9/28/2020

1

Part of the Team: How technicians can prepare for an accrediting body or regulatory inspection

Glen J. Gard CPhT, CSPT

National Manager Pharmacy Compliance, Option Care Health

Content Reviewer:

Gene B. Decaminada, RPh

Manager, Compounding Compliance

Speaker nor content reviewer have conflicts of interest to disclose

Learning Objectives

1. Identify ways a pharmacy technician can prepare for an inspection

2. Describe what role a pharmacy technician can play during an inspection

3. Explain the importance of pharmacy technician inclusion in the inspection preparation and involvement during an inspection

9/28/2020

2

What We will Discuss

• Review regulatory bodies and their authority

• Discuss the need for techs to be a part of the team

• Discuss ways to prep for visit

• Review Do’s and Don’ts when an inspector is on site

• Post inspection follow ups

Image from www.pixabay.com

Have you participated in an inspection before?

A. Yes

B. No

Who Can Inspect You

…The entire alphabet

• DEA – Drug Enforcement Agency

• FDA – Food and Drug Administration

• BOP – Boards of Pharmacy

• EPA – Environmental Protection Agency

• OSHA – Occupational Safety and Health Administration

• ACHC, PCAB, JCAHO, DNV, URAC - Accreditation Company

• OTHERS Image from www.pixabay.com

9/28/2020

3

Why Will “They” Inspect You

Cause

Routine Accreditation

Pharmacy Technicians: Part of the Team

Pharmacy Technicians are:

• Essential to daily operations

• Primary trainers

• Often the most aware of policy and how processes are applied

• Going to be observed and questioned during inspections

Image from subscription to Shutterstock

Preparing for a Visit

Play The Long Game

Image from www.pixabay.com

9/28/2020

4

Preparing for a Visit

Many Hands Make Light the Work!

Image from www.pixabay.com

Preparing for a Visit

Be prepared for a visit everyday: not just for the routine

• Annual review of policies

• Competency is not static

• Spread out reviews throughout the year

• Perform mock inspections

Preparing for a Visit

Preparing for a routine visit

• Develop work groups – utilize subject matter experts (SMEs)

• Train and prepare your team

• Review documentation

9/28/2020

5

Preparing for a Visit

Preparing for a routine visit

• Create a cross walk of standards to policy

• Perform gap analysis

Preparing for a Visit

Preparing for a routine visit

• Walk the shelves

• Walk the facility

• Invite colleagues from another location

• Assign responsibilities and roles

What Will Inspectors Do While on Site

• All relevant policies and procedures will be reviewed

• Inspectors will observe Pharmacy Technicians, Pharmacists, and others

• Inspect all areas of your facility

9/28/2020

6

What Will Inspectors Do While on Site

• Inspectors often ask the same question

• Inspectors sometimes are not knowledgeable

• Review patient charts

• Use the tracer method

Do the Following

Image from www.pixabay.com

Do’s when an inspector is on site

Ask to see identification

Request documentation

Ask the purpose of visit

9/28/2020

7

Do’s when an inspector is on site

• Immediately contact your leadership

• Inform your Team

• Be courteous, professional, and respectful

Do’s when an inspector is on site

• Only answer questions if asked

• Only answer the question asked

• Provide the requested information only

• Have your playbook prepared

What Do You Do?

The inspector wants to know how often you perform medication unit inspections.

Image from www.pixabay.com

9/28/2020

8

What Do You Do?

The inspector wants to know how often you perform medication unit inspections.

Just provide the frequency e.g. monthly

Don‘t Do the Following

Image from www.pixabay.com

Don'ts when an inspector is on site

• Do not panic (easier said then done)

• Do not make assumptions

• Do not give information not requested

• Do not answer beyond what was asked

9/28/2020

9

Don'ts when an inspector is on site

• Do not give documents without approval

• Do not give documents without reviewing

• Do not sign documents without approval

• Do not give over entire binders or folders

Don'ts when an inspector is on site

• Do not fill the silence

• Do not let your guard down

• Do not argue

• Do not become defensive

What Do You Do? The inspector has listened to your response but is now silently staring at you. Do you:

A. Begin to expound on your response

B. Begin to openly weep

C. Stay silent as well

D. Repeat your response and add more detail

9/28/2020

10

During the Inspection

• Accompany the investigators at all times

• Take thorough notes throughout the survey

• Evaluate your Team and adjust if necessary

• Stay within the normal course of a business day

During the Inspection

• Always reference policy

• Utilize available resources if you have trouble

• Make a copy / keep a copy of documents

• It’s okay to say I do not know

What Would You Do?

The inspector asks if you have any new orders for an oral suspension. They would like to observe the process from start to finish.

Image from www.pixabay.com

9/28/2020

11

What Would You Do?

The inspector asks if you have any new orders for an oral suspension. They would like to observe the process from start to finish.

Review who is currently staffing and try to use most knowledgeable

Stand alongside inspector during observations

Don’t do anything just for them

Post inspection follow ups

• Have a closing meeting

• Ask questions

• It’s okay to pushback politely

• Take detailed notes

• Review documents prior to signing

• Make sure you each get identical originals

Image from subscription to Shutterstock

Post inspection follow ups

• Follow up communication

• Plan of Correction (POC)

• Work with other departments

• Develop work groups

• Share with entire team

9/28/2020

12

Key Takeaways

• Be prepared

• Have pharmacy technicians involved

• Give everyone a role

• Stay calm

Image from www.pixabay.com

Available Resources

• Illinois BOP

• Accreditation Company Website

• ASHP Publications:

Meeting Accreditation Standards: A Pharmacy Preparation Guide

Legal Handbook for Pharmacy Technicians

References

JCHAO guide to preparing for a survey. Available at: https://www.jointcommission.org/accreditation-and-certification/become-accredited/learn-the-process/ Accessed February 27, 2020

ACHC guide to preparing for a survey. Available at: https://www.achc.org/accreditation-process.html#preparing-for-accreditation Accessed February 27, 2020

Rick Couldry, M.S., B.S.Pharm., FASHP and Korby Lathrop, Pharm.D., M.S. Member Perspectives from a Recent Joint Commission Survey. ASHP online CE. 2017

Suzanne Kluge, B.S.Pharm, RPh, BCSCP https://www.ashp.org//media/C1D8E280B5A54CCD830FD01D54FB19C4.ashx ASHP online letter 2018. Accessed February 27, 2020

https://www.jointcommission.org/accreditation-and-certification/become-accredited/learn-the-process/https://www.achc.org/accreditation-process.html#preparing-for-accreditationhttps://www.ashp.org/media/C1D8E280B5A54CCD830FD01D54FB19C4.ashx

9/28/2020

13

Your pharmacy is up for its accreditation renewal this year. Which of the following should occur?

A. Complete all competencies immediately to get them out of the way

B. Ensure all policies were reviewed in the last year

C. Review policies by completing a gap analysis of the standards

D. Ensure all policies are printed and placed into a binder ahead of

time

It is important for a pharmacy technician to be part of the inspection preparation and response team:

A. Because they are going to be spoken to or observed during the

inspection

B. Only when they are a supervisor or in management.

C. Because they have lots of free time

D. Only when they have been involved in writing a particular policy

What should a pharmacy technician do during an inspection?

A. Give inspector entire binders of documents

B. Give inspector documents without approval

C. Answer questions beyond what was asked

D. Answer question directly and only what was asked

9/28/2020

14

The inspector has asked a pharmacy technician how they perform the monthly cleaning of the cleanroom and pharmacy. How will the pharmacy technician respond?

A. Panicked and rushed since they’re nervous

B. Tell the inspector they don’t have time

C. Stop compounding and perform the monthly cleaning

D. Calmly review the policy with the inspector

During an inspection you should:

A. Explain process and policy as best you can from memory

B. Use all available resources during the inspection

C. Give the inspector original documents only

D. Allow the inspectors to rummage through file cabinets

At the conclusion of the inspection you should:

A. Sign all documents immediately

B. Have a closing meeting and ask questions

C. Try to get the inspector out quickly

D. Have a closing meeting and stay silent