Bridge Community Health Clinic

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with a technical consultant, the laboratory did not evaluate the accuracy for fifty-one of fifty-nine "Educational Blood Cell Identification" proficiency testing results in 2019 and 2020. Findings include: 1. Review of API Hematology PT records showed the laboratory did not evaluate the accuracy for fifty- one of fifty-nine ungraded "Educational Blood Cell Identification" results in 2019 and 2020. 2. Interview with a technical consultant on February 17, 2021 at 9:00 AM, confirmed the laboratory did not evaluate the accuracy for fifty-one of fifty-nine "Educational Blood Cell Identification" PT results in 2019 and 2020. 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. 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: Based on surveyor review of laboratory records and interview with the technical consultant, the laboratory director did not review the performance specification verification records on the Pentra 60C+ hematology analyzer and Pentra C400 chemistry analyzer prior to reporting patient results. Findings include: 1. Review of laboratory records for the Pentra 60C+ hematology analyzer showed the laboratory started reporting patients on December 8, 2020. Further review showed the laboratory director reviewed and accepted the verfication of performance expectations on February 12, 2021. 2. Review of laboratory records for the Pentra C400 chemistry analyzer showed the laboratory started reporting patients on December 10, 2020. Further review showed the laboratory director reviewed and accepted the verfication of performance expectations on February 12, 2021. 3. Interview with the technical consultant on February 17, 2021 at 9:50 AM confirmed the laboratory director did not review and accept the verification of performance expectations for the Pentra 60C+ hematology analyzer and Pentra C400 chemistry analyzer prior to reporting patient results. This is a repeat deficiency from August 2, 2018. -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records, lab procedures, and interview with the technical consultant, the samples for chemistry and hematology events in 2016, 2017, and 2018 were tested two times while patient samples are routinely tested once. Findings include: 1. Review of PT records for events two and three of 2016, all events in 2017, and events one and two in 2018 show two set of laboratory test results for each sample. The test results do not indicate a reason for the repeated analysis. 2. Review of lab procedures do not state that patient specimens are tested in duplicate. 3. Interview with the technical consultant on August 2, 2018 at 9: 30 AM confirmed patient samples are routinely tested once and the PT samples were not tested the same number of times as patient samples. 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 surveyor review of laboratory procedures and interview with the technical consultant, the laboratory did not have a procedure available for the chemistry 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 -- analyzer and chemistry testing. Findings include: 1. Review of the laboratory procedure manual provided no evidence of a procedure for the chemistry analyzer and chemistry testing performed in the laboratory. 2. Interview with the technical consultant on August 2, 2018 at 12:30 PM confirmed no approved procedure was available for the chemistry analyzer and chemistry testing performed in the lab. 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)