 'vff'd(� A'itM Y0a ;b"it' int eil'ktdid II Q�Yi Rtll41 �G rQuG"`C"k�ICSJI'. I J�it r G}.r,',t•tYi PMP 6.4CbFX4YQ H N H 4 /µ( f k 411 k A Ott I u a e" C F r " I IY 54 Next, we reviewed the Administration Log for the TSN Helicopter for May 19'h to identify what the flight crew reported as the drugs administered to the patients. Illustration 32 shows the entries made in the TSN helicopter's Administration log for May 19, 2022. Example 3—Illustration 32 TSN Helicopter Administration Log ... ......... ......... I V Cr ..... . ...... .. ._..."..R ., .. . .. As Illustration 32 shows, there is only one incident dated May 19'h which is Incident 2314 that administered 2-100 mcg vials of Fentanyl (administered 150 mcg and wasted 50 mcg). We also reviewed the PCR for Incident 2314 but, as shown in Illustrations 33, the PCR does not show that Trauma Star responded to an Incident 2314 on May 19, 2022. Example 3—Illustration 33 TSN Helicopter Trauma Star Patient Care Records for the Date Range May 18,2022 through May 20,2022 Incident Incident Treatment Treatment . Number Date Unit Shift Name Thne provider Dose Measure Medical Control i t / 5/I8/2022 TS3 C-Shift Fentanyl 22:50:00 RUSINOWSKI, 50 Micrograms(mcg) Protocol(Standing LYNDA order) 5/18/2022 TS3 C-Shift Fentanyl 23:20:00 JUIZ,CANLDICE 50 Micrograms(rncg) Protocol(Standing Order y i / y l 5/20/2022 TSI A-Shaft Fentanyl 5:02:00 PU'SINOWSKI, 50 Micrograms(mcg) Protocol(Standing LYNIDA Order 3�7�i �fffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffff 5/20/2022 TS2 B-Shift aDilaudid I Milligrams(mg) 5/20/2022 TS2 E-Shift Ativan I Milligrams(mg) 5/20/2022 TS3 B-Shift Fentany9 100 Micrograms(,mcg) 5/20/2022 r208 B3-Shift Fentanyl 19:42:00 PEgEZ,HAROLBD 100 Micrograms(mcg) Protocol(Standing Order) 5/20/2022 TS3 S-Shift Dilaudid 21:07:00 LEAL CONCEFCION„ I hlillagrams(mg) Protocol(Standing YANET Order) Since Incident 2314 is not recorded on the PCR, it is a possible false incident that could have led to the diversion of drugs. 55 Based on the activity on May 19'', our last step was to review the physical inventory counts on the morning of May 20, 2022 to verify that the inventory counts match the activity that occurred. Illustrations 34, 35, and 36 show what was recorded as the physical inventory counts on the morning of May 20, 2022 by the incoming and outgoing flight nurses. Example 3—Illustration 34 Monthly Controlled Substance Log-TSN Supply Room Physical Inventory Count for Morning of May 20,2022 ONT'1 L. CNTIIiCtll[J Al) SUBS °' U,=- SLOG i May 2222 _.._. _.._.. _....... ------ _.._.._.. v._._.. ...... ............. .......__ . ......... _. ........ DATE/TIAv7E A"RIWAN VERSED VAUUP.7 MORPHINE DIGAUDID FENTANVI Ki TAWNF. FLIGHT NURSE SIGNATURE RN tR �x q mt.'7 M y.. rr t tip` „S � . �� ✓c ✓ t'1� _ era- �!�, � � �, � � � , �� � ���,. ,✓.�" ✓✓ m r °�✓ a F �)ad,t L M ��' lb 2— n (7 a. �wu " �_ C R. J w1 — 56 — Example 3—Illustration 35 Monthly Controlled Substance Log—TSN Helicopter Physical Inventory Count for Morning of May 20,2022 t _...... _. ........ —__e ............._._..................... . ._. .... . LATI/I'%Ak'i ANV.AN Vl Ils1D VF.IIRAM M01 fLld"IAIdVi.. W:1"i,fvNPd6,: FL.I CxIVI Ibl M�4'�. SIGNATURE [LAI.k Lx16,1 IYI'd N d „yq N k y r `.1 1/9 r -------------- 7,7 M r L r r" ,�,� r /'� NC�,,� a°,ry �1 V C��„ (I� �r ���'l " "�()�..✓ 57 Example 3—Illustration 36 Monthly Controlled Substance Log—TSS Helicopter Physical Inventory Count for Morning of May 20,2022 I FFA'I`k NYL JU-Y'WA1Hl. F.li"rl P5t¢HSE SIGNATURE .°xsrri irrrc.rm. A rvvnia v�.vr,dran vn r�a,ri�re wirwuarv+raum� i,xu.ntrir�ira 11410 -30 �� q � ��,.R x 7 3 2 a y _.__`� �. _ ()'7415 . , � ' � ✓ % ;ter �� �� ,,� , n fi ". F fi;I -„ 1 c r .... —� ---a, 3 .� X g � 0. a "B !, a e tap 2— .L 4 ry m m n a tl � w WpW,f L �.. .............. _ ..___.w.._._ ...._.w.. w wwww Y TA Table 7 takes all the activity MCFR staff recorded for each drug on May 19, 2022 to calculate what the May 20,2022 expected morning physical count should be. This expected inventory count was compared to the actual physical inventory count conducted and found that there was a possible diversion of 4 vials of Dilaudid and 3 vials of Fentanyl. 58 Table 7 Tracking of Inventory Changes May 19,2022 Through May 20,2022 As Recorded in the MCFR Inventory Log Books Recorded 5/19/22 5/19/22 Calculated 5/20/22 Morning Administered 5/19/22 5/19/22 5/20/22 Morning Discrepancy Inventory Controlled Physical or Inventory Inventory Inventory Physical In Inventory Location Substance Count Wasted' In Out Count2 Count Count Ativan: 19 N/A 0 0 19 19 0 Dilaudid: 14 N/A 0 0 14 12 (2) TSN Supply Fentanyl: 13 N/A 0 (2) 11 10 (1) Room Ketamine: 10 N/A 0 0 10 10 0 Morphine: 0 N/A 0 0 0 0 0 Valium: 0 N/A 0 0 0 0 0 Versed: 19 N/A 0 0 19 19 0 Ativan: 5 0 0 0 5 5 0 Dilaudid: 5 0 2 0 7 5 (2) TSN Fentanyl: 5 0 2 0 7 5 (2) Helicopter Ketamine: 2 0 0 0 2 2 0 Morphine: 0 0 0 0 0 0 0 Valium: 0 0 0 0 0 0 0 Versed: 5 0 0 0 5 5 0 Ativan: 5 0 0 0 5 5 0 Dilaudid: 5 0 0 0 5 5 0 TSS Fentanyl: 5 0 0 0 5 5 0 Helicopter Ketamine: 2 0 0 0 2 2 0 Morphine: 0 0 0 0 0 0 0 Valium: 0 0 0 0 0 0 0 Versed: 5 0 0 0 5 5 0 NOTES: 1The amount recorded as administered or wasted is based on the information recorded by MCFR staff in the Patient Care Report. 2The Calculated Inventory Count for May 20,2022 takes the May 19,2022 inventory count then adds the amount of each drug that was recorded as being transferred in and subtracts the amount of each drug being recorded as transferred out,administered or wasted on May 19,2022. - 59 - Example 4: The morning physical count conducted on May 2,2022 by the incoming and outgoing flight nurses recorded on-hand supplies of 20 vials of Ativan, 16 vials of Versed, 13 vials of Dilaudid, 12 vials of Fentanyl, and 10 vials of Ketamine at the TSN Supply Room (see Illustration 37). Example 4—Illustration 37 TSN Supply Room Monthly Controlled Substance Log May 2,2022 Morning Physical Count by Incoming and Outgoing Flight Nurse 17 �WU i III IIII.D DDIP'F III D01 1 6D SUBSTANCE L.mD � "�`II'NA0.w➢MA STAR IIAII II;NIICAy SUUPIIFILY N°BO(AV i 0.1 May 2022 ......... ......... ... ____. ......_..e................................................................................ ................_..... ...._..,,.w............,..�..,..., .................. ...... HRN q 1'iSE.................... ........ ._....,................................ DATE C TIME ATIVAN VERSED VAL➢UM MORPHINE; UILLAAUUDW FENTANVL KET'AMINfi { SIGNATURE � J I ff t✓r� �, L y7 e After the morning physical count,the flight nurse sent an email to Headquarters reporting different numbers than were on the morning physical count. The flight nurse requested a restock of Fentanyl, Dilaudid, and Versed in the email as shown in Illustration 38. Example 4—Illustration 38 May 2,2022 Email from On-Duty Flight Nurse to Headquarters for Inventory Restock From: McKaige-Heydi To: CantralVed ��bstao7ceOtfj, E Subject: TS North Supply Room Narcotic Order Date: Monday,May 2,2022 7:25:14 AM Der n Hanel, Need Fentanyl (30) 16 14 Dilaudid (20) 13 07 Versed (20) 16 04 Ativan (10) 20 0 Ketamine (10) 10 0 60 Illustration 39 is the entry in the Headquarters' Monthly Controlled Substance Log recording that on May 2, 2022, Headquarters transferred 7 vials of Dilaudid, 14 vials of Fentanyl, and 4 vials of Versed to the TSN Supply Room. Example 4—Illustration 39 Headquarters' Monthly Controlled Substances Log August 14,2021 Entry Showing Restock Request To TSN Supply Room ... MCFR HEADQUARTERS COWROLLED SUBSTANCE LOG **Log ma y IIwt contain rrrrare than one yerar- AHven Dilaudid Feekanyk Kafiamine morpidne Vellum Versed Added or Pulted!?lTans r 2mg 2mg img 200 mg 10ang iomg 2mg JA# Pried .......... _ ._ ........ .____.........__.... .........__ ... ..,_...... ............................_.__._, oaks Ouanauea, .. ......Ouarlms. Ousmftles QuaMNss Ouanaaes Ousnitlas _,..Ouanatias $ear# . ..... .... _... .. ...._... ...... ...,...., IN CYLIT IN OUT On tN OUT On In OUT IN OUT On IN .OUT On IN OUT On Sign Sign Hand Hand H Hand edam! HanddelL TO Gram /"'� r w+�*a4 d�' „,s^"°'✓" �.,--'" �,^''--'"" „�py.�•»^� ._ .�.. . ra+�,l k vuc.K! , - _.... To l From aA4 144-4 T�From �IoEQ ✓ ' g ik"'"ay TOO XAPMN°6Yr10 f From w Ix3 �._` ` `' ... .... .. M Ott . Tof Fmm �� . 7?.� m _..�� lug �✓ QtT41- ,}'m De& i t Vol N From Both the Headquarters' inventory records and the TSN Supply Room Inventory Changes Log (Illustration 40) show 7 vials of Dilaudid, 14 vials of Fentanyl, and 4 vials of Versed being transferred to the TSN Supply Room on May 2, 2022. Example 4—Illustration 40 TSN Supply Room Inventory Changes—To and From Logistics May 2,2022 Entry of Drugs Received From Headquarters II"III°° 0 1t ONT'14 11,I ED S4RIBSTAN tau„N '0 V`CA6Pt1AA STAR OVCEICACM SU 14111 Y VvMO 1I 1,f May 2022 .... ..... A vf.a�a�l lM�r,�t. t'R.Cf.I"I �l llcy nl� Il,.h4 lC7If II:Id:.... M 1 dr t,I! Xw MI h.7! W�f,v4 aE itr': Ii ff _ram f .......... . w t � Ct!i ��A g � �...�' .._... .. ......... .�.. ......... ....�...�'����� 61 To ensure that the next day's physical inventory count was accurate due to the restock of inventory, we traced the subsequent entries made in other TSN Supply Room inventory logs and the helicopters' inventory logs for May 2, 2022. Illustrations 41 and 42 show the morning physical inventory counts of drugs for both helicopters. Example 4—Illustration 41 TSN Helicopter Monthly Controlled Substance Log—May 2,2022 Morning Physical Inventory Count by Incoming/Outgoing Flight Nurses I _w .. _,__w__w.__ --...... .....__ __.,ww,w ._... G'YA'ir,/'I"IRAI: ,ft 1'[!fFel'E VI"Ct4+fi.E7 VAal FiJ6uC P�f7Fl[G�I-{Ildlc C114.f4f I;'lIO F,N"I`okIVYI., [uEi'r'ti 4�1M11: P116.41fff SIGNATURE I+dPb rtP a e ar r wI .,) I '�'— 4:,✓ �' � b Jf�� �� 2 ���"s 7,Fz;, .t' I- Example 4—Illustration 42 TSS Helicopter Monthly Controlled Substance Log—May 2,2022 Morning Physical Inventory Count by Incoming/Outgoing Flight Nurses I � .......... -_-._ ._...._.._. _�_._ FENTANYL_- KETAMINE FLIGHT NURSE SIGNATURE DATE/TIME ATIVAN VERSED VALIUM MORPHINE DILAUDIO RNW k"i ,' dam, r rs a. d ,.lu ( �✓� � 2-t 62 On May 2, 2022, the TSN Supply Room's Inventory Changes To and From Helicopter Log documents that 1 vial of Versed, 2 vials of Dilaudid, and 3 vials of Fentanyl were transferred to the TSS helicopter for Incident2071.Illustration 43 shows the entries recorded in the TSN Supply Room's Inventory Changes Log and Illustrations 44 shows corresponding entries in the TSS helicopter's Inventory Change Log. Example 4—Illustration 43 TSN Supply Room Inventory Changes—To Helicopter May 2,2022 Entries ........ . _.......... .III ... . ...: .......... r 112022 11 I,Hr I u r 0 Or � r �........, .. 0, J�........, "° p A. I0 .. ..... w.. .... . !....... .... (ra... 1J.. .... ........ (.. y mr r Example 4—Illustration 44 TSS Helicopter Inventory Changes Received From TSN Supply Room May 2,2022 Entries for Incident 2071 IN 11ENTORY CHANGES .... ...... ... .rM k,aauap ..Vvi-,M .....V.fiinnn V6<Nup+pxnu¢u.._ �mdhd ,....�......... ..,.,,.,,.,...,.,, .,,,,,.,,,.,..... .,..,. .....,_ ......,._ _ .....,�..�...,...., 4pspaera¢1LiaG p`euuilsnnuap d k If4rlk"II"N l Ca",C:. Ik'°A.Y<Ip Vl p.&DFQ:;/ IN+teJW'4ryrymW r: Wa-, pd.oaioohu U'H N 4d "eh p NE,,`:6 IA ..... � t.......t .•. m....p � ...€ A tfµ.W .......rt]`I..�..�. .,...�f�.......�/...,...,fl � ./)plyli&IN t54 63 Next, we verified that there was a corresponding entry made in the TSS helicopter's Administration Log to ensure drugs were administered to a patient for the listed incident. Illustrations 45 shows the entries made in the TSS helicopter's Administration Log for May 2, 2022. The TSS Administration Log shows flight staff reported administering 1-10 milligram (mg) vial of Versed(administered 1 mg and wasted 9 mg), 1-2 mg vial of Dilaudid, and 3-100 mcg vials of Fentanyl (administer 225 mcg and wasted 75 mcg) for incident 2071. Example 4—Illustration 45 TSS Helicopter Administration Log—May 2,2022 Entry for Incident 2071 f ....... .......... ............. _ . ........ To confirm the accuracy of the TSS Administration Log for Incident 2071, we next reviewed the corresponding PCR for Incident 2071 to verify that flight staff reported the same amounts being administered in this medical record.As Illustration 46 shows,the PCR does not show that Trauma Star responded to an Incident 2071 on May 2, 2022. Example 4—Illustration 46 All Patient Care Records for the Date Range May 1,2022 through May 3,2022 Incident Treatment Treatment Number Incident©ate unit Shift Name Time Provider Dose Measure Medical Control Ir/ i 5/1/2022 TS3 A-Shift Fentanyl 14:36:00 MCKAIGE,HEIDI 25 Micrograms(mcg) Protocol(Standing Order' 5/1/2022 TS1 A-Shift Fentanyl 20:30:00 RUSINOWSKI,LYNDA 100 Micrograms Qmcg) Protocol(Standing Order) '.... S/1/2022 TS1 A-Shift Fentanyl 21:42:00 CALANTE,RAFAEL 100 Micrograms(mcg) Protocol(Standing Order r '.... S/2/2022 R08 B-Shift Fentanyl 17:36:00 WELBAUM,TYLER 50 Micrograms(mcg) Protocol(Standing Order) r '.. 5/2/2022 TS1 B-Shift Fentanyl 22:43:00 RUSINOWSKI,LYNDA 75 Micrograms(mcg) Protocol(Standing Orden It is difficult to determine whether the entry for Incident 2071 was recorded in error due to sloppiness and it should have been recorded as Incident 2074 to be consistent with what is reported on the PCR. Even if Incident 2071 should have been recorded as 2074 in TSS's Administration 64 Log and Inventory Change Log, there are inconsistencies between the amounts reported as administered. According to the PCR, only 1-100 mcg vial of Fentanyl was administered while the Administration log reported 1-10 mg vial of Versed, 1-2 mg vial of Dilaudid, and 3-100 mcg vials of Fentanyl were administered. As a result, there is a possible diversion of two vials of Fentanyl, one vial of Versed and one vial of Dilaudid. Based on the activity on May 2nd, our last step was to review the physical inventory counts on the morning of May 3, 2022 to verify that the inventory counts match the activity that occurred. Illustrations 47, 48 and 49 show what was recorded as the physical inventory counts on the morning of May 3rd by the incoming and outgoing flight nurses. Example 4—Illustration 47 Monthly Controlled Substance Log-TSN Supply Room Physical Inventory Count for Morning of May 3,2022 WI14TF��I�a� ,u COUTROL�1. a tUlll mS ICY ��LOG MA STA11:1 ROOM � 1 u y 2022 .... . ...... _.-_..__..._...... .................................... ...._.._.... _......._... _._. ,................._v.......ww_.._.............................. DATE TItlAE' ATIWAN VERSED VALIUM MORPHINE DIL�AUDID FLNTANYL KF:'7AMtNE FLI(dHT NURSE SIGNATURE PRO / 4 _ Ca T 0 65 Example 4—Illustration 48 Monthly Controlled Substance Log-TSN Helicopter Physical Inventory Count for Morning of May 3,2022 TV MF qq .... uHr.INOH unrimi. I . ._._.. ...... ................_ _.._.w.._."."......... ... ,......M"," ............_....._....... Lldrvrrl iIM4' e1"l1VPn@l VFHSF_I�7 +IVINI" 11fLAUIM1 I'EWM1NYL IC4..YWall"', IUGH1�Afl4"SE SIGNATURE urea a j' ...,.....r' ...._ �_.. „ k ✓ % _ _ ;____._. A �. a r -:,7z 7z T 5 ". , Z5 5 w rm r � c Example 4—Illustration 49 Monthly Controlled Substance Log-TSS Helicopter Physical Inventory Count for Morning of May 3,2022 ..........___ Ow, I I __...... _.........._. _._ ______.._...._ _.v....._.,.,,,, ..w.._.... ._w._.. _ .._. _........................................_.___............ _w..... .__......_... _.... _ DATEMME ATIVAN VERSED VALIUOA MORPHINE DILAUDID RENTANVL KETAMINE. FLIGHT NURSE SIGNATURE fiM IF rt m m rzr -, 10 2� ............. ILI 44 ¢¢ a a 'N.?'"gy°�ro�.m,✓. �' N flry 1N�A ""�J ) d, "? !b P,:»r iy, g� ...................... -� —.!.5 5/"� ,,, �✓��.�,�, �, yg 74 Lr 6 — 66 — Table 8 summarizes the activity MCFR staff recorded for each drug on May 2, 2022 to calculate what the May 3,2022 expected morning physical counts should be. This expected inventory counts were compared to the actual physical inventory counts conducted and found that there was a possible diversion of 2 vials of Dilaudid, 3 vials of Fentanyl, and 2 vial of Versed. Table S Tracking of Inventory Changes May 2,2022 Through May 3,2022 As Recorded in the MCFR Inventory Log Books Recorded 5/2/22 5/2/22 Calculated 5/3/22 Morning Administered 5/2/22 5/2/22 5/3/22 Morning Discrepancy Inventory Controlled Physical or Inventory Inventory Inventory Physical In Inventory Location Substance Count Wasted' In Out Count2 Count' Count Ativan: 0 N/A 0 0 0 0 0 Dilaudid: 38 N/A 0 (7) 31 31 0 Fentanyl: 123 N/A 0 (14) 109 109 0 Headquarters Ketamine: 6 N/A 0 0 6 6 0 Morphine: 0 N/A 0 0 0 0 0 Valium: 0 N/A 0 0 0 0 0 Versed: 78 N/A 0 (4) 74 74 0 Ativan: 20 N/A 0 0 20 20 0 Dilaudid: 13 N/A 7 (2) 18 17 (1) TSN Supply Fentanyl: 12 N/A 14 (2) 24 22 (2) Room Ketamine: 10 N/A 0 0 10 10 0 Morphine: 0 N/A 0 0 0 0 0 Valium: 0 N/A 0 0 0 0 0 Versed: 16 N/A 4 (1) 19 18 (1) Ativan: 5 0 0 0 5 5 0 Dilaudid: 5 0 1 0 6 5 (1) TSN Fentanyl: 5 0 2 (1) 6 5 (1) Helicopter Ketamine: 2 0 0 0 2 2 0 Morphine: 0 0 0 0 0 0 0 Valium: 0 0 0 0 0 0 0 Versed: 5 0 1 0 6 5 1 (1) Ativan: 5 0 0 0 5 5 0 Dilaudid: 5 0 0 0 5 5 0 TSS Fentanyl: 5 0 0 0 5 5 0 Helicopter Ketamine: 2 0 0 0 2 2 0 Morphine: 0 0 1 0 1 0 1 0 0 0 Valium:j 0 1 0 1 0 1 0 1 0 0 0 Versed:1 5 1 0 1 0 1 0 1 5 1 5 1 0 NOTES: 1The amount recorded as administered or wasted is based on the information recorded by MCFR staff in the Patient Care Report for Incident 2074- assume incident number was recorded incorrectly in other log books due to sloppiness 2The Calculated Inventory Count for May 3,2022 takes the May 2,2022 inventory count then adds the amount of each drug that was recorded as being transferred in and subtracts the amount of each drug being recorded as transferred out,administered or wasted on May 2,2022. 3The Recorded 5/3/2022 Morning Physical Count is the amount reported as counted as being on hand in each respective location's Monthly Controlled Substance Log.For Headquarters,this amount is the amount recorded after transferring inventory to the TSN Supply Room on May 2,2022. — 67 — This page is intentionally left blank. Appendix III Federal Schedule of Controlled Substances - 68 - Federal Schedule of Controlled Substances Schedule I Examples: LSD and heroin • A high potential for abuse • No currently accepted medical use in treatment in the United States (typically only authorized for research purposes) • Lack of accepted safety for use of the drug or other substance under medical supervision Schedule II Examples of MCFR Inventory: Morphine,Dilaudid, and Fentanyl • A high potential for abuse • Currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions • Abuse of the drug may lead to severe psychological or physical dependence Schedule III Examples of MCFR Inventory: Ketamine • Less potential for abuse than the drugs in Schedules I and II • Currently accepted medical use in treatment in the United States • Abuse of the drug may lead to moderate or low physical dependence or high psychological dependence Schedule IV Examples of MCFR Inventory: Ativan,Versed, and Valium • Low potential for abuse relative to the drugs in Schedule III • Currently accepted medical use in treatment in the United States • Abuse of the drug may lead to limited physical dependence or psychological dependence relative to the drugs in Schedule III Schedule V Example: Cough medicine with codeine • Low potential for abuse relative to the drugs or other substances in Schedule IV • Currently accepted medical use in treatment in the United States • Abuse of the drug may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Schedule IV 69 Appendix IV Correspondence Between MCFR Management And The Medical Director - 70 - COUDIV Of MOMIA, The I lorida Keys OFFICE OFTHE Ftpj,,CHIEF 4()0 631"Street Ocean 0 Marathon,1`133050 Phone:(305)299-6020 August 0,2022 Professional Ernergcncy Services,Inc. c/o Dr.Sandra Schwernmer 10 High Point Road Tavernier,FL 31070 Retion Receilrt Requested RF: Medical Director Contract Notice Action Requesteel Dear Dr,Schwrinnier, After reviewing your agreentent for"Medical Dirwor"services,it has come to my attention that several critical responsibilities that are contained in the Contract between Professional Errwrgency Services,Inc, and the Monroe County Board of County Cornmis%ionevs(BBC Q and Board of Governors of Fire and Ambulance District 1(806),the"Contract,"are not Iveing contlifetely fulfilled. Therefore,this letter will servo as Notice that action is requested by professional Emergency Service Inc. to strengthen its perforarance with the terms of the Contract with the Monroe County BOCUBOG The attached "Exhibit A" will outline the, sections of Contract that require action and are specific tireasures requested for conformance with the terms of the Contract. Monroe County Fire Rescue is ,hereby requesting that these actions he completed within the next ninety calendar(90)days so that your firrit will rernarn in compliance with its Contract. If you have arty questions or require further information,please do not hesitate to contact tile at the,office (305)289-6342 or by cellular(105)09-7603. sincerel 0, Steven Hudson Fire Chief,NCDA.,EFO c: R.L Colina,B.S,,Deputy Chief' Alvin Bentley,Division Chief Aviation 71 August 0,2022 Page 2 of 5 ENhibit A Excerpts from"Contract Between the Monroe County Board of County Commissioners and the Board of Governors of Fire and Anibulance District I and Professional Emergency Services"Inc.for Medical Direction for Monroe County Fire Rescue(MCFR)." 4.9,1 Medical director slikill participate in Trausna Star Safety and Quality Assurance Corruniuces,and shall attend quarterly ineefings to review safety policies,pro lures,unusual occurrences,safety issues, and audit compliance with satcry policies and procedures. 1. Expectation: Document the Trauma Star Safety and Quality Assurance,Program and attendance to meetings to review safety policies,procedures,unusual occurrences, safety issues,and audit compliance with safety policies and procedures. Action Requested:Attend Quarterly Meetings.The tollorwing are the proposed dates for the Trauma Star Safety and Quality Assurance Committee meetings: a. Septerniaer 15,2022 It. December 8,2022 c. March 16,2023 d. June 15,2023 In accordance with Section 4.9.1 of the Contract,your attendance is requested at these meetings,. 4.10,1 Medical Director shall ensure,initial and coutinucif rnedical qualifications and proficiency of MCFR personnel. 2. Expectation:Medical Director perform assessments of the department's new employees. Action Requested:Provide a written review of the department's new employees at their nine(9)month evaluation period."Exhibit B"is the list of new employees providing emergency medical care,their evaluation period and the evaluation due dates.Reviews shall be submitted to the Deputy Fire Chief within 10 days of the evaluation due dates. — 72 — August 9,2022 Page 3 of 5 4,10.2 Medical Director shall establish and periodically update the ininimurn personnel training standards and certification requirements for all MCFR pers(>nnel who provide emergency medical care. Stich standards shall include the,requirements for orientation and initial training,continuing medical education,standards for professional conduct and evaluation standards and procedures, 3. Expectation:Medical Director provide review of the departatent's medical orientation agenda or updated minimum training standards. Action:Provide discussit"i agenda that will be included on the,Monroe County Fire Rescue Orientation Agenda for all new Firefighter/lENtr's on or before August 31, 2021 Additionally,attend an orientation meeting and provide initial training for MC FR persmocl providing emergency medical care. 4,11 Quality assurance 4,11.I Medical Director,in coordination with MCFR,shall develop,implement,and maintain an effective patient care Quality Assurance System to assess the medical performance of all ccrtificcitlicensed MC FR response personnel. 4. Deficiency:Quality Assurance System provided to MCF'R. Action Requested:Provide written Quality Assurance Program for review by the,Fire Chief to be submitted on or before August 31,2022, 4.11,5 Medical Director or designee,shall review,in conjunction with MC FR Battalion Chiefs or their designees,patient care reports on an ongoing basis;review all protocol deviations and initiate or recommend corrective action,Mcdicul Director or designee shall review at least 40 patient care reports Iv, r month.MCFR shall provide electronic copies of patient carc rclx)rts, 5. Expectation:Medical Director perform review of minimurn number of patient care reports per month,for at least six(6)months. Action Requested:Review minimum of 40 patient care reports for July 2022 and provide details,including summary of incidents to(Ite,Deputy Fire Chief by August 31,2021 Medical Director has access to patient care incident reports through ESO password protected software or any reports that have been provided by MCFR staff through a secure — 73 August 9,2022 Page 4 of 5 4.11,7 Medical Director shall participate in ficId activity and system nionitoring to include the following: 4.11 J 1 Ride along and observe field activity as a crewmember on a rescue as needed.System monitoring shall include visiting fire stations when needed to discuss issues with MCFR personnel, 6. Expectation:Medical Director perforrn ride along amessments for Firefighter/Paramedles within the last twelve(12)months. Action Requested:Schedule through the Deputy Fire Chief to perform ride-along as,stssments for Firefighter/Paramedics who are in the proccss of precepting. The(M- site assessments shall be conducted prior to,November 10,2022. 4,12 f.Aucational Programs 4.12,1 Medical Director, shall participate in educational programs at all levels, to include all c,crtified/licensciJ responsc personnel, 4.12.2 Medical Director or designee shall oversee a mimmurn of ten (10) hours as year of continuing medical education related to pre-hospital care or teaching or a combination of'both. *12.4.2 Monitoring and auditing at least one(1)class session of every Continuing Medical FArication(CME)course held in which Medical Director is issuing CME;and.. . 7. Expectation: Medical Director conduct art educational program at MCFR or perform on site educational monitoring within the last twelve(12)months. Action Requested:Provide a minimum of out medical education class related to pre- hospital care over a 3-day period to all shifts(A/B/C). 11w,class may be coordinated through the Battalion Chief for the Training Division.Classes shall be completed ort or before December 31,2022. 4,,12.5 Medical Director shall maintain necessary and appropriate instructor certifications and participate as Medical Director for critwational programs sfx)nsored by MCFR such its ACLS.PALS, BLS'ctc. S. Expettation:Certifications for ACLS,PALS.BJJS are provided to MCFR. Action Requested:Provide copies of certifications. — 74 — A ugmst 0,2612 page s or s Exhibit B Name EVIII211911 Eam Review Due Date 1. Alexander Andalia 9 Months August 8,2022 I David tsar 9 Months August 8,2022 3. Ariel I kpez 9 Months August 8,2022 4, Spencer Saluburg 9 Months August 8,2022 5, Diego Belerano 6 Months August 28,2022 6. Victor Clavelo,Garcia 6 Months August 28,2022 7, Krysten Fcho 6 Months August 28,2022 S. Cesar Fernandez 6 Month,,, August 28,2022 9 Jarnes Findlay 6 Months August 28,2022 10.Desmond Fox 6 Months August 28,2022 11. Honzik Frystiky 6 Months August 28,2022 12.Dayron Garcia 6 Months August 28,2022 13, Randy Gonzalez 6 Months August n,2022 14.Jesus Hernandez, 6 Months August 28,2022 15. Matthew Hill 6 Months August 28,2022 16. Elizabeth Jacoby 6 Months AklgtoL 28,2022 17.Jaedon Johnson 6 Months August 28,2022 18, Eric Lopez 6 Months August 28,2022 19. Joel Lopez 6 Months August 28,2022 20.Jordan Lyon 6 Months August 29,2022 21.Adrian Parra 6 Months August 28,2022 22. Robert Rodriguez 6 Months August 29,2022 23. Nicholas Roman 6 Months August 29,2022 24,Sainantha Seat 6 Months August 28,2022 25.Mark Serrano 6 Months August 28,2022 20,Austin Taylor 6 Months August 28,2022 27.William Yuque 6 Months August 28,2022 28, Kevin Cossio 11 Months September 6,2022 29, Joseph liernandez I I Months September 6,2022 .10,Christopher Baylis I I Months, Septcmbcr 12,2022 31. 32. Adrian Macias Ricard I I Mornhs� SeTtembe-t 6,2022 33,Carlos Nava Orosco 11 Months September 6,2022 34, Luis 0arcia 6 Months October 25,2022 35.Lisandro Gonzalez 6 Monihs October 25,2022 36.Robo Rvii 6 Months October 25,2022 - 75 - Coulltv of Monroe OFFICE OF THE 1"be Florida Kevs IFI�M CHIFF 490 634 Street Ocean Marathon,,FL 33050 Phone (305)289-6020 September 15,2022 Professional Emergency Services,Inc c/o Dr, Sandra Schwernmer 10 High Point Road Tavernier,FL 33070 'Sent Via Email RE,- Reporting Request Dear Dr. Schivernmer, This is a follow up to the recent meeting held with Monroe County Fire Rescue staff',and the letter sent on Aug nst 9,2022,regarding contract requirements, Moving fonvard, the Deparmient would like to receive a formal niontbly report to document the activities you Perforated on behalf of Monroe County Fire Rescue. This will include, but not be limited to, the contractual requirements, a list of the patient care reports reviewed by incident number, and a list of all individuals you spoke with and the purpose. Regarding our request for a medical directive,the entail you sent on September 1,2022,at 8:15-.52 a.m, is not in an acceptable format. The format requested for the medical directive should be on a signed form that the Department may distribute and post. Please see the attached template for your nose, As you know,the Department's personnel have specific assignments and follow a chain of cornmand. Therefore,if you require specific information front staff,please let me know what you need by email, and I will assign one of my team members to forward the information requested within a reasonable time period. If you have any cluestions or require,further information,please do not hesitate to contact me at the office (305)289-6342 or by cellular(305)699-7603, Sincerely, Steven Hudson Fire Chief,M,B.A,,EFO Attachment c: R.L.Colimi,B.S.,Deputy Chief Alvin Bentley,Division Chief Aviation Charles Mather,Battalion Chief Training James Molenaar,E,,Aj.,Assistant County Attorney — 76 — Countv of Monroe fie Florida Keys OFFICT OF THI FIRE CHIEF 490 63"1 Street Ocean Marathon,FL 33050 Phoxre:(305)299-6020 September 20,2022 Professional Emergency Services,Inc, co Dr,Sandra Schweninier 10 High Point Road Tavernier,FL 33070 Sent Via Email RE" Medical Director Contract Notice-Pao Action Requested Dear Dr. Schwermner, Thank you for the tele one conversation yesterday and your willingness to assist in the,development and restructuring of our EMS Division, In addition, after reviewing our agreement and the provided documents for "Medical Director" services, that are contained in the Contract behveen Professional Emergency Sen^ices, Inc,and the Monroe County Board of County Commissioners(BOCC)and Board of Governors of Fire and Ambulance District I(BOG),the"Contract,"and services have been satisfied. Therefore,this letter will se.ne as written notification that Professional Emergency Service Inc.complies and is in good standing with the ternis of its Contract with the Monroe,County BOCCYBOG. If you have any questions of require further information,please do not hesitate to contact me at the office (305)289-6342 or by cellular(305)699-7603. Sincerely, Steven Hudson Fire Urief,1%4,13.A.,EFO — 77 — Appendix V Gross Pay and Hours Worked By Chief Flight Nurse Calendar Years 2017 to 2022 - 7g - v_ f1 o O � T T T �+ v l 2 2 Q A f1 G m D 2 v O M O! O j O C C N N O W 0_ O G N 0) S L - G1 N <. nGi nGi o c y ni ni f1 or o 3 p O opi r,� O Jc < N 3 3 D 3 D o rAo 00 c f1 s Z 0 0 m 0 Q N N A v 03 S N D 3 OC 3 p ? J N < OA y N Z 0) Qp 2 p1 O N 1p N 0 1 W J O V � 00 A 100 N O l0 N N 90 M A W W O In O! 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