Ch Pc Med-Care Of Fairfield

Summary Statement of Deficiencies 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 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 surveyor review of the Test Report (TR) and interview with the Testing Personnel (TP), the laboratory failed to report SARS-CoV-2 IgG tests results accurately from May 2020 to the date of survey. The finding includes: 1. The laboratory performed non Food and Drug Administration (FDA) cleared tests and there was no statement stating "This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests. This product has been authorized only for detecting the presence of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3 (b)(1), unless the declaration is terminated authorization is revoked sooner". 2. The TP confirmed on 11/14/23 at 11:45 am that tests SARS-CoV- 2 IgG tests were not reported accurately. 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 -- D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Test Reports (TR) for Virology and Chemistry tests and interview with the Testing Personnel (TP), the laboratory failed to have a Reference Interval (RI) on TR from 6/1/22 to the date of survey. The findings include: 1. The TR did not have a RI for estimated Glomerular Filtration Rate (eGFR) and Sars-Cov-2. 2. The The TP confirmed on 11/14/23 at 12:00 pm the laboratory failed to include a RI for the aforementioned analytes. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to follow its policies and procedures for assessing the competency of two of two TP from 4/28/17 to the date of the survey. The findings include: 1. The CA form indicated all criteria for review were completed but there was no documented evidence category 2, 3, 4, 6, 7, 10 and 12 were performed. 2. The TP #1 listed on CMS form 209 confirmed on 3/28/19 at 10:25 am that the laboratory did not follow its CA procedure. 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: a. Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow the "Flag Procedure" for flags obtained on Hematology tests performed on the Sysmex XP-300 analyzer from 1/2/19 to the date of the survey. The finding includes: 1. The PM stated to "check smear" or 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 -- perform plasma replacement for samples with flags but there was no documented evidence for ten of ten flagged samples the PM was followed. 2. The TP #1 listed on the CMS form 209 confirmed on 3/28/19 at 1:50 pm that the Flag Procedure was not followed. b. Based on surveyor review of the PM and interview with the TP, the laboratory failed to follow the "Flag Procedure" for flags obtained on Urine Microalbumin (UM) tests performed on the Beckman Coulter AU 480 from 1/2/19 to the date of the survey. The finding includes: 1. A review of the UM test results revealed ten of ten samples had flags but there was no documented evidence the laboratory had attempted to correct the flag. 2. The TP #1 listed on the CMS form 209 confirmed on 3/28/19 at 2:20 pm that the Flag Procedure was not followed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that PS procedures were performed on the Sysmex XP 300 analyzer were adequate from 4/11/17 to the date of survey. The finding includes: 1. There was no documented evidence Reportable Range Verification was performed. 2. The TP #1 listed on the CMS form 209 confirmed on 3/28/19 at 11:15 am that PS records were not adequate. D5783