Foothill Family Clinic Draper

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 record review and interview with the technical consultant (TC), the laboratory failed to have a procedure to assess the competency for one of one technical consultant. Findings Include: 1. A review of the laboratory procedures revealed the laboratory failed to have a policy or procedure to assess the competency of the position of technical consultant for 1 of 1 technical consultant. 2. An interview on 06/16/2022, at 14:30, the Technical Consultant (TC), confirmed the laboratory failed to have a policy or procedure to assess the competency for the position of technical consultant. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on record review, direct observation, and interview with Testing Personnel #3 (TP3) and Technical Consultant (TC), expiration dates were not written on open vials 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 -- of hematology controls (Coulter 4C-ES Cell Control) and Potassium Hydroxide (KOH) reagent. The laboratory runs approximately 3,000 hematology tests per year. Findings include: 1. During observation of laboratory on 06/16/2022 at 14:40, laboratory failed to document expiration dates on 3 of 3 open tubes of Coulter 4C-ES Cell Control. 2. Record review of the package insert for Coulter 4C-ES Cell Control showed an open vial expiration of 35 days from the date of open. 3. An interview on 06/16/2022 at 15:25 with TC confirmed that they do not write expiration date upon opening Coulter 4C-ES Cell Control. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review, direct observation, and interview with the technical consultant, 3 of 3 thermometers used to monitor room temperature, freezer temperature, and refrigerator temperature had expired calibrations and were not calibrated per manufacturer's instructions. Findings include: 1. Record review failed to include documentation of calibrating thermometers. 2. The laboratory failed to have a written policy for the calibration of thermometers for room temperature, freezer, or refrigerator. 3. In an interview on 06/16/2022 at 15:25, the Technical Consultant (TC) confirmed that thermometers are not calibrated and that there is no policy to calibrate thermometers. 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: Based on record review, interview with Technical Consultant (TC), and direct observation of testing area, controls are not being performed each day of patient testing for Potassium Hydroxide (KOH) prep slides. The laboratory performs approximately 13 KOH tests per year. 1. Record review did not include records of quality control (QC) being performed prior to patient testing. 2. In an interview on 06 /16/2022 at 15:25, the TC confirmed that KOH controls are not run with each day of patient testing. 3. During observation of laboratory on 06/16/2022 at 14:40 no controls for KOH testing were found in the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation and interview with the testing personnel and technical consultant, the laboratory failed to retain the instrument printouts for complete blood count testing that identified the instrument that performed proficiency testing for 1 of 6 testing events reviewed. Findings include: 1. The laboratory printed proficiency testing results via the Laboratory Information System printer. The location for the instrument performing tests was not printed for the 1st event of 2019. 2. Laboratory agency report form review included the test results summary recorded by testing personnel for the 1st event of 2019 matching the reported results on the proficiency test graded performance report.. 3. In an interview with the testing personnel on 04/17/2019 at approximately 12:30 P.M. staff confirmed she performed proficiency testing at the Draper location. The technical consultant stated via email on 04/17/2019 the results were not printed from the location where testing was performed but printed from the central laboratory location upon receipt of the proficiency testing agency summary report form sent to her by the testing personnel. The technical consultant and the testing personnel 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 -- confirmed they did not print the results from the AcT Diff II instrument performing the complete blood count tests. -- 2 of 2 --