Darryl S. Rich, Pharm.D., M.B.A., FASHP Surveyor, The Joint Commission The Joint Commission © Copyright, The Joint Commission The Joint Commission & the Pharmacy Buyer: Update for 2009 Objectives Brief overview of the current Joint Commission Accreditation and Survey Process. The Joint Commission © Copyright, The Joint Commission Discuss major standards and national patient safety goals of relevance to purchasing managers. Accreditation and Certification Triennial (3 yr) on-site survey Annual Periodic Performance Reviews (PPR) Continuous performance measurement requirements (Core Measures) Sentinel Event Reporting/Review. The Joint Commission © Copyright, The Joint Commission – Ad hoc off-cycle surveys Core Measures Must generate run or control charts on each measure quarterly and must analyze and improve if over three or more consecutive quarters for the same measure, identify the hospital as a negative outlier. The Joint Commission © Copyright, The Joint Commission Must collect data on each measure in 4 selected core measure sets and report them to the Joint Commission quarterly The Joint Commission © Copyright, The Joint Commission Sample Report • Heart Attack Care (AMI) • Heart Failure (CHF) • Pneumonia • Critical Care • Children’s Asthma • Inpatient Psychiatric Services • Surgical Care (SCIP) • Venous Thromboembolism (VTE) • Stroke The Joint Commission © Copyright, The Joint Commission Core Measures Accreditation Programs Hospitals and critical access hospitals Home care services Long term care services Behavioral health care services Freestanding ambulatory organizations Freestanding laboratories The Joint Commission © Copyright, The Joint Commission – Pharmacies (home infusion, mail-order) – DMEPOS suppliers Certification Programs – – – – – Primary Stroke Center Chronic Kidney Disease COPD Diabetes (Inpatient) Transplant Center The Joint Commission CMS-programs – Lung Volume Reduction Surgery – Ventricular Assist Device Healthcare Staffing © Copyright, The Joint Commission Disease Specific Care The Joint Commission © Copyright, The Joint Commission The Survey Process Some Important Points Accreditation evaluates if the appropriate systems are in place to provide safe and effective healthcare. Only TJC standards surveyed – not others*. TJC standards specify what – not how. Focus is on patient safety and performance improvement (CQI) Standards are optimal achievable – not minimum or best practices. The Joint Commission * Do survey applicable law and regulation. © Copyright, The Joint Commission – Accreditation DOES NOT evaluate clinical practice or medical care decisions. Surveys The Joint Commission © Copyright, The Joint Commission Unannounced Full Survey (18-39 months) Special Unannounced Survey for Cause Random Validation Survey Extension Survey Conditional Follow-up Survey Surveyors Hospitals – Physician, Nurse, Administrator – Engineer – Ambulatory Surveyor – As appropriate: – CALS Survey The Joint Commission © Copyright, The Joint Commission Home Care, Behavioral, Long Term Care Survey Process – – – – – – Medication Management Infection Control Data Use Environment of Care/Disaster Planning Competence/Credentialing Leadership Priority Focus Process The Joint Commission © Copyright, The Joint Commission Unannounced Tracer Methodology System Tracers Priority Focus Process Clinical Service Groups – Selection of Tracer Patients – Selection of Priority Processes to Review – Identification of Relevant Standards The Joint Commission © Copyright, The Joint Commission Priority Focus Areas 2009 SII: Standard Improvement Initiative New numbering system (MM.01.02.04) Chapters reorganized alphabetically – Some new chapters – EM, TS, WT, RC Some requirements eliminated/moved EP’s rewritten for clarity but nothing new The Joint Commission © Copyright, The Joint Commission – Documentation & written policy/process identified Medicare Deemed Status – TJC standards more closely aligned with Medicare Conditions of Participation – TJC interpretation based on CMS interpretation – CMS input into survey process changes – New EP’s based on language specificity in COP Effective July 1, 2009 The Joint Commission © Copyright, The Joint Commission Implications of the Medicare Improvements for Patients and Providers Act of 2008 – Accred. Participation Requirements (APR) – Environment of Care (EC) – Emergency Management (EM) – Human Resources (HR) – Infection Prevention and Control (IC) – Information Management (IM) – Leadership (LD) – Life Safety (LS) – Medication Management (MM) – Medical Staff (MS) The Joint Commission – National Patient Safety Goals (NPSG) – Nursing (NR) – Provision of Care, Treatment & Services (PC) – Performance Improvement (PI) – Record of Care, Treatment and Service (RC) – Rights and Responsibilities of the Individual (RI) – Transplant Safety (TS) – Waived Testing (WT) Not Department Specific! © Copyright, The Joint Commission Manual Chapters Standards Standard Number (e.g. MM.04.01.02) Standards Statement (not scored) Rationale (not scored) Elements of Performance (scored) The Joint Commission © Copyright, The Joint Commission – Categories A (yes/no), C (frequency) – Direct Impact/Indirect Impact Scoring Requirement for Improvement (RFI) Surveyor only present report of findings Central Office determines accreditation status based on findings – Minimum number of direct impact standard scored required for central office review. The Joint Commission © Copyright, The Joint Commission – Any Standard with an EP scored noncompliant or partially compliant. – Direct vs. Indirect Impact Normal Follow-up Evidence of standards compliance (ESC) Six months after survey: – Submit data on MOS over past 4 months. The Joint Commission © Copyright, The Joint Commission – 45 days after survey for each standard with direct impact EP’s scored. – 60 days after survey for standards with only indirect impact EP’s scored. – “Measure(s) of success” (MOS) for some. Results posted on website (Quality Check). Accreditation Provisional Accreditation Conditional Accreditation Preliminary Denial of Accreditation Denial of Accreditation Not Accredited (never applied) The Joint Commission © Copyright, The Joint Commission Publicly Disclosed Decisions The Joint Commission © Copyright, The Joint Commission Standards and National Patient Safety Goals MM.2.20 Medication Storage MM.3.20 Medication Orders MM.4.10 Pharmacist Review MM.7.10 High Alert Medications MM.4.30 Medication Labeling MM.2.30 Emergency Meds all others 1% or less. The Joint Commission 37% 16% 5% 3% 3% 2% © Copyright, The Joint Commission Top MM Standards Scored Non-Compliant in 2008 Top Med-related NPSG Scored Non-Compliant in 2008 The Joint Commission 25% 19% 12% 15% 4% 2% © Copyright, The Joint Commission 3D Med Labeling in Procedures 8A Admission Med Reconciliation 8B Transfer/DC Med Reconciliation 2B Unapproved Abbreviations 3C: Look-Alike, Sound-Alike Drugs 1A: Two patient identifiers MM.02.01.01 Medication Selection and Procurement 2008 Non-Compliance = <0.5% Elements of Performance 1. Written criteria for formulary additions 2. Criteria, at minimum includes: Effectiveness, drug interactions, potential for errors/abuse, ADE, sentinel event advisories, other risks, costs. 3. Process to monitor pt. response to new drugs 4. Maintain formulary (incl. strength & dosage) 5. Formulary list is readily available The Joint Commission © Copyright, The Joint Commission – Elements of Performance 6. Standardize/limit number of available drug concentrations 7. Process for non-formulary medications 8. -- Implement this process 9. Formulary medications reviewed annually 10.Process to communicate medication shortages to LIP/staff 11.-- Implements this process The Joint Commission © Copyright, The Joint Commission MM.02.01.01 (cont.) Elements of Performance 12. Develops/approves medication substitution protocols for shortages/outages 13. -- Implement these substitution protocols 14. Communication process for substitution protocols to LIP/staff 15. -- Implements this communication process The Joint Commission © Copyright, The Joint Commission MM.02.01.01 (cont.) 2008 Non-compliance = 34.0% #1 MM Non-compliance Issue - #4 among all standards. EP 6. The hospital prevents unauthorized individuals from obtaining medications in accordance with its policy and law and regulation. – Medication Security The Joint Commission © Copyright, The Joint Commission MM.03.01.01 Safe Storage Medication Security effective 1/28/07 – All drugs and biologicals be kept in a secure area, and locked when appropriate. – Schedules II, III, IV, and V drugs must be kept locked within a secure area. – Only authorized personnel may have access to locked areas, as defined in policy. The Joint Commission © Copyright, The Joint Commission Revised Medicare Conditions of Participation – Federal Register 11/27/06, Medication Security L&D and ICUs considered secure if entry and exit are limited to appropriate staff, patients & visitors OR Suite is secure only if active and staffed Due to mobility, mobile carts must be in a locked room or under constant surveillance. Janitors, maintenance and other staff may have access ONLY if in organization policy Revised Interpretive Guidelines for Hospital COP. CMS Memo S&C-08-12, February 8, 2008 The Joint Commission © Copyright, The Joint Commission Medications at bedside only if self-administered MM.03.01.01 (cont.) No EP 1 EP 2. The hospital stores medications according to the manufacturer’s recommendations or, if none, according to a pharmacist's instructions. EP 3. The hospital stores controlled (scheduled) medications to prevent diversion, in accordance with law and regulation (DEA, state). The Joint Commission © Copyright, The Joint Commission – Refrigerator Temperatures MM.03.01.01 (cont.) EP 4. Written policy addressing the control of medication between receipt (removal from storage) by individual HCP (MD, RRT, RN ) and medication administration EP 5. The policy is implemented The Joint Commission © Copyright, The Joint Commission – including safe storage, handling, security, disposition, and return to storage. MM.03.01.01 (cont.) Elements of Performance 7. Stored drugs and components of drugs are labeled with contents, expiration date and appropriate warnings. Expiration date, not date opened 8. Removal & separate storage of expired, damaged, outdated medications 9. Storage and precautions for concentrated electrolytes 18. Periodic inspection of drug storage areas The Joint Commission © Copyright, The Joint Commission Most Ready-to-Administer MM.03.01.01, EP 10 – Floor stock medications MM.05.01.11, EP 4 – Medications dispensed – must be in the most ready-to administer form available from a manufacturer (unit dose, pre-filled syringes, premixed bags) either: Using the drug in that form repackaged by a licensed repackager. Using the drug in that form prepared or repackaged by the pharmacy. The Joint Commission © Copyright, The Joint Commission Using the manufacturer’s product NPSG.03.05.01 Anticoagulation Management – Note: For pediatric patients, pre-filled syringe products should only be used if specifically designed for children. The Joint Commission © Copyright, The Joint Commission EP 2: To reduce compounding and labeling errors, the hospital uses only oral unit dose products, pre-filled syringes, or pre-mixed infusion bags when these types of products are available. MM 03.01.03 Emergency Medications 2008 Non Compliance = 3.4% (#4) Elements of Performance 1. Medical staff decide which emergency medications and supplies will be accessible Crash cart, Emergency Boxes/Kits 2. Emergency medications/supplies are accessible in patient care areas 3. Unit-dose, age-specific, & most ready-toadminister form available 6. Replacement of emergency medications and supplies as soon as possible. The Joint Commission © Copyright, The Joint Commission 2008 Non Compliance = <0.5% Elements of Performance 1. Defines when medications brought in by patient or MD can be administered 2. Prior to use, identification and visual evaluation of integrity 3. Inform prescriber/patient if medications brought in are not permitted The Joint Commission © Copyright, The Joint Commission MM.03.01.05 Medications Brought In MM.05.01.07 Medication Preparation 2008 Non-Compliance = 2.5% (#6) Elements of Performance 1. Pharmacy compounds/admixes all compounded sterile preparations, except: Urgent situations where delay could harm patient When the product’s stability is short. Compounded product = 2+ drugs Admixture = addition of drug to <50ml bag/bottle. Exception: Closed transfer system Does not apply to reconstitution The Joint Commission © Copyright, The Joint Commission Elements of Performance 2. Use of clean/sterile techniques and clean, uncluttered, and functionally separate area for preparation. 3. Staff visually inspect medication for particulates, discoloration, or loss of integrity 4. Laminar airflow hood/ISO Class 5 environment in pharmacy and where product will not be used within 24 hours. A Word About USP 797 The Joint Commission © Copyright, The Joint Commission MM.05.01.07 (cont.) New COP Related EP – EP 6: In-house preparation of radiopharmaceuticals is done by, or under the supervision of, an appropriately trained registered pharmacist or doctor of medicine or osteopathy. The Joint Commission © Copyright, The Joint Commission MM.05.01.07 Medication Preparation MM.05.01.09 Medication Labeling – An immediately administered medication is one that is prepared or obtained, taken directly to a patient, and administered to that patient without any break in the process. 2. Label information in standardized format The Joint Commission © Copyright, The Joint Commission 2008 Non-compliance = 2.8% (#5) Elements of Performance 1. Medication containers are labeled whenever medications are prepared but not immediately administered MM.05.01.09 (cont.) Medication name, • strength, amount Expiration date (when used >24 hrs) Expiration time (if <24 hours) For compounded IV admixtures and TPN: Date prepared and diluent used When preparing individualized meds for multiple patients OR when medication is prepared by someone other than person administering it: The Joint Commission Patients name Location where medication is to be delivered Directions for use, accessory and cautionary instructions © Copyright, The Joint Commission Medication Labeling NPSG NPSG 03.04.01: Label all medications and solutions on and off the sterile field (25%) Use of pre-labeled containers or syringes not acceptable Preprinted labels OK The Joint Commission © Copyright, The Joint Commission – All medications and solutions labeled. – Name, strength, etc. – Actual containers labeled. – Must be labeled immediately before or after transfer as part of same process. 2008 Non-compliance = <0.5% Elements of Performance 1. Process for providing medications when pharmacy is closed When non-pharmacist health care professionals obtain medications after pharmacy closed: 2. Medications limited 3. Medications stored/secured outside pharmacy The Joint Commission © Copyright, The Joint Commission MM.05.01.13 Medication After Hours Elements of Performance 4. Only designated prescribers/nurses have access to limited supply (never to pharmacy) 5. Quality control measures are used to prevent medication retrieval errors 6. Pharmacist available on-call or at another location to answer questions and access pharmacy after-hours. 7. Implements process The Joint Commission © Copyright, The Joint Commission MM.05.01.13 (cont.) 2008 Non-compliance = 0.6% Elements of Performance 1. Written policy for retrieval/handling recalled and discontinued medications by mfgr/FDA 2. Implements policy 3. When drug recalled/discontinued, notifies those who prescribe, dispense, administer 4. Inform patients when their medications are recalled and discontinued. The Joint Commission © Copyright, The Joint Commission MM.05.01.17 Recalled, Discontinued Medications 2008 Non-compliance = <0.6% Elements of Performance 1. Determines under what circumstances unused, expired, or returned medication will be managed by the pharmacy or hospital 2. Process for returning medications to pharmacy’s control 3. When outside sources used for destruction 4. Implements process The Joint Commission © Copyright, The Joint Commission MM.05.01.19 Returned Medications MM.06.01.05 Investigational Medications 2008 Non-compliance = <0.5% Elements of Performance Written process: 1. Use of investigational medications review, approval, supervision, and monitoring. 2. Specifies pharmacy controls storage, dispensing, labeling, and distribution 3. Accommodates continued participation 4. Processes implemented The Joint Commission © Copyright, The Joint Commission – EC.02.02.01 Hazardous Material 2008 Non-compliance = 1% Elements of Performance 1. The hospital maintains a written, current inventory of hazardous materials and waste that it uses, stores, or generates. 3. Has written procedures (including precautions, PPE) to follow in response to hazardous material and waste spills or exposures. 4. Procedures are implemented The Joint Commission © Copyright, The Joint Commission The only materials that need to be included on the inventory are those whose handling, use, and storage are addressed by law and regulation. Hazardous Medications EC.02.02.01 MM.01.01.03 4. Minimizes risks associated with managing hazardous medications. The Joint Commission © Copyright, The Joint Commission 8. Minimizes risks associated with disposing hazardous medications. 11. Has all hazardous material and waste permits, licenses, manifests, and MSDS required by law and regulation. Emergency Management The Joint Commission © Copyright, The Joint Commission EM.01.01.01 – The hospital keeps a documented inventory of the resources and assets it has on site that may be needed during an emergency, including… medicationrelated resources and assets. EM.02.01.01 – Addresses preparedness, mitigation, response and recovery. – Identifies the hospital’s capabilities and establishes response procedures for when the hospital cannot be supported by the local community for at least 96 hours. The Joint Commission © Copyright, The Joint Commission Emergency Operations Plan Emergency Operations Plan The Joint Commission © Copyright, The Joint Commission EM.02.02.01 Emergency Operations Plan addresses – How the hospital will communicate with purveyors of essential supplies, services, and equipment during an emergency. Emergency Operations Plan EM.02.02.03 Emergency Operations Plan addresses – Including access to and distribution of caches that may be stockpiled by the hospital, its affiliates, or local, state, or federal sources. 2. Medical Supplies 3. Non-medical Supplies The Joint Commission © Copyright, The Joint Commission 1. How the hospital will obtain and replenish medications and related supplies required throughout the emergency & recovery from it. EM.02.02.03 (con’t) 4. How it will share resources and assets with other health care organizations within the community, if necessary. 5. -- and outside the community in the event of a regional or prolonged disaster. 6. How it will monitor quantities of its resources and assets during an emergency. 9. Arrangements for transporting some or all patients, their medications, supplies, equipment, and staff to an alternative care site, if necessary. The Joint Commission © Copyright, The Joint Commission Emergency Operations Plan addresses EOP Implementation EM.02.02.03 EM.03.01.01 Documented annual review of its inventory list. EM.03.01.03 Implements its EOP (real or drill) twice a year (not table-top). The Joint Commission © Copyright, The Joint Commission 12. The hospital implements the components of its Emergency Operations Plan that require advance preparation to provide for resources and assets during an emergency. NPSG 02.02.01 Do Not Use Abbreviations The Joint Commission © Copyright, The Joint Commission 2008 Non-compliance = 18.3% QD, QOD, U, IU, MS, MgSO4, MS04, Leading decimal, trailing zero Computer entries, preprinted forms. NPSG 03.03.01 LASA Drugs The hospital identifies a list of look-alike/sound-alike medications used by the hospital. The hospital reviews the list of look-alike/sound-alike medications at least annually. The hospital takes action to prevent errors involving the interchange of the medications on the list of lookalike/sound-alike medication list. The Joint Commission © Copyright, The Joint Commission 2008 Noncompliance = 5% (#9 tied) Elements of Performance NPSG 03.03.01 (cont.) Top Compliance Issue – Not following own policy e.g. insulin not segregated in unit refrigerators The Joint Commission © Copyright, The Joint Commission – Most organizations not implementing effective actions – most errors in past year have been related to LASA issues. Other Standards IM.03.01.01 The Joint Commission © Copyright, The Joint Commission – Knowledge based information are up-todate and available. For Further Information Sentinel Event Alert Joint Commission Online – Pre-publication Standards Current Standards (CAMH) and Perspectives must be obtained from hospital TJC coordinator The Joint Commission © Copyright, The Joint Commission www.jointcommission.org – FAQ for current standards – FAQ for current NPSG – Copy of 2009 NPSG – Current and Past Copies of: Questions – Calling the Standards Interpretation Unit at 630792-5900 – Submitting the question in writing by using the following on-line form: http://www.jointcommission.org/Standards/Online QuestionForm/ The Joint Commission © Copyright, The Joint Commission For questions about the interpretation of Joint Commission standards, organizations (or the public) can submit their questions by either: Disclaimer These slides are only meant to be cue points, which were expounded upon verbally by the original presenter and are not meant to be comprehensive statements of standards interpretation or represent all the content of the presentation. Thus, care should be exercised in interpreting Joint Commission requirements based solely on the content of these slides. These slides are copyrighted and may not be further used, shared or distributed without permission of the original presenter or the Joint Commission The Joint Commission © Copyright, The Joint Commission This presentation is current as of June 21, 2009. The Joint Commission reserves the right to change the content of the information, as appropriate.