Cooper Institute Reproductive Laboratory

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 the review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report from 2023 to 2024, the AAB-MLE proficiency testing policy, the proficiency testing results in 2023, and confirmed in an interview, the laboratory failed to self-evaluate missing proficiency testing event for 6 of 6 analytes. The findings were: 1. Review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report from 2023 to 2024 revealed the laboratory did not receive grades from 2nd event in 2023. 2. Review of the AAB-MLE proficiency testing policy titled AAB-MLE Proficiency Testing Service Evaluating Your Proficiency Testing Results revealed "II. If PT results for any analytes are unsatisfactory:...C. If any of the above appear to be the reason for the PT problems: 1. Document the cause and the

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D2017 - 42 C.F.R. 493.807 Reinstatement After Failure D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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: 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 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company American Association of Bioanalysts (AAB), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Endocrinology for the analyte Thyroxine (TY). (Refer to D2107) D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing records from American Association of Bioanalysts (AAB), it was determined the laboratory had not successfully participated in proficiency testing for the analyte Thyroxine under the specialty of Endocrinology for 3 of 3 testing events and has not demonstrated sustained satisfactory performance on two consecutive proficiency events since the unsuccessful scores. Findings include: 1. Chemistry Q1 2021 first event the laboratory received an unsatisfactory score of 0% for the analyte Thyroxine 2. Chemistry Q2 2021 second event the laboratory received an unsatisfactory score of 0% for the analyte Thyroxine. * The 2021 first event and 2021 second event resulted in initial unsuccessful proficiency testing performance. 3. Chemistry Q3 2021 third event the laboratory received an unsatisfactory score of 0% for the analyte Thyroxine. * The 2021 third event constituted non-initial unsuccessful proficiency testing performance. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing -- 2 of 3 -- records from American Association of Bioanalysts (AAB), it was revealed the laboratory failed to achieve satisfactory performance for the analyte Thyroxine for 3 of 3 events in 2021. Findings include: 1. A review of the laboratory's AAB proficiency test results revealed the laboratory received an unacceptable score of 0% for the analyte TY (Thyroxine) for the following 3 events: - Chemistry Q1 2021 first event - Chemistry Q2 2021 second event - Chemistry Q3 2021 third event 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 a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. (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 a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. (Refer to D2107) -- 3 of 3 --

Summary Statement of Deficiencies 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 a review of the Letter of Authorization, a random review of patient test records from September 2020 to April 2021, and staff interview, it was revealed that the laboratory failed to have documentation of reporting SARS-CoV-2 test results as required for 3 of 3 patients whose specimens were run using the Elecsys Anti-SARS- CoV-2 immunoassay from September 2020 to April 2021. Findings include: 1. A review of the Letter of Authorization for the Elecsys Anti-SARS-CoV-2 immunoassay (dated November 25, 2020) revealed the following: "Authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and public health authorities, as appropriate." 2. A random review of patient test records from September 2020 to April 2021 revealed the laboratory failed to have documentation of reporting SARS-CoV-2 test results as required for the following 3 patients: Patient ID: HT Run: 3/26/21 SARS-CoV-2 test result: non-reactive (negative) Patient ID: SM Run: 4/2/21 SARS-CoV-2 test result: non-reactive (negative) Patient ID: DL Run: 4/7/21 SARS-CoV-2 test result: reactive (positive) 4. 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 -- An interview with the laboratory director on 4/22/21 at 1:00 p.m. in the break room, after review of the records, confirmed he was unaware that the laboratory was required to report SARS-CoV-2 test results. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the American Association of Bioanalysts (AAB) attestation forms, a review of the laboratory's AAB proficiency testing records from 2019 and 2021, and staff interview, it was revealed that the laboratory failed to have documentation of the laboratory director or designee signing 4 of 7 attestation statements for 2019 and 2021. Findings include: 1. A review of the AAB attestation form revealed the following: "In addition to the analysts' signature, one of the following must sign once for all analytes reported on this form: Director, Technical Consultant, or Technical Supervisor." 2. A review of the laboratory's AAB proficiency testing records from 2019 and 2021 revealed the following 4 events were missing the laboratory director or designee's signature on the attestation forms: - Q3 Chemistry 2019 (third event) - Q2 Chemistry 2019 (second event) - Q1 Chemistry 2021 (first event) - Q1 Nonchemistry 2021 (first event) 3. An interview with laboratory director on 4/21/21 at 12:15 p.m. in the break room, after review of the records, confirmed the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- 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 a review of the American Association of Bioanalysts (AAB) website, a review of the laboratory's AAB proficiency testing records for 2019 and 2020 and staff interview, it was revealed that the laboratory failed to have documentation of verifying the accuracy of analytes that were not graded by the proficiency testing program for 4 of 4 events in 2019 and 2020. Findings include: 1. A review of the Frequently Asked Questions section found on the AAB website (https://www.aab-pts. org/faq#4) stated the following: " ? = This score may not truly evaluate performance for this specimen which was not graded because of a lack of participant consensus. You have received a default score of 100 for this sample because our statistical checks indicated your group was not valid. If you are outside the given acceptable range, you either need to justify why this range is not appropriate or treat this as a miss requiring

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D2017 - 42 C.F.R. 493.807 (a) - Reinstatement After Failure D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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: 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 -- Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2018-2020, it was determined the laboratory has not successfully participated in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the analyte Human chorionic gonadotropin (hCG). D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory had not successfully participated in proficiency testing for the satisfactory performance in the specialty of Endocrinology for the analyte Human chorionic gonadotropin (hCG) for 3 of 3 consecutive testing events in 2020. Three out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for subspecialty of Endocrinology for the 2020 AAB Chemistry 1st, 2nd, and 3rd events. 2. A proficiency desk review of the AAB proficiency testing records from 2019-2020 confirmed that the laboratory received an Endocrinology score of 0% for the 2020 AAB Chemistry 1st, 2nd, and 3rd events. 3. The laboratory must demonstrate sustained satisfactory performance (>/= 80%) on two consecutive testing events for reinstatement. 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to -- 2 of 5 -- achieve satisfactory performance (80% or greater) for the Human chorionic gonadotropin (hCG) analyte in 3 of 3 consecutive testing events. Findings were: 1. A review of the CMS (Center for Medicare Services) national database from 2020 revealed the laboratory received a score of '0' for HCG for 3 of 3 events. 2020 AAB 1st event 2020 AAB 2nd event 2020 AAB 3rd event 2. A proficiency desk review of the AAB proficiency testing records from 2019-2020 confirmed the laboratory received a score of '0' for hCG for 3 of 3 events. 2020 AAB 1st event 2020 AAB 2nd event 2020 AAB 3rd event 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed that the laboratory failed to attain an overall testing event score of at least 80 % for 3 of 3 Endocrinology events which constitutes unsatisfactory performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for Endocrinology on the 1st, 2nd, and 3rd events of 2020 for this facility. 2. A proficiency desk review of AAB proficiency testing records for 2019-2020 revealed the facility to attain an overall testing event score of at least 80 % for 3 of 3 Endocrinology events in 2020. 2020 AAB 1st event - 0% 2020 AAB 2nd event - 0% 2020 AAB 3rd event - 0% D2100 ENDOCRINOLOGY CFR(s): 493.843(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2019 - 2020, it was revealed that the laboratory failed to participate in the 1st, 2nd, and 3rd endocrinology events of 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the subspecialty of endocrinology on the 1st, 2nd and 3rd events of 2020 for this facility. 2. A review of AAB proficiency test records revealed the laboratory received a 0% for the subspecialty of endocrinology for the 1st, 2nd, and 3rd events in 2020 for -- 3 of 5 -- "Failure to Participate." The PT summary was rated by the provider as unsatisfactory performance for all analytes for testing events 2020-1; 2020-2; and 2020-3 endocrinology. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to achieve satisfactory performance (80% or greater) for the HCG (Human chorionic gonadotropin) analyte in 3 of 3 consecutive testing events in 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" in 3 of 3 consecutive testing events for the HCG analyte in 2020. 2020 AAB 1st Chemistry event 2020 AAB 2nd Chemistry event 2020 AAB 3rd Chemistry event 2. A proficiency desk review of the AAB proficiency testing records from 2019-2020 confirmed that the laboratory received an endocrinology score of 0% in 3 of 3 consecutive testing events for the HCG analyte in 2020. 2020 AAB 1st Chemistry event 2020 AAB 2nd Chemistry event 2020 AAB 3rd Chemistry event D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance 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 CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for 3 of 3 consecutive testing events for the subspecialty of Endocrinology in 2020. Three out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for subspecialty of Endocrinology for the 2020 AAB Chemistry 1st, 2nd, and 3rd events. 2. A proficiency desk review of the AAB proficiency testing records from 2019-2020 confirmed that the laboratory received an Endocrinology score of 0% for the 2020 AAB Chemistry 1st, 2nd, and 3rd events. 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 -- 4 of 5 -- with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Findings were: 1. A review of the laboratory proficiency testing results revealed that the laboratory director failed to ensure that the laboratory participated successfully. (refer to D6016) By not providing overall management and direction of the laboratory, the laboratory director could not ensure the accuracy or reliability of all laboratory services provided by the facility. 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 proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an approved proficiency testing program. (refer to D2108, D2107) -- 5 of 5 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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 a review of the CMS (Center for Medicare Services) national database and a 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 -- proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2018-2020, it was determined the laboratory has not successfully participated in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the analyte Human chorionic gonadotropin (hCG). 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to achieve satisfactory performance (80% or greater) for the Human chorionic gonadotropin (hCG) analyte in 2 of 3 consecutive testing events. Findings were: 1. A review of the CMS (Center for Medicare Services) national database revealed the laboratory received a score of '0' for HCG. 2020 AAB 1st event 2020 AAB 2nd event 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020 confirmed the laboratory received a score of '0' for hCG. 2020 AAB 1st event 2020 AAB 2nd event 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed that the laboratory failed to attain an overall testing event score of at least 80 % for 2 of 3 Endocrinology events which constitutes unsatisfactory performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for Endocrinology on the 1st and 2nd events of 2020 for this facility. 2. A proficiency desk review of proficiency testing records for 2019-2020 revealed the facility to attain an overall testing event score of at least 80 % for 2 of 3 Endocrinology events. 2020 AAB 1st event - 0% 2020 AAB 2nd event - 0% D2100 ENDOCRINOLOGY CFR(s): 493.843(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 -- 2 of 4 -- within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019 - 2020, it was revealed that the laboratory failed to participate in the 1st and 2nd endocrinology events of 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the subspecialty of endocrinology on the 1st and 2nd events of 2020 for this facility. 2. A review of AAB PT records revealed the laboratory received a 0% for the subspecialty of endocrinology for the 2020-1st Chemistry and 2020-2nd event PT for "Failure to Participate." The PT summary was rated by the provider as unsatisfactory performance for all analytes for testing events 2020-1 and 2020-2 endocrinology. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to achieve satisfactory performance (80% or greater) for the HCG (Human chorionic gonadotropin) analytes in 2 of 3 consecutive testing events. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" in 2 of 3 consecutive testing events for the HCG analyte. 2020 AAB 1st Chemistry event 2020 AAB 2nd Chemistry event 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020 confirmed that the laboratory received an endocrinology score of 0% in 2 of 3 consecutive testing events for the HCG analyte. 2020 AAB 1st Chemistry event 2020 AAB 2nd Chemistry event D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance 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 CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for 2 of 3 consecutive testing events for the subspecialty of Endocrinology. Two out of three -- 3 of 4 -- overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for subspecialty of Endocrinology for the 2020 AAB Chemistry 1st and 2nd events. 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020 confirmed that the laboratory received an Endocrinology score of 0% for the 2020 AAB Chemistry 1st and 2nd events. 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 a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Findings were: 1. A review of the laboratory proficiency testing results revealed that the laboratory director failed to ensure that the laboratory participated successfully. (refer to D6016) By not providing overall management and direction of the laboratory, the laboratory director could not ensure the accuracy or reliability of all laboratory services provided by the facility. 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 proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an approved proficiency testing program. (refer to D2108, D2107) -- 4 of 4 --