Luminary Dermatology Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Luminary Dermatology PA on 7/1-7/2/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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: Based on observation, review of reagent records, and interview, the laboratory failed to ensure protection from chemical hazards for seventeen months (2/2024 to 7/2025). Findings included; 1. During a tour of the laboratory on 7/1/25 at 11:11 a.m., Xylene Substitute was observed stored in the safety cabinet. The primary container for the Xylene Substitute label included the hazard sign for respiratory and stated under precautionary statements-"Avoid breathing vapors". A laminated sheet was observed in the safety cabinet with the stored reagents which included hazards for each reagent, for Xylene Substitute it stated "Danger! Harmful if inhaled." The manufacturer safety data sheet (SDS), with a revision date of 10/05/2016, for the Xylene Substitute stated to use only outdoors or in a well ventilated area. 2. The histology tech confirmed on 7 /1/25 at 11:11 a.m., the laboratory did not have a fume hood to mitigate exposure to harmful chemical fumes from the Xylene Substitute. The histology tech stated on 7/1 /25 at 11:30 a.m., the laboratory had moved to the current location 2/2024 (specific date unknown) and had not installed a fume hood. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 -- (e)(5) Ensure that the quality control and quality assessment 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 review of the policy and procedure manual, review of records, and interview, the Laboratory Director failed to establish a comprehensive quality assessment program to encompass all aspects of laboratory services from 5/5/23 to 7/1 /25. Findings included: 1. The laboratory Policy and Procedure manual was reviewed and approved by the Laboratory Director 1/20/2025. There was no policy for a quality assessment program approved by the Laboratory Director included in the Policy and Procedure manual. 2. The last documented quality assurance performed by the laboratory was prior to the last survey on 5/5/23. 3. The Laboratory Director on 7/02 /2025 at 8:00 a.m. confirmed the above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Luminary Dermatology PA on 08 /16/21. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of maintenance records, review of the laboratory's procedure manual, review of the cryostat instrument manual, and interview with the Administrator, the laboratory failed to document humidity for 5 of 5 days of testing (3/29/21, 4/26/21, 5 /24/21, 7/12/21, and 8/9/21). Findings Included: Review of maintenance records revealed the humidity percentage was not documented on the 5 days that testing was performed, 3/29/21, 4/26/21, 5/24/21, 7/12/21, and 8/9/21. Review of the Microm cryostat instrument manual revealed that operating conditions require a humidity of less than 60%. Review of the laboratory's procedure "Thermometers/Temperature Controls" dated 4/12/21 revealed that "Temperature and humidity must be taken daily and recorded in the lab." Interview on 08/16/21 at 10:30 AM, the Administrator stated the percent humidity was not recorded because they did not have a device to record humidity. 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 --