Skin Cancer Treatment Center

Summary Statement of Deficiencies D0000 A recertification survey was conducted from January 09, 2025 to January 15, 2025. SKIN CANCER TREATMENT CENTER clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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, record review, and staff interview the laboratory failed to store 100% Reagent alcohol, and Eosin-Y Alcoholic 1% according to Mercedes Scientific Safety Data Sheets (SDS), and Acetone according to the Avantik's (SDS) at least since 01/25/2023. The findings included: 1-During a tour of the laboratory on 01/09 /2025 at approximately 10:45 AM., observed 4 full gallons and 1/2 gallon of 100% Reagent Alcohol, 1/4 gallon of Eosin-Y Alcoholic 1%, and one 3/4 gallon of Acetone under a bench cabinet with a sign "FLAMMABLE". 2-Review of Mercedes Scientific SDS for Reagent Alcohol, 100% (Anhydrous) - MER 1200 and Eosin Y Stain Solution, 1% Alcohol - MER 4131 reagents, stated under Precautionary Statements - Storage, "Store locked up" also in section 7. HANDLING AND STORAGE: Storage Conditions - Store in an approved Flammable Liquids storage area. 3-Review of Avantik SDS for Acetone CAS number 67-64-1, stated under Storage, "Store locked up" also in section 7. HANDLING AND STORAGE: Storage Conditions - Store locked up. 4-Phone interview on 01/15/2025 at approximately 1:15PM, the laboratory director confirmed that the reagents were not stored locked up or in an approved flammable liquid storage area. 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 D0000 A recertification survey was completed on 3/23/2021 at Skin Cancer Treatment Center. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following conditions were not met : 5400- Analytic Systems D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation and interview, the laboratory failed to have Histology reagents that were not expired in the chemical cabinets.(See 5417) D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to have Histology reagents that were not expired in the chemical cabinets. Findings Included: This is a repeated deficiency from 4/4/2019. During an observation of the chemical cabinets 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 -- following Histology reagents were revealed as expired: 1. Eosin Working Solution expired 10/16/19 2. OCT Embedding Matrix for Frozen Sections expired 01/2021 3. Submount mounting medium expired 01/02/2021 4. SafeClear Xylene Substitute expired 08/2020 During an interview on 3/23/2020 at 10:00am, the laboratory director confirmed the histology reagents were expired. -- 2 of 2 --

Summary Statement of 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 record review and interview with the laboratory director, the laboratory failed to document the room humidity for 2 out of 2 years reviewed. Findings include: Review of the cryostat manual Leica CM1510 indicated a requirement for room humidity not above 60 %. Quality control records of histopathology room revealed that: there was no documentation of the humidity during 2017 and 2018. During an interview on 04/04/19 at 11:00 a.m., the laboratory director confirmed that there was no record of room humidity for the years of reference. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory director, the laboratory had 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 -- expired reagents in the cabinet. Findings include: During tour of the laboratory at approximately 10:30 AM on 04/04/2019 the surveyor found: a) Half full bottle of Eosin working solution lot #D238-03 expired 8/27/2016 b) Half full bottle of Hematoxylin Gill 3 lot# 050458 expired 5/2018 c) Partial used Wright Giemsa Stain lot #2269 expired 5/2014 During an interview on 4/4/2019 at 11:30 AM, with the laboratory director, she confirmed the existence of the expired reagents in the cabinet. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 record review and interview with laboratory director, the laboratory failed to perform annual preventive maintenance to microscope and cryostat for 1 out of 2 years reviewed. Findings include: Review of annual maintenance records showed no records of annual preventive maintenance for microscope and cryostat during 2018. During an interview on 4/4/2019 at 11:30 AM, with the laboratory director, she confirmed that there is no documentation that the laboratory performed the annual preventive maintenance for microscope and cryostat during 2018 -- 2 of 2 --