Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) complaint survey was completed on August 22, 2019. The laboratory was found not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of the laboratory's policy and procedures, College of American Pathologists (CAP) proficiency testing (PT) records, and interview with the blood bank supervisor (BBS), the laboratory failed to test proficiency testing samples in the same manner as patients' specimens for the specialty of Immunohematology. (Refer to D2006, D2009 and D2010) 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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 review of hematology proficiency test (PT) sample results and staff interview, the laboratory failed to test the PT samples it received from the PT testing program in the same manner it tested patient specimens. Findings include: 1. PT sample result review revealed 2018 Hematology PT sample FH13-07-B (Second Event) was examined twice on 5/15/2018. The analytes were all in normal range. 2. An interview with the hematology lead tech, in the hematology area of the laboratory, on 8/22/2019, at approximately 11:00 a.m., confirmed the aforementioned PT sample was examined in duplicate. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency test (PT) records and interview with the blood bank supervisor (BBS), the laboratory failed to attest the routine incorporation of the College of American Pathologists (CAP) proficiency testing (PT) samples into the patient workload for the specialty of Immunohematology. The findings include: 1. The laboratory did not have a signed attestation statement from the testing personnel - for PT event JAT-B2019 for the specialty of Immunohematology. 2. Testing personnel must attest that PT samples were performed accordingly to the guidelines set forth by the PT provider. 3. The laboratory supervisor confirmed on 08/22/19, at 11:30 AM, in the office, that the testing personnel failed to review and sign the PT attestation statements for the specialty of Immunohematology. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) proficiency testing (PT) documentation, testing worksheets, and an interview with the blood bank supervisor (BBS), the laboratory failed to test transfusion medicine proficiency testing (PT) samples the same number of times that it routinely tests patient samples. The findings include: 1. A review of PT records indicated the PT event JAT-18 was ran on 10/13/18 and 10/9/18 for confirmation. No patient samples were performed in duplicate on 10/13/18 and 10/9/18. Also, JAT-02 was performed on 2/20/19 at 17:51 and repeated the same day at 18:11 for confirmation. JAT-03 was performed on 2/20 -- 2 of 8 -- /19 at 19:49 and repeated the same day at 20:38 for confirmation. 2. CAP's Proficiency Test policy states, "Duplicate analyses are not permitted unless patient samples are tested in the same manner." Repeat analyses of PT samples is only acceptable if patient samples are treated in the same manner. 3. The BBS confirmed on 8/22/2019, at 11:30 AM, in the office, that the laboratory did not test PT samples the same number of times that it routinely tests patient samples. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on surveyor observation of the blood bank specimens and interview with the Blood Bank Supervisor (BBS), the laboratory failed to ensure that the appropriate staff responsible for collecting specimens labeled the tubes with the required information. The findings include: 1. The laboratory received and accepted a blood specimen (#W900567046) on 8/8/19, that did not have the collector's initials on the tube. 2. The laboratory did not document this in their specimen rejection log or