Summary:
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 observation of Histopathology chemicals/reagents during survey 8/29/18, lack of documentation of receipt dates, lot numbers, open dates and expiration dates and upon interview with the primary Histotechnologist, determined the laboratory failed to retain documentation of receipt dates, lot numbers, open dates and expiration dates of chemicals used since 2017. The findings include: 1. Observation during survey 8/29 /18 at approximately 10:30 a.m. of Histopathology chemicals/reagents used in processing Frozen Section specimens. 2. Lack of documentation of receipt dates, lot numbers, open dates and expiration dates for chemicals used in processing since 2017. 3. Interview at approximately 10:30 a.m. August 29, 2018 with primary Histotechnologist, confirmed the laboratory failed to retain documentation of receipt dates, lot numbers, open dates and expiration dates for chemicals used in processing Frozen specimens since 2017. ==================================== 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. 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 review of professional microscope service documentation and interview with the primary Histotechnologist, determined the laboratory failed to have preventive maintenance performed on the microscope for 2017 and 2018. The findings include: 1. Review of the professional microscope service documentation was lacking for 2017 and 2018. 2. Preventive maintenance had not been performed on the microscope for the two year period. 3. Interview at approximately 12:30 p.m. August 29, 2018 with primary Histotechnologist confirmed the preventive maintenance had not been performed on the microscope for the two year period. ==================================== -- 2 of 2 --