Biochemical And Molecular Genetics

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at BIOCHEMICAL AND MOLECULAR GENETICS DIAGNOSTICS LABORATORY from January 28, 2026 to January 29, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: 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 staff interview, the laboratory procedure manual failed to include how to do competency evaluations for the Technical Supervisor and General Supervisor positions in the specialty of Chemistry and Clinical Cytogenetics in 2025 and 2026. Findings included: 1- Review of FORM CMS 209 signed by the Laboratory Director on 01/05/2026, revealed the following: Laboratory Director (LD) was also Clinical Consultant. The laboratory had one Technical Supervisor (TS#1), who was also the General Supervisor (GS) for Chemistry specialty and Testing Person (TP#1). The laboratory had TS#2 for the specialty of Clinical Cytogenetics, who was also TP#2, and seven additional testing persons (TP#3, TP#4, TP#5, TP#6, TP#7, TP#8 and TP#9). 2-Review of personnel record's competency evaluations for GS/TS#1 on 01/09/2025 and 01/14/2026 revealed that it was titled for Supervisor, but it was assessed as a testing person; competency evaluations for TS#2 on 01/14/2026 revealed that he was assessed as a Medical Technologist (TP#2). Both the GS/TS#1 and the TS#2 each had an LD designation/authorizations checklist signed by the LD on 01/06/2025 and 01/05/2026. 3- Review of the laboratory procedure manual, signed by the Laboratory Director on 01/05/2026, revealed that Employee Competency Evaluation procedure with effective date 05/30/2017 did not include how to do Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- evaluations for the supervisory roles. 4- During interview on 01/27/2025 at approximately 4:39 PM, the Laboratory Director admitted that the procedure did not include how to do evaluations for a supervisor. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 03/03/2020 found that Biochemical and Molecular Genetics Clinical Laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the Occupational Safety and Health Administration (OSHA) regulations for Nitrogen storage, and based on observation and interview with laboratory staff, the laboratory failed to have an Oxygen sensor in the Liquid Nitrogen Storage Area. Findings include: Review of the OSHA procedure for Nitrogen storage, revealed that it is a requirement that for any indoor Nitrogen storage to have an Oxygen level sensor. Observation of the laboratory revealed that: The laboratory has 2 large Nitrogen Tanks in a closed laboratory area. No sensor for Oxygen level detection was available. During an interview on 03/03/2020 at 9:30 AM, the laboratory director confirmed that there was no Oxygen sensor available to monitor acceptable levels. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --