Pharmacy OneSource Blog

Part 1 - Eric Kastango and Abby Roth answer your questions about the Investigation and Remediation of Environmental and Personnel Sampling Excursions

Posted on 09/27/17

Our recent webinar, Investigation and Remediation of Environmental and Personnel Sampling Excursions, drew an audience of hundreds of pharmacy professionals. Of course, the main drawback to a big turnout is that, with limited time, not everyone has a chance to get answers to their questions. Fortunately, we saved the questions we didn’t get to during the event and will be answering them in the blog over the next few weeks. Today’s questions and answers relate to:

  • Identification of environmental and personnel sampling excursions
  • Investigation of environmental and personnel sampling excursions
  • Incubation of environmental and personnel samples

Identification of environmental and personnel sampling excursions

Should you identify organisms for gloved fingertip failures?

Identifications should be done on the ongoing gloved fingertip sampling.  Having the identifications can provide insight to any lapses in aseptic technique. Identifications are not necessary on the initial gloved fingertip competency.

My certifier only gives the genus of the microorganisms, so my report will just say "staphylococcus spp" - do they need to be testing/reporting further?

The genus level is sufficient for all organisms except for the Staphylococcus species, as 797 indicates coagulase positive staphylococcus are a concern.  There are two options for dealing with the Staphylococcus species.  They would either need to report the coagulase test result or identify to the species level and report the genus and species.

We do weekly surface sampling. Does this need to be identified to genus?

This does not need to be identified to the genus level.  However, this additional sampling needs to be in your SOP and it should be clearly indicated that identification are not being performed.  In the event these sample counts exceed the action levels, identification might be valuable in your investigation.


Investigation of environmental and personnel sampling excursions

How do you determine a recall of CSP once you have growth in a LAFW or Class ISO-5 WB?

The number of CFU/m3 must be considered.  One CFU/m3 would not be a concern, 10 CFU/m3 would be.  The types of organisms recovered should also be considered.  Recovering coagulase negative Staphylococcus species or Micrococcus species would be common organisms to recover in a PEC, especially if poor technique was used.  An investigation into many aspects would have to be conducted and a risk assessment performed to determine what the risk to the patient would be.

What can I do if my state bop suspends my HD prep and restricts my compounding to a 12hr beyond use date due to a environmental monitoring sample OOC in my clean room NOT my Pec ?

Can I use this information given to fight bop restrictions?

It is important to have an SOP for how excursions are going to be handled and all plans must be clearly defined.  Share your SOP with the state BOP.  Even if the SOP does not follow USP 797 exactly, many are accepting as long as it is a realistic, science based approach.

Is one or two colonies of Cladosporium in the entrance of Anteroom enough to start a full investigation as you described?

The presence of the mold will still require an investigation.  You must show that you are taking some kind of action.  We do not recommend taking sample on the dirty side of the LOD.  This area should have organisms as ungarbed people will be in the area.

Is it sufficient to retest after a positive sample in order to eliminate the possibility of contamination by the tester or otherwise false positive.

A retest of the area will be required as per USP 797. In the event you suspect contamination of the sample due to the sampling process, the questionable result must still be reported; the data cannot just be discarded.  There must be clear documentation showing justification as to why the sample was possibly contaminated and a final determination to the sample location status.

How common are false positives? (Due to sampling error, incubation error etc). Is there a good way to identify that a sample might be a false positive vs a true finding? And if it is determined to be a sampling error, would it change your investigation?

False positives are difficult to identify, unless there were issues with sampling handling and condensation.  In this case, there may be obvious contamination around the edges of the plate. Your laboratory should notify you in the event they suspect the samples were contaminated. They should also contact you if there were know sample handling issues or any other lab deviations that would affect your samples.  Any questionable results must remain as part of your documentation and resampling should occur.

When would you recommend that a pharmacy shut down their SEC and stop compounding? Only if the investigation shows the SEC is not functioning properly?

The investigation should dictate whether or not the SEC should be shut down.  Even if the SEC is properly functioning, major cleaning issues or improper work practices may warrant shutdown until the issues are resolved.

If you have a failing viable in your buffer room, how do you justify NOT shutting down your IV room?

It is important to remember that EM is a snapshot in time. The results of the samples usually come back about a week later.  What was in the room at that point might not be there now, especially because cleaning has occurred multiple times.  So shutting down the room now, when it might be fine doesn't make any sense.  This is why increased sampling is important.  In the event of an excursion, sampling can be done more frequently (like once a week for a month) to show that the room has indeed returned to a state of control.  Repeated excursions may warrant a shutdown and a more detailed investigation with a microbiologist.

What follow-up is required if 1 CFU of fungus is obtained in the anteroom? Does the BUD need to be reduced? What type of cleaning needs to be performed...daily/monthly/triple?

If there was one cfu of fungus (yeast or mold) in the anteroom and the count did not exceeded the action level, the BUD would not need to be reduced.  A monthly cleaning could be performed, which would include the use of a sporicidal agent.

Location of GFS...had employee claim results of positive GFS was caused by anteroom air not by fingers. Should GFS be performed in PEC?

Initial glove fingertip sampling should be performed in the area where gloves are donned.  If the testing will be in the isolator, the person must don the sterile gloves over the gauntlet gloves and sampling occurs in the main chamber of the isolator.  If your procedure is to don gloves in the buffer room, sampling is done in the buffer room. If it is to don gloves in the ante room, sampling is done in the ante room.  Ongoing gloved fingertip sampling is performed in the PEC.  Plates should not be opened until the person is ready to be sampled.

We have bacterial/fungal growth in the air but nowhere else in the cleanroom. How do you find sources of air contamination with the high air exchange rates?

You will want to be sure that unclassified air is not getting into the room through cracks or crevices.  Additionally, if your HEPA filters are remote and not right in the ceiling, there could be holes in the duct work allowing contamination to enter the room.  Some other areas to consider are garbing, proper clean room behavior and material transfer.

Some environmental sampling results trigger an Action based on the organism but do not exceed Action Level TMC. Are you suggesting cleaning, resampling, remediation & documentation when the result did not exceed Action Level TMC?

Currently USP 797 indicates: "Highly pathogenic microorganisms (e.g., Gram-negative
rods, coagulase positive staphylococcus, molds and yeasts) can be potentially fatal to patients receiving CSPs and must be immediately remedied, regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist."  So yes, to be able to show that these are immediately remedied, an investigation would be done to document the remediation process, regardless of whether or not the Action Level was exceeded.

Our Board of Pharmacy is recommending that Cleanrooms be shut down for any out of control results in the ISO 7 or 8 areas until the area is recleaned and retested. Was this the intent of the Chapter or is changing the BUD for products compounded in the room acceptable? Does the room then become a SCA?

Each excursion if different.  For 1 CFU of mold in the ante room, the room does not need to be shut down or the BUD reduced.  For 100 CFU/m3 in the buffer room, that may require a shut down.  You need to have a clear plan in place as to how you are going to handle excursions. 


Incubation of environmental and personnel samples

If pharmacy does their own incubation of samples, what is best practice to then obtain identification of microbes?

Identifications can be sent out to a contract laboratory for analysis.  You will want to discuss the identification methods they will be utilizing, how to complete the chain of custody and how to ship the samples.  The lab should be ISO 17025 accredited, with identifications being part of their accreditation scope and they should be registered with the FDA.

How long should the environmental samples be incubated and at what temperatures surface vs GFS?

Our recommendation is that for any sample taken using TSA is incubated as follows:  30-35C for 48-72 hours and then transferred to 26-30C for 5 to 7 days.  This allows for the growth of bacteria, yeast and mold and also provides the length of time needed for slower growing organisms to grow.

If only using TSA for VAS, how should the plate be incubated, ie, high temp for 7 days then low temp for 7 days or vice versa?

The chapter provides guidance incubation parameters.  Unless your facility has performed an EM performance qualification and based on the organisms recovered has determined that different incubation parameters are appropriate, we recommend following USP 797 parameters of 30-35C for 48-72 hours and 26-30C for 5 to 7 days.


Be sure to check back next week, when we’ll be answering questions on cleanroom cleaning and environmental monitoring session requirements and locations.

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Topics: environmental sampling

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