Affiliated Pathologists

Summary Statement of Deficiencies 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 surveyor review of proficiency testing performance, eight (8) randomly selected patients, and interviews with the laboratory manager (LM) and testing personnel (TP) on 06/06/2024 at approximately 12:00 pm; the laboratory failed to verify the accuracy of histopathology testing at least twice annually. The findings include: 1. The laboratory performed histopathology including Mohs surgery. The laboratory failed to perform evaluation of proficiency testing performance for histopathology for six (6) out of nine (9) testing personnel for the years 2022 and 2023. Therefore, the accuracy of the laboratory's test results cannot be assured. 2. On 06/06/2024 at 12:00 pm, the LM and TP the statement in # 1 above. 3. The laboratory's testing declaration form, signed by the laboratory director on 03/20/24 stated that the laboratory performed 120,921 tests in histopathology annually. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the surveyors' review of quality assessment policy and procedure and 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 -- interviews with the laboratory manager (LM) and testing personnel (TP) on 06/06 /2024 at approximately 1:00 pm; the laboratory failed to follow the written policy and procedure to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems for the quality assessment plan. The findings include: 1. The laboratory had an existing protocol for policy for the quality assessment (QA). The laboratory QA (referred by the laboratory as quality improvement) stated that "the laboratory team shall meet to review the prior year as quality improvement program and to structure the program for the following year". The laboratory failed to have any documentation for the annual meeting. Therefore, laboratory cannot ensure the continues improvement. 2. On the day of the survey 06/06/2024 at approximately 1:00 pm, the LM and TP confirmed that the laboratory did not have any documentation for the annual meeting. 3. The laboratory's testing declaration form, signed by the laboratory director on 03/20/24 stated that the laboratory performed 120,921 tests in histopathology and cytology annually. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on the surveyors' review of the preanalytical policy and procedures and interview with the laboratory manager (LM) and testing personnel (TP) on 06/06/2024 at approximately 3:00 pm, the laboratory failed to establish and follow a written policy and procedure for specimen acceptability and rejection criteria. The findings include: 1. The laboratory did not have a written policy for specimen acceptability and rejection. Therefore, laboratory cannot ensure the reliability of the specimens' tests results. 2. On 06/06/2024 at 3:00 pm, the LM and TP confirmed that laboratory did not have a written policy and documentation for rejected specimens. 3. The laboratory's testing declaration form, signed by the laboratory director on 03/20/24 stated that the laboratory performed 120,921 tests in histopathology and cytology annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on the surveyor's review of the procedure manuals for analytic systems and interviews with the laboratory manager (LM) on 06/06/2024 at approximately 4:00 pm, the laboratory failed to update all procedure manuals with approval, signature, and date from the current laboratory director (LD) for histopathology and cytology. The findings include: 1. The LD did not sign and date all procedure manuals. Therefore, laboratory cannot verify the procedure manuals are current for tests offered -- 2 of 4 -- by the laboratory. 2. On 06/06/2024 at approximately 4:00 pm, the LM confirmed that the laboratory did not have an updated procedure manual approved by the LD for all current tests offered by the laboratory. 3. The laboratory's testing declaration form, signed by the laboratory director on 03/20/24 stated that the laboratory performed 120,921 tests in histopathology and cytology annually. D5625 CYTOLOGY CFR(s): 493.1274(c)(3) (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 examinations and the reporting of results. The program must include the following: (c) (3) For each patient with a current HSIL, adenocarcinoma, or other malignant neoplasm, laboratory review of all normal or negative gynecologic specimens received within the previous 5 years, if available in the laboratory (either on-site or in storage). If significant discrepancies are found that will affect current patient care, the laboratory must notify the patient's physician and issue an amended report. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interviews with the cytotechnologist (CT), the laboratory failed to establish written policies and procedures to ensure that the search and review of prior negative gynecologic specimens received within the previous five (5) years for each patient with a current HSIL or malignancy was performed. Findings include: 1. On the time of the survey (06/06/2024) the laboratory failed to provide written policies and procedures to describe the laboratory's process for the search and review of all prior negative gynecologic specimens received within the previous five years, for each patient with a current HSIL or malignancy reported by the laboratory. 2. During an interview with the CT on June 6, 20224 at approximately 3:00 p.m., these findings stated in # 1 above were confirmed. 3. 3. The laboratory's testing declaration form, signed by the laboratory director on 03/20/24 stated that the laboratory performed 18,912 tests in cytology annually. 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 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: Based on review of laboratory policies and procedures, lack of statistical records and -- 3 of 4 -- interview with the cytology technologist (CT); the laboratory failed to establish written policies and procedures for the evaluation and comparison statistics. The laboratory failed to document the required annual gynecologic statistics for for the years 2022, 2023, and 2024. Findings include: 1. The surveyors' requested the of statistics report and the laboratory failed to provide written policies and procedures for the evaluation and comparison of required cytology gynecologic statistics which include: a) Cytology cases examined. b) Specimens processed by specimen type. c) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation). d) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison. e) Gynecologic cases where cytology and histology are discrepant; and f) Gynecologic cases where any rescreen of a normal or negative specimen result in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. 3. During an interview with the CT on June 6, 2024, at approximately 3:30 p.m. findings the stated in # 1 above were confirmed. 4. The laboratory's testing declaration form, signed by the laboratory director on 03/20/24 stated that the laboratory performed 18,912 tests in cytology annually. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on the surveyors' review of policies and procedures, eighteen (18) randomly chosen patients' test results (clinical bacteriology, histopathology and cytology), and interviews with the laboratory manager and and testing personnel on June 6, 2024; it was determined that the laboratory director is cited herein due to failure to ensure that several aspects of the preanalytic, analytic, and postanalytic phases of the laboratory testing were monitored. See D 5217, D5291, D5311, D5625, and D5629. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: The laboratory director is cited herein on the lack of laboratory's written policies approved, dated, and signed by the current laboratory director. Based on the surveyor's review of laboratory records and interview with the laboratory manager it was determined that the laboratory director failed to ensure that an approved, signed, and dated policy manual ( policies on all the phases of laboratory testing including: specimen rejection criteria, documents retention policy, panic values, labelling of reagents, proficiency testing policy, validation and verification policy, etc.) was updated when the previous director of operations is no longer a staff member. See D5407. -- 4 of 4 --

Summary Statement of Deficiencies 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 observation of the Hologic Panther molecular analyzer, review of laboratory policy, records, and patients test reports for the laboratory-developed tests titled, "Gyn Molecular Report: Vaginitis Panel"; the lack of laboratory records, and interview with Testing Person-7, it was determined that the laboratory failed to at least twice annually verify the accuracy of testing for Bacterial Vaginosis, Candida Vaginitis, Candida Species, Candia Glabrata, and Trichomonas Vaginalis. Findings included: a. The laboratory utilized the automated Hologic Panther analyzer to test for the following: Bacterial Vaginosis Candida Vaginitis Candida Species Candia Glabrata Trichomonas Vaginalis b. A laboratory policy stated that previously tested patients specimen would be blinded and re-tested to meet the requirement to verify accuracy of testing at least twice annually. c. Laboratory records documented such testing was performed as follows in 2019: Analyte Date ------------------------------------------------------------ Bacterial Vaginosis ...... 12/19/19 Candida ........................ 11/15/19 Trichomonas ................. 4/12/19....11/07/19 d. The laboratory was unable to provide documents for a second testing in 2019 that verifed accuracy for Bacterial vaginosis and Candida for 12 out of 13 patients reports: Date Accession # --------------------------------- 1/10/19 ....P19-00055 2/28/19 ....P19-01242 3 /12/19 ....P19-01669 4/23/19 ....P19-03982 5/30/19 ....P19-06322 6/13/19 ....P19- 07189 7/11/19 ....P19-08658 7/31/19 ....P19-09531 8/09/19 ....P19-10599 9/12/19 .... P19-12812 10/17/19.....P19-14867 11/19/19 ....P19-16970 e. Testing Person-7 affirmed (1/29/20 @ 12:30pm) the aforementioned lack of documents; and thus, the failure to at least twice annually verify the accuracy of testing. f. The reliability and quality of results reported in 2019 could not be assured when the laboratory failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- at least twice annually verify accuracy of testing. Based on laboratory information (1 /29/20), the laboratory reported 380 Bacterial vaginosis and 317 Candida results in 2019. . D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on observaton of the Hologic Panther analyzer, review of patients reports and laboratory documents for developing and validating molecular testing for bacterial vaginosis and candidiasis, the lack of laboratory documents, and interview with Testing Person-7, it was determined that the laboratory failed to validate the use of ThinPrep transport tubes. Findings included: a. Patients reports recorded Specimen Type as "Liquid based PAP". b. Validation reports stated the use of Aptima transport tubes and ThinPrep transport tubes for specimen collection The Aptima transport medium was FDA-approved for use in HPV tests. The ThinPrep transport medium was FDA-approved for HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas. c. The laboratory obtained organisms (Gardnerella vaginalis, Lactobacillus crispatus, Candida albicans, Candida glabrata) from Hologic which were then serially diluted and spiked into Aptima transport media to establish test performance characteristics. d. The laboratory was unable to provide records of spiking ThinPrep transport media with the known organisms to establish test performance characteristics. e. Testing Person-7 affirmed (1/29/20 @ 2pm) the aforementioned findings; and thus, the laboratory failed to validate the use of ThinPrep transport tubes for bacterial vaginosis and candidiasis assays. f. The reliabililty and quality of results reported for bacterial vaginosis and candidiasis could not be assured when the laboratory failed to establish test performance characteristics of the ThinPrep transport medium in these laboratory-developed, non-FDA approved tests. Based on laboratory information (1/29/20), 380 bacterial vaginosis and 317 candidiasis results were reported annually. -- 2 of 2 --

Summary Statement of Deficiencies D5453 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iv)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each test system that has an extraction phase, include two control materials, including one that is capable of detecting errors in the extraction process; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Hologic Aptima manufacturer's instructions for HPV High Risk, HPV16 Genotype, 18/45 Genotype Assays, Bacterial Vaginosis, Trichomonas, Candida, and Chlamydia / Gonorrhea (Ct/Gc) assays, and patients test results; and interview with the testing person (Technical Supervisor), the laboratory failed to include two control materials in each batch of Extractions, of which one is capable of detecting errors in the extraction process. Findings include: a. Review of patients test reports revealed results were reported as "Negative" or "Positive". b. The manufacturer provided statements and instructions for quality controls as follows: 1) The Internal Control monitors the target capture, amplification, and detection steps only; and thus, does not monitor the process of Extracting nucleic acid from the organisms. 2) External quality control materials are not included in the test kit and should be tested in conformance with local, state, and/or federal regulations; and that laboratories must establish the criteria for acceptability of the external quality control samples. c. The Technical Supervisor affirmed (11/15/17) the aforementioned manufacturer's instructions, that the Internal QC doesn't detect errors in extraction, and the failure to include external QC material in the extraction process with each day's patients specimen to detect errors leading to false negative results. d. The reliability and quality of Negative results reported without an Extraction control could not be assured. Based on the stated estimated annual test volume, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- reported results each month from 2016 to present, as follows: Monthly volume HPV 435 Bacterial vaginosis 1 Candia 1 Trichomonas 2 Chlamydia / Gonorrhea 36 e. A few examples of results reported as Negative are as follows: Date Accession # Test --------------- ----------------- ---------- 10/15/16 GY16-09469 HPV 11/23/16 P16-01224 " 12/23/16 P16-01328 " 11/22/17 P17-02890 " 11/22/17 P17-02895 HPV 10/06/16 P1600848 HPV, Ct/Gc 12/13/16 P16-01168 Ct/Gc 5/25/17 P17-00562 Bacterial vaginosis, Ct/Gc, Candida, Trichomonas 6/23/17 P17-00720 HPV, Ct/Gc, Trichomonas 6/30/17 P17-00764 Bacterial vaginosis, Candida, Trichomonas D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on survey findings and deficiency cited, the Laboratory Director is herein cited for deficient practice in ensuring that the quality control program established for molecular based assays identify failures in nucleic acid extractions as they occur. See D5453. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on the findings and deficiency cited, the Technical Supervisor is herein cited for deficient practice in establishing a quality control program appropriate for molecular based assays requiring nucleic acid extractions of the specimen. See D5453. -- 2 of 2 --