achc.org

FOR PROVIDERS. BY PROVIDERS.

ACH C AC C RE DI TAT I ON STA N DA RDS

ACHC ACCREDITATION GUIDE TO SUCCESS WORKBOOK [

PHARMACY ]

ACHC ACCREDITATION GUIDE TO SUCCESS WORKBOOK [

FOR PROVIDERS. BY PROVIDERS.

PHARMACY ]

TABLE OF CONTENTS INTRODUCTION The ACHC Difference.......................................................... 7 Programs for Accreditation........................................... 11

HOW TO USE THIS WORKBOOK Essential Components .................................................... 13 Other Tools ............................................................................ 13

QUICK STANDARD REFERENCE Section 1...................................................................................15 Section 2...................................................................................15 Section 3.................................................................................. 16 Section 4................................................................................. 16 Section 5...................................................................................17 Section 6................................................................................. 18 Section 7.................................................................................. 18

SURVEY PROCESS PRE-SURVEY PREP State and Local Regulations......................................... 21 Download Standards ........................................................21 Timeline................................................................................... 21 Standard Format............................................................... 22 Writing Policies and Procedures................................ 23 Preliminary Evidence Review...................................... 25 Completing the Application........................................ 26 Desk Review Results....................................................... 27 Preparing Your Organization........................................27 Are Your Ready?.......................................................... 27 Education of staff........................................................27 Field Visits.................................................................... 28 Auditing........................................................................... 28 Practice Run.................................................................. 28

ON-SITE SURVEY PROCESS Survey Etiquette............................................................... 29 Opening Conference........................................................ 29 Tour of Organization........................................................ 29 File/Record Selection .................................................... 29 Personnel Files............................................................ 29 Client/Patient Records............................................ 29 Staff Interviews.................................................................. 29 Observations....................................................................... 29 Home Visit............................................................................. 30 Exit Conference.................................................................. 30 POST-SURVEY PROCESS Accreditation Decisions................................................ 30 Summary of Findings....................................................... 30 Plan of Correction............................................................. 30 List of Survey Process Tools.........................................32

STANDARDS Format: Standard/Interpretation/Evidence Section 1..................................................................................53 Section 2.................................................................................. 81 Section 3............................................................................... 109 Section 4................................................................................121 Section 5 ................................................................................177 Section 6.............................................................................. 227 Section 7...............................................................................255

RESOURCES ONGOING SUPPORT ACHC Resources............................................................. 305 GAP Analysis for Non-Sterile Compounding ........................... 307 GAP Analysis for Sterile Compounding ....................................... 319

I

9

[

ACCREDITATION GUIDE TO SUCCESS ]

INTRODUCTION QUICK STANDARD REFERENCE

QUICK STANDARD REFERENCE

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

SECTION 1 TOPIC STANDARD PAGE Posting of Licenses, Permits, etc............................................................DRX1-1A, B 53 Regulatory Requests for Information...................................................DRX1-1C 54 Governing Body Requirements................................................................DRX1-2A, B, C, D 55 Conflict of Interest.........................................................................................DRX1-3A 57 Temporary Leadership..................................................................................DRX1-4A, B 58 Chain of Command/Organizational Chart..........................................DRX1-5A, B 59 Mission and Goals............................................................................................DRX1-6A, B 59 Compliance with Law, Rule and Regulation........................................DRX1-7A, B, C, E 60 ATP Requirement.............................................................................................DRX1-7D 62 Fitter Certification..........................................................................................DRX1-7E 62 Standards of Practice...................................................................................DRX1-8A 62 Supplier and Quality Standards...............................................................DRX1-9A 62 Reporting of Negative Outcomes...........................................................DRX1-10A 63 Changes in Ownership...................................................................................DRX1-11A 64

SECTION 2 TOPIC STANDARD PAGE Description of Services..................................................................................DRX2-1A 81 Patient Rights and Responsibilities.........................................................DRX2-2A, B, C 82 Abuse, Neglect, Mistreatment....................................................................DRX2-3A 84 Complaints and Grievances..........................................................................DRX2-4A, B, C 85 Securing and Releasing PHI, Privacy Notice........................................DRX2-5A, B 87 Business Associate Agreement.................................................................DRX2-5C 89 Advance Directives, CPR................................................................................DRX2-6A, B, C 89 Ethics........................................................................................................................DRX2-7A 91 Communications Barriers..............................................................................DRX2-8A 92 Cultural Diversity...............................................................................................DRX2-8B 92 Compliance Program........................................................................................DRX2-9A 94 On-Call and Staff Availability.......................................................................DRX2-10A, B, C, D, E, F 95

I

15

FOR PROVIDERS. BY PROVIDERS.

ACHC ACCREDITATION GUIDE TO SUCCESS WORKBOOK [

PHARMACY ]

SECTION 3 TOPIC STANDARD PAGE Budget...................................................................................................................DRX3-1A, B Financial Business Practices.....................................................................DRX3-2A, B Financial Record Retention........................................................................DRX3-3A Price Lists and Conveying Charges........................................................DRX3-4A, B Financial Hardship...........................................................................................DRX3-5A Compliant Billing Procedures....................................................................DRX3-6A

109 110 111 111 113 113

SECTION 4 TOPIC STANDARD PAGE Personnel File Management......................................................................DRX4-1A, B, C 122 Reference Checks...........................................................................................DRX4-2A 124 Verification of Personnel Qualifications.............................................DRX4-2B 125 TB Testing/Screening....................................................................................DRX4-2C 125 Hepatitis B Vaccine.........................................................................................DRX4-2D 126 Job Descriptions...............................................................................................DRX4-2E 126 Drivers License Requirements.................................................................DRX4-2F 127 Proof of Vehicle Insurance..........................................................................DRX4-2G 127 Background, Sex Offender and OIG Checks.......................................DRX4-2H 128 Employee Handbook......................................................................................DRX4-2I 129 Performance Evaluations............................................................................DRX4-2J 130 Employee Handbook......................................................................................DRX4-3A 130 Negative Outcomes due to Poor Performance................................DRX4-4A 131 Rehab Technician Requirements.............................................................DRX4-5A 131 Fitter Qualifications.......................................................................................DRX4-5B 132 HME Supervisor Qualifications................................................................DRX4-5C 133 Respiratory Program Supervision Requirements..........................DRX4-5D 133 Orientation..........................................................................................................DRX4-6A 134 Competence Assessments.........................................................................DRX4-7A, B 135 Annual Staff In-services...............................................................................DRX4-8A 137 Staff Supervision.............................................................................................DRX4-9A 138 Supervisor Qualifications and Requirements...................................DRX4-9B, C 139 Registered Pharmacist Availablilty........................................................DRX 4-9D 139 Annual Observation of Direct Care Staff............................................DRX4-10A 140 Contracts for Service Providers..............................................................DRX4-11A, B, C, D 140 Supervision of Infusion Nursing...............................................................DRX4-12A, B 142 Infusion Nursing Requirements...............................................................DRX4-13A, B 143 Qualifications for Pharmacy Personnel...............................................DRX4-14A, B, C, D, E, F 144 Reference Library............................................................................................DRX4-15A 145

16

I

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

I

www.achc.org

[

ACCREDITATION GUIDE TO SUCCESS ]

INTRODUCTION

QUICK REFERENCE GUIDE

SECTION 5 TOPIC STANDARD PAGE Client/Patient Record Contents..............................................................DRX5-1A, B 177 Access, Storage, Removal, Retention of Records..........................DRX5-1C 180 Record Entries – Clarity and Signatures..............................................DRX5-1D 181 Client Assessments........................................................................................DRX-2A­‑H 181 Client/Patient Assessments......................................................................DRX5-3A-I 187 Client Participation in Plan of Care/Service......................................DRX5-4A, B, C, D, E 193 Client/Patient Education.............................................................................DRX5-5A, B, C, D, E 195 Infusion Supplies.............................................................................................DRX5-6A 198 Medication Review.........................................................................................DRX5-7A, B, C 198 Supply of Ongoing Services/Products.................................................DRX5-8A 200 Client/Patient Referral Process..............................................................DRX5-9A, B 201 Verification of Licensure.............................................................................DRX5-10A 201 Informing Clients of Delivery.....................................................................DRX5-11A, B 202 Unmet Client Needs.......................................................................................DRX5-12A 202 On-site Services...............................................................................................DRX5-13A, B 203 Assurance of Proper Equipment..............................................................DRX5-14A 204 Client/Patient Transfer or Discharge....................................................DRX5-15A, B, C, D, E 205 Product Demonstration................................................................................DRX5-16A 208 Administration of Medication...................................................................DRX5-17A, B 208

SECTION 6 TOPIC STANDARD PAGE PI Program Description/Requirements...............................................DRX6-1A, C 227 Designation of PI Coordinator..................................................................DRX6-1B 229 Annual PI Report..............................................................................................DRX6-1D 229 PI Activity/Audit Descriptions..................................................................DRX6-2A 230 Required PI Audits/Activities PI Assessment..............................................................................................DRX6-3A 230 Audit of Service Provision......................................................................DRX6-3B 231 Satisfaction Surveys.................................................................................DRX6-3C 231 Client/Patient Record Review..............................................................DRX6-3D 231 Client/Patient Complaints.....................................................................DRX6-3E 232 Incidents..........................................................................................................DRX6-3F 232 Billing and Coding Errors.........................................................................DRX6-3G 234 RTS Assembly Forms................................................................................DRX6-3H 234 Written Plans of Correction.......................................................................DRX6-4A 235 Annual Organization Evaluation...............................................................DRX6-5A 235 Governing Body Responsibilities............................................................DRX6-6A 236

I

17

FOR PROVIDERS. BY PROVIDERS.

ACHC ACCREDITATION GUIDE TO SUCCESS WORKBOOK [

PHARMACY ]

SECTION 7 TOPIC STANDARD PAGE Infection Control Program Requirements..........................................DRX7-1A, B, C 256 Evaluation of Infection Control Program............................................DRX7-1D 260 Safety Education.............................................................................................DRX7-2A 260 Client/Patient Safety in the Home.........................................................DRX7-2B 261 Fitter Service Quality Product Provision.............................................DRX7-3A 262 RTS Service Quality Product Provision................................................DRX7-3B 262 Emergency Preparedness...........................................................................DRX7-4A, B, C 263 Fire Safety...........................................................................................................DRX7-5A, B, C 263 Hazardous Materials.....................................................................................DRX7-6A, B 267 Medication & Product Recall.....................................................................DRX7-7A, B 268 Sterile Compounding Preparations........................................................DRX7-8A, B, C, D 269 Pharmaceutical Storage..............................................................................DRX7-9A, B, C 271 Enteral Nutrient Storage and Delivery.................................................DRX7-10A, B, C 271 Incident Reporting..........................................................................................DRX7-11A, 273 Product Provision, Equipment Management....................................DRX7-12A, B, C, D 274 Provision of Back-Up Equipment............................................................DRX7-12E 280 Delivery of MSP Products...........................................................................DRX7-12F 280 Oxygen Transfilling.........................................................................................DRX7-13A 281 Pharmacy Equipment Maintenance.......................................................DRX7-14A 282 Fitter/RTS Equipment Offerings.............................................................DRX7-15A 282 Fitter/RTS Provision of Warranty...........................................................DRX7-16A 283 Clinical Research..............................................................................................DRX7-17A 283 REMS (SRX)........................................................................................................DRX7-18A 284 Waived Testing..................................................................................................DRX7-19A, B 284 High Risk Drugs.................................................................................................DRX7-19C 284 REMS (AIC, IRN, IRX)......................................................................................DRX7-20A, B 284 Monitoring of Patient (AIC)........................................................................DRX7-21A 285 Labeling of Medications...............................................................................DRX7-21B 285

18

I

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

I

www.achc.org

[

ACCREDITATION GUIDE TO SUCCESS ]

SURVEY PROCESS WRITING POLICIES & PROCEDURES

WRITING POLICIES & PROCEDURES (P & Ps) Before you prepare the PER, you need to ensure your organization has well-written policies and procedures that not only provide staff direction but also meet the ACHC standards. Well-written policies and procedures provide consistency of care and can be the focus of your defense in litigation. A POLICY TEMPLATE IS PROVIDED AT THE BACK OF THIS SECTION AS A REFERENCE TOOL.

I f you are unclear as to whether the policy and procedure meets the standard, it will most likely be questionable to the surveyor as well.

WHAT’S THE DIFFERENCE BETWEEN A POLICY AND A PROCEDURE?  policy is the “what” statement. It provides broad direction for actions and decision making. Policies are often based A on regulations that specify what an organization must do or provide. A procedure is the internal process your organization develops and follows to implement a policy. A procedure is the “who, when and how” details of the policy. Be careful not to make procedures too restrictive. Also, write procedures to meet mandatory requirements and to provide consistency, but allow enough flexibility to permit staff to use their own judgment, as appropriate.

HOW TO GET STARTED:  irst, assemble all applicable Federal, State, local and ACHC regulations and standards. Remember, the strictest F regulation/standard is what must be implemented in order to be in compliance.  ecide how you are going to organize your policies and procedures. Some organizations find that multiple manuals D are required (i.e., an Operations manual and a Human Resources manual). Within each manual, subgroups/chapters are often needed; you may decide to organize by department or by subject matter. Some organizations use the ACHC section headings as a way to organize their policy manuals.

FORMAT: All P & Ps must follow a standard format to ensure consistency and that all relevant items are included. The header must include:  he name of your organization T The title of the P & P The number of the P & P The effective date of the P & P

I

23

[

ACCREDITATION GUIDE TO SUCCESS ]

POTENTIAL STAFF INTERVIEW AUDIT TOOL [

PHARMACY ]

ЇЇ BO



POTENTIAL STAFF INTERVIEW QUESTIONS

OW ARD NE OF R/ DI CE RE CT O ЇЇ OR CU S ST OM ER SE ЇЇ RV DE ICE LIV ER YP ER ЇЇ SO CL NN INI EL CA LO RL ЇЇ ICE TE NS CH ED NIC IAN ЇЇ MA NA GE R ЇЇ AT PO RF IT T ER

FOR PROVIDERS. BY PROVIDERS.

To whom would you report changes in ownership, governing body or management to? Can you describe your duties and accountabilities? Can you describe your orientation process? Were you oriented to your position? Can you describe the chain of command? Are you familiar with the agency’s mission statement? What are the agency’s goals and how do you impact them? What are the DMEPOS Supplier and Quality Standards? How do they affect your job? What negative outcomes must you report to ACHC? Have you had any negative outcomes? What type of organizational changes would you report to ACHC? List 3 -4 Patient Rights: How are DMEPOS Supplier Standards communicated with clients/ patients? Who would you report any alleged violation involving mistreatment, neglect, or abuse to a client/patient and in what time frames? Who would you report verified violations to and in what time frame? What is your process for handling a client/patient complaint? What are the time frames for responding to client/patient complaints? What written information do you provide your clients/patients concerning confidentiality of client/patient-specific information? How do you provide information regarding Advance Directives to clients/patients? What training did you receive on the agency’s policies and procedures on ethical issues? Give an example of an ethical issue you may encounter in your day to day work.

I

37

[

ACCREDITATION GUIDE TO SUCCESS ]

POTENTIAL STAFF INTERVIEW AUDIT TOOL

[

PHARMACY ]

ЇЇ BO



POTENTIAL STAFF INTERVIEW QUESTIONS

OW ARD NE OF R/ DI CE RE CT O ЇЇ OR CU S ST OM ER SE ЇЇ RV DE ICE LIV ER YP ER ЇЇ SO CL NN INI EL CA LO RL ЇЇ ICE TE NS CH ED NIC IAN ЇЇ MA NA GE R ЇЇ AT PO RF IT T ER

FOR PROVIDERS. BY PROVIDERS.

Is loaner equipment available? Equipment for demonstration/ trial? Describe the Performance Improvement initiative your organization is currently working on. How are you involved in the PI program? Describe the projects you are involved with. What resources are provided for the PI program? What type of infection control education do you provide to clients/patients? What infection control procedures do you follow when delivering or picking up equipment? What type of education and/or training have you received in regard to safety related issues? What type of safety issues do you address while in the client/ patient home? What training have you received in regard to the process for meeting client/patient needs during a disaster/crisis? How do you store enteral products? How do you assure timely delivery? Describe the accident/incident reporting process. Explain how equipment is stored, cleaned and transported. Explain how you do a home assessment. How do you properly clean and process returned/dirty equipment? What type of back-up equipment is provided to clients/patients? Explain the transfilling process. What selection of products can you choose from to best meet client/patient needs? What type of warranty do you offer clients/patients?

I

39

Company Steps

ACHC Steps

[ 48 Hours ]

Download free standards achc.org

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

Store.achc.org Agreement for accreditation servics sent to customer

[ Approx. 2-3 Business Days ]

Company Accreditation Advisor will review documents for completeness and enter information into system

Obtain User Name & Password for Customer Central

[ Approx. 7 Business Days ]

ACHC surveyor will receive the documents submitted by the company

Accreditation Advisor will submit organization for scheduling and a surveyor will be offered the survey

Submit signed agreement for accreditation services back to the Accreditation Advisor within 14 calendar days

[ Approx. 5 Business Days ]

ACHC surveyor will submit findings back to the Accreditation Advisor

[ Approx. 15 Business Days ]

Decision sent to company

Reviewed by Clinical Director or designee

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

[ Approx. 60-120 Days ]

ACHC will conduct the on-site survey

ACCREDITATION PROCESS

FOR PROVIDERS. BY PROVIDERS.

achc.org

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

[

ACCREDITATION PROCESS TIMELINE

ACCREDITATION GUIDE TO SUCCESS ]

I

51

[

ACCREDITATION GUIDE TO SUCCESS ]

SECTION 1 STANDARDS

ЇЇ Interpretation: The organization demonstrates knowledge of both CMS DMEPOS Supplier and Quality Standards. Compliance is demonstrated through the implementation of standards in all aspects of the day to day operations of the organization.

The Surveyor will expect the organization’s staff to have knowledge of both CMS DMEPOS Supplier and Quality Standards. When staff is interviewed, they should be able to cite 3-4 of the standards and explain how the standards affect them and their job. Compliance is demonstrated through the implementation of standards in all aspects of the day-to-day operations of the organization. The organization must have inventory present or available through contracts with vendor/manufacturer for all products listed on the DMEPOS Addendum. Any contracts for products/inventory must be in writing and signed and dated. COD status with a manufacturer/supplier is not acceptable if this is your only source of inventory. The organization must be able to demonstrate on the day of survey the inventory, contracts for the inventory, staff, education, and training necessary to provide any product or service you wish to list on the addendum. The addendum will be filled out, dated, and signed by you and the Surveyor while they are on site. New addendum items for products and services you intend to provide in the future cannot be added to the addendum on the day of survey unless you are able to receive and fill an order for that item on the day of survey.

STANDARD DRX1-10A: (SERVICES APPLICABLE: CRCS, FITTER, HME, MSP, RTS, AIC, IRN, IRX, SRX) 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. Incidents are 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

Minutes of board meetings should include any negative outcomes affecting accreditation, licensure, or Medicare/ Medicaid certification. During interviews with administration, ownership, or board members they should be able to explain what a negative outcome is and what is required to be reported to ACHC. They should also be able to say whether you have had a negative outcome. While there will not be board minutes for some organizations (e.g., sole proprietorships, partnerships, etc.), there should be documentation of any negative outcomes. See the Governing Body/Board of Directors Meeting Agenda Template at the end of this section.

I

63

[

ACCREDITATION GUIDE TO SUCCESS ]

SECTION 1 STANDARDS

TOOLS AVAILABLE TO ASSIST WITH SECTION 1: ЇЇ Section 1 Compliance Checklist ЇЇ Organizational Chart ЇЇ Governining Body/Board of Directors Meeting Agenda Template ЇЇ Conflict of Interest & Disclosure Statement ЇЇ Acknowledgement of Confidentiality of Information ЇЇ Orientation Requirements for Governing Body ЇЇ Section 1 Self-Audit

I

65

[

ACCREDITATION GUIDE TO SUCCESS ]

AUDIT TOOLS

[

PHARMACY ]

FOR PROVIDERS. BY PROVIDERS.

PI AUDIT DESCRIPTIONS PI Activity/Audit Descriptions

Description of Audit/Indicators: Conducted By:

Frequency of Activities:

Data Collected From:

Threshold/Goal:

Plan for re-evaluation if threshold/goal is not met:

All PI reports will be presented to the PI committee and the Governing Body/owner. In the event an audit fails to meet a threshold/goal, a written plan of correction will be created that indicates plans to re-evaluate.

Creation Date

Form # X

I

241

[

ACCREDITATION GUIDE TO SUCCESS ] [ PHARMACY ]

GAP GAPANALYSIS ANALYSIS

Accreditation for Non-Sterile Compounding (Ref. USP ) Accreditation for Non-Sterile Compounding (Ref. USP ) Standard

Description

4

Written policies and procedures are established in regard to all pharmacy services being provided under the direction of a Registered Pharmacist who has documented training and competency in the scope of services provided.

Yes

No

N/A Action

Personnel records contain evidence of documented training and competency of the Supervising Registered Pharmacist. 5

Written policies and procedures identify the method and frequency for assessing Pharmacy Technicians by the Registered Pharmacist to ensure that care/services are provided appropriately. Personnel records contain evidence of Pharmacy Technician assessments.

6

Written policies and procedures define any special education, experience or certificates necessary for pharmacy personnel to prepare non-sterile compounding. Qualifications vary based upon classification of drugs, State Board of Pharmacy requirements, and requirements defined by USP . Personnel records contain evidence of ongoing training for compounding personnel. The training includes, but is not limited to:

Ї The principles and practical skills of non-sterile compounding aseptic technique

Ї Hand hygiene and garbing procedures Training is documented for personnel who perform non-sterile Compounding Preparations:

Ї At orientation Ї Annually 7

Personnel demonstrate knowledge and understanding of contamination control and aseptic techniques in accordance with written policies and procedures, USP , state-specific Board of Pharmacy regulations and federal law. Quality control records are present that demonstrate compliance with contamination control. Discuss the initial and ongoing training you received on contamination control.

8

Personnel responsible for the cleaning and maintenance of equipment are trained and competent in the use of all equipment. Training logs/files contain evidence of training.

10

The organization has written policies and procedures that address timeliness of shipping errors, turnaround time, and lost shipments, which include:

I 309 I 2