Sonoma Specialty Hospital

Summary Statement of Deficiencies D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records, CASPER report, and interview with the technical supervisor (TS) and general supervisor (GS); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for various analytes in routine chemistry. The finding included: 1. Based on review of PT and CASPER report records, API reported: Event Analyte Score Q1-2023 AST (SGOT) 60% Q2-2023 Ph Blood Gas 60% Q3-2023 PO2 Blood Gas 40% Q2-2023 PCO2 Blood Gas 60% 2. Based on the laboratory testing declaration submitted at the time of the survey on 05/31/2024 the laboratory analyzed and reported approximately 25,959 routine chemistry tests during the time the laboratory had unsatisfactory proficiency testing results. 3. The TS affirmed 05/31/2024 at approximately 12:15 p.m. that the laboratory received the above unsatisfactory proficiency testing scores. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records, CASPER records, and interviews with the technical supervisor (TS) and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- general supervisor (GS); it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent which is unsatisfactory performance for the coagulation Prothrombin Time analyte. The findings included: 1. Based on review of API and CASPER PT records, the laboratory obtained the following unsatisfactory scores: Q3-2021 0% Q2-2023 60% 2. The TS affirmed on May 31, 2024, at approximately 12:30 p.m. that the laboratory obtained the PT scores in 1. 3. According to the laboratory testing declaration submitted on the day of the survey, the laboratory performed approximately 210 Prothrombin Time testing annually. 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 review of the second event of 2021 (Q2-2021) and second event of 2023 (Q2-2023) of the American Proficiency Institute (API) proficiency testing (PT) records, random patient sampling test results, and interview with the technical supervisor (TS) and general supervisor (GS); it was determined that the laboratory failed to attain a score of at least 100 percent of acceptable responses for Compatibility Testing. 1. The API reported for Immunohematology Q2-2021 event unacceptable performance score of 80% for Compatibility Testing, and for Q2-2023 a score of 60%. 2. The laboratory analyzed and reported compatibility testing during the period wherein the laboratory received an unsuccessful proficiency testing score, and patients' results could not be assured. 3. The TS and GS affirmed on May 31, 2024, at approximately 12:00 p.m. that the laboratory received the above unsatisfactory proficiency testing score. 3. Based on the laboratory testing declaration signed by the laboratory director on May 31, 2024, the laboratory tests 112 samples for Compatibility Testing. D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on the lack of documentation, review of randomly chosen patient test results, and interviews with the technical supervisor (TS) and general supervisor (GS); it was determined that the laboratory failed to provide test requisition and results for two (2) out of five (5) records reviewed for the years 2021 and 2023. Findings included: 1. The laboratory was not able to retrieve documentation to show requisition and final reports for all tests ordered and reported for the years 2021 and 2023. 2. For two (2) out of five (5) randomly chosen patient test results reviewed covering period from 4/27 /2021 to 03/14/2024 documentation was not retained or accessible for all tests performed in the laboratory for the years 2021 and 2023. 3. The TS and GS affirmed on May 31, 2024, at approximately 3:00 p.m. that the laboratory had no -- 2 of 4 -- documentation to show for the tests requisition or patient log results for the patients reviewed for the years 2021 and 2023. 4. 5. The laboratory reportedly performs approximately 40,657 tests annually. 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 the incomplete laboratory's verification of performance characteristics for high complexity testing for Procalcitonin and C-Reactive Protein (CRP), interview with the laboratory's technical supervisor (TS) and general supervisor (GS), and review of five (5) randomly selected patient test records; the laboratory failed to demonstrate that it established performance specifications comparable to those established by the manufacturer. The findings included: 1. The laboratory had only partial documentation to show for performance specifications, lacking calculation of accuracy and precision testing performance characteristic and documentation. The laboratory must be able to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics and those to be approved by the laboratory director before starting testing patients' samples: (A) Accuracy (B) Precision (C) Reportable range (D) Reference Range 2. The laboratory was unable to provide for review additional documents using patient samples to establish precision performance specification for Procalcitonin and C-Reactive Protein (CRP). 3. The TS affirmed at the time of the survey on 05/31/2024 at approximately 12:15 p.m. that no additional documents could be retrieved to show that performance specification were performed prior to reporting patient test results when the laboratory went live testing and reporting Procalcitonin and C-Reactive Protein (CRP) diagnostic tests. 4. Based on the estimated annual tests volumes signed by the laboratory director on 05/24/2024; the laboratory performed and reported approximately 25,959 routine chemistry diagnostic tests which include Procalcitonin and C-Reactive Protein (CRP). The precision and accuracy of the reported tests results could not be assured. D5815 TEST REPORT CFR(s): 493.1291(h) When the laboratory cannot report patient test results within its established time frames, the laboratory must determine, based on the urgency of the patient test(s) requested, the need to notify the appropriate individual(s) of the delayed testing. This STANDARD is not met as evidenced by: Based on the lack of laboratory's policies, review of patient test records randomly selected, and interview with the technical supervisor (TS); it was determined that the laboratory failed to have a policy for turn-around time (TAT) for all tests performed in -- 3 of 4 -- the laboratory. 1. The laboratory failed to provide TAT of testing for five (5) out of five (5) randomly chosen patients at the time of the survey (May 31, 2024). The laboratory did not provide a TAT policy which may adversely impact patient management. 2. The laboratory TS on May 31, 2024, at approximately 12:30 p.m. affirmed that the laboratory did not have a TAT policy to notify any delay on testing to the physician. 3. The laboratory's testing declaration form, signed by the laboratory director on 5/24/2024, stated that the laboratory performs 40,657 tests annually for which a TAT policy was not available. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must 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. This STANDARD is not met as evidenced by: Based on the surveyor's tour of the laboratory, review of the laboratory's records and interviews with the laboratory's technical supervisor, general supervisor, and testing personnel on May 31, 2024; it was determined that the laboratory director is cited herein due to failure to ensure that several aspects of the preanalytic, analytic, and postanalytic phases of the laboratory testing were monitored. See D2088, D2122, D3027, and D5815. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on interviews with the technical supervisor and general supervisor, review of proficiency test reports documents, verification of performance specifications, and policies and procedures record on May 31, 2024; the laboratory director failed to ensure that laboratory personnel are properly trained and competent when performing the test methods as required for accurate and reliable results. See D2173 and D5421. -- 4 of 4 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte Alanine Aminotransferase (ALT), resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, ALT, as follows: 2020 Q3 2021 Q1 ALT 60% 40% Q1 = First Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, ALT. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) 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 desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, ALT, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2096) -- 2 of 2 --

Summary Statement of Deficiencies D2025 BACTERIOLOGY CFR(s): 493.823(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 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, laboratory proficiency reporting from API, and an interview with laboratory Technical Supervisor (TS) on 2/24/2021 between 1:00 p.m. and 4:00 p.m., it was determined that the laboratory did not participate in the Bacteriology proficiency testing for Q3 cycle 2020. Findings include: 1. On 2/24/2021, an inspection was conducted between 1:00 p.m. and 4:00 p. m. 2. During a review of the laboratory documentation from API (agency providing the proficiency specimens), it was noted at approximately 3:45 p.m. that there was not a submission of Bacteriology proficiency results for Q3 cycle 2020. 3. The resulting proficiency score was 0 given no submission 4. The TS affirmed that no Bacteriology results were submitted 5. The laboratory has discontinued any Bacteriology testing, starting with Q1 2021. 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 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 -- proficiency testing performance from CMS, laboratory proficiency reporting from API, and an interview with the laboratory Technical Supervisor (TS) on 2/24/2021 between 1:00 p.m. and 4:00 p.m., it was determined that there were two unacceptable (below 80 %) proficiency testing (PT) results for CK for Cycle 3 in 2019. Findings include: 1. On 2/24/2021, an inspection was conducted between 1:00 p.m. and 4:00 p. m. 2. During a review of the laboratory documentation from API (agency providing the proficiency specimens), it was noted at approximately 2:30 p.m. that there were two unacceptable PT results for cycle Q3 CK on the 2019 report. The laboratory utilizes the Vitros 5600 instrument for general chemistry testing. The TS recognized these atypical results. 3. The findings and acceptable ranges were as follows: Analyte: CK (2/5 unacceptable) Sample Actual Result Expected Result (range) CM12 497 255- 474 CH14 255 129-242 4. The TS affirmed the unacceptable results listed above. ______ The 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, laboratory proficiency reporting from API, and an interview with laboratory Technical Supervisor (TS) on 2/24/2021 between 1:00 p.m. and 4:00 p.m., it was determined that there were four unacceptable (below 80 %) proficiency testing (PT) results for Bilirubin, Total (TBIL) for Cycle 1 in 2020. Findings include: 1. On 2/24 /2021, an inspection was conducted between 1:00 p.m. and 4:00 p.m. 2. During a review of the laboratory documentation from API (agency providing the proficiency specimens), it was noted at approximately 3:00 p.m. that there were four unacceptable PT results for cycle Q1 for TBIL on the 2020 report. The laboratory utilizes the Vitros 5600 instrument for general chemistry testing. The TS recognized these atypical results. 3. The findings and acceptable ranges were as follows: Analyte: TBIL (4/5 unacceptable) Sample Actual Result Expected Result (range) CH01 1.6 .3-1.2 CH02 2.4 .9-1.8 CH04 7.9 4.1-6.3 CH05 4.7 2.3-3.6 4. The TS affirmed the unacceptable results listed above. __ The 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, laboratory proficiency reporting from API, and an interview with laboratory Technical Supervisor (TS) on 2/24/2021 between 1:00 p.m. and 4:00 p. m., it was determined that there were four unacceptable (below 80 %) proficiency testing (PT) results for ALT/SGPT for Cycle 3 in 2020. Findings include: 1. On 2/24 /2021, an inspection was conducted between 1:00 p.m. and 4:00 p.m. 2. During a review of the laboratory documentation from API (agency providing the proficiency specimens), it was noted at approximately 3:30 p.m. that there were two unacceptable PT results for cycle Q3 for ALT/SGPT on the 2020 report. The laboratory utilizes the Vitros 5600 instrument for general chemistry testing. The TS recognized these atypical results. 3. The findings and acceptable ranges were as follows: Analyte: ALT /SGPT (2/5 unacceptable) Sample Actual Result Expected Result (range) CH12 98 52- 80 CH15 71 31-48 4. The TS affirmed the unacceptable results listed above. 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. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a review of the proficiency laboratory documentation records and interviews with the TS, it was determined that the laboratory director failed to ensure the verification and accuracy of test results of regulated analytes and to identify failures as they occurred for the previously mentioned Cycles for 2019 and 2020 proficiency testing. The findings include: See D-2087 (3 deficiencies) and D-2025 (one deficiency) -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on observation of BioRad MRSA Selective agar media available for use, review of patients test reports, the lack of proficiency testing reports and laboratory proficiency testing records for "Culture MRSA Screen", and interview with the Technical Consultant, the laboratory failed to enroll in proficiency testing for bacterial culture to screen for Methicillin Resistant Staphylococcus aureus (MRSA). Findings include: a. The laboratory was unable to provide for review proficiency testing scores and proficiency testing records for bacterial culture to screen for MRSA. b. The Technical Consultant affirmed (4/04/18) the aforementioned failure to enroll in 2016 to 2018, date of this survey. c. The reliability and quality of results reported could not be assured. Based on the stated estimated annual test volume, the laboratory reported approximately 137 results annually using bacterial cultures to screen for MRSA. A few examples are as follows: Date Recv'd Accession / ID -------------------------------------------------------- 1/26/16 ... ... ..... ...414981 1/29/16 ..................415404 2/09/16 ..................416788 6/02/16 ... ... ..... ...432238 10/04/16 ... ... ..... ...446209 1/03/17 ................. 457688 1/20/17 ................. 459881 10/30/17 ... ... ..... ...504538 1/01/18 ..................523534 1/18/18 ... ... ... .....529861 . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D2021 BACTERIOLOGY CFR(s): 493.823(b) 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 review of 2016 - 2017 Microbiology proficiency testing reports from API (American Proficiency Institute), laboratory proficiency testing records for bacterial Blood Culture, and patients test reports; and interview with the Technical Consultant, the laboratory failed to participate in 2 out of 6 events. Findings include: a. API reported no scores for Blood Culture proficiency testing in the 2nd events of 2016 and 2017. b. The Technical Consultant affirmed (4/04/18) the aforementioned lack of participation; and thus, unsatisfactory analyte performances in bacterial Blood Culture. c. The reliability and quality of results reported could not be assured. Based on the stated estimated annual test volume, the laboratory reported approximately 86 results for Blood Culture Screening each month during the timeframes April to August in 2016 and 2017. A few examples are as follows: Date Recv'd Accession / ID -------------------------------------------------------- 5/04/16 ... ... ..... ...428571 6/19/16 ... ... ..... ...434497 7/26/16 ... ... ..... ...438740 8/20/16 ... ... ..... ...441181 4/27/17 ..................470970 . 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 review of 2016/event 1 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and API (American Proficiency Institute), laboratory proficiency testing records for cardiac markers CK Iso (Creatine kinase Isoenzyme)/ CKMB (Creatine Kinase-Muscle/Brain) using the Vitros 5600 analyzer, and patients test reports; and interview with the Technical Consultant, the laboratory failed to attain a score of at least 80%, constituting unsatisfactory analyte performance for CKMB. Findings include: a. CMS and CAP reported the unsatisfactory score of 40% based on the laboratory's reporting of 3 unacceptable results out of 5 for proficiency testing. b. The Technical Consultant affirmed (4/04/18) the aforementioned unacceptable results and scores for CK-MB; and thus, unsatisfactory analyte performance. c. The reliability and quality of results reported could not be assured. Based on the stated estimated annual test volume, the laboratory reported approximately 4 to 5 CKMB results each month during the timeframe January to -- 2 of 5 -- April 2016. A few examples are as follows: Date reported Accession ------------------------------------------ 1/03/16 ... ... ... .... ...411927 2/06/16 ... ... ... .... ... 416582 3/01/16 ... ... ... .... ...419807 4/14/16 ... ... ... .... ...425917 . D2098 ENDOCRINOLOGY CFR(s): 493.843(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 review of 2017/event 3 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and API (American Proficiency Institute), laboratory proficiency testing records for Free T4 (Free Thyroxine) and TSH (Thyroid Stimulating Hormone) using the Vitros 5600 analyzer, and patients test reports; and interview with the Technical Consultant, the laboratory failed to attain scores of at least 80%, constituting unsatisfactory analyte performances. Findings include: a. CMS and CAP reported the unsatisfactory scores based on the laboratory's reporting of unacceptable results for proficiency testing as follows: Analyte Score Unacceptable Results --------------------------------------------------------------- Free T4 ....60%......3 out of 5 TSH ... .....60%.......3 out of 5 b. The Technical Consultant affirmed (4/04/18) the aforementioned results and scores for Free T4 and TSH; and thus, unsatisfactory analyte performances. c. The reliability and quality of results reported could not be assured. Based on the stated estimated annual test volume, the laboratory reported approximately 32 Free T4 results and 73 TSH results each month during the timeframe September to December 2017. A few examples are as follows: Date Accession Test ----------------------------------------------------- 9/13/17 ... ...489754 ... ..... TSH 9/14/17 ... ...489753 ... ..... Free T4 10/13/17 ... ...497495 ... ......Free T4 10/18 /17 ... ...497496 ... ......TSH 11/08/17 ... ...507116 ... ..... TSH 11/08/17 ... ...507139 ... ..... Free T4 12/13/17 ... ...516587 ... ..... Free T4 12/13/17 ... ...516588 ... ..... TSH . D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of 2017/event 3 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and API (American Proficiency Institute) and interview with the Technical Consultant, the laboratory failed to attain an overall testing event score of at least 80%, constituting unsatisfactory performance in Endocrinology. Findings include: a. CMS and CAP reported the unsatisfactory score of 66% overall in Endocrinology based on individual analytes scores as follows: Free T4 . ...60% HcG ... .... 80% TSH ... .....60% b. See D2098 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on review of 2016/event 1 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and API (American Proficiency Institute), laboratory proficiency testing records for coagulation test Prothrombin Time (PT/ ProTime) using the Siemens CA 600 analyzer, and patients test reports; and interview with the Technical Consultant, the laboratory failed to attain a score of at least 80%, constituting unsatisfactory analyte performance for ProTime. Findings include: a. CMS and CAP reported the unsatisfactory score of 60% based on the laboratory's reporting of 2 unacceptable results out of 5 for proficiency testing. b. The Technical Consultant affirmed (4/04/18) the aforementioned unacceptable results and scores for ProTime; and thus, unsatisfactory analyte performance. c. The reliability and quality of results reported could not be assured. Based on the stated estimated annual test volume, the laboratory reported approximately 96 Prothrombin Time results each month during the timeframe January to April 2016. A few examples are as follows: Date Accession ------------------------------------------ 1/11/16 ... ...412951 2/17/16 ... ... 417995 3/31/16 ... ...424294 4/02/16 ... ...424511 . 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 2016 - 2017 proficiency testing reports from API (American Proficiency Institute), laboratory proficiency testing records for Troponin using the Alere Biosite Triage test system, and patients test reports; and interview with the Technical Consultant, the laboratory failed to verify the accuracy of Troponin. Findings include: a. The laboratory chose to participate in API's proficiency testing program, "Cardiac Markers", as the means to satisfy the requirement to verify the accuracy of testing for Troponin at least twice annually. b. For the 1st event of 2016, the laboratory reported 4 unacceptable result out of 4 as follows: Sample Reported Expected ---------------------------------------------------------------- CM - 02 1.720 0.371 - 0.587 CM - 03 0.760 0.210 - 0.411 CM - 04 10.900 1.115 - 1.725 CM - 05 5.260 0.609 - 0.977 c. The Technical Consultant affirmed (4/04/18) the aforementioned results; and thus, accuracy was not verified. d. The reliability and quality of results reported could not be assured. Based on the stated estimated annual test volume, the laboratory reported approximately 33 results for Troponin each month during the timeframe January to May 2016. A few examples are as follows: Date recv'd Accession ------------------------------------------ 1/03/16 ... ... ....411927 2/06/16 ... ... .... 416582 3/01/16 ... .... ...419807 4/14/16 ... .... ...425917 . D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on reviews of the list of tests performed (LAB 144A, 4/04/18), laboratory documents, and patients' test records; the lack of laboratory documents, observation of the Beckman Coulter DxH 600 automated hematology analyzer and the microscope in the laboratory, and interview with the Technical Consultant/Technical Supervisor, the laboratory failed to have a system that twice a year evaluated and defined the relationship between automated and manual methodologies for Differentials in 2016. Findings include: a. The Laboratory Testing Declaration and patients test records revealed the laboratory reported hematology Differential results using the automated Beckman Coulter DxH 600 analyzer and manual microscopic examinations by testing personnel. b. The laboratory provided for review (4/13/18) documents comparing the relationship between automated and manual differential results for 2017. c. The laboratory was unable to provide for review documents for 2016, and written policy, procedure, and process for a system that compared the two methods for reporting Differential results. d. The Technical Consultant/Technical Supervisor affirmed (4/04 /18) the aforementioned lack of written policy and procedure; and thus, the failure to have a process and practice to compare automated and manual results for Differentials twice each year. e. The relationship between automated and manual results reported were not defined for 2016. Based on the stated estimated annual test volume the laboratory reported approximately 5,208 automated and 157 manual Differentials. A few examples are as follows: Date recv'd Accession ------------------------------------- 6 /02/16 ............432082 10/24/16 ............448693 11/29/16 ............453316 12/21/16 ............456016 -- 5 of 5 --