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: Based on personnel records review, the environmental vapor analysis record (year's 2016 and 2017) review and interview with the laboratory director and testing personnel on May 17, 2018 at 10:28 AM, it was determined that the pathology laboratory did not performed the environmental vapor analysis. The findings include: 1. The environmental vapor analysis record showed that the last laboratory vapor analysis was performed in year 2017 (April 11, 2017). 2. The laboratory director stated on May 17, 2018, that the vapor analysis for year 2017 (April 11, 2017) were not done. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on personnel records, environmental vapor analysis records review and interview with the laboratory director and testing personnel on May 17, 2018 at 10:28 AM, it was determined that laboratory director failed to ensure compliance with the 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 -- requirements for facility administration. The finding includes: 1. The laboratory director did not assure that the: a. pathology laboratory did not performed the environmental vapor analysis. Refer to D3001. -- 2 of 2 --