Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based upon review of records and discussion with staff, records revealed that the Proficiency Testing (PT) is not divided equally among testing personnel. Findings include: 1. There are four (4) testing personnel listed on the CMS 209 form. Upon review of PT records it was noted that only two (2) of the four (4) performed PT in 2017 and 2018. 2. Primary testing personnel confirmed that the routine rotation of PT sample testing is not shared by all staff members during interview on 04/01/2019 at approximately 1300. 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 Proficiency Testing (PT) records for 2017 and 2018 and discussion with staff, it was revealed that all attestation pages were not available for review for 2018. Findings include: 1. Upon review of the PT records notebook for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 2018, there was no attestation page available for PT event #1 and #3. 2. Primary testing personnel confirmed this during interview on 04/01/2019 at approximately 1300. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based upon review of records and interview with the staff, it was revealed that