Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain a copy(s) of the attestation statement and instrument printouts for one of three proficiency testing events reviewed (Event 3/2017) for Hematology testing (CBC-Complete Blood Count). Findings Include: 1) Review of Event 3/2017 proficiency testing documentation, indicated none was available for the attestation statement and instrument printouts. 2) Medical record review indicated Patients #s 7-9 (PT7-PT9) had CBC testing performed during Event 3/2017 on the following dates: PT-7=12-18- 17 PT-8=11-2-17 PT-9=10-9-17 3) In interview on 7/25/18 at 3:20pm and 3:24 pm, SP-1 (staff person #1) confirmed the laboratory failed to maintain a copy(s) of the attestation statement and instrument printouts for Event 3/2017. 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 --