Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, instrument print out, and interview with the laboratory technical consultant on December 18, 2024, at 2:40 pm, the laboratory failed to follow CBC test procedure for 1 patient out of 6 patients, reviewed. The findings include: 1. The laboratory used Micros ES60 automated CBC instrument from Horiba to perform CBC test. measure. The instrument print out showed an asterisk (*) following the PLT results and an SCH flag for the sample ID 00322185. To resolve the issue, the test procedure stated, "An asterisk following the parameter PLT indicates that for 3 counts analyzed, all 3 counts are outside of the instrument precision limit. Re-run the specimen to verify results" and "SCH flag: suspect presence of schistocytes or platelet aggregates. Redraw in sodium citrate tube and multiply by 1.1 for platelet results only or send sample to a reference lab". However, the laboratory did not repeat the specimen to verify results and did not redraw in sodium citrate tube or send out to a reference lab. Instead, the laboratory repeated the test 2 more times with the new specimens from 2 redraws. Hence, the patient went through 3 blood draws. Therefore, the accuracy of the reported PLT results cannot be assured and might have had harmed the patient. In addition, 3 blood draws within 6 minutes might burdened the patient. 2. The laboratory technical consultant on December 18, 2024, at 2:40 pm, affirmed that the laboratory did not follow its procedure for the CBC test. 3. The laboratory's testing declaration form, signed by the laboratory director on 12/12/2024, stated that the laboratory performed approximately 3,250 CBC tests, annually. 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 -- D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, patient test results and interview with the laboratory technical consultant on December 18, 2024, at 2:40 pm, it was determined that the laboratory director failed to direct the overall operation of the laboratory. The findings include: See D5401 and D6070. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, test results and interview with the laboratory technical consultant on December 18, 2024, at 2:40 pm, the laboratory director failed to ensure that the laboratory personnel are performing the test methods as required for accurate and reliable results. The findings include: See D5401 and D6070. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, instrument print out and interview with the laboratory technical consultant on December 18, 2024, at 2:40 pm, it was determined that the laboratory testing person #1 failed to follow the laboratory's procedure for the CBC test. The findings include: See D5401. -- 2 of 2 --