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 a review of the American Proficiency Institute (API) proficiency testing records and an interview with the Laboratory Director (also the Technical Consultant) the laboratory failed to ensure Testing Personnel (TP) signed attestation statements for three of six 2016-2017 surveys. The findings include: 1. A review of the 2016-2017 API proficiency testing records revealed TP had not signed attestation statements for the following surveys: a. third Chemistry event in 2016 b. first Chemistry event in 2017 c. third Hematology event in 2017 2. During an interview on 5/16/2018 at 11:25 AM, the Laboratory Director reviewed the proficiency testing records with the surveyor and confirmed the above noted findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. 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 -- This STANDARD is not met as evidenced by: Based on a review of 2017-2018 American Proficiency Institute (API) proficiency testing records and an interview the Laboratory Director (also the Technical Consultant), the laboratory failed to retain all proficiency testing records for three of four surveys in 2017- 2018. The findings include: 1. A review of the 2017-2018 API proficiency testing records revealed the laboratory failed to retain the following: a. attestation statement and instrument printouts for the second Chemistry survey event in 2017. b. attestation statement, report form, and instrument printouts for the third Chemistry survey event in 2017. c. attestation statement, report form, and instrument printouts for the first Hematology survey event in 2018. 2. The Laboratory Director (also the Technical Consultant) confirmed during an interview on 5/16/2018 at 11:25 AM, the laboratory had not retained all required proficiency testing records for the above surveys. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the 2017 American Proficiency Institute (API) proficiency testing records, policy and procedure manual, and an interview with the Laboratory Director (also the Technical Consultant), the laboratory failed to document