Summary:
Summary Statement of Deficiencies D0000 During an initial certification survey completed on 05/04/2021 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following conditions: 42 CFR Part 493.801 Enrollment and testing of proficiency samples 42 CFR Part 493.1250 Analytic Systems 42 CFR Part 493.1403 Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR Part 493.1409 Laboratories Performing Moderate Complexity Testing; Technical Consultant 42 CFR Part 493.1421 Laboratories Performing Moderate Complexity Testing; Testing Personnel D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the review of Centers for Medicare and Medicaid Services (CMS) CASPER (Certification and Survey Provider Enhanced Reporting) Report 155 (historical report containing a summary of proficiency test (PT) scores), manufacturer instructions and interview with the Laboratory Manager, the laboratory failed to enroll in proficiency testing for Sodium, Potassium, Chloride, TCO2 (Total Carbon Dioxide), Ionized Calcium, Glucose, Urea Nitrogen, Creatinine, Hematocrit (human electrolytes, metabolites, and coagulaton markers) testing performed using the i-STAT Chem 8+ Abbott Chemistry handheld, in vitro analyzer. The laboratory tested 166 patients from Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- May 1, 2020 to April 28, 2021. Findings are: A. Review of the CMS CASPER 155 Report revealed no proficiency testing scores for 2020 and 2021. B. During interview on 4/22/21 at 9:54 am the Laboratory Manager stated the laboratory was not enrolled in proficiency testing. C. Review of the manufacturer's Urgent Product