Summary:
Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on Proficiency Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Endocrinology and the test analyte urine Human Chorionic Gonadotropin (uHcg), Thyroid Stimulating Hormone (TSH) The following scores were assigned: Speciality Endocrinology 2022 first event = 72% 2022 second event = 100% 2022 third event = 0% (failure to participate) uHcg 2022 first event = 20% 2022 second event = 100% 2022 third event = 0% (failure to 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 -- participate) TSH 2022 first event = 60% 2022 second event = 100% 2022 third event = 0% (failure to participate) This is considered unsuccessful PT performance. Refer to D2107 and D2108 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte's Cortisol, Free Thyroxine (F T4) and Triiodothyronine (T3) The following scores were assigned: 2022 third event = 0% (failure to participate) This is considered an unsatisfactory PT 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte uHcg and TSH The following scores were assigned: uHcg 2022 first event = 20% 2022 second event = 100% 2022 third event = 0% (failure to participate) TSH 2022 first event = 60% 2022 second event = 100% 2022 third event = 0% (failure to participate) This is considered unsuccessful PT performance. 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 Proficiency Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Endocrinology. The following scores were assigned: Speciality Endocrinology 2022 first event = 72% 2022 second event = 100% 2022 third event = 0% (failure to participate) This is considered unsuccessful PT performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 2 of 3 -- 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 PT desk review of the CMS PT and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for thespecialty Endocrinology and test analytesuHcg, TSH, Coritsol, FT4, and T3 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 PT desk review of the CMS PT and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialty Endocrinology and test analyte's uHcg, TSH, Cortisol, FT4, and T3. The following scores were assigned: Speciality Endocrinology 2022 first event = 72% 2022 second event = 100% 2022 third event = 0% (failure to participate) uHcg 2022 first event = 20% 2022 second event = 100% 2022 third event = 0% (failure to participate) TSH 2022 first event = 60% 2022 second event = 100% 2022 third event = 0% (failure to participate) This is considered unsuccessful PT performance. Cortisol, F T4 and T3 The following scores were assigned: 2022 third event = 0% (failure to participate) This is considered an unsatisfactory PT performance. -- 3 of 3 --