John C Fremont Healthcare District

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for evaluation of proficiency testing performance from CMS, the laboratory proficiency reporting from API, and an interview with the laboratory Technical Supervisor (TS) on 9/28/2021 between 8:30 a.m. and 11:30 a.m., it was determined that there were two unacceptable (below 80 %) proficiency testing (PT) results for Ammonia (serum) for Cycle 2 in 2020. Findings include: 1. On 9/284/2021, an inspection was conducted between 8:30 a.m. and 11:30 a.m. 2. During a review of the laboratory documentation from API (agency providing the proficiency specimens), it was noted at approximately 9:30 a.m. that there were two unacceptable PT results for Cycle 2 Ammonia on the 2020 report. The laboratory utilizes the Siemens Xpand instrument for chemistry testing. The TS recognized these atypical results. 3. The findings and acceptable ranges were as follows: Analyte: Ammonia Serum (2/2 unacceptable) Sample Actual Result Expected Result (range) 1 140 150-184 2 117 122-149 4. The TS confirmed the unacceptable results listed above. 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 --

Summary Statement of Deficiencies D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on observation of Immucor reagents for typing blood, review of 2017 proficiency testing reports for Compatibility Testing from CMS (report 155D, Individual Profile) and AAB (American Association of Bioanalysts), laboratory proficiency testing records, and patients test records; and interview with the Technical Supervisor (Testing Person-1), the laboratory failed to attain the score of 100% constituting unsatisfactory performance. Findings included: a. The laboratory utilized the manual method to determine the compatibility of donor blood to the patient. b. Laboratory proficiency testing records revealed the laboratory reported 1 unacceptable result out of 5 to AAB. c. The Technical Supervisor (Testing Person-1) affirmed (3/06 /19 at 3pm) the aforementioned findings and the final score of 80%. d. The reliability and quality of patients' Compatibility Testing could not be assured when proficiency testing failed to attain 100%. Based on the stated annual volume, the laboratory reported approximately 10 Compatibility Tests per month during the timeframe September 2017 to January 2018. 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 --