2/15/2012 Disclaimer The ASHP Research and Education Foundation requires that all faculty disclose any relevant financial relationships. These relationships should not be assumed to have an adverse should not be assumed to have an adverse Patricia C. Kienle, R.Ph., MPA, FASHP impact on faculty presentations. Director, Accreditation and Medication Safety No relevant financial relationships exist. Cardinal Health Pharmacy Solutions Patricia C. Kienle is an employee of Cardinal patricia.kienle@cardinalhealth.com Health. 1 2 Objectives Who Makes the Rules? List recent changes in CMS Hospital Conditions of Participation related to medications Accreditation Identify the top Joint Commission non-compliant Regulations medication issues medication issues Cite recent changes in JC standards Practice Discuss the requirements for medication integrity State the required elements of a medication order List policy requirements for timing of medication administration How We Treat Patients 3 4 Regulatory Agencies More Regulatory Agencies Federal and state Drug Enforcement Administration agencies that affect Food and Drug Administration licensing and/or operation Occupational Health and Safety Administration Occupational Health and Safety Administration of a hospital of a hospital Nuclear Regulatory Commission Centers for Medicare and Medicaid Services (CMS) … State Department of Health State Board of Pharmacy 5 6 1
2/15/2012 Accreditation Organizations Standards of Practice The Joint Commission United States Pharmacopeia American Osteopathic Association ASHP – Best Practices Healthcare Facilities Accreditation Program DNV Healthcare National Integrated Accreditation for Healthcare Organizations 7 8 CMS Conditions of Participation Parts of the CoPs Basis for regulatory Condition of Participation requirements and Tag number accreditation standards Interpretive Guidelines Pharmaceutical Services Pharmaceutical Services, Survey Procedures and Medical Records Nursing Services Nuclear Medicine 9 10 § 482.25 Pharmaceutical Services … Pharmaceutical Services … Meet needs of the patients All drugs and biologicals kept in a secure area, and locked when appropriate Drug storage Controlled substances locked within a secure area Responsible pharmacist Only authorized personnel have access to locked O l th i d l h t l k d Adequate number of personnel areas Accurate records of scheduled drugs Outdated, mislabeled, or otherwise unusable drugs Controlled and distribution meets applicable and biologicals not available for patient use standards of practice, law, and regulation Compounding only under pharmacist supervision and consistent with laws Policies 09-02-H, 09-03-P, 18-09-H, 20-01-H, RX15-05 Policies 02-02-P, 02-05-P, 22-01-P, RX15-03, RX15-04 11 12 2
2/15/2012 … Pharmaceutical Services Other Medication ‐ Related CoPs Only authorized personnel remove drugs and Medical Record Services biologicals from a storage area § 482.24(c)(1) Automatic stop order policy Orders Errors, ADRs, and incompatibilities reported to E ADR d i tibiliti t d t Protocols P t l attending physician and hospital committee Nursing Services § 482.23(c) Abuses and losses of controlled substances reported to DOP and CEO Administration of medications Drug information available to professional staff Nuclear Medicine Services § 482.53(b) Formulary system In-house preparation of radio pharmaceuticals Policies 05-01-P, 08-02-H, 10-05-H, 20-01-H, RX14-01, RX15-01 13 Policies 10-02-H, 13-01-H, RX08-02 14 Recent CoP Changes TJC Top Non ‐ Compliant Issues Orders and protocols Rank Standard Non- Required elements Compliant Authentication of multi-page orders 1 1 RC 01 01 01 RC.01.01.01 The hospital The hospital 65% 65% Timing of medication administration Ti i f di ti d i i t ti maintains complete and accurate Change in the “30 minute” rule medical records for each patient 6 MM.03.01.01 The hospital 33% safely stores medications 10 MM.04.01.01 Medication orders 28% are clear and accurate Policies 10-02-H, 13-09-H 15 16 2011 Joint Commission Changes Key Areas for Compliance Selection MM.02.01.01 Selecting Medications Pediatric issues Select Store Prelabeling of syringes Storage Integrity of meds Integrity of meds Orders Monitor Order Protocols Dispensing Labeling syringes Administer Dispense Administration Timing Policies 08-02-H, 11-05-P, 11-09-H 17 18 3
2/15/2012 Selection of Medications Storage of Medications MM.02.01.01: The hospital selects and procures Security medications Safety EP 2: The hospital develops criteria for selecting Integrity of medications medications, which, at a minimum, include the di ti hi h t i i i l d th following: … Population(s) served (for example, pediatrics, geriatrics) … Also added pediatric focus to two PC standards Pain management and risks for falls Policies 08-02-H, 08-03-H, 22-20-P Policies 09-01-P, 09-02-H, 13-03-H, RX15-05 19 20 Security – Controlled Substances Security – All Medications Lock all controlled Lock all meds unless hospital policy permits substances otherwise Include C-V Define who is authorized to access medications Include procedural Automated and manual systems must meet same I l d d l A t t d d l t t t areas and clinics standards No unauthorized Flush solutions access Policies 09-01-P, RX15-05 21 22 Are these secure? Integrity of Medications In date Correct temperature Use manufacturer’s information information Policies 09-01-P, 09-02-H, 09-03-P, 09-04-H 23 24 4
2/15/2012 Manufacturers’ Information Use Manufacturer’s Storage Info CMS CoP § 482.41 – Temperature Control Storage temperature Room temperature The hospital must ensure that …pharmaceuticals are stored properly and in accordance Moving refrigerated with with…manufacturer s recommendations… manufacturer’s recommendations items to room items to room temperature MM.03.01.01 – Safe Storage Moving room EP 1 - The hospital stores medications according to temperature items to the manufacturers’ recommendations or, in the warmers absence of such recommendations, according to a pharmacist’s instructions Problematic drugs Policies 09-01-P, 09-02-H, 09-04-H, 09-06-H Policies 09-02-H, 09-04-H, 09-06-H 25 26 Manufacturers’ Information Refrigerator to room temperature Succinylcholine, insulin, lorazepam Room temperature to refrigerator Magnesium citrate, barium Room temperature to warmer Irrigation solutions IV contrast Point-of-Care ial/bag systems BUD of bag outside of overwrap Policies 09-01-P, 09-02-H, 09-04-H, 09-06-H 27 28 Orders – Required Elements Orders Name of patient Must be unambiguous Age and weight of patient, when applicable Legible Date and time of the order Complete Dated and timed D t d d ti d Drug name Applies on any type of order Exact strength or concentration, when applicable Handwritten Dose, frequency, and route Preprinted Quantity and/or duration, when applicable Electronic Specific instructions for use, when applicable Protocols Name of prescriber Detailed information in CoP Policies 10-01-H, 10-02-H, 10-09-H Policies 10-01-H, 10-02-H, 10-09-H 29 30 5
2/15/2012 Medication Protocols Is this a clear, unambiguous order? Develop with prescriber(s) Consistency of practice Unique name of protocol Avoid therapeutic duplication if possible A id h i d li i if ibl Orders require objective parameters Taper Titrate Therapeutic duplication CMS views this as a medical decision, not one of convenience or non-LIP judgement Policies 10-01-H, 10-02-H, 10-09-H 31 32 Prelabeling Syringes Is this safe? NPSG.03.04.01: Labeling medications Deals with labeling during procedures MM.05.01.09: Medications are labeled Communication between The Joint Commission and the American Society of Anesthesiologists The Joint Commission no longer prohibits pre-labeling syringes Policies 11-05-P, 11-09-H, 22-05-H Policy 11-09-H 33 34 Policy Elements Medication Administration Timing Change in the “30 minute rule” Establish standard times November 2011 change in CMS Interpretive Develop written policy that includes Guidelines and Survey Procedures Meds not eligible for standard dosing times Change advocated by ASHP, ISMP, and Joint Ch d t d b ASHP ISMP d J i t Meds eligible for standard dosing times Commission Time-critical scheduled medications Hospital needs to define policy and medications that Action for medications outside of scheduled dosing are time-critical and must be given within 30 minutes times and windows of the scheduled time Policies 13-01-H, 13-09-H Policies 13-01-H, 13-09-H 35 36 6
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