Altoona Endocrine Services Llc

Summary Statement of Deficiencies 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 observation of the laboratory microscope, lack of documentation, and interview with manager, the laboratory failed to perform maintenance/ calibration on 1 of 1 microscope used to analyze fine needle aspirates (FNA) microscopic examinations from 09/16/2019 to the day of survey. Findings include: 1. On the day of survey, 09/16/2021, observation of the laboratory microscopes revealed, the microscope did not have a service sticker. 2. The laboratory manager stated, the microscope was purchased in January of 2021, but could not provide records of purchase. 3. The laboratory could not provide previous calibration records for the Amscope T720 microscope used prior to 2021. 4. The laboratory could not provide a microscope maintenance/ calibration procedure. 5. The manager confirmed the findings above on 09/16/2021 around 9:20 am. 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 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 review of test report, reagent expiration instruction, and interview with the laboratory manager (LM), the laboratory used expired Quick Link III in 2018. Findings include: 1. The laboratory Quick Link III instruction concludes as follows: Solution Lot # Expiration (1). Fixation 8061 01-18-2020 (2). Solution 1 3071 03-31- 2015* (3). Solution 2 4133 05-13-2016* *Expired stain reagent 2. The laboratory 2018 patient report summarizes below: Date Patient # Quick Link III 11/01 01, 02 Performed 11/02 03 Performed 11/05 04 Performed 3. Total 4 patient specimens tested using expired Quick Link III reagents (2 of 3) in November 2018. 4. The laboratory reported all these (4 of 4) patient test results. 5. The LM confirmed above findings on 11/06/2018 at 10:30 AM. ====================================== 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 --