Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records for this laboratory, the Laboratory Director (LD) failed to sign attestation documents for Hematology and Blood Bank testing since the last survey in 2016. Findings include: 1. Upon review of hematology PT records, the LD failed to sign off on the attestation sheet for 2017 and 2018. 2. Based upon review of Rh typing PT records, the LD failed to sign off on the attestation sheet for 2017 and 2018. 3. Based on discussion with the staff member interviewed during the survey 10/02/2018 at approximately 1130, she confirmed the LD does not routinely sign off the attestation sheet with PT testing. 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 upon review of records and discussion with staff, the Laboratory Director (LD) / Technical Consultant (TC) failed to perform annual competency assessment of staff performing Rh typing. Findings include: 1. During the survey on 10/2/2018, no competency assessment for Rh typing could be produced for two (2) out of two (2) 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 -- testing personnel. 2. Discussion with one staff member interviewed 10/02/2018 at approximately 1200 confirmed that no competency assessment has been conducted by the LD/TC since the last CLIA survey in 2016. -- 2 of 2 --