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 Testing (PT) reports for 2018 sent to the state agency and review of documentation presented during the survey conducted on November 20, 2018, the laboratory failed to successfully participate in a PT program for the regulated analyte, pH (Blood Gas) under the sub-specialty of Routine Chemistry. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 2nd event of 2018 for the regulated analyte, pH Blood Gas, with a score of 60%. 2. The laboratory's PT Performance was unsatisfactory for the 3rd event of 2018 for the regulated analyte, pH Blood Gas, with a score of 20%. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, pH Blood Gas, for the 2nd and 3rd event of 2018 resulting in unsuccessful PT performance. See D2016 for findings. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on view of three patient test reports (18397, 18357, 17905) from 09/14/2018, 06 /26/2018 and 03/09/2018 respectively, and interview with the laboratory personnel, the laboratory failed to scan each test report into the relevant patient's medical record as required by the laboratory's policy. Findings include: 1. The three reports listed above could not be located in the electronic medical records of the patients. 2. The laboratory personnel indicated that reports were consistently not being scanned per laboratory policy. 3. There was no