Henry Ford Royal Oak Laboratory

CLIA Laboratory Citation Details

1
Total Citation
1
Total Deficiency
1
Unique D-Tag
CMS Certification Number 23D0364543
Address 110 East 2nd Street, Royal Oak, MI, 48067
City Royal Oak
State MI
Zip Code48067
Phone(248) 940-4225

Citation History (1 survey)

Survey - May 29, 2018

Survey Type: Standard

Survey Event ID: LRX011

Deficiency Tags: D5209

Summary:

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to ensure written competency policies were implemented for two (#2 and #3) of four testing personnel in 2017. Findings include: 1. On May 29, 2018 at 9:40 AM, record review of the competency assessments revealed for two (#2 and #3) of four testing personnel there was no documentation to show that competency assessments had been performed and documented in 2017. 2. On May 29, 2018 at 9:40 AM when queried, technical consultant (TC) #1-#3 as listed on the CMS-209 were unable to provide the surveyor the documentation requested for 2017. 3. During the interview on May 29, 2018 at 9: 40 AM, TC #1-#3 confirmed the competency assessments were not performed and documented in 2017 for testing personnel #2 and #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 1 --

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