Novant Health Pineville Primary Care

CLIA Laboratory Citation Details

1
Total Citation
2
Total Deficiencyies
1
Unique D-Tag
CMS Certification Number 34D0933738
Address 10514 Park Road, Charlotte, NC, 28210
City Charlotte
State NC
Zip Code28210
Phone704 384-9960
Lab DirectorRICHARD RACHIMA

Citation History (1 survey)

Survey - November 19, 2019

Survey Type: Standard

Survey Event ID: MB9611

Deficiency Tags: D2104 D2104

Summary:

Summary Statement of Deficiencies D2104 ENDOCRINOLOGY CFR(s): 493.843(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of 2018 and 2019 American Proficiency Institute(API) proficiency testing (PT) records and interview with the Technical Consultant(TC) 11/19/19, the laboratory failed to submit PT results within the time frame specified by API for the 2019 Chemistry-Core 3rd event, resulting in a score of 0% for serum human chorionic gonadotropin(HCG). Review of 2018 and 2019 API PT records revealed the online submission due date for the 2019 Chemistry-Core 3rd test event was Friday, 9/13/19, 11:59pm eastern time. Review of records revealed the laboratory tested the serum HCG proficiency samples on 8/29/19, but the testing personnel did not submit the PT results on the day of testing. The laboratory failed to submit the results prior to the submission due date, and the laboratory received a score of 0% (failure to submit) for the test event. Documentation was available that the TC self-graded the PT results. During interview at approximately 10:30am, the TC confirmed that the laboratory's PT results were not submitted by the due date and the results were self-graded. 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 --

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