Foothill Family Clinic-North

Summary Statement of Deficiencies D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on review of the Henry Schein OneStep+ Strep A Dipstick manufacturer's instructions, patient results, observation of the hallways connecting the patient exam rooms, and interview with the technical consultant (TC), the laboratory failed to ensure contamination of patient specimens is minimized. Findings: 1. Review of the Henry Schein OneStep+ Strep A Dipstick manufacturer's instructions stated, "Do not eat, drink, or smoke in the area where the specimens and kits are handled." 2. Interview with the TC confirmed "The MA tape the Strep container with the reagent, test strip and patient specimen to the door of the patient exam room and read the result after the required time." 3. Observation of the hallways connecting the patient exam rooms showed access by patients and staff. Patients including children and staff had access to the taped specimens located on the patient exam room door. Observation of drinks were located in the hallway. 4. The laboratory results approximately 350 rapid Strep A tests. 5. Interview with the TC on August 23, 2022 at 12:00 PM confirmed the laboratory failed to ensure the laboratory area was maintained to minimize contamination of patient specimens. 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 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 -- 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)

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 3 to 8 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 08/09/2019 at approximately 3:30 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 --