Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record and patient sample log review and interview with the technical consultant (TC), the laboratory did not handle hematology PT specimens in the same manner as patient samples. Findings: 1. All patient samples which enter the laboratory are recorded on a patient log. 2. During an interview on 2 /20/18 at 11:15 AM, the TC stated that hematology PT samples were not listed individually on the patient log in the same manner as patient specimens. 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 maintenance log record review and interview with the technical consultant Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (TC), the laboratory failed to ensure that the lot numbers and expiration dates of hematology reagents were documented to ensure that they are not used when they have exceeded their expiration date. Findings: 1. The laboratory documents the lot number and expiration date of the hematology reagents on the bottom of the "Instrument Maintenance Sheet." The form instructs testing personnel to "Complete information below when replacing pocH-100i reagents." 2. Instrument Maintenance Sheets from November, 2017 to January, 2018 were reviewed. The Instrument Maintenance sheet for December, 2017 showed that the "pocH-pack L Reagent" was put on the instrument on 12/11/17 and expired 1/24/18; and 3. The Instrument Maintenance Sheet for January, 2017 did not show that a new "pocH-pack L Reagent" was recorded or put on the instrument. 4. During a tour of the laboratory at 11:45 AM, it was observed that there was a "pocH-pack L Reagent" in use that was not expired, but not logged on the Instrument Maintenance Sheet. 5. During an interview on 2/20 /18 at 12:30 PM, the TC confirmed that the lot numbers and expiration dates of all hematology reagents used in the laboratory were not documented on the Instrument Maintenance Sheets. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: I. Based on review of the standard operating procedure manual (SOPM), quality assurance (QA) plan, QA records, and interview with the technical consultant (TC), the laboratory director (LD) failed to ensure that the QA plan was maintained to identify failures and