Wmps At Berkshire Cosmetic & Reconstructive

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on interview with the Laboratory Director (LD) and review of the preventive maintenance logs, the laboratory failed to perform and document monthly maintenance as instructed by manufacturer in the specialty of Histopathology. Findings include: 1. Record review on 4/28/2025 of the laboratory's Cryostat 2023, 2024 and 2025 to date preventative maintenance logs revealed: a. The laboratory failed to perform the required monthly maintenance for 6 of 12 months in 2023. b. The laboratory failed to perform the required monthly maintenance for 2 of 12 months in 2024. 2. Record review on 4/28/2025 of the Cryostat instrument manual revealed: a. Monthly Maintenance Chart "Decontaminate and Defrost." "Empty waste container and disinfect with 10% bleach." 3. Record review on 4/28/2025 of the laboratory's Cryostat 'Decontamination and Cleaning' Procedure revealed: a. "Routine decontamination and defrosting must be performed." b. "Decontaminate by using 10% bleach (sodium hypochlorite) once monthly or more often if necessary." c. "Defrost the cryostat once a month." d. "Note the decontamination/cleaning on the 'Cryostat area QC log'." 4. Staff interview with the LD on 4/28/2025 at 10:05 AM confirmed the above findings. 5. The laboratory performs 1,500 tests annually in the specialty of Histopathology. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) provide a safe environment in which employees are protected from physical, chemical, and biological hazards; 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory director (LD) the LD failed to ensure the physical plant and environmental conditions ensure a safe environment where employees are protected from physical, chemical, and biological hazards. This is a repeat violation. Findings include: 1. Record review on 4/28/2025 of the laboratory's eyewash maintenance and function check records revealed the laboratory failed to check the eyewash for 1 of 12 months in 2024. 2. Interview with the LD on 4 /28/2025 at 10:00 AM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the WMPS at Berkshire Cosmetic & Reconstructive Surgery laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Please refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. . 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: Based on interview, the Laboratory Director failed to ensure that the physical plant and environmental conditions provided a safe environment in which employees were protected from physical, chemical, and biological hazards as evidenced by the following: Emergency Eyewash Station: a) On the day of the survey the maintenance records of the emergency eyewash were reviewed. The review revealed that the documentation that the eyewash was being checked was only documented for one week in January of 2023 (1/6/23) and only two weeks in February, 2023 (2/12/ and 2 /27). There was no documentation that the eyewash was checked weekly in March or the first week of April of 2023. b) The Laboratory Director interviewed on 4/13/23 at 10:28 AM confirmed that documentation was not being appropriately maintained that the emergency eyewash was being routinely checked and maintained on a weekly basis . 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 --