Develop a Cleanroom Certification Checklist


November 2020 - Vol.17 No. 11 - Page #36

Recently, The Joint Commission and state boards of pharmacy have increased their scrutiny of aseptic technique, cleanroom cleaning, and certification of cleanrooms. It is not uncommon that a surveyor will spend time examining certification reports and inquiring about results and trends. It is prudent that the designated person who reviews certification reports does not simply accept them as is, but spends the requisite time appraising the data to draw their own conclusions, analyze patterns, and determine where remediation is needed. Therefore, it is critical to develop a checklist to guide the assessment of certification reports.

Before proceeding, review the practices of the certification company. Questions to ask include:

  • Does the company specialize in pharmacy cleanroom certification or do they certify many types of facilities?
  • Is the company following the most recent USP <797> and Controlled Environment Testing Association (CETA) guidelines?
  • Is the company familiar with cleanroom design and HVAC adjustments?
  • Is the company open to discussions on how to improve the certification process?
  • Does the company ensure dynamic conditions are being met?

After reviewing the practices of the certification company, schedule an appropriate time for the certification, undergo the certification process, use a checklist to review your report, and complete any necessary remediation activities.

Scheduling Certification Services

Scheduling certification can be a complex task. It is important to schedule certification during low-risk patient care activities to decrease the risk of contamination to patient doses. It is also essential to avoid having certification personnel obstructing workflow. At the same time, dynamic conditions are necessary to emulate normal workflow during the certification process. Thus, selecting a time where limited, lower-risk activities are occurring is advantageous. (However, note that initial commissioning certification that occurs after construction should not be performed under dynamic conditions; the first certification after construction should occur after a triple terminal cleaning and prior to any operations occurring.)

Communication

After the certification process, effective communication with the certification company is critical. Any action levels that have been exceeded should be immediately reported to the designated person—do not wait for the final report to arrive. This is especially important if a highly pathogenic organism is found. The designated person then needs to determine the correct actions for remediation or if closure of the compounding area is required. Note that it is important that the final report is received in a timely manner; as incubation requires a minimum of 14 days, it is reasonable for reports to arrive 2.5 to 3 weeks after certification. Check with the state board of pharmacy to determine if there is any requirement on how to save the report (paper or electronic format) or if a hard signature is required.

Reviewing Your Report

Each certification company will have a unique format for the report. Become familiar with the formatting so it is easy to locate the most important information or respond to a surveyor asking for a specific item. Use of a standard checklist (see TABLE 1 for a sample checklist) is recommended to ensure all elements of the certification process are accounted for and within range.

Click here to view a larger version of this Table

Only the designated person or qualified designee should complete the checklist. Consider an electronic spreadsheet for tracking numeric elements and identifying trends. An example of a concerning trend would be the gradual increase in positive viable surface samples on a work surface within the buffer room. This would suggest that cleaning may not be occurring consistently, and that a remediation plan would be necessary.

Note that the certifier may indicate “pass” for various elements within the report, but these items should not be accepted without investigation. For example, the certifier may indicate “pass” for viable surface sampling when there is only 1 CFU in an ISO 7 area, and technically this is correct. However, it should be concerning if the CFU identified is Clostridium difficile. This finding should be thoroughly investigated due to the significant risk of contamination.

After the checklist is complete and any immediate concerns have been addressed, schedule a meeting with pharmacy, facility engineering, regulatory, and infection prevention and control to discuss the results and trended previous results. Minutes should be recorded and stored with certification reports for surveyor reference and any future questions from pharmacy and hospital leadership. Be sure the post-certification meeting covers:

  • Overall pass/fail results
  • Adjustments needed in secondary engineering controls
  • Trends in particle counts within secondary and primary engineering controls
  • Concerns with viable growth (air and surface) numbers and identification
  • Remediation necessary based on certification results
  • Documentation for future regulatory surveys

The Remediation Process

Remediation can take many different approaches. The institution’s regulatory team may dictate a specific form be used for documentation consistency. Otherwise, providing a narrative of the actions taken (see FIGURE 1) may help best describe the situation, or tracking results and individual remediation activities on a smaller scale may be easier in a spreadsheet (see TABLE 2).

Click here to view a larger version of this Table

The most important element of remediation is to state the facts and to be thorough describing follow-up activities. Burying any findings within certification reports or not acknowledging them in the remediation report may be tempting to try to achieve a perfect score, but seasoned surveyors know this is not realistic. Cleanrooms are dynamic areas and are constantly battling human contamination.

Share remediation documentation with regulatory staff to get feedback and ensure it will meet surveyor expectations. If any documentation is kept on paper or requires signatures, scan backup copies in secure files. Failure to document any of these activities or to follow through on remediation actions can lead to findings and citations from regulatory agencies.

Conclusion

The certification process becomes easier to navigate over time; getting to know individuals in engineering, regulatory, and the infection prevention and control teams will further ease the process. Following a standard certification checklist will help to track results and set a framework for response to these results. Each member of your certification report review team will have a different and unique perspective to contribute. Additionally, working with a responsive and knowledgeable certification company can make responding to certification results quicker and clearer.


Ashley Duty, PharmD, MS, BCSCP, is the clinical pharmacy operations manager at Children’s Mercy Kansas City. She earned a Doctor of Pharmacy from Ohio Northern University and a Master of Science in Health-System Pharmacy Administration from Northeast Ohio Medical University. Ashley completed a Health-System Pharmacy Administration residency at the Cleveland Clinic. Her professional interests include sterile compounding operations, medication safety, informatics, and leadership development.

Joanna Robinson, PharmD, MS, BCSCP, is the pharmacy operations manager at the University of Kansas Health System. She attended the University of Kansas School of Pharmacy and completed a Health-System Pharmacy Administration residency at Wake Forest Baptist Medical Center. Joanna’s professional interests include sterile and non-sterile compounding operations and medication safety.


FIGURE 1

Narrative of Actions Taken During Cleanroom Remediation Process

On 7/12/17, XYZ Hospital inpatient pharmacy received notification from ABC Certification Company via email about viable air sampling results exceeding action levels in the Oncology Satellite pharmacy, specifically the hazardous buffer room. Management determined that day at 1700 the cleanroom had to be closed and re-sampling had to occur due to board of pharmacy rules and statutes. Signs were posted on the door of the room that the pharmacy was closed. All pharmacy personnel and affected health care providers were notified that operations would continue via the main pharmacy.

On 7/13/17, pharmacy management and trained environmental services personnel did two thorough cleanings of ceilings, walls, floors, and work surfaces. The cleanroom remained closed during this time. Hospital infection control staff visited to discuss potential sources of contamination of the area and said they would get back to pharmacy management but did not see anything obvious at that time.

On 7/14/17 at 0900, ABC Certification Company returned to the Oncology Satellite to retest particle counts and viable air sampling. A pharmacy manager simulated dynamic conditions for testing. The cleanroom remained closed during this time.

On the afternoon of 7/21/17, pharmacy management received an email from ABC Certification Company stating that the particle sampling performed on 7/14/17 was acceptable per USP <797> standards. The CFUs that were reported to management were below action level and not highly pathogenic. ABC Certification Company said that the report would be finalized the following week for pharmacy management. Pharmacy management discussed the findings overall and looked at previous particle counts. They determined there was no pattern of exceeding action levels and that perhaps the particles were generated from clothing and equipment from ABC Certification Company.

The cleanroom was cleaned again on 7/21/17 per normal business, restocked over the weekend, and resumed normal operations on 7/24/17.

On 7/27/17, pharmacy management received and reviewed both reports from ABC Certification Company.

______________________________          7/28/17
John Smith
Pharmacist in Charge

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