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 a proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports, and the College of American Pathologists (CAP) PT records, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality Immunology/subspecialty General Immunology & test analyte Immunoglobin E (IgE). The following scores were assigned: Speciality Diagnostic Immunology/Sub-Speciality General Immunology /IgE 2021 second event = 0% (non-participation) 2021 first event = 0% (non- participation) This is considered an unsuccessful PT performance. Refer to D2084 and D2085. 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 -- D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 PT desk review of the CMS PT data reports, and the CAP PT records, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Immunoglobin E (IgE). The following scores were assigned: IgE 2021 second event = 0% (non-participation) 2021 first event = 0% (non- participation) This is considered an unsuccessful PT performance. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(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 PT desk review of the CMS PT data reports, and the CAP PT records, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the speciality Immunology/subspecialty General Immunology. The following scores were assigned: Speciality Diagnostic Immunology/Sub-Speciality General Immunology 2021 second event = 0% (non-participation) 2021 first event = 0% (non-participation) This is considered an 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 PT desk review of the CMS PT data reports and the CAP PT summary reports, the laboratory director failed to fulfill the laboratory director's responsibilities to ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the Speciality Immunology/Sub- speciality General Immunology and the test analyte IgE. 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 -- 2 of 3 -- 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 data reports and the CAP PT summary reports, the laboratory director failed to fulfill the laboratory director's responsibilities laboratory director's responsibilities to ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the Speciality Immunology/Sub-speciality General Immunology and the test analyte IgE. The following scores were assigned: Speciality Diagnostic Immunology /Sub-Speciality General Immunology/IgE 2021 second event = 0% (non-participation) 2021 first event = 0% (non-participation) This is considered an unsuccessful PT performance. -- 3 of 3 --