Mymichigan Medical Center Town Centre Lab

CLIA Laboratory Citation Details

1
Total Citation
2
Total Deficiencyies
1
Unique D-Tag
CMS Certification Number 23D0679721
Address 4599 Towne Centre Road, Saginaw, MI, 48604
City Saginaw
State MI
Zip Code48604
Phone(989) 497-3020

Citation History (1 survey)

Survey - April 19, 2023

Survey Type: Standard

Survey Event ID: QUDI11

Deficiency Tags: D5217 D5217

Summary:

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with Technical Consultant (TC) #1, the laboratory failed to verify the chemistry Beta Hydroxybutyrate (BHOB) test at least twice annually for 1 (2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's twice annual verification of accuracy documents revealed a lack of documents for 1 (2022) of 2 years of testing. 2. The surveyor requested verification of accuracy documentation for testing performed in 2022 on 4/19/2023 at 11:26 am and it was not made available. 3. An interview on 4/19/2023 at 11:26 am TC#1 confirmed the laboratory had not verified the accuracy in 2022. 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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