Family Medicine Of White Hall

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based upon interviews with laboratory staff members, complete blood cell count (CBC) Quality Control (QC) reports, patient result reports, and lack of documentation, the laboratory reported patient CBC result without performing required quality control on one of twenty-one days of testing in October 2024. Findings follow: A) Reviewing Quality Control Procedures documents states, "1. At least two levels of quantities controls must be ran each day." No level of CBC quality controls were performed on 10/23/24. B) Review of CBC QC Levey Jennings report for October 2024 revealed that there was no evidence of QC being performed on Wednesday 10/23/24. C) Review of patient results reports revealed that CBC's were performed and reported on patient 17873 on Wednesday, 10/23/24. D) Upon request, the laboratory could not provide the documentation of QC results for CBC testing on 10/23/24. E) In an interview on 9/17/25 at 12:19 p.m. the Testing Personnel -1 listed on form CMS 209 confirmed that CBCs were performed and reported on that day, identified above, without the required quality control being performed. 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 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 review of the 2023 CMS Casper Reports 096D, 0153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Aspartate aminotransferase (AST/SGOT). 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 as 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 review of the 2023 CMS Casper Reports 096D, 0153D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte AST. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte AST in the first proficiency testing event of 2023. B. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte AST in the second proficiency testing event of 2023. 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 review of 2023 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the 2023 proficiency testing event, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Chemistry test of AST. -- 2 of 2 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Through a review of the laboratory Policy and Procedure Manual, observations made during a tour of the laboratory, lack of documentation, as well as interviews with laboratory staff, it was determined the laboratory failed to follow written policies for positive identification of urine specimens. As evidenced by: A. A review of the laboratory policy for specimen labeling revealed "All specimens are labeled to assure optimum integrity of the specimen through all phases of testing. The label is to include patient's full name and other unique identifier. (Date of birth, chart number or accession number.) " B. During a tour of the laboratory, at 1349 on 7/2/2019, the surveyor observed fifteen urine containers in the laboratory sink. Three of fifteen urine containers were labeled with the patients first and last name only. C. In an interview at 1349 on 7/2/2019, laboratory personnel #3 (as listed on form CMS 209) confirmed the urine containers were not labeled according to laboratory policy. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 -- This STANDARD is not met as evidenced by: . Through a review of the TOSOH AIA-360 instrument manual, maintenance records for 2019, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to document maintenance with at least the frequency specified by the manufacturer. As evidenced by: A. The laboratory utilizes the Bioscience TOSOH AIA-360 Immunoassay analyzer to process Free Thyroxine (FT4), Total Triiodothyronine (TT3), Thyroid Stimulating Hormone (TSH), Prostate Specific Antigen (PSA) and Testosterone. B. A review of the Bioscience TOSOH instrument manual revealed the six month maintenance for the TOSOH Immunoassay analyzer: "Replace filters for diluent and wash bottles." C. A review of the TOSOH AIA-360 maintenance schedule for 2018 (twelve of twelve months) and 2019 (six of six months) revealed the six month maintenance was performed in January and June of 2018 and June of 2019 (three of four times due). Maintenance was not performed in January of 2019. D. In an interview on 7/3/2019 at 0930, laboratory personnel # 4 (as listed on CMS form 209) confirmed the lack of documented six-month maintenance for the TOSOH Immunoassay analyzer. -- 2 of 2 --