New England Urology

Summary Statement of Deficiencies D0000 A CLIA paper desk review of proficiency testing was conducted for the the New England Urology laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Based on evidence of unsuccessful proficiency testing performance for the subspecialty area of Bacteriology, the following Condition level deficiency was deemed to be not met: Condition 42 CFR 493.803 - Proficiency Testing - Successful Participation. . 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 proficiency testing review for calendar years 2022 and 2023, (three testing events), the laboratory failed to successfully participate (achieve a score of 80 percent 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 -- or more) in a proficiency testing program for the subspecialty of Bacteriology . The laboratory achieved a score for Bacteriology of zero (0) percent (failure to participate - refer to D2021) for the second testing event of 2022 and the first testing event of 2023. . D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: . Based on American Proficiency institute (API) proficiency testing record review on 4 /4/23 for calendar years 2022 and 2023 (three testing events) and interview, the laboratory failed to participate in the second testing event of 2022 as well as the first testing event of 2023 for the subspecialty area of Bacteriology resulting in unsatisfactory performance and a score of zero (0) percent for each of the two testing events. The technical consultant confirmed in an email on 4/4/23 that the laboratory had stopped testing due to lack of personnel. However, this notification to the State agency was after the issuance of scores by the proficiency testing provider and there was no prior to notification to the state agency regarding cessation of Bacteriology testing. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the New England Urology laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) review and interview with Technical Consultant (TC) on 12/21/2022, the laboratory did not document and maintain a copy of all PT records as evidenced by the following: The surveyor reviewed American Proficiency Institute (API) PT records for calendar years 2021 and 2022 (6 testing events). The review revealed that signed attestation statements provided by the PT program were not available for the following events: Seven (7) out of sixteen (16) attestation statements were not signed by the analyst and the laboratory director: 1. API Chemistry Core 2021 Events 1, 2, and 3. 2. API Microbiology 2021 Events 1, 2, and 3. 3. API Chemistry Miscellaneous 2022 Event 2. The TC confirmed in an interview on 12/21/2022 at 11:00 AM that not all attestation statements were signed by the analyst and laboratory director. The laboratory performs 1000 bacteriology tests, 200 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 -- parasitology tests, 1000 general immunology tests, and 11,100 chemistry tests annually. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a record review, manufacturer's instructions, and interview with the Technical Consultant (TC) on 12/21/2022, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for two (2) of two (2) analyzers as evidenced by the following: The surveyor reviewed maintenance records for the two (2) analyzers. The review revealed the following findings: (1) On 12/21/2022 at 10:40 am, the TC stated the following: (a) Estradiol, FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), PRL (Prolactin), PSA (Prostate Specific Antigen), PTH (Parathyroid Testing Hormone), SHBG (Sex Hormone Binding Globulin), Testosterone, And Vitamin D testing were performed on the Beckman-Coulter Access II analyzer; (b) Chlamydia and Gonorrhea (CT/NG) and Trichomonas vaginalis (TV) testing were performed on the Cepheid GeneXpert analyzer. (2) On 12/21/2022, a review of the manufacturer's maintenance requirements identified the following: (a) Beckman Coulter Access 2 (i) Weekly (aa) Clean Instrument Exterior (bb) Inspect Liquid Waste Bottle (cc) Check Waste Filter Bottle (dd) Inspect/Clean Primary Probe (ee) Replace/Clean Aspirate Probes (b) Cepheid GeneXpert (i) Weekly (aa) Power Down the GeneXpert instrument (bb) Power Down the GeneXpert computer (ii) Quarterly (aa) Clean plunger rod and cartridge bays (3) A review of maintenance records between August 2021 through December 2021 revealed the following: (a) Beckman Coulter Access 2 (i) Weekly maintenance had not been documented as performed between: (aa) 08/23/2021 and 09 /07/2021 (bb) 08/17/2021 and 09/29/2021 (b) Cepheid GeneXpert (i) Weekly maintenance had not been documented as performed between: (aa) 08/12/2021 and 08 /23/2021 (bb) 09/17/2021 and 09/29/2021 (ii) Quarterly maintenance had not been documented as performed between: (aa) 06/11/2021 and 12/18/2021 The TC confirmed in an interview on 12/21/2022 at 12:04 PM that the laboratory failed to document the maintenance tasks as performed. The laboratory performs 1000 bacteriology tests, 200 parasitology tests, 1000 general immunology tests, and 11,100 chemistry tests annually. . D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be -- 2 of 3 -- established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on quality control (QC) record review and interview with Technical Consultant (TC) on 12/21/2022, the laboratory did not verify the new lot number of control material as evidenced by the following: The surveyor reviewed QC records for the Beckman-Coulter Access II Analyzer. The review revealed that the new lot numbers of control material were not verified for the Biorad Lyphocheck Immunoassay Plus Control Lot #'s 40401 and 40403 when the new lot numbers were placed in service on 11/17/2022. QC was not verified for seven (7) of the ten (10) chemistry analytes: Estradiol, FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), PRL (Prolactin), Total PSA (Prostate Specific Antigen), Free PSA (Prostate Specific Antigen), and Total Testosterone and the one (1) of one (1) immunology analyte: AFP (Alpha-Fetoprotein). The TC confirmed in an interview on 12/21/2022 at 1:20 PM that the laboratory failed to verify the new lot numbers of control material for seven (7) chemistry analytes and one (1) immunology analyte tested on the Beckman-Coulter Access II Analyzer. The laboratory performs 11,100 chemistry tests and 1,000 immunology tests annually. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: . Based on personnel competency record review and interview with the Technical Consultant (TC) on 12/21/2022, the TC failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least annually, after the first year the individual tested patient specimens as evidenced by the following: The surveyor asked for the personnel competency records for review. The review revealed that annual competency evaluations were not performed and documented at least annually for one (1) out of the one (1) newly hired testing person (TP) after the first year of performing moderate complexity testing. The TC confirmed in an interview on 12/21/2022 at 9:34 AM that the TC failed to perform and document an annual competency evaluation for one (1) of the newly hired TP's after the first year of performing moderate complexity testing. The laboratory performs 1000 bacteriology tests, 200 parasitology tests, 1000 general immunology tests, and 11,100 chemistry tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the New England Urology laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on record review and interview with the technical consultant (TC) on 7/28/21, the laboratory failed to enroll and participate in an HHS approved proficiency testing (PT) program for the General Immunology subspecialty for which it seeks certification as evidenced by the following: The surveyor reviewed American Proficiency Institute (API) PT records from calendar years 2019, 2020, and 2021on 7 /28/21. The review revealead that the laboratory did not enroll in an HHS approved PT testing program for the General Immunology subspecialty test Alpha Fetoprotein (AFP). The TC confirmed in an interview on 7/28/21 at 10:05 AM that the laboratory failed to enroll in an HHS approved PT program for General Immunology. The laboratory performs approximately 100 AFP tests annually. (Refer to D6041) . D2021 BACTERIOLOGY CFR(s): 493.823(b) 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 -- 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 record review and interview with the TC on 7/28/21, the laboratory failed to participate in PT events resulting in a score of zero (0) percent for the Bacteriology specialty. Findings include: The surveyor reviewed API PT records on 7/28/21 for calendar years 2019, 2020, and 2021. The review revealed that the laboratory failed to participate in the Bacteriology third event in 2019. The TC confirmed in an interview 7 /28/21 at 10:00 AM that the laboratory failed to participate resulting in a score of zero (0) percent for the third Bacteriology testing event in 2019. . 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 record review and interview on 7/28/21 with the TC, the laboratory failed to verify the accuracy of tests twice annually. Findings include: The surveyor reviewed API PT records for calendar years 2019, 2020, and 2021. The review revealed: 1. The laboratory was not enrolled in API PT for Sex Hormone Binding Globulin (SHBG). The laboratory failed verify the accuracy of SHBG at least twice annually in 2019, 2020, and 2021. 2. In 2019, API provided 2 testing events for Endocrinology tests. The laboratory scored 0% (Failed to Participate) in 2019 Event 2 for Estradiol, Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Parathyroid Hormone (PTH), Prolactin, Prostate Specific Antigen (PSA), and 25- hydroxyvitamin D. The laboratory failed to verify the accuracy of these tests twice annually in 2019. 3. Free Prostate Specific Antigen (PSA): The laboratory scored 67% in 2019 Event 1 and 0% 2019 Event 2 (Failed to Participate). The laboratory failed to verify the accuracy of PSA twice annually in 2019. 4. Parathyroid Hormone (PTH): The laboratory scored 50% in 2020 Event 1, 0% in 2020 Event 2, and 0% in 2020 Event 3 (Failed to Participate). The laboratory failed to verify the accuracy of PTH twice annually in 2020. 5. Testosterone: The laboratory scored 50% in 2020 Event 1 and 0% in 2020 Event 3 (Failed to Participate). The laboratory failed to verify the accuracy of Testosterone twice annually in 2020. 6. Trichomonas Vaginalis (TV): The laboratory scored 60% in 2019 Event 2 and 0% in 2019 Event 3 (Failed to Participate). The laboratory failed to verify the accuracy of TV twice annually in 2019. The TC confirmed in an interview on 7/28/21 at 10:00 AM that the laboratory failed to verify the accuracy of Endocrinology and Parasitology tests at least tests twice annually. The laboratory performed approximately 20,540 Endocrinology tests and approximately 250 Parasitology tests annually. . -- 2 of 4 -- D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: . Based on record review and interview on 7/28/21 with the TC, the laboratory failed to perform and document review of all unsatisfactory scores and

Summary Statement of Deficiencies D0000 A CLIA paper desk review of proficiency testing was conducted on 9/3/19 for the New England Urology Laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Based on evidence of a second occurrence of unsuccessful proficiency testing performance for the human chorionic gonadatropin (hCG) analyte, the following Condition level deficiencies were deemed to be not met: Condition 42 CFR 493.803 - Proficiency Testing - Successful Participation. Condition 42 CFR 493.1403 - 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 4 -- Based on record review on 9/3/19 of calendar years 2018 and 2019 proficiency testing results (four testing events), the laboratory failed to successfully participate (achieve a score of 80 percent or more) in the American Proficiency Institute (API) proficiency testing program for the Human Chorionic Gonadotropin (hCG) analyte as evidenced by the following First Unsuccessful Occurrence: The laboratory achieved a testing event score for the the subspecialty of Endocrinology of forty (40) percent for the second testing event of 2018 and a score of zero (0) percent (failure to participate - refer to D2100) for the third testing event of 2018 resulting in the first instance of unsuccessful performance for the the subspecialty of Endocrinology and the hCG analyte . Second Unsuccessful Occurrence: The laboratory achieved a testing event score for the the subspecialty of Endocrinology of zero (0) percent (failure to participate - refer to D2100) for the third testing event of 2018 and a score of sixty (60) percent for the second testing event of 2019 resulting in the second instance of unsuccessful performance for the the subspecialty of Endocrinology and the hCG analyte. It was confirmed in an email interview on 9/3/19 with the technical consultant that the laboratory was unsuccessful in the proficiency testing events listed above. Based on this evidence the laboratory failed to undertake the appropriate training and /or technical assistance necessary to correct the problem of unsuccessful proficiency testing performance for the hCG analyte in the subspecialty of Endocrinology. Refer to D2100, D2105, and D2107. . 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 proficiency testing record review for calendar years 2018 and 2019 (four testing events), the laboratory failed to participate in the third testing events of 2018 resulting in a score of zero (0) for the proficiency testing event for the Human Chorionic Gonadotropin (hCG) analyte. . D2105 ENDOCRINOLOGY CFR(s): 493.843(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on record review on 9/3/19 of calendar years 2018 and 2019 proficiency testing results (four testing events), the laboratory failed to undertake effective remedial action in response to unsatisfactory American Proficiency Institute proficiency testing program testing results for the Human Chorionic Gonadotropin (hCG)analyte as evidenced by the following: First Unsuccessful Occurrence: The laboratory achieved a testing event score for the hCG analyte of forty (40) percent for the second testing event of 2018 and a score of zero (0) percent (failure to return results within the time frame specified - refer to D 2100) for the third testing event of 2018 resulting in the first instance of unsuccessful performance for the hCG analyte. Second Unsuccessful Occurrence: The laboratory achieved a testing event score for the hCG analyte of zero (0) percent (failure to return results within the time frame specified - refer to D 2100) and a score of sixty (60) percent for the second testing event of 2019 resulting in the second instance of unsuccessful performance for the hCG analyte. Based on a second occurrence of unsuccessful proficiency testing for the hCG analyte the laboratory failed to undertake the appropriate training and/or technical assistance necessary to correct the problem of unsuccessful proficiency testing performance for the hCG analyte. 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 proficiency testing (PT) record review and interview, the laboratory failed to achieve satisfactory performance for the human chorionic gonadatropin (hCG) analyte resulting in two unsuccessful proficiency testing events as evidenced by the following: First unsuccessful occurrence: The laboratory achieved an overall testing event score for hCG of forty (40) percent for the second testing event of 2018 and a score of zero (0) percent (failure to participate) for the third testing event of 2018 resulting in the first instance of unsuccessful performance for the hCG analyte. Second unsuccessful occurrence: The laboratory achieved an overall testing event score for hCG of zero (0) percent (failure to participate) for the third testing event of 2018 and a score of sixty (60) percent for the second testing event of 2019 resulting in the second instance of unsuccessful performance for the hCG analyte. It was confirmed in an email interview on 9/3/19 with the technical consultant that the laboratory was unsuccessful in the proficiency testing events listed above. . D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the deficiencies cited herein, the laboratory director failed to ensure that effective remedial action was instituted in response to unsatisfactory proficiency -- 3 of 4 -- testing results resulting in the second unsuccessful performance for the Human Chorionic Gonadotropin (hCG) analyte (refer to D2016). -- 4 of 4 --

Summary Statement of Deficiencies D0000 An initial CLIA certification survey was conducted for the New England Urology laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 proficiency testing (PT) review and interview, the laboratory failed to successfully participate (achieve a score of 80 percent or more) in a proficiency testing program for the human chorionic gonadotropin (hCG) analyte as evidenced by the following: a. The laboratory utilizes American Proficiency Institute (API) for PT. b. A review of two (2) testing events for 2018 revealed the laboratory achieved a score 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 -- of forty (40) percent for the second event and a score of zero (0) percent for the third event. c. The technical consultant confirmed through interview on 11/28/18 at 11 AM that the laboratory failed to successfully participate in PT for hCG. (Refer to D2098 & D2107) 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 proficiency testing record review and interview, the laboratory failed to attain a score of least eighty (80) percent in the American Proficiency Institute (API) proficiency testing (PT) program for the human chorionic gonadotropin (hCG) analyte as evidenced by the following a. The laboratory achieved a testing event score for the hCG analyte of forty (40) percent for the second testing event of 2018. b. The laboratory achieved a testing event score for the hCG analyte of zero (0) percent (failure to participate) for the third testing event of 2018. c. The technical consultant confirmed through interview on 11/28/18 at 11 AM that the laboratory failed to attain a score of at least eighty (80) percent in each testing event for hCG. 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 proficiency testing (PT) record review and interview, the laboratory failed to achieve satisfactory performance for the human chorionic gonadotropin (hCG) analyte as evidenced by the following: a. The laboratory achieved an overall testing event score for the hCG analyte of forty (40) percent for the second testing event of 2018 and a score of zero (0) percent (failure to participate) for the third testing event of 2018 resulting in the first instance of unsuccessful performance for the subspecialty of Endocrinology. b. The technical consultant confirmed through interview on 11/28/18 at 11 AM that the laboratory failed to achieve satisfactory performance for the hCG analyte in two consecutive testing events -- 2 of 2 --