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 upon review of records and discussion with testing personnel (TP) and the laboratory director (LD), the laboratory failed to ensure the attestation page for proficency testing (PT) was signed by both TP and the LD. Findings include: 1. No attestation signature from the LD was noted for events 2 and 3 in 2017. 2. No attestation signature from the LD was noted for events 1, 2 and 3 in 2018. 3. No attestation signature from the TP was noted for events 2 and 3 in 2017. 4. No attestation signature from the TP was noted for events 1 and 2 in 2018. 5. Failure to sign the attestation form for the above events was confirmed by TP and LD during interview 4/29/2019 at approximately 1230. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based upon review of records and discussion with testing personnel (TP) and the laboratory director (LD), biannual verificationn for potassium hydroxide (KOH) mounts and wet mounts was not being documented in writing. Findings include: 1. No written training verification for a new employee or a 6 month written verification 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 -- could be provided during survey 4/29/2019. 2. No written verification of biannual verification for 2017 and 2018 for a long term TP employee could be provided during survey 4/29/2019. 3. The LD confirmed there was no written record of biannual verification during interview 4/29/2019 at approximately 1230. -- 2 of 2 --