Holtville Family Practice, Llc

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 reviews of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Testing Personnel 1 (TP1), the laboratory failed to implement a mechanism to verify the accuracy of the White Blood Count (WBC) Differential, a regulated analyte. The surveyor noted the PT failures occurred in two consecutive events out of three in 2025. The findings include: 1. A review of the API PT records revealed the WBC Differential evaluations were unsuccessful for the following events: a) 2025 Hematology Second Event, 60 percent b) 2025 Hematology Third Event, 48 percent 2. A review of the PT performance review and

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 a review of the American Proficiency Institute (API) Hematology proficiency testing (PT) records, a review of the policy and procedure manual, and an interview with Testing Personnel #1, the laboratory failed to ensure the Laboratory Director and Testing Personnel signed the attestation statement for four of seven 2020- 2022 PT surveys. The findings include: 1. A review of the attestation statements for the 2020-2022 API Hematology PT records revealed the following: A) 2020-Event #3 and 2022-Event #1: No signature by the Laboratory Director B) 2021-Event #2: No signature by Testing Personnel #3 C) 2021-Event #3: No signature by Testing Personnel #1 2. A review of the policy and procedure manual revealed under "Guidelines for Proficiency Testing" which specified the laboratory should retain "copies of the attestation form signed by the testing personnel and the laboratory director...". 3. During an interview on August 4, 2022, at 10:45 AM, surveyor reviewed the instructions on the attestation statement requiring the Laboratory Director (or designee) and testing personnel to sign the document; Testing Personnel #1 confirmed the Laboratory Director and Testing Personnel had failed to sign the attestations for the above surveys. . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least 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 -- semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the personnel records, the policy and procedure manual, and an interview with Testing Personnel #1, the Technical Consultant (also the Laboratory Director)failed to evaluate and approve the semi-annual competency assessment for one of one new testing personnel performing moderate-complexity patient testing. The findings include: 1. A review of the testing personnel records revealed Testing Personnel #2 was trained to perform CBC's (Complete Blood Counts, a moderate- complexity test) in June 2021. The semi-annual competency assessment was performed in October 2021 and signed by the CRNP (Certified Registered Nurse Practioner), however there was no documentation of the Technical Consultant's review and approval (as indicated by a signature and date). 2. A review of the policy and procedure manual under Quality Assessment on page 3 revealed, "...D. Since competency assessment is the responsibility of the Technical Consultant, the reviews will only be personnel who meet the regulatory qualification requirements for the technical consultant.". 3. During an interview on August 4, 2022, at 10:45 AM, Testing Personnel #1 confirmed the CRNP, who is not qualified to perform the duties as the Technical Consultant, reviewed and signed the semi-annual competency. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of the 2020-2022 personnel records, the policy and procedure manual, and an interview with Testing Personnel #1, the Technical Consultant (also the Laboratory Director) failed to evaluate and approve the annual competency assessment for three of three testing personnel performing moderate-complexity patient testing. The findings include: 1. A review of the testing personnel records revealed the annual competency assessments performed from October 2020 through April 2022 for Testing Personnel #1, #2, and #3 were performed and signed by the CRNP (Certified Registered Nurse Practioner. There was no documentation of the Technical Consultant's review and approval (as indicated by a signature and date). 2. A review of the policy and procedure manual under Quality Assessment on page 3 revealed, "...D. Since competency assessment is the responsibility of the Technical Consultant, the reviews will only be personnel who meet the regulatory qualification requirements for the technical consultant.". 3. During an interview on August 4, 2022, at 10:45 AM, Testing Personnel #1 confirmed the CRNP, who is not qualified to perform the duties as the Technical Consultant, reviewed and signed the annual competencies. SURVEYOR ID #s 32558 and 46291 Licensure and Certification Surveyors -- 2 of 2 --

Summary Statement of Deficiencies 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 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)