Pafford Health Systems, Medical Clinic

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 2022 and 2023 CMS Casper Reports 0155D, 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 Total Bilirubin (TBIL) 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 2022 and 2023 CMS Casper Reports 0155D and 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 Total Bilirubin (TBIL) Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a sore of 0% for the analyte TBIL in the third proficiency testing event of 2022. B. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analyte TBIL in the first 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 2022 and 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 2022 and 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 TBIL. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This is the CLIA initial survey of the laboratory. The following condition level deficiency was cited: 493.1250 - Analytic Systems D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Through a review of validation documentation for tests performed on the Triage instrument, through a review of quality control documentation for D-dimer and Cardiac Panel performed on the Alere Triage instrument, through a review of patient test records, a review of Solana assay documents, a review of patient and quality control documentation on the Solana instrument, through lack of documentation, and through interviews with laboratory staff, it was determined the laboratory failed to meet analytic systems requirements, as evidenced by: D5423 - the laboratory failed to validate normal ranges for the Triage test system D5447 - the laboratory failed to perform two levels of quality control each day patient specimens were tested D5449 - the laboratory failed to run negative controls for tests performed on the Solana test system each day of patient testing D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces 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 -- a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Through a review of validation documentation for tests performed on the Triage instrument, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to validate normal ranges for the Triage test system. Survey findings include: A. The surveyor reviewed documentation presented as validation records for the Triage test system. During the review, the surveyor noted that there was no documentation of validation of normal ranges for the moderate complexity D-dimer or Cardiac Panel tests performed. B. In an interview, at 11:37 on 5/17/2022, the technical consultant (listed as #2 on the form CMS-209) stated there was no documentation available to indicate the laboratory validated the normal ranges in use on the Triage. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of quality control documentation for D-dimer and Cardiac Panel performed on the Alere Triage instrument, through a review of patient test records, through lack of documented quality control results, and through interviews with laboratory staff, it was determined the laboratory failed to perform two levels of quality control each day patient specimens were tested. Survey findings include: A. A review of quality control records for D-dimer and for the Cardiac Panel performed on the Alere Triage instrument revealed the quality control for these tests was performed monthly instead of each day of testing patient samples. A review of quality control results from May 2021 (when the laboratory first started testing) through April 2022 revealed quality control documented for D-dimer and the Cardiac Panel on 5/10/2021, 6/9/2021, 7/9/2021, 8/11/2021, 8/26/2021, 9/25/2021, 11/3/2021, 12/6/2021,1/13 /2022, 2/11/2021, 3/28/2021, and 4/28/2021. There was no other documentation of quality control for these tests. B. During an interview, at 12:23 on 5/17/2022, the technical consultant (listed as #2 on the form CMS-209) stated that the laboratory performs quality control monthly on the the Triage test system instead of each day of testing. C. A review of six randomly chosen patient test records from 2022 revealed that six of six were performed on days without documented quality control. Patients tested on days without quality control are as follows: Patients #1 and #2, from the patient identifier list, were reported on 5/9/2022; Patient #3, from the patient identifier -- 2 of 3 -- list, was reported on 3/7/2022; Patient #4, from the patient identifier list, was reported on 3/2/2022; Patient #5, from the patient identifier list, was reported on 4/20/2022; and Patient #6, from the patient identifier list, was reported on 4/18/2022. D. In an interview, at 12:40 on 5/17/2022, the technical consultant (listed as #2 on the form CMS-209) confirmed quality control was not documented on the days when the patients listed above were reported. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of Solana assay documents, a review of patient and quality control documentation on the Solana instrument, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to run negative controls for tests performed on the Solana test system each day of patient testing. Survey findings include: A. A review of the Quality Control section of the Solana assay documents for SARS-Cov-2 assay (listed as moderate or high complexity in the FDA/ EUA) revealed the following statement: "It is recommended that the reactivity of each new lot and each new shipment of the Solana SARS-Cov-2 Assay be verified on receipt and before use. External control tests should be performed thereafter in accordance with appropriate federal, state and local guidelines." B. A review of patient and control documentation from January through March 2022 revealed that negative control was not documented in 158 of 158 runs on 20 days of testing. C. In an interview at 12:48 on 5/17/2022, laboratory employee #4 (as listed on the form CMS- 209) confirmed the lack of testing negative controls for testing performed on the Solana. He further stated that they didn't have to run negative controls because the manufacturer doesn't require it. -- 3 of 3 --