Revere Health Provo Family Medicine/Urgent Care

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 a review of competency assessment documentation, policies and procedures, and an interview with the Technical Consultant staff, the laboratory failed to establish and follow written policies to assess competency for 5 of 5 Technical Consultants (TC) for the years 2020 and 2021. Findings include: 1. A review of competency assessment documentation at approximately 12:15pm on 8/29/22, revealed that the laboratory failed to document competency assessments for 5 of 5 TCs during 2020 and 2021. 2. A review of the laboratory's policies and procedures at approximately 12: 30pm on 8/29/22, revealed that the laboratory had failed to establish policies and procedures to assess TC competency. 3. In an interview with TC2 at approximately 12: 35pm on 8/29/22, it was confirmed that the laboratory had failed to establish policies and procedures to assess TC competency. 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 --

Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on test record review, lack of documentation, patient chart review, and interview with staff; 1 of 5 Complete Blood Count (CBC) test reports reviewed failed to include the correct date of collection/receipt. Finding include; 1. Test report for 641283 documents a CBC collected on 09/30/19. 2. Patient chart for patient 641283 lacked documentation that a CBC was collected on 09/30/19. 3. Patient chart review documented that 641283 had a CBC ordered and collected on 11/30/19. 4. Staff stated on 02/06/20 at approximately 3:00 pm that the testing personnel had written the incorrect date of collection/receipt, and testing on 641283 was collected on 11/30/19. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on test record review and interview with staff, the laboratory failed to include the identity of personnel performing 2 out of 5 Complete Blood Count (CBC) tests reviewed. Findings include: 1. Laboratory records for patient 641283 tested on 11/30 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- /19, and 1000043434 tested on 01/04/20 failed to include the identity of personnel who performed CBC testing. 2. Staff confirmed on 02/06/20 at approximately 3:00 pm they were unable to confirm the testing personnel for patient 641283 and 1000043434 CBC tests performed. -- 2 of 2 --