Summary:
Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: D3001 Based on a walk through of the laboratory and interview with the the lab manager during survey on May 22, 2024, the laboratory failed to ensure adequate arrangement of space for conducting all phases of testing. Findings include: 1. During a walk through of the laboratory's physical space during the survey 05/22/2024, the following items were observed: a. The workbench space is not adequate for test performance. b. The laboratory space was also shared by two providers as office space. c. Open water bottles and a coffee mug were inside the laboratory where the providers use it as office space. . 2. Based on an interview with the lab manager at 1415 on 05/22/2024, the laboratory was moved to a provider office in January 2024 after a flood from a water line break. 3. The laboratory reports performing 500 Mohs procedures per annually. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: 3009 Based on a walk through of the laboratory and interview with the lab manager during the survey 05/22/2024, the laboratory failed to comply with federal OSHA standards: Bloodborne pathogens standard: I. 29 CFR 1910.1030(d)(2)(ix)- Eating, 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 -- drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. II. 29 CFR 1910.1030(d)(2)(x)-Food or drink shall not be kept in refrigerators, freezers, shelves, cabinets, countertops or benchtops where blood or potentially infectious materials are present. Findings include: 1. During a walk through of the laboratory's physical space during the survey 05/22/2024, the following items were observed: a. Open water bottles and a coffee mug were inside the laboratory where the providers use as office space. b. There were no signs entering the lab stating that no food or drinks are allowed. 2. Based on an interview with the lab manager at 1415 on 05/22/2024, the laboratory was moved to a provider office in January 2024 after a flood from a water line break. 3. The laboratory reports performing 500 Mohs procedures per annually. 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: D3011 Based on a walk through of the laboratory space and an interview with the lab manager during the survey 05/22/2024, the laboratory failed to establish and observe safety procedures that provide protection from biohazardous materials. Findings include: 1. During a walk through of the laboratory's physical space during the survey 05/22/2024, the following items were observed: a. Open water bottles and a coffee mug were inside the laboratory where the providers use as office space. b. There were no signs entering the lab stating that no food or drinks are allowed. c. Lab coats were not worn by staff in the laboratory. 2. Based on an interview with the lab manager at 1415 on 05/22/2024, the laboratory was moved to a provider office in January 2024 after a flood from a water line break. The lab manager confirmed that there was no signs stating no food or drinks allowed in the lab and that providers were allowed to have drinks at their desk area within the laboratory. 3. The laboratory reports performing 500 Mohs procedures per annually. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: D6083 Based on a walk through of the laboratory's physical space and an interview with the laboratory manager during survey 05/22/2024, the laboratory failed to ensure appropriate and adequate physical plant and environmental conditions for testing. Findings include: 1. During a walk through of the laboratory's physical space during the survey 05/22/2024, the following items were observed: a. The workbench space is not adequate for test performance. b. The laboratory space was also shared by two providers as office space. c. Open water bottles and a coffee mug were inside the laboratory where the providers use it as office space. 2. Based on an interview with the lab manager at 1415 on 05/22/2024, the laboratory was moved to a provider office -- 2 of 3 -- in January 2024 after a flood from a water line break. The lab manager confirmed that this was the only space available for specimen processing and testing. 3. The laboratory reports performing 500 Mohs procedures per annually. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: D6084 Based on a walk through of the laboratory's physical space and an interview with the lab manager during survey 05/22/2024, the Laboratory Director (LD) failed to provide a safe environment where employees are protected from biological hazards. Findings include: 1. During a walk through of the laboratory's physical space during the survey 05/22/2024, the following items were observed: a. The workbench space is not adequate for test performance. b. The laboratory space was also shared by two providers as office space. c. Open water bottles and a coffee mug were inside the laboratory where the providers use it as office space. d. Staff were not wearing lab coats in the laboratory area. e. There were no signs designating no food or drinks in the lab. 2. Based on an interview with the lab manager at 1415 on 05/22/2024, the laboratory was moved to a provider office in January 2024 after a flood from a water line break. The laboratory manager confirmed that no signs was present stating no food or drinks allowed in the laboratory and that staff were allowed drinks at their desk area within the laboratory. 3. The laboratory reports performing 500 Mohs procedures per annually. -- 3 of 3 --