Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on lack of Puerto Rico Proficiency Testing Program (PRPTP) records review from February 2019 to December 2020 and laboratory director interview on February 9, 2021 at 10:35 AM, it was determined that the laboratory failed to maintain the proficiency testing event records. The findings include: 1. Proficiency Testing (PRPTP) records were reviewed from February 2019 to December 2020. 2. Review of proficiency testing records from February 2019 to December 2020, showed that the laboratory did not maintain the following proficiency testing event records: September 2020, October, 2020, November 2020 and December 2020. 3. The laboratory director confirmed on February 9, 2021, that the laboratory did not maintain these proficiency testing event records. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons 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 -- other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review and laboratory director interview on February 9, 2021 at 10:40 AM, it was determined that the laboratory failed to take and document