482.25 Condition of Participation: Pharmaceutical Services
482.25 Condition of Participation: Pharmaceutical Services Condition-A-0489 Standards-A-0490 through A-0511 2
482.25 Condition of Participation: Pharmaceutical Services Pharmaceutical services that meets the needs of patients Directed by a registered pharmacist Policies and procedures that minimize drug errors Delegation of duties -A-0489 3
482.25 Condition of Participation: Pharmaceutical Services The hospital must have pharmaceutical services that meet the needs of the patients The scope and complexity must be consistent with the volume and types of patients -A-0490 4
CMS Survey Process for 482.25 Evidence of the scope and complexity of pharmaceutical services Evaluation of pharmaceutical services by pharmacy staff Availability and timeliness of medications -A-0490 5
482.25(a) Pharmaceutical Services: Pharmacy Management and Administration The medical staff is responsible for developing policies and procedures that minimize drug errors. The pharmacy or drug storage area must be administered in accordance with accepted professional principles. -A-0491 6
482.25(a) Pharmaceutical Services: Pharmacy Management and Administration Pharmaceutical services includes: Procuring, manufacturing, compounding, packaging, dispensing, ordering, distributing, disposition, use, and administering of medications, biologicals, chemicals, and medication related devices Provision of medication related information Provision of medication related care -A-0491 7
482.25(a) Pharmaceutical Services: Pharmacy Management and Administration Policies and procedures to minimize drug errors High alert medications Investigational medications Adherence to professional standards Standardization of medication delivery devices Up to date resource information Availability of pharmacy expertise -A-0491 8
482.25(a) Pharmaceutical Services: Pharmacy Management and Administration Policies and procedures to minimize drug errors Standardization of prescribing and communication practices Avoid dangerous abbreviations Include all elements of the order Alerts for sound alike/look alike drugs Use of pre-printed order sheets Prohibition of resume orders -A-0491 9
482.25 Condition of Participation: Pharmaceutical Services Policies and procedures to minimize drug errors Availability of patient specific information Patient weights Non-punitive reporting of medication errors and ADRs Monitoring drug recalls QAPI integration -A-0491 10
CMS Survey Process for 482.25 Ensure procurement, distribution, and control of all medications Pharmacy or drug storage area Delegation of policies and procedures Policies and procedures according to accepted professional principles Training Monitoring for adherence to policies and procedures -A-0491 11
482.25(a)(1) Pharmaceutical Services: Pharmacy Management and Administration The hospital must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services. -A-0492 12
CMS Survey Process for 482.25(a)(1) Pharmacy directors responsibilities Appointment by governing body Education and training Job description Time present in pharmacy Oversight and accountability Specific responsibilities -A-0492 13
482.25(a)(2) Pharmaceutical Services: Pharmacy Management and Administration The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services. -A-0493 14
CMS Survey Process for 482.25(a)(2) Determine the hours of operation Review the number of pharmacy employees Review the types of pharmacy employees Review the training of the pharmacy employees Interview hospital staff regarding the length of time to get medications on the units and in the ED -A-0493 15
482.25(a)(3) Pharmaceutical Services: Pharmacy Management and Administration Current and accurate records must be kept of the receipt and disposition of scheduled drugs. Accountability procedures Records of receipt and disposition Trace movement of medications Monitoring drug records System to monitor loss or theft -A-0494 16
CMS Survey Process for 482.25(a)(3) Review records for controlled substances (scheduled drugs) Track scheduled drugs through the service Determine there is a system for theft, loss, or diversion Review policies and procedures -A-0494 17
482.25(b) Pharmaceutical Services: 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. Controlled Substance Act http://www.fda.gov/regulatoryinformation/legisl ation/ucm148726.htm#cntlsbb -A-0500 18
482.25(b) Pharmaceutical Services: Delivery of Services (cont.) Medication orders Therapeutic appropriateness Drug duplication Appropriateness of the drug, dose, frequency, route, and method of administration Drug and food interactions Allergies -A-0500 19
482.25(b) Pharmaceutical Services: Delivery of Services (cont.) Other Medication Management Issues Recalls Patient s own medications Administration Documentation Reconciliation Scheduled medications that are not administered -A-0500 20
482.25(b) Pharmaceutical Services: Delivery of Services (cont.) Monitoring the effects of medications Review clinical and lab data Review physical signs and symptoms Assess the patient s perception -A-0500 21
CMS Survey Process for 482.25(b) All medications are reviewed by a pharmacist Medication orders are clarified and documented Monitors for effectiveness of medication therapies Process for recalls is implemented -A-0500 22
CMS Survey Process for 482.25(b) (cont.) Evaluation, use, and monitoring of drug delivery systems Limits on high alert medications Reporting of serious adverse drug reactions Unauthorized usage and distribution Drug storage -A-0500 23
482.25(b)(1) Pharmaceutical Services: Delivery of Services All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. Development of policies and procedures to ensure medications are prepared by authorized personnel Follow safe preparation procedures -A-0501 24
482.25(b)(1) Pharmaceutical Services: Delivery of Services Compounding Pharmacies Registered Outsourcing Facility (503B) 503A Pharmacies -A-0501 25
482.25(b)(1) Pharmaceutical Services: Delivery of Services Registered Outsourcing Facility (503B) Drug Quality and Security Act (DQSA) Election to register as outsourcing facility Complies with FDA s Current Good Manufacturing Practice (CGMP) requirements http://www.fda.gov/drugs/guidancecomplianceregula toryinformation/pharmacycompounding/default.htm Inspected by FDA Meet conditions for reporting ADRs and providing info about the medications compounded -A-0501 26
482.25(b)(1) Pharmaceutical Services: Delivery of Services 503A Pharmacies Compounding pharmacy Not registered with FDA Regulated under state Board of Pharmacy Hospital responsible for demonstrating that medications are prepared under accepted professional standards -A-0501 27
CMS Survey Process for 482.25(b)(1) Compounding, labeling, and dispensing medications by qualified persons Policies and procedures Drug storage areas Removing medications when the pharmacy is closed Compounded sterile products (CSPs) according to USP 797 Quality oversight of compounding facilities -A-0501 28
482.25(b)(2)(i) Pharmaceutical Services: Delivery of Services All drugs and biologicals must be kept in a secure area, and locked when appropriate. Restricted access Closed units Anesthesia carts Automated dispensing units -A-0502 29
CMS Survey Process for 482.25(b)(2)(i) Review policies and procedures address securing medications Review policies and procedures and interview patients that are self-administering medications Observe drug storage areas -A-0502 30
482.25(b)(2)(ii) Pharmaceutical Services: Delivery of Services Drugs listed in Schedules II, III, IV, and V of the Comprehensive Abuse Prevention and Control Act of 1970 must be kept locked within a secured area. Automated dispensing devices Mobile medication carts -A-0503 31
CMS Survey Process for 482.25(b)(2)(ii) Review policies and procedures regarding storage of controlled drugs Observe controlled drug storage areas Observe automated dispensing devices -A-0503 32
482.25(b)(2)(iii) Pharmaceutical Services: Delivery of Services Only authorized personnel may have access to locked areas. Policies and procedures Supervision requirements -A-0504 33
CMS Survey Process for 482.25(b)(2)(iii) Review policies and procedures that define authorized personnel Review policies and procedures for limiting access to locked storage areas Observe drug storage areas -A-0504 34
482.25(b)(3) Pharmaceutical Services: Delivery of Services Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use. Pharmacy labeling, inspection, and inventory management system Beyond use dates (BUD) Labeling of floor stock Unit dose packaging -A-0505 35
CMS Survey Process for 482.25(b)(3) Review labels of drug containers Review floor stock medications Review unit dose medications Inspect patient specific and floor stock medications for expired, mislabeled or unusable medications -A-0505 36
482.25(b)(4) Pharmaceutical Services: Delivery of Services When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service in accordance with Federal and State law. Policies and procedures for meeting patient s needs Safeguards -A-0506 37
CMS Survey Process for 482.25(b)(4) Review hours of operation Review policies and procedures for removal of medications from the pharmacy by nonpharmacists Review documentation (log) of medications removed Interview the Pharmacist regarding supply of after hours medications and oversight of after hours medication removals -A-0506 38
482.25(b)(5) Pharmaceutical Services: Delivery of Services Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff. Facility makes determination -A-0507 39
CMS Survey Process for 482.25(b)(5) Review policies and procedures Review medical records Interview nursing and pharmacy staff -A-0507 40
482.25(b)(6) Pharmaceutical Services: Delivery of Services Drug administration errors, adverse drug reactions (ADRs), and incompatibilities must be immediately reported to the attending physician and to the hospital s quality assessment and performance improvement program (QAPI). Development of policies and procedures Non-punitive reporting of medication errors -A-0508 41
CMS Survey Process for 482.25(b)(6) Review policies and procedures for medication errors, adverse drug reactions (ADRs), and incompatibilities Review patient s medical records Review the medication error reporting process Review QAPI data, P&T minutes Review reporting requirements to State and Federal agencies -A-0508 42
482.25(b)(7) Pharmaceutical Services: Delivery of Services 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 CEO, as appropriate. -A-0509 43
CMS Survey Process for 482.25(b)(7) Observation of medications and accounting records Review controlled drugs inventory records Interview pharmacist regarding policies and procedures Review actions for accounting problems Review actions for suspected diversion -A-0509 44
482.25(b)(8) Pharmaceutical Services: Delivery of Services Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff. Pharmacist must be available for consultation -A-0510 45
CMS Survey Process for 482.25(b)(8) Review the resource information available at nursing stations Review the process for EHR updates Interview the pharmacist -A-0510 46
482.25(b)(9) Pharmaceutical Services: Delivery of Services A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs. Medications available for dispensing and administration Non formulary approval and procurement process Procurement of medications in a disaster -A-0511 47
CMS Survey Process for 482.25(b)(9) Review the formulary and interview the pharmacist regarding the formulary Review process that ensures medications are periodically reviewed for safety and efficacy Review process for adding medications Review process for communicating additions, deletions, short supply medications, disaster Determine availability of medications -A-0511 48