Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on observation and interview with the technical consultant, the laboratory (lab) director did not perform competency assessments of the technical consultant for carrying out duties required of a technical consultant. Findings: 1. The laboratory did not have a written responsibility and duty statement for the technical consultant to determine duties assigned to her; 2. Competency assessment records for the technical consultant were requested at the time of survey, but the lab was unable to produce them; and 3. During interview in the afternoon, on the day of survey, the technical consultant confirmed that the lab did not have competency evaluations for duties performed. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on observation and interview with the technical consultant, the laboratory (lab) did not have proficiency test procedures to check the accuracy of the [-2] proPSA Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- antigen (P2 PSA/ isoform of free PSA). Findings: 1. The P2 PSA antigen is a measured analyte that is used for calculating the health index of the patient; and 2. The laboratory did not perform and did not have written procedures to check the accuracy of the P2 PSA antigen test at least two times each year (such as split sampling or other means); and 3. This was confirmed during interview with the technical consultant in the afternoon of the day of survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory staff, the laboratory (lab) did not have a written standard operation procedure manual (SOPM) for performing chemistry testing in the laboratory. Findings: 1. The SOPM for chemistry testing was requested on the day of survey, lab staff were unable to locate the SOPM and when interviewed in the afternoon on the day of survey, staff stated that the SOPM could not be located; 2. The laboratory did not have an SOPM that was reviewed, and approved in writing by the lab director; and 3. The lab did not have written procedures for ordering lab tests, patient identification, specimen collection and labeling of samples to assure positive identification, specimen rejection procedures, labeling and storage of specimens held for testing, step by step testing procedures, quality control procedures, preventive maintenance procedures, data management and reporting of test results, proficiency testing procedures, reportable ranges for each analyte, normal patient reference ranges for each analyte, identification of testing person, quality assurance,