Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 9, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview the facility failed to authorize the PT program to release all PT data to CMS as required. Findings include: 1, American Academy of Family Physicians (AAFP) PT document review revealed the facility's PT results were not reported to CMS in 2017, 2018, and 2019 thus far. 2. An interview with the credentialing coordinator on 4/9/2019 in a medical office at approximately 2:30 p.m. confirmed the PT results were not released for the aforementioned dates. 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, 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 -- 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 American Academy of Family Physicians (AAFP) proficiency test (PT) document review and staff interview, the laboratory failed to successfully participate in a PT program approved by CMS. Findings include: Refer to D2046 D2046 MYCOLOGY CFR(s): 493.827(e) 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) document review and staff interview, the laboratory failed to achieve an overall testing event score of satisfactory performance for two consecutive testing events is unsuccessful PT performance. Findings include: 1. American Academy of Family Physicians (AAFP) PT report review revealed the laboratory failed the following Mycology (Dermatophyte Screening) PT events: 2018 -- Event B (60 percent); Event C (40 percent). 2. An interview with the credentialing coordinator in a medical office on 4/9/2019 at approximately 2:30 p.m. confirmed the aforementioned PT event failures in 2018. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to establish and follow written policies and procedures to assess testing personnel (TP) competency. Findings include: 1. SOP review revealed the laboratory did not establish and follow a six-procedure policy and procedure for evaluating TP competency. 2. An interview with the credentialing coordinator in a medical office on 4/9/2019 at approximately 2:30 p.m. confirmed the SOP did not contain a competency policy and procedure. -- 2 of 6 -- 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 proficiency test (PT) document review and staff interview, the laboratory failed to document PT