Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on the surveyor's review of College of American Pathologists (CAP) proficiency testing (PT) records for all three events of 2017, and the first and second events of 2018, and an interview with a testing person, the laboratory failed to rotate the PT samples among all testing personnel who routinely perform hematology testing on the hematology instrument. Findings: A review of the PT attestation statements confirmed that 5 out of 5 hematology challenges were tested by the same testing person. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the surveyor's review of laboratory policies, the personnel competency evaluation records, and an interview with a testing person, the laboratory failed to follow the laboratory's written policies and failed to perform annual competency reviews of the testing personnel for the 2017 calendar year. 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 -- D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's procedure manual and an interview with a testing person, the laboratory failed to follow the laboratory's established written Quality Assessment (QA) policy and procedure to monitor, assess, and when indicated, correct problems. FINDINGS: A testing person confirmed on October 11, 2018, at approximately 11:30 AM, that the laboratory failed to perform and document an annual QA review for all phases of hematology testing for the 2017 calendar year. PLEASE NOTE: This is a recited deficiency from the onsite survey conducted on November 01, 2016. 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: Based on the surveyor's review of the laboratory's policy/procedure manual and an interview with a testing person, the laboratory director failed to ensure that the laboratory's quality assessment (QA) policy/procedure was followed. Refer to: D5291 PLEASE NOTE: This is a recited deficiency from the onsite survey conducted on November 1, 2016. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on the surveyor's review of personnel records and an interview with a testing person, the laboratory director (acting as the technical consultant) failed to perform annual competency evaluations for the testing personnel for the 2017 calendar year. Refer to: D5209 -- 2 of 2 --