Mogen Body Genetics Lab

Summary Statement of Deficiencies D0000 A remote recertification survey was performed on 07/29/25 and 07/30/25. Standard- level deficiencies cited. D5209 Based on review of Centers for Medicare and Medicaid (CMS) Personnel Form 209, personnel records, and interview with the Quality Assurance (QA) Manager, the laboratory failed to perform competency assessment in 2024 for one of two Technical Supervisors based on job responsibilities. Findings included: 1. Review of the submitted CMS 209 form, signed and dated by the laboratory director on 07/23/25, listed two Technical Supervisors (TS). 2. In an interview on 07/23/25 at 2:20 am (US CST), the QA Manager stated Technical Supervisors were assessed annually based on job responsibilities. 3. Review of 2024 personnel records for Technical Supervisors revealed no annual competency assessment based on job responsibilities for one of two Technical Supervisors (TS #2). 4. In an interview on 07/29/25 at 2:36 am (US CST), the QA manager confirmed the findings. Word Key US CST = United States Central Standard Time D5413 I. Based on manufacturer's instructions, environmental records, and interview with Technical Supervisor #1 (TS #1), the laboratory failed to ensure the manufacturer's requirements for humidity for 12 of 12 months. Findings included: 1. TS #1 confirmed on 07/30/25 at 01:14 am (US CST), the laboratory performed mutation analysis (genetic screening) allele specific polymerase chain reaction (ASP) using Applied Biosystems 2720 Thermocyclers. 2. Review of manufacturer's user guide section, "Environmental Considerations" stated, "Maintain a noncondensing relative humidity between 20-80%.". 3. Review of 2024 environmental logs revealed no evidence of documentation or monitoring of humidity. 4. In an interview on 07/30/25 at 2:00 am (US CST), TS #1 confirmed the laboratory failed to ensure the manufacturer's requirements for humidity. II. Based on manufacturer's instructions, environmental records, and interview with Technical Supervisor #2 (TS #2), the laboratory failed to ensure the manufacturer's requirements for Flow Cell cartridges for seven of seven days. Findings included: 1. TS #2 confirmed on 07/30/25 at 03:10 am, the laboratory performed Next Gen Sequencing (NGS) using the following: a. 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 -- Illumina NextSeq 550 instrument b. NextSeq 500/550 High Output Flow Cell Cartridges 2. Review of manufacturer's instructions "Contents and Storage" stated: b. NextSeq 500/550 High Output Flow Cell Cartridge - storage requirement of 2C to 8C 3. Review of environmental records from 06/01/25 through 06/07/25 revealed temperatures warmer than the manufacturer's requirement for seven of seven days. a. 06/01/25 - documented temperature 9.6C b. 06/02/25 - documented temperature 9.0C c. 06/03/25 - documented temperature 9.5C d. 06/04/25 - documented temperature 9.4 C e. 06/05/25 - documented temperature 9.6C f. 06/06/25 - documented temperature 9.6C g. 06/07/25 - documented temperature 9.3C 4. In an interview on 07/30/25 at 03: 30 am (US CST), TS #2 confirmed the laboratory failed to ensure the manufacturer's storage requirements. III. Based on manufacturer's instructions, environmental records, and interview with Technical Supervisor #2 (TS #2), the laboratory failed to ensure the manufacturer's requirements for reagent cartridges for four of six days. Findings included: 1. TS #2 confirmed on 07/30/25 at 03:10 am, the laboratory performed Next Gen Sequencing (NGS) using the following: a. Illumina NextSeq 550 instrument b. NextSeq 500/550 High Output Reagent Cartridges 2. Review of manufacturer's instructions "Contents and Storage" stated: b. NextSeq 500/550 Reagent Cartridges - storage requirement of -25C to -15C 3. Review of environmental records from 06/02/25 through 06/07/25 revealed temperatures warmer than the manufacturer's requirement for four of six days. a. 06/02/25 - documented temperature -11.4C b. 06/03/25 - documented temperature -14.0C c. 06/06/25 - documented temperature -14.0C d. 06/07/25 - documented temperature -11.6C 4. In an interview on 07/30/25 at 03:25 am (US CST), TS #2 confirmed the laboratory failed to ensure the manufacturer's storage requirements. Key Word US CST = United States Central Standard Time D5775 Based on record review and interview with Technical Supervisor #1 (TS #1), the laboratory failed to perform instrument comparison studies at least twice a year for one of one year (2024). Findings included: 1. In an interview on 07/30/25 at 01:14 am (US CST), TS#1 confirmed that the laboratory performed mutation analysis (genetic screening) allele specific polymerase chain reaction (ASP) using nine Cleaver Scientific Electrophoresis instruments. Instrument Serial Numbers: G-22 - MS100730007 G-26 - MS100713015 G-28 - MS101208093 G-29 - MS100713015 G- 30 - MS101208092 G-33 - MS100713012 G-37 - MS101208095 G-96 - MS180523072 G- 97 - MS180523008 2. Review of laboratory's 2024 comparison studies revealed one comparison study (performed on 10/07/24). 3. In an interview on 07/30/25 at 1:30 am (US CST), TS #1confirmed the laboratory failed to perform comparison studies at least twice a year as indicated above. Key Word US CST = United States Central Standard Time D6128 Based on review of Centers for Medicare and Medicaid (CMS) Personnel Form 209, personnel records, and interview with the Quality Assurance (QA) Manager, the Technical Supervisor failed to perform competency assessment in 2024 for one of five testing persons performing high complexity testing at least annually. Findings included: 1. Review of the submitted CMS 209 form, signed and dated by the laboratory director on 07/23/25, revealed Testing Person #1 (TP #1) listed to perform high complexity testing. 2. Review of 2024 personnel records for five testing persons performing high complexity testing revealed no annual competency assessed for TP #1. 3. In an interview on 07/29/25 at 2:08 am (US CST), the QA manager confirmed the findings. Key Word US CST = United States Central Standard Time -- 2 of 2 --

Summary Statement of Deficiencies D0000 Federal Jurisdictional Survey (international) The laboratory was found in compliance with standard level deficiencies cited: D5413 Based on direct observation, lack of documentation, manufacturer's instructions, and interview, the laboratory failed to monitor temperatures and document those conditions in the laboratory as evidenced by: Refrigerator with patient Controls 1. In direct observation on 7/25/2019 @1050 Refrigerator #8 the temperature was not being monitored. The following selected controls were stored in the refrigerator: 22.1.2.3 V529 96.1.1.687V 43.1.31674 43.1.2.1674 2. The laboratory printed out a document from a temperature monitoring system. The temperature was 0 degrees. 3. In interview with the Quality Assurance person she stated. " I think the temperature monitor is 0 degrees C all of the time." The Quality Assurance person called maintenance @1051 and maintenance stated that the temperature monitoring system was not connected. 4.The laboratory did not have a procedure in place at the time of the survey. Room Temperature PCR room 1. In review of the manufacturer's instructions applied Biosystem quick guide, states,"operating temperature 15-30 degrees C" 2. The laboratory could not provide documentation that they took room temperature on a daily basis. The laboratory did not have a procedure in place at the time of the survey. The laboratory labeled them PS 27,31,32,26 Room Temperature storage room 1. In review of the manufacturer's instructions on the box of the Qiagen symphony DNA mini kit reagents states, "store at 15-25 degrees C" 2. The laboratory couldn't provide documentation that they took room temperature on a daily baisis. The laboratory did not have a procedure in place to monitor room temperature at the the time of the survey 3.In direct observation @1053 the following reagents were observed on the shelf: DNA Qiagen Symphony DNA mini kit lot#160050504 expiration date 09-06-2019 DNA Qiagen Symphony DNA mini kit lot#1633010845 D6121 Based on review of the laboratory's procedures, interviews, and lack of documentation, the laboratory failed to have procedures in place for evaluation of competency of staff with 5 of 6 components for 2018 and 2019 as evidenced by: 1. In review of the laboratory's procedures, the laboratory did not have a procedure in place 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 -- to perform competencies. The laboratory did not have procedures for 5 of 6 of the required components: Monitoring the recording and reporting of test results Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records Direct observation of performance of instrument maintenance and function checks; Assessment of problem solving skills. 2. The laboratory couldn't provide documentation for all testing personnel competencies for 2018 and 2019, for all testing personnel listed on the CMS-209 form. 3. In interview with the Laboratory Director and Quality Assurance person, on 7/24/2019 @1221 stated that they don't have competency. The CLIA inspector had to show both individuals the brochure for competencies and where to find it on the CLIA website for further guidance. -- 2 of 2 --