Urban Pediatrics

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 an interview with the Laboratory Director (LD), the laboratory failed to follow their written policies and procedures for annual competency assessment for five out of five Testing Personnel (TP) performing moderately complex hematology procedures. This deficient practice had the potential to affect all patients tested in the specialty of hematology. Findings include: 1. Review of the laboratory's 'Lab Manual' policies and procedures found the following statement: "...Employees will be reviewed semiannually for the first year, then annually thereafter..." 2. Review of the laboratory's competency assessment documentation found the lab failed to complete a 2019 annual competency assessment for TP #1, TP #2, TP #3, TP #4 and TP#5 as stated in the approved policy. 3. An interview with the LD, on 1/16/20 at 10:33 am, confirmed that the lab failed to complete a 2019 annual competency assessment for TP #1, TP #2, TP #3, TP #4 and TP#5 as stated in the approved policy. 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 D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the laboratory's test records, and interviews with the Technical Consultant (TC) and Lab Director (LD), the laboratory failed to have an adequate manual system in place to ensure the hematology results were accurately and reliably sent to the final test report. Findings Include: 1. Review of 2 of 2 of the laboratory's test records indicated white blood count results reported. 2. The surveyor requested printouts of the reported results or a patient log containing white blood count results. 3. The TC and LD confirmed the patient results were manually entered into the patient charts directly from the instrument. There was no available log to verify results/data was accurately entered into the laboratory's information system. The interviews occurred on 02/21/2018 at 10:20 AM. 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 --