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 Puerto Rico Proficiency Testing Program (PRPTP) records review ( years 2018 to 2019 and laboratory director interview on November 5, 2019 at 9:30 A.M., it was determined that the laboratory failed to maintain a copy of all the proficiency testing program attestation statements in record (signed by the analyst and the laboratory director) for a minimum of two years. The findings include: 1. The PRPTP records were review from February 2018 to October 2019. 2. On November 5, 2019 at 9:30 A.M, the PRPTP records showed that the laboratory did not maintain a copy of the proficiency testing program attestation statement for the first 2019's proficiency testing event (February 2019). 3. The laboratory director confirmed on November 5, 2019 at 9:30 A.M, that the copy of the proficiency testing program attestation statement of February 2019 was not maintained in records. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on routine chemistry calibration verification records (years 2018 and 2019) reviewed and laboratory director interview on November 5, 2019 at 10:30 AM., it was determined that the laboratory failed to retain all the printout of the calibration verification procedures for the routine chemistry tests processed by the Daytona system. The findings include: 1. The laboratory performed the following tests by the Daytona system: glucose, triglycerides, cholesterol and HDL-cholesterol. 2. On November 5, 2019 at 10:30 AM, the routine chemistry calibration verification records showed that the laboratory performed a calibration verification procedures on October 24, 2019. However, the laboratory did not have available the printout of this calibration verification procedures. 3. The laboratory director confirmed on November 5, 2019 at 10:30 AM, that the printout for the calibration verification procedures was not available. D5779