Spero Health - Core Lab

Summary Statement of Deficiencies 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 staff interview and tour of the facility on 08/25/2021. The laboratory director failed to ensure regulated medical waste was stored correctly from 12/01 /2018 through 08/24/2021. Findings include: 1. There were seven (7) medical waste containers observed in the hallway during the laboratory tour on 08/25/2021 at 09:30 AM. 2. Each Container measured nineteen (19) inches wide by nineteen inches wide by twenty four (24) inches tall. During an emergency, this situation could cause a hindrance to personnel exiting the building. 3. The medical waste containers were taking up approximate fifty percent (50%) of the four (4) foot hallway leading to the outside exit. 4. The staff stated in an interview at 12:52 PM on 08/25/2021, the laboratory stored regulated medical waste in the hallway from 12/1/2018 through 08 /24/2021. Staff acknowledged the laboratory failed to ensure the hallways were not used for storage of regulated medical waste from 12/01/2018 through 08/24/2021. 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 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on staff interview and record review on August 15, 2019, the laboratory failed to perform methods comparison between the two (2) Liquid Chromatography-Mass Spectrometry (LCMS) analyzers from August 30, 2017 through August 14, 2019. Findings include: Record review on 08/15/19, revealed there was no documented evidence the laboratory performed methods comparison between method one ( 1) and method two (2) of the Liquid Chromatography-Mass Spectrometry (LCMS) from 08 /30/17 through 08/14/19. Interview with the Laboratory Staff, on 08/15/19 at 1:59 PM, revealed the laboratory did not have a system in place to ensure the two (2) analyzers had methods comparisons performed on a six (6) month interval from 08/30 /17 through 08/14/19. 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 --