Name: XXXXX XXXX Title: XXXXXXXX
Address: XXXXXXXXXXX Organisation: College of American Pathologists
Contact Number: XXXXXXX Address: XXXXXXXXXXXX
Email id: XXXXXXXXXXX Date: XXXX
Respected Sir / Madam,
I would hereby like to draw your attention to the fact that the laboratory, XXXXX, in which I have been working for the past three months, has undergone a CAP on-site survey on XX.XX.XXXX. The respected Inspectors had found some Phase II discrepancies. I would like to apologise to the concerned authority and take responsibility of it.
Kindly find the attachment, which is an explanation for such discrepancies from our end. I ensure that the problems would be solved soon and definitely before the next round of CAP inspection.
Kindly consider my request.
Subject: Response on the recent On-Site Survey
1) In response to the establishment of PT for ESRs, we have not established (PT) for ESR, wherein the red blood cells are continuously in sediment. The main reason is that there is an ongoing research for developing a more sophisticated tool for management of the PT in the ESR. The researcher working in the laboratory have the hope of coming up with a prefect alternative to PT to be included in the ESR, in order to make it more powerful and resilient. The ESR is being discontinued until the time something is in place and the expected period would be one month for the PT to be implemented.
2) In response to the low score in PT Challenges, the score of 80% in the PT Challenges for the urine creatinine is below acceptable level. However, it should be increased by taking up specific measures like revising the kit.
3) The maintenance of the documents for electrical ground checks for centrifuge have not been undertaken adequately and not replaced. For making sure that no possible risk of electrical hazards remains, maintenance have been undertaken on a regular basis. The earth grounding and the wiring of the wall outlet receptacle has been done. The line voltage is in alignment with the particular voltage required. No three-to-two wire adapter or two-wire extension is used. A two-wire receptacle strip is also not used that is of non-grounding type. These are the guidelines for proper handling of centrifuge and avoiding risks of inconvenience that are adhered to.
4) Receiving no response from the remote location while testing the blood bank refrigerator, is a major concern. It is important to increase the knowledge level of the workers working in the laboratory related to the CLIA requirement of preservation through which they can take these things seriously, and avoid repeating same mistake in the near future (Buppert, 2008). Again, proper check and balance factor is essential in this particular aspect to make the things in the favour of the laboratory. All the employees will be retrained on this aspect and during the training process the employees will be given guidelines on how to manage the operating procedure. It would be stated that the appointed remote location charge person of the day has to respond within 10 minutes to the alarm. There will be a drill conducted twice a year on remote alarm in order to make all employees capable to responding in an appropriate manner.
5) In response of the missing of Material Safety Data Sheet (MSDS), we have located the backup files of the missing sheets from the manufacturers websites and placed the MSDS sheets in the respective files. The supervisor will keep a track of all the chemicals in the future and it is the responsibility of the supervisor to make sure that the MSDS sheets are kept in the respective files before the chemicals are used for service. The MSDS sheets will be compared with the chemicals every two months and if any such sheets are foud to eb missing, they will be recovered from the website of the manufacturer. According to the requirement of CLIA, the MSDS that contain the information relating to potential hazards and safety should be maintained accordingly in the file (Gagnon & Whalen, 2000). In case of missing, strict probing will be initiated against the people who are liable to maintain and filing of these documents. Legal actions may be taken against the individuals, subjected to the intensity of the missing information.
6) We have an idea that as per the requirement of CAP/CLIA, the reticulocyte procedure that contains the information related to the blood cells should be reported and recorded in the files to be used for the audit purpose (Voytek, 2003). Missing of this information from the file is yet again a serious concern, and legal action will be taken against the responsible person. However, much of emphasize would have been diverted on the aspect of gaining the immature red blood cells again.
In response to found outdated alkaline phosphatase reagent, we would like to ensure the CLIA inspection team that we are not utilizing the outdated alkaline phosphatase reagent that found in the refrigerator in the back-up Chem analyzing procedure, but we only consider the same for some analysis purpose in particular. We have an idea that using outdated alkaline phosphatase reagent can cause numerous health hazards and no one in the laboratory is even daring to play with the health of the individuals. However, we will take a note of the same, and make sure that similar issue will not rise again.
In case of any further clarification, please feel free to contact us
Manager ABC Laboratory
Buppert, C. (2008). Nurse practitioner's business practice and legal guide. Sudbury, Mass.: Jones and Bartlett.
Gagnon, M., & Whalen, R. (2000).CLIA policy on new laboratory instruments. Diagnostic Cytopathology23(6), 435-435. https://dx.doi.org/10.1002/1097-0339(200012)23:63.0.co;2-u
Voytek, T. (2003). A kinder and gentler CLIA?. Diagnostic Cytopathology, 29(3), 123-124. https://dx.doi.org/10.1002/dc.10366
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