THE BASICS THE BASICS STAFF EDUCATION DRUG DIVERSION TASK FORCE 4/8/2016. MSHP Annual Meeting 2016

Transcription

1 /8/01 MSHP Annual Meeting 01 DEA Audit and Investigation Lessons Learned: Training, Reporting, Surveillance, Auditing and Technology Erasmo (Ray) Mitrano, RPh, MS, Senior Director Controlled Substance Compliance and Surveillance Massachusetts General Hospital Boston, MA THE BASICS THE BASICS years readily retrievable data DEA binder Hospital licensed sites Biennial inventory Power of Attorney forms DEA/DPH licenses Suspicious monitoring Inventory integrity Business Associate Agreement DEA 10 filings Files CSOS order/invoice matching DEA forms Reverse distributor Weekly CS inventories Narcotic vault Limited access and hours Process to remove employees from system Nationally certified techs DRUG DIVERSION TASK FORCE Executive Sponsor: SVP Administration Executive Sponsor: SVP Patient Care Sr. Director Control Substance Compliance &Surveillance Nursing Quality & Safety Director & Staff Associate Chief Nurse & Staff Police & Security Director & Staff Chief Pharmacy Officer & Staff Chief Compliance Officer & Staff 1

2 /8/01 Pharmacy, nursing, anesthesia Annual mandatory training Signs and symptoms Nurse training Phase I Wasting, disposal, returning Phase II Control substance electronic surveillance training Phase III Best practices/discrepancy Phase IV Override list changes Wasting complete doses Withdrawing without an order Dropping/breaking containers Removal for discharged patient Withdrawing for patient who do need pain meds Volunteers for overtime often Willing to float or stay late often Comes into work when not assigned or scheduled Readily volunteers to medicate other patients Volunteers to waste medication that was not administered by him/her Removal under someone else Giving less than what was ordered Canceled transactions Duplicative doses Asks a colleague to witness a waste that has already been wasted Frequent trips to bathroom Long trips off unit Discrepancies between patient reports of pain relief and charted meds Consistently signing out maximum amount of narcotics SURVEILLANCE ORGANIZATIONAL DASHBOARD Nursing Measures Anomalous User and User Activity Checks. (Daily) Activity and User Checks (S S H) Shift Discrepancy Checks done by pharmacy daily and tracked nursing is first call Pharmacy / Anesthesia Measures Post Case Reconciliation Compliance (Daily) Pharmacy Measures Annual Inventory DEA 10 Filings DPH Filings Discrepancy Checks (Daily) Dispense > Report (Daily) Global List Transaction Review (Monthly) Inventory Integrity Checks Endoscopy (Monthly) Override Report (Daily) Site Visits Suspicious Order Monitoring (Monthly) MGH DDTF Controlled Substance Dashboard December 01 Feb 1 Mar 1 Apr 1 May 1 Jun 1 Jul 1 Aug 1 Sep 1 Oct 1 Nov 1 Dec 1 Nursing Measures Anomolous User and User Activity Checks Activity and User Checks (S S H) Pharmacy / Anesthesia Measures Post Case Reconciliation Compliance NURSE DISCREPANCY CHECK Pharmacy Measures Annual Inventory. /8/01 DEA 10 Filings DPH Filings Discrepancy Checks (Daily) start July 1, 01. n/a n/a n/a n/a n/a Dispense > Report. n/a n/a Global List Transaction Review n/a n/a Inventory Integrity Checks Endoscopy. Two nurses complete discrepancy check at change of shift Discrepancy identified Nurses check ADM Transaction by item report and complete review Discrepancy not resolved... Immediately call Pharmacy & notify nurse director and/or clinical nursing supervisor Override Report Site Visits Chelsea Danvers Revere MGH vault Suspicious Order Monitoring

3 /8/01 ANOMALOUS USAGE REPORT ADM OVERRIDE REPORT omni_stid xact_dati pat_id MRN pat_name item_id rx_name qty_rem user_name Compliant? Comments Resolution MGBLA1L : * Smith, John MGBLA1L :00 * Smith, John RN y Drug Returned RN n No Med Order to Omnicell MGELL0L :1 ***179 Doe, Jane 8900 Oxycodone MG/ML ML SOLUT RN y MGELL07L :0 ***17881 Richard, Richard MGELL :11 ****917 Shine, Sun MGELL :0 ***1008 Bright, Star 800 Lorazepam MG/1ML 1ML VIAL MG/1ML 1ML MGELL1B :0 ****91 Stein, Frank N GREATER THAN G NAME March 17, 01 1: AM METHADONE ORAL SOLN MG/ML QTY: 1.00 March 17, 01 9:1 AM METHADONE ORAL SOLN MG/ML QTY: 1.00 March 17, 01 :8 PM METHADONE ORAL SOLN MG/ML QTY: 1.00 March 17, 01 11:1 PM METHADONE ORAL SOLN MG/ML QTY: 1.00 L NAME March 17, 01 :1 PM hydromorphone MG/ML 1ML SYRINGE QTY:.00 March 17, 01 7:0 PM hydromorphone MG/ML 1ML SYRINGE QTY:.00 March 17, 01 7:9 PM hydromorphone MG/ML 1ML SYRINGE QTY:.00 March 17, 01 9:1 PM hydromorphone MG/ML 1ML SYRINGE QTY:.00 March 17, 01 10: PM hydromorphone MG/ML 1ML SYRINGE QTY:.00 March 17, 01 11:9 PM hydromorphone MG/ML 1ML SYRINGE QTY:.00 L NAME March 17, 01 9:17 PM OXYCODONE MG TABLET QTY: 8.00 L NAME March 17, 01 :0 AM OXYCODONE IMMED RELEASE 0 MG TAB QTY:.00 March 17, 01 9:7 AM OXYCODONE IMMED RELEASE 0 MG TAB QTY:.00 March 17, 01 11: AM OXYCODONE IMMED RELEASE 0 MG TAB QTY: NAME March 17, 01 1:8 AM OXYCODONE MG TABLET QTY:.00 March 17, 01 : AM OXYCODONE MG TABLET QTY:.00 March 17, 01 8:1 AM OXYCODONE MG TABLET QTY:.00 OR POST-CASE RECONCILIATION Post Case Reconciliation Monthly Compliance Trending (Sorted by Incident) "Y" = PCR was Compliant Months user_name y n % y n % y n % y n % y n % y n % y n % Gelineau, Amanda Maria % 1 9.% % % % % Spencer, Rebecca % 91.% 100.0% % % Greenberg, Deborah.% % 100.0% 100.0% % 8 8.8% Levine, Amy 100.0%.% 100.0% 100.0% 1 7.0% Lighthall, Samantha 0.0% 100.0% 100.0% 100.0% 0.0% 1 7.0% Holley, Catherine.% 100.0% 100.0% 0.0% Gao, Lei % % % % 100.0% % 8 99.% Walsh, Tomas 8 9.1% % % 100.0% % % Sayal, Puneet 88.0% 100.0% 100.0% 8 9.% Bartels, David DB#0 1 9.% % % % 99.% Norato, Christine % 0 9.% % % % % 99.% Yelle,Marc % 9.9% 100.0% % % % Kim, Peggy % 1 8.7% % % Cox, Jessica # % % 100.0% 100.0% % Vanneman, Matthew % % % % 100.0% % % Safavi, Kyan DB# % % % % % % Dougherty, Kelly % % 100.0% 100.0% 100.0% % % REPORTING REPORTING & AUDITING Utilize organizational safety report system to file loss Rule of Thumb: < or > Regulatory filings DPH within 7 days (<) Massachusetts regulation DEA 10 with hours (>) Addendums within days Will document what disciplinary action took place Other agencies BOP, DPH, CMS, FDA, BORN, BORM

4 /8/01 AUDIT Trending reports Event type, medication, location, user Post case reconciliation Employee volume comparisons Accountability audits selected drug by independent auditor annually On site record audits of all DEA licenses Biennial inventory, powers of attorney, forms, DEA 10 s, invoices Pharmacy employees Null transactions, destock, overrides Suspicious monitoring Number of Submissions REPORT TRENDING Month of Submittal Trend Category FENTANYL 0 MCG/ ML FENTANYL 0 MCG/ ML FENTANYL LORAZEPAM METHADONE OXYCODONE MIDAZOLAM ATIVAN (LORAZEPAM) (blank) MORPHINE SULFATE DILAUDID (HYDROMORPHONE HCL) FENTANYL (PATCH) FENTANYL 0 MCG/ ML; VERSED (MIDAZOLAM) PREGABALIN VERSED (MIDAZOLAM) Individually Reported Medications AUTOMATION AND TECHNOLOGY AUTOMATION/TECHNOLOGY Understanding how technology works/limitations ADM, anesthesia workstation, surveillance systems, pharmacy CS inventory system e.g. When patients are discharged from system System configurations Upgrades/system enhancements Access to quick and usable data years worth of readily retrievable data

5 /8/01 ORDERING, RECEIVING, STORAGE, RETURNING PHARMACY CONTROLS Ordering Different than person receiving Limited to certain employees/poa Receiving Totes immediately to vault and processed CSOS matching Limiting vault and staff access Distribution Limited daily pulls Locked delivery cabinets Storage Patients own meds Cameras Biometrics Override list Profile vs. non profiled Downtime procedures Returning Return bins Drug waste Reverse distributors A key component for drug diversion training is: Review signs and symptoms of an impaired individual Understanding regulatory reporting requirements Understanding that patient safety is a top priority All of the above It is imperative to have collaboration between Pharmacy, Nursing, Anesthesia, Compliance and Police and Security for a strong drug diversion surveillance program True False???????? Thank You!!