Summary:
Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on Cytology Cytospin centrifuge maintenance worksheet records review (from year 2021 to 2022) and interview with the laboratory director on February 8, 2023 at 11:27 am, it was determined that the laboratory failed to follow the established manufacturer's monthly preventive maintenance when 749 out of 749 cytology patient samples were processed and reported from January 1, 2021 to December 31, 2021: and 289 out of 289 cytology patient samples were processed and reported in the year 2022 on 5 out of 12 moths of year 2022. The findings include: 1. On February 8, 2023 at 10:34 am, the laboratory cytology Cytospin centrifuge maintenance worksheet records were reviewed (from year 2021 to 2022), and showed that the laboratory failed to perform the monthly preventive maintenance which included: grease rubber seal of centrifugal chamber, grease rotor and lube motor shaft. 2. The laboratory failed to perform the cytology Cytospin centrifuge monthly preventive maintenance from January 1, 2021 to December 31, 2021, also during the following months of year 2022: June, July, August, October and December. 3. On February 8, 2023 at 11:27 am, the laboratory director confirmed that the laboratory did not perform the manufacturer's cytology Cytospin centrifuge monthly preventive maintenance from January 1. 2021 to December 31, 2022. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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: 1. Based on Gemini AS Slide Stainer Maintenance worksheet record review (years 2021 and 2022), and interview with the laboratory director on February 8, 2023, at 10: 30 a.m., it was determined that the laboratory failed to follow, the every six months, the established manufacturer's preventive maintenance during years 2021 and 2022. The findings include: a. On February 8, 2023, at 10:30 a.m., the Gemini AS Slide Stainer Maintenance worksheet record review, showed that the laboratory must performed, every six months the filter replacement. The records showed that for year 2021 the laboratory performed the preventive maintenance only in December 2021. The laboratory did not perform any every six months maintenance during year 2022. b. On February 8, 2023, at 11:30 a.m., in interview with laboratory director she confirmed that the laboratory did not perform the manufacturer's preventive during year 2021 and 2022. c.The laboratory processed and reported 12,179 out of 12,179 surgical samples for histology from July 1,2021 to December 31,2022. 2. Based on microtome's maintenance's worksheet record review (from year 2021), and interview with the laboratory director on February 8, 2023, at 10:52 a.m., it was determined that the laboratory failed to follow the established manufacturer's monthly preventive maintenance when 7270 out of 7976 surgical samples for histology were processed from January 1, 2021, to December 31, 2021. The findings include: a. On February 8, 2023, at 10:52 a.m., the microtome's maintenance's worksheet records were reviewed showing that the laboratory failed to perform the monthly preventive maintenance which included: lubricate microtome components w/oil 405. The laboratory had five microtomes. b.The laboratory failed to perform the monthly preventive maintenance in the following microtomes: 1. serial #01-44836: January 2021, February 2021, May 2021, June 2021, and August 2021 (5 out of 12 monthly preventive maintenance). 2. serial #01-44837: January 2021, February 2021, May 2021, June 2021, July 2021, and November 2021. (6 out of 12 monthly preventive maintenance). 3. serial #01-53227: January 2021, February 2021, May 2021, June 2021, July 2021, and August 2021. (6 out of 12 monthly preventive maintenance). 4. serial #01-51368: January 2021, February 2021, April 2021, May 2021, June 2021, July 2021, August 2021, September 2021, October 2021, November 2021, and December 2021. (11 out of 12 monthly preventive maintenance). 5. serial #01-45112: January 2021, February 2021, April 2021, May 2021, June 2021, July 2021, August 2021, and September 2021. (8 out of 12 monthly preventive maintenance). c. During interview with the laboratory director, on February 8, 2023, at 11:30 a.m., she confirmed that the laboratory did not perform the manufacturer's monthly preventive maintenance from January 1, 2021 to December 31, 2021. D5781