Summary:
Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 2/27/18, deficiencies were cited for Glacier Community Health Center in Cut Bank, MT. 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 observation, record review, and interview, the laboratory failed to enroll for proficiency testing for one of nine analytes from 1/18/17 through 2/27/18. The findings include: 1. On 2/27/18 at 2:00 p.m., a Frend analyzer was observed in the laboratory. 2. On 2/27/18 at 2:00 p.m., staff member A stated free thyroxine 4 (FT4) was tested on the Frend starting 1/18/17. 3. A review on 2/27/18 at 2:20 p.m. of the American Proficiency Institute (API) paperwork lacked documentation of proficiency testing for FT4. 4. A review on 2/27/18 at 3:35 p.m. of the Glacier Community Health Center December 2017 Quality Assessment documentation included FT4 on the list of analytes performed on the Frend analyzer. It also stated proficiency testing enrollment had been verified for participation in 2018 on 9/25/17. 5. On 2/27/18 at 4:35 p.m., staff member A stated the laboratory did not have proficiency testing for FT4. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --