Pathologists Bio-Medical Laboratories, Pllc

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 11/05/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on surveyor's observations, review of laboratory's policies/procedures, laboratory's records and staff interview, the laboratory failed to follow its own policy for monitoring and documenting temperature to ensure stored slide preservation for two of two rooms with stored specimen slides. Findings included: 1. Surveyor's observations on 11/05/2024 at 0900 hours in the facility revealed the laboratory stored specimen slides in two different rooms, the reception room and a storage room. 2. Review of laboratory's "Specimen and Records Retention Policy" (document Gen Lab 25, last approved 05/08/2024) revealed: "Slides/blocks are stored at ambient room temperature for optimum preservation. Slide/block storage room temperatures are monitored to ensure this." The policy did not define acceptable ambient temperature range for slide storage. 3. Review of laboratory's records revealed there was no documentation of temperature monitoring for the two rooms where specimen slides were stored. 4. In an interview on 11/05/2024 at 1230 hours in the breakroom, the facility's Senior Manager for Safety, Quality and Compliance (as indicated on submitted Survey Entrance/Exit Conference Form) confirmed the findings. D5401 PROCEDURE MANUAL 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 -- CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, electronic quality control (QC) records, patient test records and staff interview, the laboratory failed to ensure stain /slide acceptability was documented in the electronic system as per its own protocol for four of sixty-nine instances documentation was required from January to June 2023. Findings included: 1. Review of laboratory's "Routine Stain Quality" policy (document Histo 55, last approved 02/15/2024) revealed: "The Pathologists perform a quality control assessment of routine stains when reviewing slides for diagnosis." And, "1. The Pathologist completes the PBM Slide Discrepancy Application that accompanies the assigned workload daily ... 2. The Pathologist notes any discrepancies with the workload received. 3. In the event there are no discrepancies present, the Pathologist checks the box indicating, "There were no discrepancies present with today's workload." 4. If there are no issues with the H&E staining, the pathologist checks the box indicating that the H&E stain quality in that day's workload was satisfactory." 2. Review of laboratory's electronic QC records From January to June 2023 revealed the following four of sixty-nine reviewed PBM Slide Discrepancy Application records did not have the boxes for "no discrepancies present" or "H&E stain quality" marked as required: Id: Discrepancy date: 6795 01/13/2023 6797 01/13/2023 6800 01/13/2023 7256 03/27/2023 3. Review of laboratory's patient test records revealed the following patient samples were evaluated within the workload without the required PBM electronic documentation of workload discrepancy and H&E stain quality: Sign-Out Date: 01/13/2024 Cases signed out: PS23-1776 PS23-1864 PS23-1865 PS23-1866 PS23-1868 PS23-1869 PS23-1873 PS23-1875 PS23-1885 PS23-1896 PS23-1963 PS23-2004 PS23-2009 PS23-2012 PS23-2019 PS23-2024 PS23-2028 PS23-2041 Sign-Out Date: 03/27/2023 Cases signed out: PN23-1170 PN23-1185 PS23-16321 PS23-16368 PS23-16369 PS23- 16960 PS23-16963 PS23-16966 PS23-16967 PS23-16971 PS23-16977 PS23-16978 4. In an interview on 11/05/2024 at 1130 hours in the breakroom, the facility's Senior Manager for Safety, Quality and Compliance (as indicated on submitted Survey Entrance/Exit Conference Form) confirmed the findings. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially 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: Based on surveyor's observations, review of manufacturer's instructions, laboratory's -- 2 of 3 -- policies/procedures, maintenance records and staff interview, the laboratory failed to document microscope maintenance for two of two microscopes in use in 2023 and 2024. Findings included: 1. Surveyor's observations on 11/06/2024 at 0910 hours in the facility revealed two microscopes, one in each of the two pathologists' offices. These were: a. Olympus BX-43F; Serial Number 4J44798 b. Olympus BX-51TF; Serial Number 4B16343 2. Review of manufacturer's "Olympus Instructions BX43" and "Olympus Instructions BX51/52" (www.Manualslib.com) for the above microscopes revealed: "Maintenance and Storage 1. To clean the lenses and other glass components, simply blow dirt away using a commercially available blower and wipe gently using a piece of cleaning paper (or clean gauze). If a lens is stained with fingerprints or oil smudges, wipe it gauze slightly moistened with commercially available absolute alcohol." Manufacturer's instructions did not define required frequency of maintenance. 3. Review of laboratory's "Microscope Maintenance" policy (document Gen Lab 16, last approved 06/18/2024) revealed: "PROCEDURE Cleaning: 1. Using lens paper apply a drop of lens cleaning solution formulated for cleaning microscope lenses, to the lens paper and carefully clean all optical surfaces ... 2. Using a dry piece of lens paper remove any excess liquid and remaining dust particles for(sic) lens surfaces. 3. Use canned air to blow away any remaining dust from the body of the microscope." Laboratory policy did not specify required frequency of microscope maintenance. 4. Review of laboratory's microscope maintenance records revealed the laboratory did not document microscope maintenance/cleaning for either of the above two microscopes in 2023 and 2024. 5. In an interview on 11/05/2024 at 1330 hours in the breakroom, the facility's Senior Manager for Safety, Quality and Compliance (as indicated on submitted Survey Entrance/Exit Conference Form) confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, lack of morphology certification records and interview with the Quality Manager the laboratory failed to follow manufacturer's instructions to evaluate gynecologic cytology specimens using the Hologic ThinPrep Pap Test in 2022 and to the date of the survey in 2023. Findings include: 1. The HOLOGIC THINPREP 2000 SYSTEM OPERATOR'S MANUAL states: "Evaluation of microscope slides produced with the THINPREP 2000 SYSTEM should be performed only by cytotechnologists and pathologists who have been trained to evaluate THINPREP prepared slides by HOLOGIC or by organizations or individuals designated by HOLOGIC." 2. The Survey Team requested and the laboratory failed to provide the required morphology certification for one of one Technical Supervisor who performed diagnostic interpretations of Hologic ThinPrep Pap Tests in 2022 and to the date of the survey in 2023. Technical Supervisor includes: -Technical Supervisor B 3. During an interview on August 22, 2023 at 1:30 PM these findings were confirmed by Quality Manager. D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: A. Based on review of laboratory policies and procedures, statistical records and interview with the Quality Manager the laboratory failed to follow written policies and procedures for the evaluation and comparison of one of three nongynecologic cytology statistics. The laboratory failed to document one of three required annual nongynecologic statistics in 2021 and 2022. Findings include: 1. The laboratory failed to follow the policy QUALITY MANAGEMENT PROGRAM which stated: - "Statistical records are maintained, and evaluated at least annually, that include the number of cytopathologic specimens, the type/sources of specimens, and cases by diagnostic category." 2. The Survey Team requested and the laboratory failed to provide records of one of three required annual nongynecologic statistics in 2021 and 2022. Statistic includes: -Number of nongynecologic cases reported by diagnosis, including the number reported as unsatisfactory 3. During an interview on August 22, 2023 at 9:05 AM these findings were confirmed by Quality Manager. B. Based on review of laboratory policies and procedures, lack of statistical records and interview with the Quality Manager the laboratory failed to follow written policies and procedures for the evaluation and comparison of six of six gynecologic cytology statistics. The laboratory failed to document six of six required annual gynecologic statistics in 2021 and 2022. Findings include: 1. The laboratory failed to follow the policy QUALITY MANAGEMENT PROGRAM which stated: -"For gynecologic cytopathology cases, statistical records are maintained of the number of cases of the following cytopathology results. 1. Diagnostic category (including unsatisfactory cases), by preparation type 2. Significant cytologic/histologic discrepancies (as defined by laboratory policy) 3. Total number of negative cases rescreened before sign-out 4. Cases for which the rescreen resulted in reclassification as premalignant or malignant 5. Cases for which histopathology results are available to compare with malignant or high-grade squamous epithelial (HSIL) cytopathology results" 2. The Survey Team requested and the laboratory failed to provide records of six of six required annual gynecologic statistics in 2021 and 2022. Statistics include: -Number of cytology cases examined -Number of specimens processed by specimen type - Number of patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation) -Number of gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison -Number of gynecologic cases where cytology and histology are discrepant -Number of gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms 3. During an interview on August 22, 2023 at 9:05 AM these findings were confirmed by Quality Manager. D5655 CYTOLOGY -- 2 of 4 -- CFR(s): 493.1274(e)(4) (e) Slide examination and reporting. The laboratory must establish and follow written policies and procedures that ensure the following: (e)(4) Unsatisfactory specimens or slide preparations are identified and reported as unsatisfactory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview with the Laboratory Director/Technical Supervisor A the laboratory failed to establish and follow written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory. 2. During an interview on August 22, 2023 at 8:45 AM these findings were confirmed by Laboratory Director /Technical Supervisor A. D5657 CYTOLOGY CFR(s): 493.1274(e)(5) (e) The laboratory must establish and follow written policies and procedures that ensure the following: (e)(5) The report contains narrative descriptive nomenclature for all results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview with the Laboratory Director/Technical Supervisor A the laboratory failed to establish and follow written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report nongynecologic cytology test results. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to define the criteria used and the system of narrative descriptive nomenclature used by the laboratory to report nongynecologic cytology test results. 2. During an interview on August 22, 2023 at 8:45 AM these findings were confirmed by Laboratory Director/Technical Supervisor A. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of final cytology test reports and interview with the Quality Manager 24 of 24 final cytology test reports from December 2021 to June 2022 failed to -- 3 of 4 -- indicate the address of the laboratory where the test was performed. Findings include: 1. The Survey Team reviewed 24 final cytology test reports from December 2021 to June 2022. Twenty-four of 24 final cytology test reports failed to indicate the address of the laboratory where the test was performed. 2021 test reports include: -PG21- 16871 -PG21-16872 -PG21-16890 -PG21-16900 -PG21-16908 -PG21-16921 -PG21- 16943 -PG21-16946 -PG21-16962 -PG21-16969 -PG21-16987 -PG21-16996 -PG21- 17004 -PG21-17015 2022 test reports include: -PG22-1089 -PG22-1111 -PG22-1883 - PG22-2691 -PG22-2678 -PG22-2677 -PG22-2694 -PG22-2749 -PG22-2774 -PG22- 3215 2. During an interview on August 22, 2023 at 11:00 AM these findings were confirmed by the Quality Manager. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 4 of 4 --