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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for the Sodium analyte in the Subspecialty of Routine Chemistry for events 2017-3 and 2018-2. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two out of three PT events for the Sodium analyte within the Subspecialty of Routine Chemistry - Event 2017-3, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- score 60% and Event 2018-2, score 60%. 2. Surveyor review of the API PT evaluation reports on July 26, 2018 confirmed the failed PT scores which results in a failure to successfully participate in PT for Sodium. 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) PT records, the laboratory failed to have successful performance in PT for the Sodium analyte in the Subspecialty of Routine Chemistry for events 2017-3 and 2018- 2. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two out of three PT events for Sodium in the Subspecialty of Routine Chemistry - Event 2017-3, score 60% and Event 2018-2, score 60%. 2. Surveyor review of the API PT evaluation reports on July 26, 2018 confirmed the failed PT scores. This results in a failure to achieve an overall testing event score of satisfactory performance for two out of three testing events which is unsuccessful PT performance. -- 2 of 2 --