Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed on June 10, 2019 at Delta Pathology Group, LLC at Cytogenetics Solutions, CLIA ID # 19D2158118. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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: I. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for General Supervisor were complete. Findings: 1. Review of the laboratory's "Competency Assessment" policy revealed the laboratory did not include competency assessment criteria or frequency of performance for personnel serving as the General Supervisor. 2. Review of personnel records for the General Supervisor revealed the laboratory did not perform a competency assessment for her duties as General Supervisor. 3. In interview on June 10, 2019 at 9:23 am, the General Supervisor confirmed the Laboratory Director did not perform a competency assessment for her duties as General Supervisor. II. Based on record review and interview with personnel, the laboratory failed to establish and follow procedures for testing personnel competency assessments. Findings: 1. Review of the laboratory's "Competency Assessment" policy revealed the laboratory did include the tasks evaluated. 2. Further review of the laboratory's "Competency Assessment" policy revealed a "Competency Assessment Checklist" as the form utilized for evaluations. 3. Review of the competency assessment for the Testing Personnel revealed the laboratory utilized a "Delta Pathology Group Competency Checklist," not the "Competency Assessment 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 -- Checklist" included in the policy manual. 4. Further review of the "Delta Pathology Group Competency Checklist" revealed the laboratory included the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 5. In interview on June 10. 2019 at 9:43 am the General Supervisor, who also serves as Testing Personnel, stated she serves as a first or second reader for cytogenetic specimen slides. The General Supervisor further stated at 12:03 pm, Delta is in the process of updating the personnel competency forms. 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 record review and interview with personnel, the laboratory failed to establish complete policies and procedures. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not establish complete policies for the following: a) Twice a year verification for accuracy of Cytogenetic testing to include frequency, acceptability criteria, and