48 th Annual Meeting. On the Radar: Regulatory Basics. Regulatory Agencies. The Joint Commission. Disclosure. Objectives. The Joint Commission

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1 48 th Annual Meeting On the Radar: Regulatory Basics Alissa Voils, PharmD, MSHA Assistant Director, Inpatient Operations UF Health Shands Hospital Regulatory Agencies The Joint Commission (TJC) Florida Board of Pharmacy Centers for Medicare and Medicaid Services (CMS) Agency for Health Care Administration (AHCA) Occupational Safety and Health Administration (OSHA) Environmental Protection Agency (EPA) Navigating the Oceans of Opportunity Disclosure I do not have a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation The Joint Commission Mission: To continuously improve health care for the public, in collaboration with stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value Vision: All people always experience the safest, highest quality, best value health care across all settings Objectives Discuss key regulatory agencies, their scope, and objectives Define common regulatory acronyms Discuss significance of regulatory compliance and how it applies to you Review most common medication management regulatory compliance issues Review hospital and departmental survey readiness strategies The Joint Commission Largest accrediting body in health care Establish standards for care Develop quality metrics Demonstrates compliance with CMS Conditions of Participation Other health care organization accrediting agencies Healthcare Facilities Accreditation Program (HFAP) Det Norske Veritas Healthcare, Inc. (DNV) Center for Improvement in Healthcare Quality (CIHQ) Certification/SurveyCertificationGenInfo/Downloads/CMS-Approved-Accreditation- Organizations.pdf 1

2 Florida Board of Pharmacy Legislatively established to ensure pharmacists and pharmacies meet minimum requirements for safe practice Responsible for licensure, monitoring, and education Authorized to inspect any site in the state containing drugs and medical supplies Annual inspections or every 2 years if passing inspections and no discipline for most current 3 years (64B ) Occupational Safety and Health Administration Assure safe and healthful working conditions by setting and enforcing standards and by providing training, outreach, education and assistance Hazardous materials handling, hazardous waste, PPE, noise, egress, fire safety, emergency plans Inspect without advance notice Inspections focus on imminent danger, fatalities and casualties, complaints, referrals from other agencies, and planned investigations for high-hazard industries Centers for Medicare and Medicaid Services Goals: Covering more Americans Coordinating better care and lowering costs Making Americans healthier by preventing illness CMS investigates complaints against and randomly validates TJC accredited organizations CMS requirements and TJC elements of performance are aligned Environmental Protection Agency Federal research, monitoring, standard-setting, and enforcement activities to ensure environmental protection State Agency Florida Department of Environmental Protection Pharmaceutical waste management Resource Conservation and Recovery Act (RCRA) Universal Pharmaceutical Waste (UPW) Agency for Health Care Administration Mission: Better health care for all Floridians Administer state Medicaid program License and regulate health facilities Share health care data through Florida Center for Health Information and Policy Analysis Goals: Reduce # uninsured Target fraudulent providers Maximize $$ to serve patients TJC Medication Management Standards Top non-compliant standards 2013 (1 st 6 months) MM Medication Storage 33% MM Medication Orders 24% MM Pharmacist Review 15% NPSG Labeling in Procedures 12% MM High Alert Meds 6% MM Medication Labeling 6% NPSG Med Reconciliation 5% Joint Commission Resources Quality & Safety Network. Resource Guide. Solutions Part 3: How to Meet the Most Challenging MM Medication Management and Patient Care Standards. Medication 5/22/14. Preparation 5% 2

3 Medication Storage MM The hospital safely stores medications EP2: Store according to manufacturer recommendations Refrigerated meds stored in refrigerator or nonrefrigerated out of the refrigerator (RSI, kits) Evidence that refrigerator temps are logged daily and appropriate actions for excursions are noted Vaccine refrigerator temperature monitoring twice daily Temps logged daily for warmers, appropriate storage temp and beyond use dating for items placed in warmer Medication Orders MM Medication orders are clear and accurate Hospital policy to define acceptable types of med orders and associated processes Range orders Blanket resume orders prohibited Device orders Process for clarifying med orders Verbal/telephone orders minimized Indication for all med orders Order sets reviewed in defined timeline Medication Storage EP3: Medications are secure Controlled Substances Carts Stashed meds Tube stations in secure area Bedside meds secured EP4: Policy to address control of meds between receipt and administration by HCP EP6: Prevent unauthorized access to meds Pharmacist Review MM A pharmacist reviews all med orders Prior to dispensing or removing from ADC or floor stock unless licensed independent practitioner controls ordering, prep, and administration ED exception Radiology Non 24 hour pharmacy responsibilities Qualified HCP reviews in pharmacist absence Pharmacist performs retrospective review Medication Storage EP7: Meds are labeled with contents, expiration date, warnings Unlabeled or inappropriately labeled MDV Items in warmers dated appropriately EP8: Expired meds removed, stored separately EP18: Periodic med storage inspections Labeling in Procedures NPSG Label all meds, med containers, and solutions on and off sterile field Label when transferred from original container and not administered immediately Label even if only one med used Include med name, strength, diluent and volume, expiration date if not used within 24 hours, expiration time if less than 24 hours Discard any unlabeled solutions Discard all at end of procedure 3

4 High Alert Medications MM More likely to be involved in errors or sentinel events High Alert Med Policy High alert and hazardous identified in writing Hazardous med handling and disposal How is policy implemented? Medication Preparation MM Med prep by pharmacy unless urgent situation where delay could harm patient Functionally separate prep area on nursing units ISO class 5 for sterile product prep In house prep of radiopharmaceuticals under supervision of pharmacist or physician Medication Labeling MM All meds and med containers must be labeled When prepared but not immediately administered Labels for meds prepared in hospital contain med name, strength, amount, prep date, diluent for IVs Exp date if not used within 24 hours, exp time if expires in less than 24 hours If prepare meds for multiple patients or if prepared by someone other than the person administering: Patient name, location, directions, accessory labels Other Survey Tips Include individuals in the MM session that understand the processes and can effectively respond; from various areas Be able to discuss processes for handling drug shortages, how communicated to medical staff, strategies to minimize potential for error Nurses should be able to discuss under what circumstances an IV would not be prepared by pharmacy Be able to discuss committee structures and representation; minutes readily retrievable Medication Reconciliation NPSG A good faith effort to obtain an accurate med list Upon admission Non 24 hour settings should define specific information to collect Provide written list of meds upon discharge Educate patient on importance of maintaining an accurate list and providing copy to PCP Impacts Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) %20Mail%20Survey%20Materials%20%28English%29%20March% pdf Other Survey Tips If CPOE, know what areas are on auto-verify and what drugs pharmacy does or does not verify Make sure personnel files are up to date Files randomly selected for review If file format standardized across the organization, much easier for surveyor to find what they need and complete this task Proof of primary source licensure verification before employees begin work and prior to expiration Competency based orientation Annual competencies 4

5 Board of Pharmacy Current permit, DEA registration, and pharmacists licenses displayed Proper tech ratio, board approval for 2:1 or 3:1; P&P detailing utilization of techs Supplies including balance and weights CS records maintained for 4 years & readily retrievable, DEA 222 forms completed properly, current biennial inventory available, P&P for destruction of unusable CS Prepack P&P, appropriate labeling of prepacks, checked by pharmacist Compounding Sterile Preparations (64B ) High risk Media fills for all personnel compounding high risk within 6 months Antimicrobial testing prior to dispense if >25 units prepared Medium and low risk Media fills within 12 months State of Florida, Department of Health, Investigative Services, Class II Institutional Pharmacy Inspection Form, Board of Pharmacy Inventory checked for outdates at least every 4 months Pharmacist compounds or is physically present to verify accuracy Records indicate pharmacist that reviewed med orders CQI program outlined in P&P, summary of quality related events reviewed by committee quarterly State of Florida, Department of Health, Investigative Services, Class II Institutional Pharmacy Inspection Form, Beyond Use Dating High Risk 24 hours CRT 3 days refrigerated Medium Risk 30 hours CRT 9 days refrigerated Low Risk Storage 48 hours CRT 14 days refrigerated All CSPs 45 days frozen U.S. Pharmacopeia, 2012 USP 35 NF 30, USP-NF General Chapter <797>, Pharmaceutical Compounding Sterile Preparations, Board of Pharmacy 64B will incorporate the following USP chapters effective October 1, 2014 Chapter 797, Pharmaceutical Compounding-Sterile Preparations; Chapter 1160, Pharmaceutical Calculations in Prescription Compounding; Chapter 71, Sterility Tests; Chapter 85, Bacterial Endotoxins Test; Chapter 731, Loss on Drying; and Chapter 1231, Water for Pharmaceutical Purposes. Notice of Proposed Rule Change, Department of Health, Board of Pharmacy, 64B Standards of Practice for Compounding Sterile Preparations (CSPs) Immediate Use Products Simple aseptic manipulations No more than 3 non-hazardous drugs including infusion solution Prep does not exceed 1 hour No direct exposure via contact contamination Administration begins within 1 hour of start of prep Must be labeled if not administered by the person who prepared 5

6 Compounding Environment Compounding environment certified by independent contractor Annually for medium and low risk Semi-annually for high risk ISO 8 anteroom ISO 7 buffer room/clean room (separate high risk area) No sinks or drains in buffer area ISO 5 laminar air flow hoods CMS update 6/6/2014 Timing of Medication Administration Policy must specify: Meds that are eligible and not eligible for scheduled dosing times Administration of eligible meds outside administration times Are patients assessed for risk, especially with high alert meds; do staff know intervention protocols? IV med patient monitoring IV opioids-over-sedation, respiratory depression particularly post-op CMS Manual System Pub State Operations Provider Certification, DHHS, CMS, Transmittal 116, June 6, Cytotoxic Prep & Handling Cytotoxics prepared in vertical BSC in negative pressure room Staff garbed in protective apparel including at least gloves and gown with tight cuffs Spills kits available Appropriate disposal of cytotoxic waste AHCA Validate consultant pharmacist of record, appropriate permit(s), licenses current P&T committee meets regularly, minutes available Comprehensive pharmacy P&P, evidence that periodically reviewed How does pharmacy support hospital QI committee? Consistent with Florida statutes, ASHP, FDA, USP Compounding Sterile Preparations (64B ) P&P includes: Use of SDV/MDV not to exceed USP 797 Training and evaluation of aseptic technique Verification of accuracy and sterility Environmental quality and control Current references readily available Appropriate disposal containers and garb Documented ongoing QA at regular intervals Documentation of observation/skills based training OSHA More hospital full time employee days lost compared to other high risk industries Negatively impacts workers comp claims, staffing, morale, and patient safety Create safety culture; awareness of physical environment and work practices Remove employee and patient hazards Safety Data Sheets Safe storage and proper handling of flammables, cytotoxics, hazardous materials 6

7 Florida Department of Environmental Protection Universal Pharmaceutical Waste Must have an EPA identification number before accumulating Universal Pharmaceutical Waste Container must be closed except when adding or removing waste Container labeled with phrase universal pharmaceutical waste Container must be labeled with accumulation start date Hazardous Waste Determination Resources zardous_waste_determination_guidance.pdf aceuticals.htm Regulatory Compliance Supports safe, high quality health care Improves coordination of care Prevents injury and illness Protects community and environment Financial benefit through insurance contracts, recognition as a quality provider, avoidance of fines The right thing to do 7

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