Scope of the Problem. Leadership Engagement. Leadership Engagement. Risk of Harm to Patients. Risk of Harm to Patients 6/13/2016

Transcription

1 Protecting Patients from Harm: Establishing an Institutional Diversion Program Kimberly S. New JD BSN RN Scope of the Problem All facilities face this issue Diversion can t be prevented entirely Substantial safety, quality, regulatory and legal risk Mitigate risk with formal program, transparency and culture change Copyright 2016 Kimberly New. All rights reserved. Leadership Engagement Safety emerges is central aim of quality Patient safety events may not be completely eliminated, harm to patients can be reduced Leadership engagement in patient safety and quality initiatives is imperative because 75% to 80% of all initiatives that require people to change their behaviors fail in the absence of leadership managing the change Comprehensive Accreditation Manual for Hospitals: The Patient Safety Systems Chapter Leadership Engagement Hospital leaders provide the foundation for an effective patient safety system Promoting learning Motivating staff to uphold a fair and just safety culture Providing a transparent environment in which quality measures and patient harms are freely shared with staff Providing the resources and training necessary to take on improvement initiatives 2015 Comprehensive Accreditation Manual for Hospitals: The Patient Safety Systems Chapter Risk of Harm to Patients Receiving care from impaired provider Untreated pain Exposure to bloodborne pathogens or exposure to unsafe substances Risk of Harm to Patients Care delivered by an impaired provider Withholding medications from patients in need or administering substitution Transmission of bloodborne pathogens or exposure to unsafe substances (Ochrobactrum anthropi) 1

2 Risk of Harm to Institutions Risk of Harm to Staff Liability-civil, regulatory 340B and GPO compliance Negative publicity (brand at risk) Loss of license Accidents while working impaired DUI accidents and fatalities Progression to illicit drugs and high-risk behaviors Health related consequences of drug misuse Incarceration Overdose Suicide Risk of Harm to Colleagues Distress and disbelief in work colleagues Staffing deficits Expense of hiring and training new staff Risk of Harm to Community Ga Anesthesia Assistant Arrested For DUI Propofol In Wrong Way Crash Beverly Wilkins Home care nurse accused of stealing medication, driving while drugged [The nurse] was arrested for OVI after she was involved in a vehicle crash with a parked car. Police located vials of medication and syringes on the floorboard of her vehicle, in her purse and in her pocket. Ongoing Threat 7,200 McKay-Dee and Davis Hospital patients could have been exposed to hepatitis C 3,500 Scripps Health and Swedish Hospital patients offered hepatitis C testing Goals Prevent, detect and respond Culture of ongoing awareness and accountability More than 200 patients seen at Shore Medical Center notified of potential exposure to hepatitis C 2

3 Who? Who Gets Involved in Diversion? Bad people? Less caring? Desire for drugs motivated career choice? Just nurses? What Does a Diverter Look Like? Common Factors High achiever Significant stress in personal life Night shift Critical care or other unit where nursing staff have increased autonomy Agency or traveler Legitimate prescription for drug being diverted Loved by patients and staff alike Generally, healthcare workers divert for personal use and are extremely secretive about it Anywhere controlled substances are found by anyone intent on diverting! Where? 3

4 High Risk Areas Critical care and emergent care Surgical care (inpatient, outpatient, specialty) L&D Procedural areas Units that don t operate around the clock Pharmacy Why? Occupational Factors Suppression of feelings and emotions Compassion fatigue and burnout Physical demands of job, injuries and chronic pain Ease of access to prescriptions and medication Knowledge and sense of control What? Injectables: Hydromorphone Morphine Pills and liquids: Hydrocodone Oxycodone Patches Fentanyl Drugs of Choice Drugs of Choice Benzodiazepines (lorazepam, alprazolam, clonazepam) Drugs to ease withdrawal and enhance impact of opioid (ondansetron, promethazine, diphenhydramine) Others (cyclobenzaprine, gabapentin, ketorolac) Anesthesia gases 4

5 Common Behaviors What to Look For? Early signs: Frequent disappearances, in the bathroom or dirty utility room for prolonged periods; Volunteer for overtime, come to work when not scheduled; Come to work before shift starts and stays late; Recurrent removal of controlled medications near or at end of shift or at the end of a stretch of shifts; Common Behaviors Early signs: Help colleagues medicate their patients and review medication orders of patients not caring for; Heavy or no wasting of drugs; Picking the same people to waste with; and Pattern of holding waste until oncoming shift. Common Behaviors Later Signs: Unpredictable work performance, recurrent mistakes, poor judgment and bad decisions; Interpersonal relations suffer, becomes volatile, isolated, sullen; Blames environment and other for errors Arrives to work late, uncharacteristic no shows, takes lots of sick days; and Frequent personal crises. Other Signs Drug related items in staff bathrooms Taking personal bags, totes purses into medication room How? 5

6 Drug Transactions Behaviors are late signs: Patterns for patients Patterns over time for user Patterns for handling non-preferred drugs Methods/Signs of Diversion Removal of medication when not needed Removal for discharged patient Removal of duplicate dose Removal of/diversion from fentanyl patches Methods/Signs of Diversion Removal of medication without order Failure to waste Frequent wasting of entire doses Substitution in administration and wasting Methods/Signs of Diversion Dividing Doses Order is for 2 mg morphine IV q 2 hr prn 2 mg syringe is available Nurse administers 1 mg dose at 8 am and another 1 mg dose at 9 am Patient has received 2 mg in 2 hr. Nurse has 2 mg of waste where he would have had none if he had administered the medication in one dose as envisioned Methods/Signs of Diversion Removal of larger doses than necessary Withdrawal from PCA and drip lines Removal under sign-on of colleague Removal of unspent syringes from sharps boxes Pilfering patient medications brought from home Methods/Signs of Diversion Removal of oral and injectable opioid at the same time Frequent breaking of containers for injectables Null/canceled transactions, particularly for a specific bin Cycle counts Floor charges 6

7 Program Essentials Program Operations and Oversight Diversion Specialist Daily operations-surveillance Database Other Key Functions Education Institutional resource Diversion risk rounds Community, LE and regulatory liaison Program Operations and Oversight Diversion Response Team Multidisciplinary Input from manager of suspected staff member Short notice and after normal business hours Diversion Committee multidisciplinary High level Ensures support and direction for program Data tracking over time 27 Diversion Committee Membership Chair: Diversion Specialist Anesthesia Nursing (general, procedural) Pharmacy (med safety, narc) Security Risk Management Accreditation Chief Medical Officer Compliance Infection prevention Human Resources Employee Health Finance Laboratory Research Ad hoc Important Elements Policies to prevent, detect and properly respond to diversion Shared responsibilities between key departments Method of auditing Prompt attention to suspicious data Collaborative relationship with external agencies Education for all staff Diversion risk rounds Policies 7

8 Policies-Prehire Screening 21 CFR Employee screening procedures Obtaining certain information is vital to assess the likelihood of an employee committing a drug security breach Need to know is a matter of business necessity, essential to overall controlled substances security Conviction of crimes and unauthorized use of controlled substances are activities that are proper subjects for inquiry Policies-Prehire Screening 21 CFR Sources of information for employee checks DEA recommends that inquiries concerning employees' criminal records be made as follows: Local inquiries. Inquiries made by name, date and place of birth, and other identifying information, to local courts and law enforcement agencies for records of pending charges and convictions. DEA inquiries. Inquiries furnished to DEA Field Offices along with written consent from the concerned individual for a check of DEA files for records of convictions. The Regional check will result in a national check being made by the Field Division Office. Policies-Medication Handling Transporting, wasting, returns, removal from packaging, discrepancies, time from dispense to admin, documentation of doses and issues 42 CFR (a)(3) - Current and accurate records must be kept of the receipt and disposition of all scheduled drugs 42 CFR (b)(2)(i-ii) - All drugs and biologicals must be kept in a secure area, and locked when appropriate Policies-Accountability and Security 42 CFR (a) Standard: Pharmacy Management and Administration The hospital s pharmacy service must ensure safe and appropriate procurement, storage, preparation, dispensing, use, tracking and control, and disposal of medications and medication- related devices throughout the hospital, for both inpatient and outpatient services. Policies-Review of Orders 42 CFR (b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. Safe dispensing of medications must be in accordance with accepted standards of practice and includes, but is not limited to: Reviewing all medication orders (except in emergency situations) for appropriateness by a pharmacist before the first dose is dispensed. Policies-Controls and Safeguards 42 CFR (b)(1) - Medications must be dispensed by the hospital in a manner that is safe and meets the needs of the patient: Quantities of medications are dispensed which minimize diversion and potential adverse events while meeting the needs of the patient; 8

9 Policies-Security and Process Improvement 42 CFR (b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. Drugs and biologicals must not be stored in areas that are readily accessible to unauthorized persons If there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the hospital is expected to evaluate its current medication control policies and procedures, and implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained All controlled substances must be locked Are medication storage areas periodically inspected by pharmacy staff to make sure medications are properly stored? Determine that security features in automated medication distribution units are implemented and actively maintained, e.g., that access authorizations are regularly updated to reflect changes in personnel, assignments, etc. Policies-Surveillance and Auditing Surveillance/auditing What will be done, by whom and how often Statistical thresholds Requirements when threshold met Take emotion out of detection Ensure consistency across health system Be aware of investigator bias Policies-Diversion Response Reasonable suspicion drug testing What constitutes reasonable suspicion, what method of drug test, who will test and where, refusal to be tested, observed or not Employment disposition for confirmed diversion 21 CFR Illicit activities by employees Employees who possess, sell, use or divert controlled substances will subject themselves not only to State or Federal prosecution Employer will immediately determine status of continued employment by assessing the seriousness of the violation, the position of responsibility held by the employee, past record of employment, etc. Policies-Diversion Response Staff Reporting Internal and external reporting 42 CFR (b)(7) - Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate Billing revision and patient notification 21 CFR Employee responsibility to report drug diversion Reports of drug diversion by fellow employees is necessary and also serves the public interest at large An employee with knowledge of drug diversion from his employer by a fellow employee is obligated to report to a responsible security official of the employer Confidentiality for those reporting Employer shall inform all employees concerning this policy 9

10 Robust Reporting DEA (Form 106) State Licensure Board and/or Professional Assistance Department of Health (patient harm issues and/or possible bloodborne pathogen exposure) Law Enforcement - crimes, issues of abuse/neglect/reckless endangerment, fraud Pharmacy Board Institutional Infection Control Dept Involvement of Infection Prevention Keep informed of all cases Assistance with ascertaining risk of transmission Interface with Public Health as necessary Assistance with BBP testing of diverter Testing for BBP Bloodborne pathogen testing at time of drug screen Confidential Voluntary but encouraged Non-punitive Public Health Role Risk assessment with facility collaboration/cooperation Identification/notification of patients at risk Investigation of potential secondary exposures Further investigation/testing as warranted External Reporting 21 CFR Other security controls for practitioners Registrants required to notify the DEA Field Division Office in their area, in writing, of the theft or significant loss of any controlled substance within one business day of discovery of such loss or theft. Also complete and submit to the Field Office, DEA Form 106, "Report of Theft or Loss of Controlled Substances" regarding the theft or loss. Theft and Loss Diversion is theft, not loss Updates every 30 days For loss, no single objective standard, but instead view in context of a registrant's business activity and environment When in doubt, registrants should err on the side of caution in alerting the appropriate law enforcement authorities, including DEA, of thefts and losses of controlled substances 10

11 Policies-Tampering and Substitution Formal policy and widespread education Visualize medications prior to administration Promptly report concerns and leave the evidence in situ Involve Security, photograph evidence, and establish a proper chain of custody BBP transmission has to always be a strong consideration with injectables Auditing Standard Nursing Auditing Peer to peer comparison Discrepancies daily Overrides daily Other reports as available (undocumented doses, undocumented waste, etc.) Specialized Auditing-Critical Care Infusions-tracking amount infused, closing the loop on patient specific medications, wasting accuracy PCA keys/lock-box keys Bedside procedures Handoffs Specialized Auditing-ED Trauma processes, use of alias Discharged patients with active profiles Sedation and procedures Delays between dispense and administration/waste Handoffs EMS Replenishment Specialized Auditing-Labor and Delivery Nurses pulling medications for MDs Verbal orders at the time of delivery Documenting and linking epidural waste to dispense Physical security risks in C-Section suites Sleep aides at odd hours 11

12 Specialized Auditing-OR and Procedural Areas Pulling medications in large quantities Sequential dosing over time Hand-offs Delayed waste Kits Dual sources Specialized Auditing-OR and Procedural Areas Waste in different location than dispense Wasting on call Inconsistent processes (nurses/anesthesia) Separate EHR or manual records Orders and Prescribing Practices Availability of paper prescription blanks Treatment of prescription blanks by nursing CPOE order verification Education Education All-inclusive (non-clinical, medical staff) At hire and annually Huddles and focused education Special events Education of All Staff Personal observation is vital! It may be the only clue. All-inclusive At hire and at least annually Emphasize recognition and reporting Use actual cases Be sure to discuss assistance options available (prior to committing a felony) Goal Develop a culture in which employees recognize the risks and feel individual responsibility for reporting 12

13 Diversion Risk Rounds Risk Rounds Unannounced and at least quarterly Still Not Convinced? Final Selling Points! Increased focus on inpatient processes CMS surveyor - IJ for unsecured controlled substances Dignity Health - $1.55 million Mass General $2.3 Million Settlement Kimberly New JD BSN RN Kim_New@DiversionSpecialists.com (865) Copyright 2016 Kimberly New. All rights reserved. 13