Summary:
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 surveyor review of laboratory temperature records and patient logs, and interview with the technical supervisor, the laboratory did not document the temperature of the cryostats two of four days of use in May 2019. Findings include: 1. Review of cryostat temperature records for May 2019 showed documented temperatures for cryostat number 1 and number 2 on only two days, May 1 and May 8, 2019. 2. Review of Mohs patient logs from May 2019 showed the physician, Staff A, performed Mohs procedures on May 1, 8, 15, and 22, 2019. 3. Interview with the technical supervisor, staff A, on May 24, 2019 at 9:50 AM confirmed Mohs procedures were performed on May 15 and May 22, 2019 and confirmed staff did not document the temperatures of the cryostat. 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. 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 surveyor observation of reagents in use in the laboratory and interview with the technical supervisor, the laboratory used Surgipath Scott's Tap Water Substitute Working Solution from February 27, 2019 through May 22, 2019 after the expiration date of January 20, 2019. Findings include: 1. Observation of the staining reagents currently in use in the laboratory revealed one bottle of Surgipath Scott's Tap Water Substitute Working Solution (Reference number 3802901). The bottle showed an opened date of February 27, 2019 and showed the manufacturer's expiration date of January 20, 2019. 2. Interview with the technical supervisor, staff A, on May 24, 2019 at 9:50 AM confirmed laboratory staff used the reagent after the expiration date. D6069 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(a) Each individual performs only those moderate complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities. This STANDARD is not met as evidenced by: Based on surveyor observation of testing supplies and interview with the dermatology manager and the technical consultant, three physicians in the dermatology area performed microscopy procedures that the laboratory director had not authorized. Findings include: 1. Observation of testing supplies in the dermatology area on May 24, 2019 at 10:05 AM revealed a microscope, slides, potassium hydroxide (KOH) reagent, and Chlorazol Black and Toluidine Blue stains. 2. Interview with the dermatology manager, staff B, on May 24, 2019 at 10:05 AM revealed three physicians perform microscopy procedures in the department including KOH and scabies examinations. Further interview revealed procedures were not available for these tests in the department. 3. Interview with the technical consultant, staff C, on May 24, 2019 at 10:30 AM revealed the director had not authorized the performance of microscopy procedures using KOH, Chlorazol Black, or Toluidine Blue in the dermatology area. Further interview confirmed the technical consultant had not been aware of the testing and had not evaluated competency of the staff performing these microscopy procedures. -- 2 of 2 --