Ameripath Lubbock 501(A)

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory policy, College of American Pathologists (CAP) proficiency testing (PT) records, and confirmed in interview, the laboratory failed to attest to the routine integration of proficiency samples into the patient workload for one of two events in 2023 (Flow Cytometry Interpretation Event A) and two of two PT events in 2024 (Flow Cytometry Interpretation Events A and B). Findings included: 1. Review of the laboratory policy titled " POLICY FOR PROFICIENCY TEST (PT) HANDLING AND RESULT SUBMISSION " stated: " 5. POLICY ... PT samples must be examined, handled, and tested along with the laboratory's regular workload by testing personnel using routine methods and treated in the same manner as patient samples to the extent possible ... 12. ADMINISTRATIVE REVIEW FOR THE SUBMISSION OF PT RESULTS ... Testing personnel or other designated individual(s) in the department must transfer all required information onto a copy of the PT result form, or into the on-line result entry site of the PT provider. All required information regarding instrumentation, method, results obtained, units of measure, attestation statements, etc. must be recorded and reviewed. Test records must clearly identify the individual(s) who performed the PT. The Technical Supervisor /Consultant, Department Supervisor, Manager, or designee must perform a final review of the paperwork to detect clerical errors, errors in methods, units, factors, etc. This final administrative review may also involve transcription of information from a 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 -- copy to the original survey form, into the on-line result entry site of the PT provider, or a review of the information uploaded via CAP Direct Transmission. The attestation form (or copy of the completed form) must be signed by the Laboratory Director, or designee, and all individuals involved in testing. This signature does not have to be obtained prior to reporting results to the PT provider." 2. Review of the CAP proficiency testing records revealed: "Attestation/Use of Other Form Attestation Statement As stated in the February 28, 1992 United States Federal Register under Subpart H 493-801 (b) (1), "the individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient work load using the laboratory's routine methods." The laboratory director or designee and the testing personnel must sign on the result form. You may use the attestation page provided in the kit instructions or, alternatively, print, sign, and retain a copy of this page for your records and inspection purposes." 3. Further review of CAP proficiency testing records in 2023 and 2024 revealed the laboratory director or designee and the testing personnel failed to sign the attestation statement for the following Flow Cytometry Interpretation Events: 2023: Event A 2024: Events A and B 4. During an interview at 11:50 a.m. on 11/04/2024, the Quality Assurance Manager and Quality Assurance Specialist, after a review of the records confirmed the above findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of laboratory policy, College of American Pathologists (CAP) proficiency testing (PT) records and confirmed in interview, the laboratory failed to review and evaluate the ungraded results obtained on proficiency testing for two of two events in 2024 (Flow Cytometry Interpretation Events A and B). Findings included: 1. Review of the laboratory's PT policy "Policy for Review and Evaluation of Proficiency Test Results" stated: "5. POLICY The laboratory director must ensure timely, ongoing evaluation of all proficiency testing (PT) and alternative performance assessment (APA) results. Evaluation must include the following: Results that are formally evaluated (graded). Results that are not formally evaluated (ungraded). Results from educational challenges ... Review and evaluation of PT and APA results must be performed by: The Technical Supervisor/Consultant responsible for the testing area. QA Director/Manager. Laboratory Director. NOTE: If the Laboratory Director does not personally review all reports, they must at least review monthly summaries of laboratory performance and

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 accuracy assessments and interview, the laboratory failed to verify the accuracy of its interpretation of its oral pathology cases for one of one year reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Pathologist Assessment by Second Review (PASR), approved 09/04/2022, under 2 SCOPE stated, "This policy applies to all Anatomic Pathologists that perform examinations on tissue biopsies, dermatopathology specimens, non-gynecological and selected gynecological cytology in Quest Diagnostic laboratories." The policy did not include the subspecialty of oral pathology. B. Review of the CMS form 116 showed an annual test volume of 3 cases in the subspecialty of oral pathology. C. Review of the Quarterly Summary of Pathologists Second Review and Quality Assurance for Q1 2021, Q2 2021, and Q3 2021 (and to date in Q1 2022 and Q2 2022) showed no subspecialty for oral pathology. D. Peer reviews for the subspecialty of oral pathology were requested on October 5, 2022, at 1500 hours. Interview with the QA Manager on October 5, 2022, at 1500 hours acknowledged oral pathology was not addressed in the policy and peer reviews not distinguished from other specialties, so she didn't know if any peer reviews had been performed. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES 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): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, pre-survey paperwork, competency evaluations and interview, the technical supervisor failed to ensure competency evaluations were performed for six of seven testing personnel performing a combination of histopathology, cytology, oral pathology, and hematopathology interpretations for two of two years reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Competency Assessment, approved 2/01 /2022, stated under 2. SCOPE, "This policy and process applies to departments with personnel involved in any phase of the testing process (pre-analytic, analytic, and post- analytic). This includes: All testing departments..." Under 4. DEFINITIONS for term "Competency assessment" stated, "Definition An objective evaluation that helps ensure a person continues to perform testing accurately, proficiently, and according to established processes and procedures"... and for "Test System" stated, "The process that includes pre-analytic, analytic, and post-analytic steps used to produce a test result or set of results. A Test System may be manual, automated, multi-channel or single-use and can include reagents, components, equipment or instruments required to produce results." Under 5.2 Competency assessment frequency stated, "During the first year of an individual's duties, competency must be assessed at least semiannually. When an individual has completed the first 2 semi-annual assessments, performance must be assessed at least annually (per calendar year), thereafter." At "6.0 PROCESS 6.1 General Competency Assessment Requirements 6.1.1 Elements for Evaluating Testing Personnel For each Test System, evaluate all six CLIA required elements for competency assessment. The six elements are as follows: 1. Direct observations of routine patient test performance, including, as applicable, patient identification and preparation, and specimen collection, handling, processing, and testing. 2. Monitoring the recording and reporting of test results, including, as applicable, reporting critical results. 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. 4. Direct observation of performance of instrument maintenance and function checks. 5. Assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 6. Evaluation of problem-solving skills." B. Review of the CMS form 209 showed seven testing personnel, including the Laboratory Director. C. Attempted review of competency evaluations showed none available for review. Competency evaluations were requested on October 5, 2022, at 1500 hours. D. Interview with the QA Manager on October 5, 2022, at 1500 hours confirmed there were no competency evaluations performed for pathologists for the position of testing personnel. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed -- 2 of 3 -- specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, peer reviews, and interview, the technical supervisor failed to ensure peer reviews were performed for four of five testing personnel performing cytology interpretations for one of one years reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Competency Assessment, approved 2/01/2022, stated under 2. SCOPE, "This policy and process applies to departments with personnel involved in any phase of the testing process (pre-analytic, analytic, and post-analytic). This includes: All testing departments..." Under 4. DEFINITIONS for term "Competency assessment" stated, "Definition An objective evaluation that helps ensure a person continues to perform testing accurately, proficiently, and according to established processes and procedures"... and for "Test System" stated, "The process that includes pre-analytic, analytic, and post-analytic steps used to produce a test result or set of results. A Test System may be manual, automated, multi-channel or single-use and can include reagents, components, equipment or instruments required to produce results." At "6.0 PROCESS 6.1 General Competency Assessment Requirements 6.1.1 Elements for Evaluating Testing Personnel For each Test System, evaluate all six CLIA required elements for competency assessment. The six elements are as follows: ... 5. Assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples." B. Review of the laboratory's policy and procedure titled Pathologist Assessment by Second Review (PASR), approved 09/04/2022, under 1 PURPOSE stated, "Pathologists that perform gross and microscopic examinations on tissue biopsies, dermatopathology specimens, non- gynecological or gynecological cytology will have a portion of their work evaluated by peer review to determine the need for an increase in the review rate, directed continuing education or other