Tch Family Medical Clinic

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on January 12, 2026, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 -42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 a review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) proficiency testing records, the laboratory failed to achieve successful 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 -- performance in two of two consecutive testing events in 2025, resulting in unsuccessful performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) proficiency testing records from 2025, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of two consecutive testing events for hematocrit (HCT) testing. Two out of two overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. The findings included: 1. A review of the CASPER Report 155 listed the following scores for the PT analyte HCT: Event, Analyte(test) - Score 2025 Event 2, HCT - 40% 2025 Event 3, HCT - 60% 2. A desk review of API proficiency testing records for 2025 confirmed that the laboratory received a test score of 40% in event 2, and a 60% in event 3 for HCT testing. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) proficiency testing records from 2025, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for hematocrit (HCT) testing for two of two consecutive events in 2025. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) proficiency testing records from 2025, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for hematocrit testing for two of two events in 2025. Refer to D2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Base on direct observation, review of CMS116, urinalysis reference manual, and confirmed in interview, the laboratory failed to have an appropriate centrifuge for one of one test: urine sediment analysis. 1. Direct observation in the laboratory at 13:30 hour on 11/10/2021 revealed a singular centrifuge with a fixed RPM of approximately 3,369. 2. Review of 'Preanalytical requirements of uinalysis' by Joris Delanghe and Marijn Speeckaert (published in Biochemia Medica 2014;24(1)89-104) Section 'Manual Methods' states: "A 5-minute centrifugation time at 400 g [RCF, relative centrifugal force (g) = 1.118 x 10 (^-5) x radius (cm) x RPM (revolutions per minutes)] preferably at 4(degrees) C is necessary for optimal sediment concentration." 3. Review of the CMS116, Section VII 'PPM Testing' lists their estimated annual volume for PPM tests performed at 100. 4. Interview with the laboratory supervisor at 13:35 hours on 11/10/2021 in the hallway confirmed that the centrifuge in the laboratory was the one utilized for urine centrifugation for microscopic urine sediment analysis. Key: CMS - Centers for Medicare and Medicaid Services PPM - Provider Performed Microscopy RPM - Revolutions per minutes C - Celsius cm - centimeters 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 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory policy, the CMS116, and confirmed in interview the laboratory failed to have a procedure in place for one of three tests: the processing and examination of microscopic urine sediment. 1. Direct observation of a microscope in the laboratory at 13:20 hours on 11/10/2021 and subsequent interview with the laboratory supervisor at 13:21 hours on 11/10/2021 revealed that providers perform microscopic urine sediment analysis when clinically indicated for patient. 2. Review of the laboratory's 'Routine Urinalysis' policy signed by the laboratory director on 9/12/2019, revealed that the laboratory did not have a procedure in place for the processing and examination of microscopic urine sediment. 3. Review of the CMS116, Section VII 'PPM Testing' lists their estimated annual volume for PPM tests performed at 100. 4. Interview with the laboratory supervisor in the hallway at 13:30 hours on 11/10/2021 confirmed they did not have a formal policy in place. Key: CMS - Centers for Medicare and Medicaid Services PPM - Provider Performed Microscopy 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)

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 review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2018 and 2019, confirmed by staff interview, the laboratory failed to successfully verify the accuracy of vaginal direct preparation slide interpretation in the second and third testing events of 2018. Findings: 1. Results for API PT for non- regulated tests in 2018 included the following: Microscopy: Vaginal Wet Preparation 2018 1st event: 100% 2018 2nd event: 0% 2018 3rd event: 0% Long Term Score: Unsuccessful 2. In an interview at the site on 12-05-2019, the laboratory director (CMS form 209) confirmed the reported results as accurate. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --