Sutter Maternity & Surgery Center

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of random selected patiens sampling test orders and interviews with the technical consultants (TSs), it was determined that the laboratory failed to have a written or electronic request for patient testing from an authorized person. The findings included: 1. On the day of the survey March 13, 2024 for one (1) out of five (5) patients' test requisitions requested for review the laboratory had no documentation to show of a test order from an authorized person. 2. For one (1) out of five (5) random selected patients test orders reviewed covering period from 2/19/2022 to 2/13/2024, the laboratory analyzed and reported Fern test results without a written or electronic request for patient testing from an authorized person. 3. The TSs confirmed that the laboratory has no documentation to show for a written or electronic request for the above patient test results from an authorized person. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; 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 observation, review of the laboratory records, and interview with the technical consultants; it was determined that the laboratory director failed to be responsible for the overall operation, including, but are not limited to ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic and analytic phases of testing. The findings included: See D5301 and D6054. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment procedures, lack of competency assessment documents for all testing personnel (TP) and technical consultants (TCs) available for review, and interviews with the TCs; it was determined that the TCs had failed to perform and document annually the competency of the TP and other TCs as required annually. The findings included: 1. At the time of survey March 13, 2024, there were no competency evaluation documents for two (2) out of ten (10) randomly chosen test competency records. 2. No competency records were available for the year 2023 for one TP and one TC to include: 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 3. The TCs confirmed on March 13, 2024, at approximately 12:45 p.m. statement 2 above. 4. Based on the laboratory's testing declaration submitted and signed by the laboratory director March 11, 2024, there were 1,217 tests analyzed and reported without competency evaluation for all TP and TCs. -- 2 of 2 --

Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the proficiency testing (PT) report from API, a review of the laboratory proficiency report and an interview with the LP (laboratory personnel), it was determined that the laboratory failed to participate in the event 3, 2019 events for Chemistry. The inspection was completed on 4/28/2021 between 1:00 p.m. and 3:00 P. M. Findings include: 1. A CLIA inspection was completed on 4/28/2021 between 1:00 p.m. and 3:00 p.m. 2. The laboratory submits PT results each quarter to API for Chemistry 3. After a review of the CMS 96 report and the laboratory API report for event 3, 2019, it was determined that no proficiency scores were submitted 4. The LP reviewed the findings and affirmed the results (failure to submit resulting in a score of 0). 5. No PT results for this cycle were documented for the following (analyte/analyte number): Routine Chemistry (0245) Ph Blood Gas (0315) PO2 Blood Gas (0325) PC02 Blood Gas (0335) Glucose (0415) K (0465) NA (0475) 6. Proficiency results for Chemistry were submitted by this laboratory for Events 1 and 2 in 2019 and Events 1,2 and 3 for 2020 and Event 1 for 2021. D2123 HEMATOLOGY 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 -- CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the proficiency testing (PT) report from API, a review of the laboratory proficiency report and an interview with the LP (laboratory personnel), it was determined that the laboratory failed to participate in the event 3, 2019 events for Chemistry. The inspection was completed on 4/28/2021 between 1:00 p.m. and 3:00 P. M. Findings include: 1. A CLIA inspection was completed on 4/28/2021 between 1:00 p.m. and 3:00 p.m. 2. The laboratory submits PT results each quarter to API for Hematology 3. After a review of the CMS 96 report and the laboratory API report for event 3, 2019, it was determined that no proficiency scores were submitted 4. The LP reviewed the findings and affirmed the results (failure to submit resulting in a score of 0). 5. No PT results for this cycle were documented for the following (analyte/analyte number): Hematology (0760) HGB (0795) 6. Proficiency results for Hematology were submitted by this laboratory for Events 1 and 2 in 2019 and Events 1,2 and 3 for 2020 and Event 1 for 2021. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the proficiency testing (PT) report from API, a review of the laboratory proficiency report and an interview with the LP (laboratory personnel), it was determined that the laboratory failed to participate in the event 3, 2019 events for Chemistry. The inspection was completed on 4/28/2021 between 1:00 p.m. and 3:00 P. M. Findings include: 1. See Dtag 2089 and Dtag2123. -- 2 of 2 --

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: Review of proficiency testing reports from CMS (Report 155D, Individual Laboratory Profile) and API (American Proficiency Institute), laboratory proficiency testing records for Event 1, 2017, and patients test records; and interview with laboratory personnel and the Technical Consultant revealed the failure to attain a score of at least 80 percent when performing point-of-care testing for pCO2 Blood Gas. Findings included: a. CMS and API reported the score of 40% based on the laboratory's 3 unacceptable results out of 5: PT sample Lab Result Acceptable -------------------------------------------------- BG-02 60 61 - 72 BG-03 43 46 - 57 BG-05 30 37 - 48 b. Laboratory personnel and the Technical Consultant affirmed (4/23/19 at 4pm) the aforementioned score using the EPOC analyzer; and thus unsatisfactory testing for pCO2 Blood Gas. c. The reliability and quality of results reported for pCO2 Blood Gas at point of care testing for Neonates could not be assured for the timeframe January to May 2017. Examples include 4 of 4 selected at random: Date ID ------------------------------- 1/25/17.........61638151 2/18/17.........61674452 3/13 /17.........61704005 4/20/17.........61757707 . . D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the proficiency testing report from API, laboratory proficiency testing records, and interview with laboratory personnel, it was determined that the laboratory failed to participate in Event 1, 2017, for Hematocrit. Findings included: a. API reported No Grading for 5 out of 5 samples based on the laboratory's failure to report results. b. Laboratory proficiency testing records revealed testing was performed on 2/23/17 after API's deadline for reporting. c. Laboratory personnel affirmed (4/23/19 at 5pm) the aforementioned findings; and thus the laboratory's failure to participate in the testing event. d. The reliability and quality of results reported could not be assured in the absence of participation in proficiency testing. Based on the stated annual test volume of 400, the laboratory reported approximately 166 Hematocrits during the timeframe January to May 2017. . 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 laboratory proficiency testing records for Event 2, 2017; API proficiency testing report, and patients test records; the lack of laboratory documents, and interview with laboratory personnel, it was determined that the laboratory failed to verify the accuracy of testing for ROM (Rupture of Membrane) using the Clinical Innovations ROM Plus test cartridges. Findings included: a. The laboratory chose to participate in API's proficiency testing program as the means to satisfy the requirement to at least twice annually verify the accuracy of testing for ROM. b. API reported the unsatisfactory score of 67%. c. The laboratory failed to provide for review other documents verifying the accuracy of testing during this timeframe. d. Laboratory personnel affirmed (4/23/19 at 5pm) the aforementioned score and lack of laboratory documents; and thus accuracy of testing was not verified. e. The reliability and quality of results reported for ROM could not be assured in the absence of accurate testing. Based on the stated annual test volume of 125, the laboratory reported approximately 50 results during the timeframe November 2017 to March 2018. Five reports randomly selected are as follows: Date ID ------------------------------ 11/21/17 .....G, V 12/18/17......P, J 1/23/18......L, C 2/21/18......O, C 3/19/18......T, J . D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of