Summary:
Summary Statement of Deficiencies D0000 A representative of the New Mexico State Agency completed a federal survey on 02 /07/2018. Based on survey findings the facility was not in compliance of 42 CFR 493, Laboratory Requirements. The laboratory was out of compliance with the following conditions: 42 CFR Part 493.803 Proficiency Testing, Successful Participation 42 CFR Part 493.807 Proficiency Testing, Reinstatement after failure 42 CFR Part 493.1403 Laboratory Director, moderate complexity 42 CFR Part 493.1441 Laboratory Director, high complexity 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 the review of 2016-2018 proficiency test reports from the proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- agency, Centers for Medicare & Medicaid Services (CMS) proficiency database, laboratory proficiency testing records, laboratory policy, patient records, and interviews with laboratory staff, the laboratory failed to successfully participate in proficiency testing for compatibility testing. Findings are: 1. The laboratory failed to achieve overall satisfactory proficiency test scores for 2 consecutive test events for compatibility testing in 2016. See D2162 2. The laboratory failed to achieve overall satisfactory proficiency test scores for 3 of 5 test events for compatibility testing in 2016-2017. See D2181 3. The laboratory failed to successfully participate in proficiency testing for compatibility testing and must obtain training and technical assistance to identify the cause of the failures and perform