Waynesboro Family Clinic, Pa

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D on 7/30/25 and desk review of 2025 AAB-MLE (American Association of Bioanalysts-Medical Laboratory Evaluation) proficiency testing results 9/3/25, the laboratory failed to achieve satisfactory performance for Free T4 (thyroxine) and failed to achieve overall test event scores of satisfactory for Endocrinology on 2 consecutive test events, resulting in unsuccessful participation in proficiency testing. Findings: See the deficiencies cited at D2107 and D2108. D2107 ENDOCRINOLOGY 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): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2025 AAB-MLE proficiency testing results 9/3/25, the laboratory failed to achieve satisfactory performance for Free T4 on 2 consecutive testing events, resulting in unsuccessful performance. Findings: Desk review of CMS Casper reports 153D and 155D and 2025 AAB-MLE proficiency testing results revealed the laboratory received a score of: 1. 0% for Free T4 on the 2025 M1 Event. 2. 0% for Free T4 on the 2025 M2 Event. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2025 AAB-MLE proficiency testing results 9/3/25, the laboratory failed to achieve an overall test event score of satisfactory performance for Endocrinology on 2 consecutive testing events, resulting in unsuccessful performance. Findings: Desk review of CMS Casper reports 153D and 155D and 2025 AAB-MLE proficiency testing results revealed the laboratory received an overall score of: 1. 50% for Endocrinology on the 2025 M1 Event. 2. 50% for Endocrinology on the 2025 M2 Event. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2025 AAB-MLE proficiency testing results 9/3/25, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. Findings: See the deficiency cited at D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2025 AAB-MLE proficiency testing results 9/3/25, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: See the deficiencies cited at D2107 and D2108. -- 3 of 3 --

Summary Statement of Deficiencies 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 the laboratory's policies and procedures and review of 2021, 2022, and 2023 American Association of Bioanalysts (AAB) and AAB/Medical Laboratory Evaluation (MLE) proficiency testing (PT) records 04/10/24, the laboratory failed to ensure that 3 of 9 attestation statements reviewed were signed by the testing personnel and the laboratory director. Findings: Review of the laboratory's "CMP-001 General Policies and Procedures" revealed "... 3.3 Proficiency Testing ... Proficiency Test samples are to be performed in the same manner patient samples are tested in the laboratory. ... Attestation Sheets must be signed by the performing tech and the Laboratory Director. Review of 2021, 2022, and 2023 AAB and AAB MLE proficiency testing records revealed: 1. Attestation not signed for the 2021 AAB Q3 test event. 2. Attestation not signed for the 2022 AAB Q1 test event. 3. Attestation not signed for the 2023 AAB MLE M1 test event. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of 2021, 2022, and 2023 AAB and MLE PT records and the absence of records 04/10/24, the laboratory failed to maintain a copy of all PT records for a minimum of two years from the date of the PT event for 3 of 9 test events reviewed. Findings: Review of 2021, 2022, and 2023 AAB and AAB/MLE PT records revealed: 1. No attestation statements or report forms available for review for the 2021 AAB Q1 and Q2 test events. 2. No attestation statement or report forms available for review for the 2022 Q2 test event. 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 the laboratory's policies and procedures, review of 2021, 2022, and 2023 AAB) and MLE PT records, and review of "Laboratory Incident Report Form" 04/10/24, the laboratory failed to document evaluation of all ungraded and unacceptable PT results to ensure

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2023 AAB/MLE (American Association of Bioanalysts/Medical Laboratory Evaluation) proficiency testing results 3/5/24, the laboratory failed to successfully participate in proficiency testing for TSH (thyroid stimulating hormone) on two of three consecutive testing events. Findings: See the deficiency cited at D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and desk review of 2023 AAB/MLE proficiency testing results 3/5/24, the laboratory failed to achieve satisfactory performance for TSH on two of three consecutive testing events. Findings: 1. Desk review of CMS Casper reports 153D and 155D and desk review of 2023 AAB/MLE proficiency testing results revealed the laboratory received a score of 60% for TSH on the Chemistry M1 2023 event. 2. Desk review of CMS Casper reports 153D and 155D and desk review of 2023 AAB/MLE proficiency testing results revealed the laboratory received a score of 60% for TSH on the Chemistry M3 2023 event. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and desk review of 2023 AAB/MLE proficiency testing results 3/5/24, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. Findings: See the deficiency cited at D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and desk review of 2023 AAB/MLE proficiency testing results 3/5/24, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: See the deficiency cited at D2107. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies, review of general supervisors (GS) competency records, and interview with GS #3 on 12/5/19, the laboratory failed to assess the competency of GS #3 for 2018 and 2019. Findings: Review of laboratory policies revealed the laboratory had established GS competency assessment policies. Review of personnel competency records revealed the laboratory had assessed the competency of GS #1 and GS #2 in 2018 and 2019. The laboratory failed to assess the competency of GS #3 in 2018 and 2019. Interview with GS #3 at approximately 11:00 a.m. confirmed the laboratory had no documentation of GS #3 competency assessments for 2018 and 2019. He stated he was focused on ensuring the laboratory director had reviewed the competency of GS #1 and GS #2 that he had forgotten to have documentation of his own completed. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other 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 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 9/5/19 and desk review of 2018 and 2019 AAB (American Association of Bioanalysts) proficiency testing results 11/20/19, the laboratory failed to achieve satisfactory performance for creatinine on 2 of 3 consecutive testing events. See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 9/5/19 and desk review of 2018 and 2019 AAB (American Association of Bioanalysts) proficiency testing results 11/20/19, the laboratory failed to achieve satisfactory performance for creatinine in 2 of 3 consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS 155D and 2018 AAB proficiency testing results revealed the laboratory provided incorrect responses for 2 of 5 creatinine samples and received a score of 60% for creatinine on the 2018 Q3 Chemistry event. 2. Desk review of CMS 155D and 2019 AAB proficiency testing results revealed the laboratory provided incorrect responses for 2 of 5 creatinine samples and received a score of 60% for creatinine on the 2019 Q2 Chemistry event. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 9/5/19 and desk review of 2018 and 2019 AAB (American Association of Bioanalysts) proficiency testing results 11/20/19, the laboratory director failed to ensure satisfactory performance in proficiency testing as required in Subpart H. See the deficiency cited at D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 9/5/19 and desk review of 2018 and 2019 AAB (American Association of Bioanalysts) proficiency testing results 11/20/19, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS 155D and 2018 AAB proficiency testing results revealed the laboratory provided incorrect responses for 2 of 5 creatinine samples and received a score of 60% for creatinine on the 2018 Q3 Chemistry event. 2. Desk review of CMS 155D and 2019 AAB proficiency testing results revealed the laboratory provided incorrect responses for 2 of 5 creatinine samples and received a score of 60% for creatinine on the 2019 Q2 Chemistry event. -- 2 of 2 --