Walton Family Medicine Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 24, 2024. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) and maintenance documents review, the laboratory director failed to sign off on ALL quality assessment activities on a monthly basis as required by Clinical Laboratory Improvement Amendments (CLIA) from November 2022 to day of survey 10/24/2024. Findings: 1. A review of the laboratory's (QA) activities revealed the technical consultant (TC), who is also the lab director, did not review and sign all monthly Quality Assessment(QA) activities including; daily maintenance and QC reviews for the Horiba Micros 360 Hematology analyzer. Eye wash, incubator, humidity, refrigerator and room temperature logs from November 2022 through day of survey 10/24/2024 were not reviewed by the Laboratory Director. The reviews were done by TP#2 (CMS 209) who was not qualified to do so. 2. An interview with the nurse supervisor, on 10/24/2024, at approximately 12:15 PM, in the review room, confirmed all (QA) activities were monitored and signed off by TP#2 CMS 209 who was not qualified to act as (TC) from November 2022 through day of survey 10/24/2024. D6022 LABORATORY DIRECTOR 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 2 -- CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on documents review and interview with the nurse manager, the Lab Director (LD) failed to ensure that ALL Quality Assurance (QA) guidelines were followed to identify and fix problems in the laboratory from November 2022 to 10/24/2024 as required by Clinical Laboratory Improvement Amendments (CLIA). Findings: 1. Quality Assurance (QA) document review revealed the Lab Director, who is also the Technical Consultant (TC), did NOT review and sign off on monthly Quality Assesment (QA) activities from November 2022 to 10/24/2024. 2. An interview with the nurse manager, in the review room on 10/24/2024 at approximately 12:35 PM, confirmed the Lab Director failed to ensure proper oversight of the laboratory's (QA) activities from November 2022 through day of survey 10/24/2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 16, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the proficiency test (PT) with American Academy of Family Physicians(AAFP) records and staff interview the lab failed to document

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 13, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following 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 the American Academy of Family Physicians (AAFP) Proficiency Testing documentation and staff interview, the laboratory failed to attest to the routine integration of the samples into the patient workload. Findings: 1. Review of the AAFP Proficiency Testing documentation showed that the testing personnel was writing the Laboratory Director's (LD) name on the attestation statement, when they were writing their name as testing personnel. For the third event for 2016, and all events for 2017, and the first and second event for 2018. 2. Interview with staff #2 , #3 , and #7 (CMS 209 form), on August 13, 2018 at approximately 3:45pm, confirmed that the LD was not signing the Attestation statements. The testing personnel performing the testing was writing the LD's name on the statement. 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 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 -- 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 patient reports and staff interview, the laboratory failed to include all required components on the facility's result reports. Findings: 1. Review of a sample of a patient report, the Complete Blood Cell Count (CBC) report did not have the units of measure and reference ranges on the in house performed testing. 2. Interiew with staff #2, #3, and #7 (CMS 209 form) on August 13, 2018 at approximately 4:21pm in the exam room, confirmed the patient reports did not have reference ranges or unit of measure for results of samples tested in the facility for the CBC results. -- 2 of 2 --