Sutter Gould Medical Foundation

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(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 proficiency testing (PT) records retrieved from the Certification and Survey Provider Enhanced Reporting (CASPER) and interviews with the technical consultants (TCs), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the specialty of Hematology during the first event of 2024 (Q1-2024). The findings include: 1. Based on review CASPER records, an unacceptable score of 60 percent from the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB- MLE) was obtained for Hemoglobin (Hgb) analyte in Q1-2024 for the specialty of Hematology . 2. Based on the interviews with the TCs on October 24, 2024, at approximately 10:15 a.m., the laboratory did not receive the results for Q1-2024, and even when accessed through the website, none were found prior to the survey. Thus, no

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(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 and an interview with laboratory personnel (LP) on 4 /7/22 between 8:30 a.m. and 10:00 a.m, it was determined that there were proficiency testing (PT) scores below 80 % for two parameters during two testing cycles. The issues related to Hematocrit for cycle Q1 in 2020 and Erythrocytes for cycle Q3 in 2021. Findings include: 1. On 4/7/22, an inspection was conducted between 8:30 a.m. and 10:00 a.m. 2. During a review of the laboratory documentation from AAB (American Association of Bioanalysts- the agency providing the proficiency specimens), it was noted at approximately 9:00 a.m. that the laboratory had unacceptable Hematology results as indicated below. For each of the two items listed, the section score was 60 %. The testing was completed on a Sysmex pocHi-100i device. 3. The findings and acceptable ranges were as follows: Cycle Q1 2020 Test: Hematocrit (Hct) Sample Actual Result Expected Result (range) 3 18.1 18.3-20.6 4 31.9 32.4-36.5 Cycle Q3 2021 Test: Erythrocytes Sample Actual Result Expected Result (range) 12 4.36 3.83-4.32 13 6.24 5.39-6.07 4. The LP recognized the above results. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation on the day of the survey (7/11/2019) there were fifteen (15) Blue top tubes (3.2 Na Citrate) Lot # 9002613, expiration date 6/30/2019 found, and interview with the laboratory personnel, it was determined that the laboratory had used test tubes that exceeded their expiration date. The findings included: a. Based on direct observation, on the day of the survey (7/11/2019) there were fifteen (15) Blue top tubes (3.2 Na Citrate) test tubes found in the laboratory drawer that indicated its being used or have the potential of being used even though the expiration dates had exceeded. b. The laboratory personnel confirmed (7/11/2019, 1230) that the laboratory had expired test tubes inside the laboratory's drawer; (15) Blue top tubes (3.2 Na Citrate) that had exceeded their expiration dates. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. 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 review and the lack of documentation for competency assessment and interview with the laboratory personnel, it was determined that the laboratory failed to ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. See D 5417 and D 6053 D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review and the lack of documentation for competency assessments and interview with the laboratory personnel, for six (6) out of six (6) random patient test records reviewed covering period from 7/4/2018 to 5/16/2019, it was determined that the Laboratory Director/Technical Consultant failed to perform and document the performance of individuals responsible for moderate complexity testing at least semiannually during the first year and yearly thereafter the individual tests patient specimens. The evaluations must include but are not limited to the following: The findings included: a. There was no documentation to show that the testing personnel for twelve (12) out of twelve (12) were evaluated during the first six months and annually thereafter for Hematology. The evaluation must include following: Direct observations of the testing performed (including sample handling, processing and testing) Monitoring the recording and reporting of results Direct observation of instrument maintenance Review of intermediate worksheets, quality control records. Assessment of testing previously analyzed specimens (external QC and proficiently testing) Assessment of problem solving skills b. The laboratory personnel confirmed (7/11/2019, 1230) that no competency assessments were performed and documented by the Laboratory Director/Technical Consultant. -- 2 of 2 --