Oncology & Radiation Associates Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Oncology & Radiation Associates PA on 2/9/2024 -2/27/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6063 Laboratory Testing Personnel 493.1421 D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record review and interview the Laboratory failed to verify the foreign equivalency for diploma for 1 (#C) of 3 Testing Person reviewed. (See D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and 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 the Laboratory failed to verify the foreign equivalency for diploma for 1 (#C) of 3 Testing Person reviewed. Findings include: Review of Testing Person #C's education revealed a foreign diploma. There was no foreign equivalency performed on the diploma. Testing Person #C's date of hire was 8 /13/2018. Interview on 2/27/24 at 11:28 a.m., via email the Office Manager confirmed that Testing Person #C did not have a foreign equivalency for her diploma. -- 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 observation, record review and interview, laboratory failed to check and monitor room temperature and humidity from June 2016 to May 11, 2018. The findings include: On 5/11/18 at 1:00 PM, surveyor did not observe humidity check/ room temperature monitoring device in the laboratory. Instrument maintenance records from June 2016 to May 11, 2018 did not show records of humidity check and room temperature for the laboratory. During an interview on 5/11/18 at 1:30 PM, testing person confirmed that the laboratory did not monitor the room temperature or humidity from June 2016 to May 11, 2018 and there was no humidity check/ room temperature monitoring device in the laboratory. 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 --