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ACHC ACCREDITATION GUIDE TO SUCCESS WORKBOOK [

PHARMACY ]

ACHC ACCREDITATION GUIDE TO SUCCESS WORKBOOK [

PHARMACY ]

TABLE OF CONTENTS INTRODUCTION ACHC Disclaimer.................................................................. 9 How to Use This Workbook............................................ 11 Programs for Accreditation........................................... 11 QUICK STANDARD REFERENCE Section 1.................................................................................. 13 Section 2.................................................................................. 13 Section 3.................................................................................. 13 Section 4................................................................................. 14 Section 5.................................................................................. 14 Section 6................................................................................. 14 Section 7...................................................................................15

SURVEY PROCESS PRE-SURVEY PREP Federal, State & Local Regulations............................17 Download Standards.........................................................17 Standard Format............................................................... 18 Writing Policies & Procedures ................................... 19 Submitting Required Documents................................21 Online Application...............................................................21 Extended Policy Review Option..................................22 Preparing Your Organization........................................22 Education of Staff.......................................................22 Auditing............................................................................23 Practice Run...................................................................23

ON-SITE SURVEY PROCESS Survey Etiquette.................................................................23 Opening Conference.........................................................23 Tour of Organization........................................................ 24 File/Record Selection .................................................... 24 Personnel Records..................................................... 24 Client/Patient Records............................................ 24 Staff Interviews................................................................. 24 Observations....................................................................... 24 Exit Conference................................................................. 24 POST-SURVEY PROCESS Accreditation Decisions................................................. 24 Summary of Findings........................................................25 Plan of Correction..............................................................25 Evidence................................................................................. 26

STANDARDS Format: Standard/Interpretation/Evidence Section 1.................................................................................. 1.1 Section 2..................................................................................2.1 Section 3................................................................................. 3.1 Section 4................................................................................ 4.1 Section 5 .................................................................................5.1 Section 6................................................................................ 6.1 Section 7..................................................................................7.1

RESOURCES ONGOING SUPPORT ACHC Resources................................................................R.1 ACHC Glossary for PCAB Pharmacy........................R.1 The Sterile Garbing Process ......................................R.3 Sterility and Endotoxin Testing of CSPs...............R.4 BUDs and Potency Testing...........................................R.6 PCAB Crosswalk...............................................................R.9

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ACCREDITATION GUIDE TO SUCCESS ]

INTRODUCTION

QUICK STANDARD REFERENCE

QUICK STANDARD REFERENCE

Quickly locate specific standards, policies, and requirements for successfully completing the accreditation process.

SECTION 1 TOPIC STANDARD PAGE Posting of Licenses, Permits, etc……………………………......TCRX1-A 1.1 Access to USP Standards……………………………………….TCRX1-B 1.2 Reporting of Negative Outcomes………………………………TCRX1-C 1.2

SECTION 2 TOPIC STANDARD PAGE Complaint handling……………..………………………………...TCRX2-A 2.1

SECTION 3 TOPIC STANDARD PAGE Competency Assessment Program (non-sterile)……………..TCRX3-A 3.1 Competency Assessment Program (sterile)…….…………….TCRX3-B 3.2 Training/Competency related to equipment………………….TCRX3-C 3.3 Cleaning/maintenance of equipment for patients…..………...TCRX3-D 3.3 Hazardous Chemical/Drug handling…………………………....TCRX3-E 3.3 Personnel initial training/competencies…...………………….. TCRX3-F 3.4 Adherence to regulations, proper licensure…….…………........TCRX3-G 3.4 Supervising Pharmacist’s competencies.……………………....TCRX3-H 3.4 Supervision of Pharmacy Technicians………………………......TCRX3-I 3.5 Supervision of all Pharmacy Staff……………………………...TCRX3-J 3.5 Reference Library……………….………………………………TCRX3-K 3.5

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ACHC ACCREDITATION GUIDE TO SUCCESS WORKBOOK [

PHARMACY ]

SECTION 4 TOPIC STANDARD PAGE OBRA…………………………………………………………… .TCRX4-A 4.1 Timeliness and tracking of shipments……………………...........TCRX4-B 4.2

SECTION 5 TOPIC STANDARD PAGE Performance Improvement (PI) Program Overview…………..TCRX5-A 5.1 Performance Improvement Coordinator……………………....TCRX5-B 5.2 Personnel PI Training…………….……………………………....TCRX5-C 5.2 PI Minimum Requirements for Each Activity..………… ……..TCRX5-D 5.3 PI Adverse Events, Incidents (QRE’s)……………………… ......TCRX5-E 5.3 PI Risks Including Infections……………………………...............TCRX5-F 5.4 PI Continuous Quality Control for Finished Preparations….....TCRX5-G 5.4 PI High Risk/High Volume (Non-sterile)………………..…..........TCRX5-H 5.5 PI High Risk/High Volume (Sterile)…..…………………...............TCRX5-I 5.6 PI Patient Complaints………………….……………….................TCRX5-J 5.6 PI Plans of Correction (POC)……………………………….........TCRX5-K 5.7 PI Annual Reporting………………………………………............TCRX5-L 5.7

SECTION 6 TOPIC STANDARD PAGE Infection Control Program………………………………….........TCRX6-A 6.1 Recall Program………….…………………………………...........TCRX6-B 6.2 Compounding Storage Requirements…..……………..................TCRX6-C 6.3 Storage/Shipping Integrity………………………………..…......TCRX6-D 6.4 Use, Calibration, Cleaning, Maintenance of Compounding Equipment............................................................................TCRX6-E 6.4 Ingredient Selection…………………………………………......TCRX6-F 6.4 Master Formulation Record (MFR)…..…………………….........TCRX6-G 6.5 Compounding Records (CR)………………………………...........TCRX6-H 6.6 Compounding in Accordance with USP ………..……….. TCRX6-I 6.7 Hazardous Non-Sterile Component Handling………………....TCRX6-J 6.7 Facility Maintenance/Cleaning (Non-Sterile)…………………TCRX6-K 6.8 Compounding in Accordance with USP …………….........TCRX6-L 6.8 Non-Hazardous Risk Level Controls (USP …………........TCRX6-M 6.9 Hazardous Compounding Considerations (USP ……….TCRX6-N 6.10 Cleaning/Disinfecting/Monitoring USP Environments......................................................................................................TCRX6-O 6.10 Beyond-Use-Dating (BUD’s) Non-Sterile…..………………........TCRX6-P 6.11 14

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ACCREDITATION GUIDE TO SUCCESS ]

INTRODUCTION

QUICK STANDARD REFERENCE

Beyond-Use-Dating (BUD’s) Sterile………..…………………... TCRX6-Q Sterility and Endotoxin Considerations………………………..TCRX6-R Storage Consideration Labeling for Finished Compounds…....TCRX6-S Clinical Research/Experimental Therapies ……………..……..TCRX6-T Labeling Requirements for Finished Compounds………..……TCRX6-U

6.12 6.13 6.14 6.14 6.15

SECTION 7 TOPIC STANDARD PAGE Annual documentation to be submitted to ACHC/PCAB (non-sterile)...........................................................................TCRX7-A 7.1 Annual documentation to be submitted to ACHC/PCAB (sterile)……...........................................................................TCRX7-B 7.2

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Company Steps

Create User Name & Password for Customer Central cc.achc.org

*Approximately

PCAB Steps

Account Advisor will submit organization for scheduling and a Surveyor will be offered the survey

Account Advisor will review documents for completeness and enter information into system

Surveyor will receive the documents submitted by the company

7 Business Days*

Surveyor will submit findings back to the Account Advisor

5 Business Days*

achc.org

Review Committee reviews survey findings and decision sent to company

10-15 Business Days*

855-YES-ACHC (855-937-2242) I

PCAB will conduct the on-site survey

60-90 Days*

30 Business Days

14 Calendar Days

7 Business Days*

Submit completed electronic application, PER and $1,500 deposit

Submit a Plan of Correction for any deficiencies within 30 days of notification

2-3 Business Days*

Download PCAB Accreditation Standards cc.achc.org

Accreditation Agreement (BAA/Contract) reviewed by customer, signed and returned to Account Advisor

ACCREDITATION PROCESS

[ ACCREDITATION GUIDE TO SUCCESS ]

ACCREDITATION PROCESS TIMELINE

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SECTION 1 STANDARDS

UNDERSTANDING THE STANDARDS SECTION 1 The standards in this section apply to regulatory issues.  

SECTION 1—QUICK REFERENCE TOPIC STANDARD PAGE Posting of Licenses, Permits, etc……………………………......TCRX1-A 1.1 Access to USP Standards……………………………………….TCRX1-B 1.2 Reporting of Negative Outcomes………………………………TCRX1-C 1.2

NOTE: HINTS WILL BE HIGHLIGHTED IN BLUE STANDARD TCRX1-A: (SERVICES APPLICABLE: STERILE, NON-STERILE COMPOUNDING) The organization is an established entity with legal authority to operate and has a physical location with the appropriate licensure, Articles of Incorporation, or other documentation of legal authority. ЇЇ Interpretation: The organization is an established entity with legal authority to operate, and has the appropriate Articles of Incorporation, or other documentation of legal authority. Legal authority is granted to one individual, members of a Limited Liability Corporation (LLC), a Board of Directors, usually referred to as the governing body, and as allowed in state statutes for the appropriate type and structure of the organization. The entity, individual or organization has a copy of the appropriate documentation or authorization to conduct business. If state or applicable local law requires a license or permit, the organization posts the current copy in a prominent location in all locations/branches, and/or in accordance with appropriate regulations or laws. The organization will display all licenses and/or permits required in the pharmacy operation in an area of public view: »» Resident state board of pharmacy permit/license »» Non-resident board of pharmacy permit/license as required, if applicable »» Drug Enforcement Administration (DEA) registration »» State controlled substance license, if applicable »» Pharmacists licenses »» Pharmacy technicians licenses/certificates, if applicable »» Biohazard generator permit or appropriate contract as required

The organization is in compliance with all applicable federal, state, and local laws and regulations, and has access to the pharmacy rules and regulations of all states where pharmacy services are provided. If state or applicable local laws require a license or permit, you must post the current copy in a prominent location accessible to public view in all locations/branches and/or in accordance with appropriate regulations or laws. This will also include states in which you ship products.

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You will be required to have a copy of all current applicable license(s) for each state the pharmacy ships into as well as appropriate documentation or authorization to conduct business.

STANDARD TCRX1-B: (SERVICES APPLICABLE: STERILE, NON-STERILE COMPOUNDING) The organization has access to relevant United States Pharmacopeia (USP) standards. ЇЇ Interpretation: The pharmacy has access to current USP standards that are relevant to the scope of compounding performed. Pharmacies that perform non-sterile compounding have access to relevant and current USP standards, including but not limited to USP Chapters , , , etc. Pharmacies that perform sterile compounding have access to relevant and current USP standards, including but not limited to USP Chapters , , , , etc.

Copies of the various USP Chapters can be a digital or paper copy (depending on your individual state laws).

STANDARD TCRX1-C: (SERVICES APPLICABLE: STERILE, NON-STERILE COMPOUNDING) The organization informs the accrediting body and other state/federal regulatory agencies, as appropriate, of negative outcomes from review/audits. ЇЇ Interpretation: Negative outcomes affecting accreditation, licensure, or Medicare/Medicaid certification are reported to ACHC within 30 days of the occurrence. The report includes all actions taken and plans of correction (POCs). Incidents reported to ACHC include, but are not limited to: »» License suspension »» License probation; conditions/restrictions to license »» Non-compliance with Medicare/Medicaid regulations identified during survey by another regulatory body »» Civil penalties of ten thousand dollars ($10,000.00) or more »» Revocation of Medicare/Medicaid/third-party provider number »» FDA inspections/483/warning letters forwarded to ACHC within 72 hours of receiving

There should be documentation of any negative outcomes affecting accreditation, licensure, or Medicare/Medicaid certification and that they were reported to ACHC within 30 days of the occurrence. The report includes all actions taken and POCs. During interviews, administration, ownership, or board members should be able to explain what a negative outcome is. They should also be able to state whether or not the pharmacy has had a negative outcome.

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ACCREDITATION GUIDE TO SUCCESS ]

RESOURCES

ON-GOING SUPPORT ACHC RESOURCES: ACHC Website: www.achc.org and Customer Central offer a variety of educational resources to assist with the survey process as well as information pertaining to the Pharmacy Industry. C  heck the website frequently for up to date information. Account Advisors are your personal liaison to guide you through the PCAB Accreditation process. Contact them via phone or email with any questions regarding the application process, standard interpretation, Plan of Correction, etc. The Clinical Compliance Educator provides educational workshops, educational videos, and other resources that are available on Customer Central.

ACHC GLOSSARY OF TERMS FOR PCAB PHARMACY

PCAB NON-STERILE COMPOUNDING (CFNS)

Non-Sterile Pharmacy Compounding is a process by which a pharmacist prepares drugs by combining, mixing, or altering ingredients into a pharmaceutical preparation. These preparations are designed to be administered by a route of administration that does not require sterility as result of a practitioner’s prescription drug order. Compounding includes the preparation of drugs in anticipation of receiving prescription drug orders based on routine, regularly observed prescribing patterns.

PCAB STERILE COMPOUNDING (CFST) Sterile Pharmacy Compounding is the practice of preparing sterile medications for patients through strict procedures to prevent contamination and maintain patient safety. PCAB Accreditation Standards measure a specific set of process standards that concentrate on the quality and consistency of medications that are produced.

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ACCREDITATION GUIDE TO SUCCESS ]

RESOURCES

THE STERILE GARBING PROCESS The following is a suggested method for garbing. Always refer to USP for the current process. GARBING Personnel need to be free from illness, including allergies and sunburn. The following cannot be worn or brought in the clean room: »» Sweaters, jackets, fleeces, and tank tops »» High heeled, open-toe, or sling-back shoes »» False nails or nail polish »» Gum, drinks, candy, food »» Any items not needed to complete compounding procedures Don shoe covers (or dedicated shoes) one at a time while stepping over the line of demarcation as each shoe cover is donned. If doing Hazardous Drug (HD) compounding, don an extra pair of shoe covers. Tie loose hair back. Remove all makeup and jewelry (including any piercings above the neck). Don head cover. Don facial hair cover. Don eye shields: »» Optional unless working with HD or irritants such as cleaning ceilings with designated disinfecting agent Don facial mask (check in mirror to make sure that all hair is covered). Remove debris from under nails with nail pick (under running water) and wash hands up to elbows with warm water for at least 30 seconds (using anti- or non-microbial soap). Dry hands/forearms with a non-shedding wipe (turning off water supply with this wipe, unless hands free water). Enter buffer area without touching door. Perform antiseptic hand cleansing with waterless alcohol-based surgical scrub according to manufacturer’s recommendation. Allow hands to dry (without waving them around). Don sterile, powder-free gloves according to package. DEGARBING Walk out of buffer area into the ante-area before removing and discarding sterile gloves. Remove face mask and gown. Keep hairnet, facial hair cover and shoe covers on until on the other side of the line of demarcation (dirty side). Wash hands. Exit the area and discard the remaining cleanroom garb: »» The gown may be stored in the ante-room for same day use only if not contaminated.

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