Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 06/27/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). STANDARD LEVEL DEFICIENCIES were cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, proficiency testing (PT) records and staff interview, the laboratory failed to document 1 of 4 PT records reviewed on a semi-annual basis as per its own policy. Findings included: 1. Review of laboratory's policy "Proficiency Testing" (last reviewed July 2023) revealed: "Semi-annually, the tech will send three cases containing the original slides and corresponding Mohs maps out for microscopic examination by a Board Certified Pathologist." 2. Review of laboratory's PT records revealed the following dates PT material was sent out for examination: 12/21/2022 Shipment contained cases from 2nd half of 2022 12/22/2023 Shipment contained cases from 1st half of 2023 01/10/2024 Shipment contained cases from 2nd half of 2023 06/19/2024 Shipment contained cases from 1st half of 2024 There was no semi-annual shipment of cases for review between December of 2022 and December of 2023. 3. In an interview on 06/27/2024 at 1340 hours in the break room, the facility's CEO (as indicated on submitted Survey Entrance/Exit Conference document) confirmed the findings. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: This is a repeat deficiency from 08/09/2022. Based on review of laboratory's policies and procedures, review of laboratory's Microscope Maintenance records for January to May of 2024 and staff interview, the laboratory failed to document monthly grounding checks for 5 of 5 months reviewed, as per its own policy. Findings included: 1. Review of laboratory's policy "Quality Control Program" (last reviewed by laboratory director in July of 2023) revealed: "EQUIPMENT QUALITY CONTROL - MICROSCOPE ...2. Grounding check is monitored monthly. ...4. Each action is documented on the maintenance record form." 2. Review of the laboratory's Microscope Maintenance records for January to My of 2024 revealed there was no documentation of monthly grounding checks for the following 5 of 5 reviewed months: January 2024 February 2024 March 2024 April 2024 May 2024 3. The laboratory was asked to provide the monthly grounding check documentation and no such documentation was available for review. 4. In an interview on 06/27/2024 at 1415 hours in the break room, the facility's CEO (as indicated on submitted Survey Entrance/Exit Conference document) confirmed the findings. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: This is a repeat deficiency from 08/09/2022. Based on review of laboratory's policies /procedures, H&E (hematoxylin and eosin) Stain quality control (QC) records and staff interview, the laboratory failed to document lot numbers/expiration dates of H&E Stain reagents in use for 5 of 5 months reviewed from January to May 2024. Findings included: 1. Review of laboratory's policy "Quality Control Program" (last reviewed by laboratory director in July of 2023) revealed there was no mention of requirements for quality control or documentation requirements for the H&E Stain acceptability or reagent lot/expiration dates. 2. Review of the laboratory's H&E Stain QC records for January to May 2024 revealed the laboratory did not document lot numbers or expiration dates of each of the H&E Stain reagents in use for each of the 5 months reviewed. 3. In an interview on 06/27/2024 at 1415 hours in the break room, the facility's CEO (as indicated on submitted Survey Entrance/Exit Conference document) confirmed the findings. D5781