Environmental Controls and Monitoring of a DTRS - Comments and Responses

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1 s and s Linda Martin Mid-America Transplant 212, 213, III Environmental Monitoring, section A, #3 (page 14) The guidance seems to suggest that the document contains best practices via the following comments: This guidance document provides best practice for establishing and maintaining environmental 212 controls and monitoring for any DTRS, and a tissue recovery agency should apply these 213 guidelines to each DTRS it maintains. Best practices would describe parameters and/or processes which are shown to improve or meet certain specifications. The III Environmental Monitoring, section A, #3 Microbial describes a establishing a program that outlines the sampling plan, data determination and analysis, and corrective action plans for microbial monitoring of the DTRS. Although the language included in this section uses terms like can, may, and the following recommendations can be used, there is currently no data available that indicates best practices of microbial monitoring are tied to procured tissue contamination rates or any indication that these practices result in an actual best practice. We would suggest that microbial contamination monitoring not be included in the guidance document. Most hospital and surgery centers do not currently monitor Operating Rooms for microbial contamination it is unclear in the procurement environment why a DTRS would be subject to more stringent requirement recommendations. As indicated by the absence of references, there is not currently an AORN Perioperative Practice reference for microbial monitoring. Accepted (in part); Lines 212 & 213 adjusted to soften language: "This guidance document provides a variety of approaches for establishing and maintaining environmental controls and monitoring for any DTRS, and a tissue recovery agency should consider applying these guidelines to each DTRS it maintains." Regarding "Environmental Monitoring, section A, #3 Microbial" performance of the assessment remains a "should" - this is a step that is only recommended. "If any" was added to this sentence: "The type(s) and frequency, if any, of microbial monitoring of the DTRS should be established based on this assessment. If it s determined the recovery agency will undertake microbial testing, the following recommendations can be used." George McCann Life Alaska Donor Tissue processing organizations are acutely aware of the bioburden associated with recoveries performed in the DTRS of their contracted recovery partners. It would seem most appropriate for the processor to make recommendations to the recovery agency regarding such significant ventilation changes to a recovery suite based on the trending of bioburden reports from the tissue recovered in a specific DTRS. To make general or specific recommendations in a guidance document regarding the ventilation system may: 1. Require expensive and time-consuming rebuilds, add-ons, or modifications to existing high quality recovery suites unnecessarily. 2. Require expensive and time-consuming validation and verification processes with continuous/frequent monitoring, again perhaps unnecessarily. 3. Raise the bar for FDA and other auditing agencies regarding expectations of both DTRS and other recovery suites over which a recovery agency may have significantly less control. Again, if bioburden is not an issue currently with a specific recovery agency s DTRS, this is an unnecessary recommendation and may well lead to increasing regulatory creep. I propose deleting the recommendation in the guidance document pertaining to DTRS ventilation. Accepted (in part): this text was added to the beginning of this section so it identifies applicability to new construction of a DTRS: "When planning new construction of a DTRS, there may be consideration of the following additional parameters:" Kathy Pearson LifeNet Health Page 12, Line 487 (page 12) Back-to-back recoveries are common at some high-volume recovery Suggest adding definition or agency DTRSs. Is there a maximum number of recoveries permitted specify cleaning after each. between Terminal cleaning events? No change indicated; per definition, frequency is established by the tissue bank: TERMINAL CLEANING - Thorough ceiling-to-floor cleaning and disinfection of a DTRS performed at prescribed intervals as determined by the tissue recovery agency (e.g., after each recovery event, daily, weekly), or after major disruptions (such as construction or repair)." Lt red = not accepted Page 1 of 7 February 2016

2 s and s Thank you for the opportunity to comment. It is certainly a good idea to provide guidance for tissue banks, and this document is a great opportunity to advise on best practices for DTRS. I would like to suggest to the finalizing committee that OR-like conditions should be adequate for tissue recoveries, and clean-room like conditions are not absolutely required (although many tissue banks (ours included) maintain HEPA-filtered clean room facilities as their DTRS). Many of the guidelines sound more like clean-room maintenance guidelines and I would caution about finding the right balance between sufficient information for what is needed and too much specific restrictiveness which, just because it is written here, will be seen more like requirements for best practice. If best practice is having a DTRS that is an LAF clean room then we should specify that, but I think we all realize that something less than a clean room facility is adequate, otherwise we would not allow tissue recoveries in other types of facilities. Thank you! Accepted (in part): removed use of best practice in the document (it only appeared twice), and softened languages in some areas. Lines (page 10) It is true that alcohols are not recommended for sterilizing medical and surgical materials (meaning surgical instruments used in patients) because they are not sporicidal and have difficulty penetrating protein-rich materials (ref: on.html#a1) however, alcohols clearly do fall in the chemical disinfectant category-so we cannot use the statement as written. I think the intent of this statement is to say that alcohol should not be the only disinfectant/cleaning material for large environmental surfaces. To say in a blanket statement that it should not be used to disinfect surfaces may discourage its use at all, and it does have a bacteriocidal/virucidal/fungicidal role to play in enhancing disinfectant/cleaning regimens. Furthermore, not all surfaces have visible soil/debris contamination. It seems like you want to make the point separately that detergent is important for removal of soil and debris, and alcohol cannot substitute for detergent in all forms of disinfection. Disinfectants have different modes of action and are not interchangeable. Consideration should be given to the types of disinfectants used and the role they have in the process of reducing bioburden in your environment. Alcohol should not be used as the only disinfectant on large environmental surfaces, because although it is bacteriocidal, tuberculocidal, fungicidal and virucidal, it may not be effective against some spores. Use of detergents is encouraged because they facilitate removal of soil and debris. Accepted in entirety; text suggested replaces original bullet Lt red = not accepted Page 2 of 7 February 2016

3 s and s Lines (page 10) This sounds like an extremely overly specific procedure -requiring damp dusting with a very specific type of cloth. This, in my opinion is too restrictive. If a bank has validated that after overnight nonuse, that the surfaces in a controlled environment are not contaminated, then why should we require that someone moisten a non-sterile cloth, (with potentially a non-sterile solution (see line 439)) enter the room, move around and touch everything? I would think that they are more likely to shed more microorganisms from themselves than they are to remove. Especially given that cleaning protocols for all horizontal surfaces should be in place for after each event in a DTRS. Also, if it is important for before the first recovery of the day, shouldn t it be required for before every recovery because I would think that traffic and activity in the room during a procurement procedure are more likely to generate debris that could land on a horizontal surface and if not cleaned, be present for a subsequent procedure. There are other methodologies that are suitable for preparing room surfaces and banks should be encouraged to consider how they ensure that the rooms are suitable for tissue recovery. Again this does not apply for sites that are not DTRS, then of course horizontal surfaces should be disinfected and/or covered. Tissue banks should ensure that the DTRS is suitably prepared to minimize adventitious environmental contamination prior to beginning any procedure, this may include dusting and/or disinfection of surfaces, running of HEPA filters for specified periods of time, etc. No change indicated. Language is OK as is. The language (should) is consistent throughout the guidance document that these steps are only for your consideration. See responses to comments above where it describes we have softened language: "This guidance document provides a variety of approaches for establishing and maintaining environmental controls and monitoring for any DTRS, and a tissue recovery agency should consider applying these guidelines to each DTRS it maintains. We also removed use of best practice in the document (it only appeared twice), and softened languages in other areas. Line 436 This seems like a wholesale proscription of even having a spray bottle in a facility, and maybe too restrictive. It certainly seems appropriate to have a spray bottle of alcohol for cleaning small surfaces or a dilute bleach solution for biohazard spill/containment. This type of spraying with PPE in place does not generate concerning amounts of aerosols. I don t understand how the spray mechanism provides for airborne transmission of disease from disinfectants to whom/what? Spraying and misting of No change indicated. Bullet is from current AORN cleaning chemicals can Guidelines. Their description is similar. generate aerosols which may cause respiratory symptoms (acute or chronic in personnel). If cleaning chemicals are sprayed or misted in a DTRS, appropriate PPE should be worn to protect the technician from exposure to aerosolized chemicals. Care should be taken to ensure that any sprayed chemicals or disinfectants that could have an adverse effect on tissues, equipment or supplies, do not unintentionally contaminate surgical field, supplies, or equipment. Line 447 The first part of the sentence contradicts the 2nd part of the sentence either the detergent must be used before disinfection or it may be used concomitantly. Environmental surfaces should be cleaned and disinfected according to the manufacturer s instructions. Accepted in part, however, it's important to offer these options as examples. The examples remain but were rewritten so there is no confusion regarding intent. Lt red = not accepted Page 3 of 7 February 2016

4 s and s Line 487 Specifying cleaning soiled surfaces of only high-touch objects, is overly focused Cleaning of objects in the DTRS after each recovery event should include all surfaces and special attention may need to be placed on hightouch or frequently touched objects or areas of an item (e.g., control panels, switches, knobs, handles, etc.) that may become soiled. Accepted in part, however, the guidance is not suggesting cleaning of 'all' surfaces. Bullet reworded. Be aware there are a list of items in a bullet that follows this one, and this cleaning is not terminal cleaning. Line 503 Because of the very likely potential of contamination of the floor in a DTRS and the risk of cross-contamination, shouldn t we specify that the floors should be cleaned and disinfected after each recovery event not only if they are soiled? The floors of the DTRS should be cleaned and disinfected after each recovery event. The walls should also be cleaned and disinfected if soiled or potentially soiled (e.g., by splash, splatter, or spray). Accepted. Split into two bullets. Lines This section mixes routine post event cleaning with terminal cleaning. Do you mean to differentiate by definition Terminal Cleaning from the disinfection and cleaning I think we want to specify that should happen after each recovery event (routine postevent cleaning)? If so, there probably should be a definition of Routine Post-Recovery Cleaning. All floors in the DTRS should be cleaned and disinfected after each event. Floors may be (terminally) cleaned. Accepted. Deleted the "terminal" description for cleaning floors and moved two like bullets together. This section also seems to be an extension of 503 perhaps these 2 sections should be combined. And then have more details for Terminal Cleaning grouped together Lines 516 & I am not familiar with the statement that cleaning should progress from cleanest to dirtiest area of the floor, but it seems like it s very likely to cause tracking and dragging of dirty materials over cleaned areas because one has to walk and sometimes pull cleaning buckets, etc, from the center (dirtiest area) over previously cleaned areas (e.g., the exit on a perimeter). Is this really a tried and true axiom? It seems that if disinfectant is effectively doing what it is supposed to do, that starting at a corner or wall farthest away from the exit and moving towards the exit, thereby never walking on and dragging cleaning equipment over cleaned surfaces is a better way to leave a cleaned room without re-contaminating cleaned surfaces. (Perhaps I am unfamiliar with some other organization s standard that specifies this floor cleaning method.if there is one, perhaps it should be referenced, since I m sure that I m not the only one who will feel that traversing cleaned areas from the dirtiest area has the possibility of re-contaminating the cleaned area.) Delete line 516 For lines 517 to 520: Cleaning should progress from one end of the room towards the exit. Once an area has been cleaned and covered with disinfectant, that area of the floor should not be further mopped or disturbed by walking over it, to prevent recontamination and allow adequate exposure to the disinfectant over the entire surface for the required period of time. No change necessary. The recommendation used in the guidance is from AORN's Guideline for environmental cleaning in "Guidelines for Perioperative Practice Denver, CO: AORN, Inc. (current edition)". See reference [7]. The comment is a good one but does not provide a reference. AATBt purchased the 2015 edition of the AORN Guideliens to review concurrence with the 2014 edition originally used when creating this guidance. What's written in this guidance document concurs with the new edition. Blair Haynes LifeLink Tissue Bank Line 559 Temp between 68 and 72 (lower bottom range) Many Operating Rooms are cooler than 68; we don't want to be out of range No change necessary. The range suggested for a DTRS was derived from the "Current Guidelines for Perioperative Practice from the Association of perioperative Registered Nurses (AORN)" and it's only a suggestion for a restricted area. The guidance document also describes: "The recovery agency should conduct and document a risk assessment of the environment and the rational for control levels selected." Lt red = not accepted Page 4 of 7 February 2016

5 s and s RTI II. B. 1 Recommended humidity range is provided in section III. A. RTI II. C. Validating the efficacy of cleaning processes and chemicals is best practice. RTI II. C. Lines RTI II. C. Lines Add clarification that only reusable cleaning equipment can be cleaned and disinfected for additional use. Accepted; changes made as recommended High relative humidity higher than recommended can promote microbial growth, especially molds, on environmental surfaces and thus increase bioburden. Add The cleaning process and No change necessary. The use of "best practice" in the selected chemicals should be document (it only appeared twice) was removed. The validated to ensure adequate term validation and expectations to validate procedures is not desirable for recovery-related activities and not removal of debris and required by 21 CFR Part microorganisms. Cleaning chemicals that are Accepted (in part); text adjusted to read: " Cleaning sprayed produce more chemicals that are sprayed produce more aerosols than aerosols than solutions that solutions that are poured or ready to use. If the cleaning solution is contaminated, the spray mechanism may are poured or ready to use. If aerosolize microorganisms and lead to airborne the cleaning solution is transmission of disease. Aerosols generated may contaminated, the spray contaminate the surgical wound, sterile supplies, or the mechanism may aerosolize sterile field, or may cause respiratory symptoms (acute or microorganisms and lead to chronic) in personnel." provide a route for airborne transmission of disease. Aerosols generated may contaminate contamination of the surgical wound, sterile supplies, or the sterile field. Additionally, aerosolized chemicals, or may cause respiratory symptoms (acute or chronic) in personnel. Reusable Cleaning equipment Accepted (d'oh!) should be disassembled according to manufacturers instructions for use, cleaned, disinfected with an EPAregistered disinfectant, and dried before storage and reuse. Lt red = not accepted Page 5 of 7 February 2016

6 s and s George McCann Life Alaska Donor Temperature and humidity controls for a DTRS makes good sense if environmental monitoring does not take place. If environmental monitoring is part of the quality program, the results of such monitoring should speak for themselves and be the impetus for establishing the above-mentioned temperature and humidity controls. 1. The temperature range of degrees F is fairly narrow. What is the risk of a lower temperature? 2. Specifying temperature ranges and humidity levels in the guidance document may: A. Require continuous monitoring B. Require repeated non-compliance reporting when the temp/humidity falls out of range quite burdensome when risk to recovered tissue has not been established. C. Will require the recovery agency to perform a risk assessment to justify their establishment of acceptable temperature and humidity range parameters. D. Question is it incumbent on the AATB auditor and other auditing agencies (FDA) to evaluate the risk assessment and determine whether the temp/humidity range established by the recovery agency is acceptable? Recommend deleting the suggested AORN parameters for temperature and humidity from the guidance document. No change necessary. This guidance is only advisory in nature. It's not intended to be required by AATB and is not used for accreditation inspections. The risk of a lower temperature is related to comfort. A risk assessment to justify action and alert levels is a good idea and described in this document as a consideration. The AORN Guidelines offer reference ranges (starting points) on which your decisions for your DTRS can be based. Yours can be different. RTI III. A. Line Performing a PM may not be adequate in identifying failures of a positive pressure ventilation system in a timely manner If the DTRS has positive pressure ventilation, the pressure differential between the DTRS and adjacent spaces should be monitored on a defined frequency. Agencies should follow manufacturer s recommendations for preventative maintenance. Any filters used (e.g., HEPA filters) should be inspected and replaced per manufacturer s recommendations. Accepted; changes made to read:" If the DTRS has positive pressure ventilation, the pressure differential should be monitored using a defined frequency. Agencies should follow manufacturer s recommendations for preventative maintenance, when available. Any filters used (e.g., HEPA filters) should be inspected and replaced per manufacturer s recommendations." Lt red = not accepted Page 6 of 7 February 2016

7 s and s RTI III. A. Lines The recommendations for positive airflow (pressure) should be aligned between sections II. and III. Current Guidelines for Perioperative Practice from the Association of perioperative Registered Nurses3 (AORN) and ANSI/ASHRAE/ASHE #170 suggest the following parameters for a restricted area: Air changes at least 20 per hour; and Positive airflow (pressure differential of at least inches of water). Accepted in part. In regard to pressure levels, the ANSI/ASHRAE/ASHE #170 standard is more specific than AORN's Guidelines for Perioperative Practice in the Guideline for a Safe Environment of Care, Part 2, at Recommendation IV. These descriptions have been clarified in the guidance document. AATB purchased the 2015 edition of the AORN Guidelines to review the reference used and it remains correct. RTI III. A. As a best practice, microbial detection methods should be validated to ensure that residual disinfectants do not interfere with detection. Add "Microbial detection methods should be validated to ensure there is no interference with residual disinfectants" Accepted but reworded; "To assess microbial contamination, microbial detection methods should be suitable for intended use to ensure there is no interference with residual disinfectants. Monitoring of a DTRS can involve passive and/or active sampling methods." NOTE: During January 2016, the work group requested review of the revised guidance document from Sharon Van Wicklin, the AORN representative to the Standards Coommittee. Sharon provided a very helpful, thorough review and offered a number of suggestions. s to all of them were shared with Sharon but are not included here. The work groupis grateful to Sharon for providing her expert review. Lt red = not accepted Page 7 of 7 February 2016