Summary:
Summary Statement of Deficiencies D0000 An Initial survey was conducted at GenEd Systems, LLC, CLIA ID # 19D2163647, on September 26, 2019. GenEd Systems was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director 42 CFR 493.1459 CONDITION: Laboratories performing high complexity testing; General Supervisor 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 record review and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the General Supervisor were complete. Findings: 1. Review of the laboratory's Quality Assurance policy under the "Personnel Competency" section revealed the laboratory did not include frequency of competency assessments for the General Supervisor. 3. In interview on September 26, 2019, the Laboratory Director confirmed the laboratory's policy did not include the frequency of performance of competency assessments for the General Supervisor. . D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish complete detailed written instructions for providers to maintain the integrity of samples and ensure accurate and reliable testing. Findings: 1. Review of the laboratory's "Client Manual" revealed the laboratory did not include complete specimen rejection criteria. 2. Review of the package insert for the sample collection device, ORAcollect-Dx, revealed sample stability as sixty (60) days. 3. Review of the laboratory's sample stability and shipping study revealed the laboratory validated for two (2) weeks. 4. In interview on September 26, 2019, the Chief Scientific Officer confirmed the laboratory did not include sample stability limitations in their rejection criteria. D5781