Pershing General Hospital And Nursing Home Lab

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review, conducted off-site for your laboratory on January 8, 2025. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 the findings herein, the Condition: Successful Participation (in a proficiency testing program) was not met. A review of the federal database CASPER Report 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 -- 0155D and the American Proficiency Institute (API) proficiency testing (PT) evaluation forms on January 8, 2025 found that the laboratory failed to successfully participate in a proficiency testing program. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for compatibility testing in the second PT event of 2024 and for the third PT event of 2024. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory for 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 a review of the federal database CASPER Report 0155D, the American Proficiency Institute (API) proficiency testing (PT) evaluation forms on January 8, 2025 and an email with the laboratory supervisor, the laboratory failed to successfully participate in a proficiency testing program. Findings include: 1. The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for compatibility testing in the second PT event of 2024 and for the third PT event of 2024. 2. An email correspondence from the laboratory supervisor on December 13, 2024, revealed that the laboratory failed to submit the PT results for this event. 3. Both the CASPER Report 0155D and the API PT evaluation reported a score of 80% for the second PT event of 2024 and 0% for the third PT event of 2024. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the findings herein, the Condition: Laboratories Performing High Complexity Testing; Laboratory Director was not met. A review of the federal database CASPER Report 0155D and the American Proficiency Institute (API) proficiency testing (PT) evaluation forms on January 8, 2025 found that the laboratory director failed to ensure successful participation in a proficiency testing program. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) 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 federal database CASPER Report 0155D, the American Proficiency Institute (API) proficiency testing (PT) evaluation forms on January 8, -- 2 of 3 -- 2025 and an email with the laboratory supervisor, the laboratory director failed to ensure successful participation in a proficiency testing program. Findings include: 1. The laboratory director failed to ensure successful participation with the API PT program shown by the unsuccessful performance for compatibility testing in the second PT event of 2024 and third PT event 2024. 2. Both the CASPER Report 0155D and the API PT evaluation reported a score of 80% for the second PT event of 2024 and 0% for the third PT event of 2024. 3. An email correspondence from the laboratory supervisor on December 13, 2024, revealed that the laboratory failed to submit the PT results for this event. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification and change of director survey conducted at your facility on November 19-20, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(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 federal database CASPER Report 0155D and American Proficiency Institute (API) proficiency testing (PT) performance summary, the laboratory failed to return PT results to API. Findings include: 1. The laboratory failed to return the results for the first event of 2023 for general immunology to API, resulting in a score of 0 for the testing event. 2. These findings are documented in the CASPER Report 0155D and the API performance summary for the first immunology PT event of 2023. 3. These findings were confirmed by the laboratory director 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 5 -- laboratory manager in an interview at approximately 3:00 PM on November 19, 2024. The laboratory performs approximately 24 general immunology waived tests annually. D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(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 federal database CASPER Report 0155D and American Proficiency Institute (API) proficiency testing (PT) performance summary, the laboratory failed to return PT results to API. Findings include: 1. The laboratory failed to return the results for the first event of 2023 for ABO group and D (Rho) typing to API, resulting in a score of 0 for the testing event. 2. These findings are documented in the CASPER Report 0155D and the API performance summary for the first ABO group and D (Rho) typing PT event of 2023. 3. These findings were confirmed by the laboratory director and laboratory manager in an interview at approximately 3:00 PM on November 19, 2024. The laboratory performs approximately 83 immunohematology tests annually. D2165 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(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 a review of federal database CASPER Report 0155D and American Proficiency Institute (API) proficiency testing (PT) performance summary, the laboratory failed to return PT results to API. Findings include: 1. The laboratory failed to return the results for the first event of 2023 for unexpected antibody detection to API, resulting in a score of 0 for the testing event. 2. These findings are documented in the CASPER Report 0155D and the API performance summary for the first unexpected antibody detection PT event of 2023. 3. These findings were confirmed by the laboratory director and laboratory manager in an interview at approximately 3:00 -- 2 of 5 -- PM on November 19, 2024. The laboratory performs approximately 83 immunohematology tests annually. D2174 COMPATIBILITY TESTING CFR(s): 493.863(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 a review of federal database CASPER Report 0155D and American Proficiency Institute (API) proficiency testing (PT) performance summary, the laboratory failed to return PT results to API. Findings include: 1. The laboratory failed to return the results for the first event of 2023 for compatibility testing to API, resulting in a score of 0 for the testing event. 2. These findings are documented in the CASPER Report 0155D and the API performance summary for the first compatibility testing PT event of 2023. 3. These findings were confirmed by the laboratory director and laboratory manager in an interview at approximately 3:00 PM on November 19, 2024. The laboratory performs approximately 83 immunohematology tests annually. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the laboratory 2023 and 2024 American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the laboratory manager and the laboratory director, the laboratory failed to ensure that the results that were not graded by the proficiency testing agency were evaluated and documented. Findings include: 1. A review of API PT evaluations and laboratory PT documentation for 2023 and 2024 revealed that the director failed to review the ungraded results for hematology/coagulation for the first PT events of 2023 and 2024. 2. A review of API PT evaluations and laboratory PT documentation for 2023 and 2024 revealed that the director failed to review the ungraded results for the first chemistry core event in 2024. 3. These findings were confirmed by the laboratory director and laboratory manager in an interview at approximately 3:00 PM on November 19, 2024. The laboratory performs approximately 26,440 hematology and 45,244 chemistry tests annually. -- 3 of 5 -- 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 the American Proficiency Institute (API) Proficiency Testing (PT) evaluations, lack of laboratory documentation, and an interview with the laboratory director and laboratory manager, the laboratory failed to verify the accuracy of cardiac marker, D-Dimer, at least twice a year. Findings include: 1. A review of the API PT evaluations for cardiac marker, D-Dimer, revealed that the instrument was out of service on the first and third testing events in 2023. 2. The laboratory was unable to provide evidence that an additional verification of accuracy had been performed during 2023. 3. These findings were confirmed by the laboratory director and laboratory manager in an interview at approximately 3:00 PM on November 19, 2024. The laboratory performs approximately 45,244 chemistry tests annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, a review of the ORTHO Confidence System package insert, a review of the blood bank quality control records, and an interview with the laboratory manager, the laboratory personnel failed to follow the director approved procedures. Findings include: 1. The laboratory's policy titled, "Quality Control Using ORTHO Confidence," states the required materials will be stored and used according to the manufacturer's instructions. 2. The ORTHO Confidence System package insert states to "Record results on the laboratory daily work sheet or ORTHO Confidence System Blood Bank Quality Control Record sheet." 3. A review of the blood bank quality control records from January 2023 to November 2024 which had been documented on ORTHO Confidence System Blood Bank Quality Control Record sheet, found that the following dates were not documented on the quality control record sheet, 4/18/2024, 5 /26/2024, 6/14/2024, 7/6/2024, 7/10/2024, 7/12/2024, 7/26/2024. 4. The control results for the above dates were documented on the Transfusion Service Log. No lot numbers or expiration dates were included with this documentation. 5. These findings were confirmed by the laboratory manager in an interview at approximately 12:00 PM on November 20, 2024. The laboratory performs approximately 83 immunohematology tests annually. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually -- 4 of 5 -- after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on a review of the roster provided on the CMS-209 form, a review of the annual competency assessments, and an interview with the laboratory director and laboratory manager, the technical supervisor failed to ensure that Testing Personnel number three (TP3) on the CMS-209 had documented annual competency assessments for 2023 and 2024. Findings include: 1. A review of the competency assessments for the testing personnel listed on the CMS-209 form found that there were no annual competency assessments in 2023 and 2024 for TP3. 2. These findings were confirmed by the laboratory director and laboratory manager in an interview at approximately 3:00 PM on November 19, 2024. The laboratory performs approximately 79,780 tests annually. -- 5 of 5 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of patient test reports, instrument print-outs, and an interview with the laboratory manager, the laboratory failed to establish and follow policies and procedures to ensure positive identification and optimum integrity of the patient specimens from the time of collection through the completion of testing and reporting of results. Findings include: 1. Review of SARS-CoV-2 patient test reports and instrument print-outs of testing results from 1/15/2023 through 1/31/2023 revealed that two of nine positive patient specimens been tested prior to the collected and received dates documented by the laboratory in the patient test reports. 2. The SARS- CoV-2 patient test results with a corrected report date of 1/23/2023 for the patient with initials AM were reviewed. The test report revealed that the order date was 1/17 /2023 8:04 PM and the "collected and rec'd" dates and times were 1/18/2023 at 9:02 AM. 3. Review of the instrument print-outs revealed that the specimen for patient AM had been tested on 1/17/2023 at 5:50 PM. 4. The SARS-CoV-2 patient test results reported on 1/20/2023 for the patient with initials FT were reviewed. The test report revealed that the order date was 1/19/2023 3:59 PM and the "collected and rec'd" dates and times were 1/20/2023 3:23 PM. 5. Review of the instrument print-outs revealed that the specimen for patient FT had been tested on 1/20/2023 at 2:58 PM. 6. The laboratory manager confirmed these findings in an interview on 2/1/2023 at approximately 1:30 PM. The laboratory manager indicated that due to stability the specimens were tested prior to the requisition being generated in the laboratory information system due to the lack of personnel in the departments ordering these 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 -- tests. They indicated that the remaining information and the results entry was completed once the requisition became available. The laboratory performs 6,023 SARS-CoV-2 tests annually. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on observation, review of the Allegation of Compliance (AOC) for the Statement of Deficiencies (SOD) issued 12/16/2022, review of patient test reports, and interview with the laboratory manager during the follow-up visit to assess the Allegation of Compliance for the survey completed 12/6/2022, the laboratory failed to ensure that a system was in place to promptly issue corrected reports to the authorized person ordering the test. Findings include: 1. The laboratory failed to issue the corrected Prothrombin Time (PT)/ International Normalized Ratio (INR) report for patient LW promptly. The report with the incorrect PT/INR was originally reported on 12/6/2022. The corrected results were determined on 12/20/2023 when the correct ISI value was used to determine the PT/INR. The corrected report was issued on 2/1 /2023. 2. Observation of the ISI value on the Sysmex CA-600 coagulation testing instrument on 12/6/2022 revealed that an incorrect ISI value of 1.04 was being used. The correct ISI value was 1.07. One patient had been tested on 12/6/2022 using the incorrect ISI value. 3. Review of the AOC for the SOD issued 12/16/2022 revealed that the PT/INR results for patient with initials LW were originally reported as 28.6 and 2.5. Upon investigation on 12/20/2022 the laboratory found that the results were incorrectly calculated, and the correct values were 27.8 and 2.44 for PT and INR respectively. 4. When we requested a corrected report for patient LW, the laboratory submitted a copy of the report with a "CPSI addendum" that had been added to reflect these results on 2/1/2023 1400. 5. Review of the AOC for the SOD issued 12/16/2022 revealed that "once a report is archived it cannot be edited or corrected/changed. The computer system at PGH archives the reports as soon as [all the] orders are complete for an account number." 6. Review of the AOC for the SOD issued 12/16/2022 also revealed that to add verbiage as an addendum to an archived patient report, the hospital's information technology vendor, CPSI, requires the laboratory to mail a signed and notarized hard copy of the addendum to their location in Alabama, prior to issuance of the appended report. 7. The laboratory manager confirmed these findings in an interview on 2/1/2023 at approximately 2:00 PM. The laboratory performs approximately 48798 hematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the onsite special survey for SARS-CoV-2 test reporting requirements conducted at your facility on 12/6/2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of Division records, a sample survey of patient test results from October 1, 2022 to December 6, 2022, log of reported SARS-Co-V-2 positive results, and interview with the laboratory manager, the Condition: Facility Administration was not met. The laboratory failed to report SARS-CoV-2 (COVID-19) test results as required. Findings include: 1. 1. Division records revealed that the laboratory had begun performing SARS-CoV-2 testing on 12/17/2020 using Abbott ID Now SARS- CoV-2 PCR testing and BinaxNOW COVID-19 antigen testing. 2. The SARS-CoV-2 patient test result log was reviewed from October 2022 through December 6, 2022. 3. The log of reported SARS-CoV-2 results from 12/1/2022 to 12/8/2022 submitted by Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- the laboratory manager revealed that positive test results were not reported as required for patient with initials TD tested on 11/25/2022, patient with initials EH tested on 12 /1/2022, and patient with initials LM tested on 12/2/2022. 4. The laboratory was unable to provide documentation that the postive test result was reported as required for patient with initials GB tested on 10/6/2022. 5. In an interview with the laboratory manager at approximately 5:15 PM on 12/6/2022, she confirmed these findings and stated that she was unable to access a comprehensive report of SARS-CoV-2 results that had been reported as required. The laboratory performs 6,023 SARS-CoV-2 tests annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute Proficiency Testing (PT) evaluation, the laboratory's PT documentation and an interview with the laboratory manager, the laboratory failed to ensure that

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 12/6/2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of Division records, a sample survey of patient test results from October 1, 2022 to December 6, 2022, log of reported SARS-Co-V-2 positive results, and interview with the laboratory manager, the Condition: Facility Administration was not met. The laboratory failed to report SARS-CoV-2 (COVID-19) test results as required. Findings include: 1. 1. Division records revealed that the laboratory had begun performing SARS-CoV-2 testing on 12/17/2020 using Abbott ID Now SARS- CoV-2 PCR testing and BinaxNOW COVID-19 antigen testing. 2. The SARS-CoV-2 patient test result log was reviewed from October 2022 through December 6, 2022. 3. The log of reported SARS-CoV-2 results from 12/1/2022 to 12/8/2022 submitted by Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- the laboratory manager revealed that positive test results were not reported as required for patient with initials TD tested on 11/25/2022, patient with initials EH tested on 12 /1/2022, and patient with initials LM tested on 12/2/2022. 4. The laboratory was unable to provide documentation that the postive test result was reported as required for patient with initials GB tested on 10/6/2022. 5. In an interview with the laboratory manager at approximately 5:15 PM on 12/6/2022, she confirmed these findings and stated that she was unable to access a comprehensive report of SARS-CoV-2 results that had been reported as required. The laboratory performs 6,023 SARS-CoV-2 tests annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute Proficiency Testing (PT) evaluation, the laboratory's PT documentation and an interview with the laboratory manager, the laboratory failed to ensure that

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 11/09/2020. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. 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 -- This STANDARD is not met as evidenced by: Based on review of calibration verification documentation and interview with the laboratory manager, the laboratory failed to perform calibration verification for CK- MB, troponin, myoglobin, and d-dimer on the Triage for 2019 and 2020. Findings include: Review of the calibration verification documentation for the laboratory instrumentation revealed there was no documentation of the calibration verification performed every six months for the Triage CK-MB, troponin, myoglobin, and d-dimer for 2019 and 2020. The laboratory manager interviewed during the on-site inspection on 11/09/2020 at approximately 11:00 PM confirmed the findings. The laboratory performs approximately 37,857 chemistry and 32,306 hematology tests annually. 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

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review, conducted off-site for your laboratory on 1/09/2020. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 self-reporting by the laboratory manager on 12/20/2019 of the laboratory's failure to submit the proficiency testing (PT) results before the deadline to the 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 -- American Proficiency Institute (API) PT program and PT desk review of CASPER Report 155D and the API PT evaluation report, the laboratory did not successfully participate in a proficiency testing program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two out of three testing events for the second testing event of 2018 with a score of 0% and the first testing event of 2019 with a score of 60% and a subsequent failure for the third testing event of 2019 with a score of 0%, resulted in unsuccessful proficiency testing performances for Blood Cell Identification. Findings include: The laboratory failed to maintain successful participation with the API PT program, shown by the subsequent unsuccessful performance for Blood Cell Identification, Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on self-reporting by the laboratory manager on 12/20/2019 of the laboratory's failure to submit the proficiency testing (PT) results before the deadline to the American Proficiency Institute (API) PT program and PT desk review of CASPER Report 155D and the API PT evaluation report, the laboratory did not successfully participate in a proficiency testing program for Blood Cell Identification. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two out of three testing events for the second testing event of 2018 with a score of 0% and the first testing event of 2019 with a score of 60% and a non- initial (subsequent) failure for the third testing event of 2019 with a score of 0% for the same test, resulted in unsuccessful proficiency testing performances. Findings include: Review of CASPER Report 155D and the API PT evaluation report revealed the laboratory failed to maintain successful participation with the API PT program, shown by subsequent unsuccessful performance for Blood Cell Identification. 1. An unsatisfactory score of 0% was obtained for Blood Cell Identification in the second PT event of 2018. 2. An unsatisfactory score of 60% was obtained for Blood Cell Identification in the first PT event of 2019, constituting the first unsuccessful PT performance (two out of three consecutive testing events). 3. An unsatisfactory score of 0% was obtained for Blood Cell Identification in the third PT event of 2019, constituting a subsequent unsuccessful PT performance. 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 self-reporting by the laboratory manager on 12/20/2019 of the laboratory's failure to submit the proficiency testing (PT) results before the deadline to the American Proficiency Institute (API) PT program for hematology and coagulation and PT desk review of CASPER Report 155D and the API PT evaluation report, the -- 2 of 3 -- Condition: Laboratories Performing Moderate Complexity Testing: Laboratory Director was not met. The laboratory director failed to provide overall management and direction in accordance with CFR 493.1407. Findings include: The laboratory director failed to ensure that the laboratory successfully participated in a PT program approved by CMS; as described in subpart 1 of this part for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. Refer to 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 self-reporting by the laboratory manager on 12/20/2019 of the laboratory's failure to submit the proficiency testing (PT) results before the deadline to the American Proficiency Institute (API) PT program for hematology and coagulation and PT desk review of CASPER Report 155D and the API PT evaluation report, the laboratory director failed to ensure that PT samples were tested as required under Subpart H. Findings include: Review of CASPER Report 155D and the API PT evaluation report revealed the laboratory failed to achieve satisfactory performance for Blood Cell Identification in the second testing event of 2018 with a score of 0%, first testing event of 2019 with a score of 60%, and the third testing event of 2019 with a score of 0%, resulting in a subsequent unsuccessful PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review, conducted off-site for your laboratory on 7/10/19. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 federal database CASPER Report 155D and American Proficiency Institute (API) proficiency testing (PT) evaluation forms, the laboratory 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 -- did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two out of three testing events for the second testing event of 2018 and the first testing event of 2019 with a score of 0% and 60%, respectively, resulted in unsuccessful proficiency testing performance for blood cell identification. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for blood cell identification in the second testing event of 2018 and the first testing event of 2019. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 federal database CASPER Report 155D and American Proficiency Institute (API) proficiency testing (PT) evaluation forms, the laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two out of three testing events for the second testing event of 2018 and the first testing event of 2019 with a score of 0% and 60%, respectively, resulted in unsuccessful proficiency testing performance for blood cell identification. Findings include: 1. The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for blood cell identification in the second testing event of 2018 and the first testing event of 2019. 2. CASPER Report 155D and the API PT evaluation both reported scores of 0% for the second testing event of 2018 and 60% for the first testing event of 2019 for blood cell identification. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of federal database CASPER Report 155D and American Proficiency Institute (API) proficiency testing (PT) evaluation forms, the Condition: Laboratories Performing High Complexity Testing: Laboratory Director was not met. The laboratory director failed to provide overall management and direction in accordance with CFR 493.1445. Findings include: The laboratory director failed to ensure that the laboratory successfully participated in a PT program approved by CMS; as described in subpart 1 of this part for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on desk review of federal database CASPER Report 155D and American Proficiency Institute (API) proficiency testing (PT) evaluation forms, the laboratory director failed to ensure that proficiency testing samples were tested as required. Findings include: 1. The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for blood cell identification in the second testing event of 2018 and the first testing event of 2019. 2. CASPER Report 155D and the API PT evaluation both reported scores of 0% for the second testing event of 2018 and 60% for the first testing event of 2019 for blood cell identification. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on September 18, 2018. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2127 HEMATOLOGY CFR(s): 493.851(d) 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 review of the American Proficiency Institute (API) Performance Summary and interview with the laboratory manager, the laboratory failed to return proficiency testing (PT) results to API within the time frame specified by the program in the second testing event of 2018 for hematology resulting in unsatisfactory performance. Findings include: 1. Review of the Performance Summary from API showed the laboratory scored 0% for hematology for failure to participate in the second testing event of 2018. 2. The laboratory manager indicated during the on-site survey on 9/18 /18 at approximately 3:00 PM that the PT test results were not submitted to API before the deadline. The laboratory performs approximately 32,306 hematology tests annually. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the federal database CASPER Report 155D, American Proficiency Institute (API) Performance Summary, and interview with the laboratory manager, the laboratory failed to score at least 100 percent for ABO Group typing resulting in unsatisfactory analyte performance for the first event of 2018. Findings include: 1. Review of the federal database CASPER Report 155D and the Performance Summary from API showed the laboratory scored 80% for ABO Group typing for the first event of 2018. 2. The laboratory manager confirmed the finding during the on-site survey on 9/18/18 at approximately 3:00 PM. The laboratory performs approximately 23 ABO & Rh Group typing 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 federal database CASPER Report 155D, American Proficiency Institute (API) Performance Summary, and interview with the laboratory manager, the laboratory failed to score at least 100 percent for Compatibility Testing resulting in unsatisfactory analyte performance for the first event of 2018. Findings include: 1. Review of the federal database CASPER Report 155D and the Performance Summary from API showed the laboratory scored 80% for Compatibility Testing for the first event of 2018. 2. The laboratory manager confirmed the finding during the on-site survey on 9/18/18 at approximately 3:00 PM. The laboratory performs approximately 14 Compatibility Tests annually. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the API Comparitive Evaluation for the first event of 2018 and interview with the laboratory manager, the laboratory failed to verify the accuracy of Blood Cell Identification results which were not graded. Findings include: 1. Review of the API Comparitive Evaluation for the first event of 2018 for hematology revealed that the ungraded Blood Cell Identification results were not evaluated and the Data Summary sheet was not reviewed to verify the accuracy of the results. 2. The laboratory manager interviewed during the on-site survey on 9-18-18 at approximately 3:00 PM indicated that proficiency test results that were not graded were not evaluated for accuracy. The laboratory performs approximately 32,306 hematology results annually. -- 2 of 6 -- 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 the Wellness Tuesdays information sheet and interview with the laboratory manager, the laboratory failed to have a written request for patient testing from an authorized person. Findings include: The laboratory manager interviewed during the on-site survey on 9/18/18 at approximately 4:30 PM indicated that patient specimens were tested on Wellness Tuesdays on the third Tuesday of each month without orders from a person authorized under State law to order tests or receive test results. The patients came in for testing and ordered the tests themselves. The test menu included: Comprehensive Metabolic Panel, Lipid Panel, Complete Blood Count, Hemoglobin A1c, Thyroid Stimulating Hormone (TSH), and Prostate Specific Antigen (PSA). The laboratory performs approximately 37,857 chemistry and 32,306 hematology tests annually. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to perform quality control tests with two control materials of different concentrations each day patient specimens are assayed for the Triage d-dimer test. Findings include: 1. The laboratory's procedure manual and the Triage manufacturer's d-dimer instructions stated that external quality controls are tested with each new lot number of devices and every 30 days thereafter if the same lot number is in use. There was no Individualized Quality Control Plan (IQCP) established and approved for the Triage d-dimer test to validate the laboratory's quality control procedure. 2. The laboratory manager interviewed during the on-site survey on 9/18/18 from 10:00 AM to 5:30 PM confirmed that quality controls for the Triage d-dimer test were not performed each day patient specimens were tested and no IQCP was established and approved for this test. The laboratory performs approximately 32,306 hematology tests annually. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document -- 3 of 6 -- all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, review of laboratory records and interview with the laboratory manager, the laboratory failed to perform quarterly blood bank refrigerator alarm checks as specified by internal policy. Findings include: 1. Review of the laboratory procedure for blood bank refrigerator alarm checks stated that alarm checks were to be conducted quarterly. 2. Records reviewed showed that alarm checks were not conducted in 2018 and one due in November 2017 was not conducted. 3. The laboratory manager interviewed during the on-site inspection on 9 /18/18 confirmed the findings at approximately 11:30 AM. 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. This STANDARD is not met as evidenced by: Based on review of laboratory instrument correlation records and interview with the laboratory manager, the laboratory failed to perform comparison studies for the d- dimer test performed on the Sysmex CA 600 coagulation analyzer and the Triage meter and the white blood cell differential performed manually and on the AcT 5 Diff hematology analyzer. Findings include: 1. Review of the instrument correlation records revealed that twice a year comparison studies for the d-dimer tested on the Sysmex CA 600 and the Triage meter were not conducted for 2016, 2017, and 2018. 2. Review of the correlation records for the AcT 5 Diff hematology analyzer and the manual white blood cell differential revealed that there were no records for the twice a year comparison studies for 2018. 3. The laboratory manager confirmed the findings during the on-site survey on 9/18/18 at approximately 1:00 PM. The laboratory performs approximately 32,306 hematology tests annually. 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 of laboratory personnel training and competency records and interview with the laboratory manager, the technical consultant failed to evaluate and document training and compentency of the specialty medical technician performing moderate complexity tests at least semiannually during the first year the individual began testing patient specimens. Findings include: 1. The training and competency records reviewed for the specialty medical technician did not have his semi-annual competency assessment during the first year he began testing patient specimens. His -- 4 of 6 -- initial assessment was performed in April 2015 and his next competency assessment was performed in October 2016. 2. The laboratory manager confirmed the finding during the on-site survey on 9/18/18 at approximately 3:30 PM. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of API proficiency test evaluations, procedure manual, laboratory records, laboratory personnel records, and interview with the laboratory manager, the laboratory director failed to ensure that the quality assessment program was maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. Findings include: 1. The quality assessment program failed to assure that the laboratory submitted proficiency test (PT) results to API prior to the deadline. 2. The quality assessment program failed to assure that the laboratory evaluated ungraded PT results for accuracy to identify any problems that require