Foothill Family Clinic - South

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 proficiency testing for 2020, 2021, and to date August 23, 2022, patient test volumes, and interview with the technical consultant (TC), the laboratory failed to verify the accuracy of the nonregulated analyte, manual Semen analysis (presence or absence only). Findings: 1. Review of 2020, 2021, and to date August 23, 2022 proficiency testing, showed no enrollment for the nonregulated analyte, manual Semen analysis (presence or absence only). 2. No documentation was available for review to verify the accuracy of the nonregulated analyte of manual Semen analysis (presence or absence only). 3. The laboratory reports out approximately 20 manual Semen analysis (presence or absence only) annually. 4. Interview with the TC on August 23, 2022, at 12:30 PM confirmed that the laboratory failed to verify the accuracy of the nonregulated analyte of manual Semen analysis (presence or absence only). 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 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 -- 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 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 ACT Diff II verification records review, lack of documentation, and interview with the technical consultant the laboratory failed to verify the reportable range for the ACT Diff II instrument implemented in April 2018. The laboratory performed approximately 8 to 10 CBC tests per day. Findings include: 1. ACT Diff II verification records review included documentation the laboratory received the ACT Diff II instrument in April 2018. The laboratory lacked documentation they verified the instrument reportable ranges for White Blood Cell, Red Blood Cell, and Platelet counts, Hemoglobin concentration, and Mean Corpuscular Volume measurements prior to testing patient specimens. 2. In an interview conducted on 08/12/2019 at approximately 1:30 P.M. the laboratory technical consultant confirmed the laboratory did not perform reportable range verification prior to testing and reporting patient samples. 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 --