Pharmacy Inspections for Surgery Centers

TEMPERATURE & HUMIDITY MONITORING IN CLEAN SUPPLY AREAS

Applicable to all centers (OBS and ASC, across specialties, QUAD A and AAAHC). Increasingly, surveyors are wanting to see temperature and humidity monitoring and logging for clean/sterile supply storage areas. Ultimately this goes back to manufacturer’s instructions and ensuring the supplies are kept in the range required by these IFUs. At this time we are recommending all clients implement temperature and humidity monitoring in clean/sterile supply areas. 

HAZARDOUS CHEMICALS RISK ASSESSMENT

Applicable to AAAHC accredited centers (OBS and ASCs). Twice now we have had AAAHC surveyors ask for a Hazardous Chemicals Risk Assessment, stating that an inventory alone is no longer sufficient. For this reason, we have created a sample risk assessment form. Complete this using information from your SDSe s. This should be reviewed and updated annually with your other risk assessments. 

NEW ADA RULE - IN EFFECT JULY 8TH

Applicable to any center that bills Medicare/Medicaid. There is a new ADA/HHS rule regarding Medical Diagnostic Equipment (MDE), which goes into effect July 8th, 2026. We have created a summary of the rule and a sample policy, education packet, competency validation, and stretcher assessment form. 

AAAHC 1095 UPDATES

AAAHC has made some changes to their communication practices and within the 1095 portal. First, they have reduced email volume. Weekly task reminder emails have been eliminated. They have also made an 

effort to improved the system-generated emails including adding your Business Unit ID (BU ID) numbers to all email subject lines. One change that will be helpful to many of you is an expanded functionality for Client Admin or Primary Contact user in 1095. That designation will now have the ability to complete Application Attestations, Annual Attestations, and manage Survey Quotes directly. The Chief Medical Officer is no longer responsible to complete these tasks. This means users who previously added the CMO role solely to complete these activities can now remove the CMO without loosing the ability to complete these necessary tasks. With this, the CMO role responsibilities related to Application Attestations, Annual Attestations, and Survey Quotes have been removed. Users assigned only the CMO role will no longer receive system-generated email notifications from 1095 Engage. Take some time to double check the role assignments for your organization to ensure the correct individuals are in the correct roles and those who need communications from AAAHC will receive them. If any users currently assigned only the CMO role wish to continue receiving system-generated notifications and completing Attestations or Survey Quotes, you should add the Client Admin/Primary Contact role to their user profile.

BENCHMARKING

Second quarter will close at the end of this month and Q2 Benchmarking is due by July 15th. Forms for participants are on our website. If you are having trouble accessing benchmarking documents or are realizing you did not submit Q1, please email mlee@greyandco.com. 

Hello and welcome to our first quarterly Grey & Co. time and expense. Client update. Today I’m gonna be sharing items that have come to our attention over the past quarter that I think you as our client should be made aware of. As always reach out to us if you have any questions or would like to purchase documents.

First I want to address some housekeeping items. Our summer is filling up quickly and we are going to have a staff member on maternity leave so if you wanna request a visit or a mock survey, be sure to reach out to us soon.

Next first quarter benchmarking data is due on April 15 so if you want to participate, make sure you’ve gotten those forms from Meg and have paid the fee which is $575 for the year.

Finally, we’ve released several FAQ videos and new online courses on our website that are available to time and expense clients. Our most recent course is called AAAHC from A-to-Z and is a great on onboarding tool or refresher for any of your staff responsible for assisting with accreditation.

Don’t forget, we also have safety officer and infection prevention is training that can serve as annual education for those key positions.

Now let’s get into the updates.

BYLAWS

First, let’s talk about Bylaws- During recent surveys we have had surveyors really focus on the Bylaws and whether it meets current practice, so I wanted to discuss specific things you should look for to avoid Bylaws related surprises on survey day!

Requirements for Bylaws include that they must be adopted by the Governing Body & reviewed on an annual basis, must outline Governing Body responsibilities & functions, and include specific criteria for initial appointment and reappointment of medical staff and allied healthcare providers.

Questions to ask yourself:

1. When is the last time the Bylaws were truly reviewed and revised?

2. Do they accurately reflect the current practice, makeup, structure, and responsibilities of the Governing Body?

3. Do the criteria for provider appointment and reappointment match current credentialing practice?

4. Do your Bylaws require board certification?

5. Do they require physicians to have things like hospital admitting privileges, board certification, or BLS?

6. Does that match your current practice?

ANESTHESIA CITATIONS
Next I want to talk about anesthesia reminders- We have recorded a video of anesthesia pre-survey reminders that you can share with your anesthesia providers. It is free on our websites. Here are some key points:

1. Discuss risk benefits and alternatives of the planned sedation prior to the procedure.

2. Pause during the time-out and verbally agree before pushing sedation medications.

3. If a multidose vial is accessed or stored in a patient care area it should be treated as single dose and discarded after use. If a multidose vial is accessed it should be labeled and discarded after 28 days.

4. Draw up only medications needed for the immediate next case. No pre-drawn syringes should be present- this is grounds for immediate jeopardy. 

5. Syringes should be labeled with drug, date and discard time, and your initials if not immediately administered.

6. Hand hygiene should be completed immediately before donning and immediately after removing gloves. Hand sanitizer should be kept on all anesthesia carts.

7. Anesthesia cart drawers should be accessed a little as possible once the patient is in the room to limit cross-contamination. If the drawer is accessed it must be with clean hands.

8. The top of anesthesia carts should be wiped down between procedures. If there is a towel or napkin on the cart, it must be changed between procedures.

9. Rocuronium and Succinylcholine should be refrigerated. If it is removed from the fridge it should be dated and discarded according to manufacturer’s guidelines. If Succinylcholine is stocked, MH precautions must be followed.

10. Clean tops of medication vials with alcohol swab prior to drawing up medications.

11. Swab IV port prior to pushing medications every single time.

12. EKG electrodes should remain in original packaging until use as they have an expiration date and can dry out.

13. High alert and commonly confused medications must be labeled with a sticker. Commonly confused medications must be stored apart.

14. No medications should be wasted in the sink. Controlled substances should be rendered irretrievable (chemical digestion is best).

15. Hand-off communication must include 2 full patient identifiers.

Resources:

• USP 797, https://www.usp.org/compounding/general-chapter-797

• CDC Injection Practices, www.cdc.gov/injectionsafety/index.html, www.cdc.gov/ injectionsafety/providers/provider_faqs_multivials.html 

STANDARDS UPDATES

Finally, AAAHC Standards- the public comment period for v45 revisions just closed, so be on the lookout for new a new AAAHC v45 handbook soon.

UPDATED SAMPLES:

• Manual Endoscope cleaning policy

• Competency for Scope Washing

• Anesthesia consent form

• AAAHC Written Policy List revised for v44

To purchase sample documents or to connect with one of our consultants, please email mlee@greyandco.com

Megan Werdel details the changes seen in AAAHC Standards V44 released in August 2025 and what policies require revision and updates needed in the Policy and Procedure Manual for Ambulatory Surgery Centers before the December deadline.

Megan discusses the differences between Ambulatory Surgery Centers (ASC) and Office-Based Surgery Centers (OBS).