Summary:
Summary Statement of Deficiencies D0000 An entrance conference was held 11/14/2019 with the Office Manager. The survey process was discussed. An opportunity for questions and comments was given. Based upon the onsite survey conducted 11/14/2019, this facility was found NOT to be in compliance with CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 493.1215 Hematology 493.1403 Laboratory Director Moderate Complexity Testing An exit conference was held on 11/14/2019 with the laboratory director. The exit conference attendee was advised the laboratory was out of compliance and advised of conditions and deficiencies found during the survey. An opportunity for questions and comments was provided. 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 review of proficiency testing records for American Proficiency Institute (API) 2019 Hematology/ Coagulation 2nd Event dated 7/18/2019 the laboratory did not test the proficiency testing samples in the same manner as it would a patient sample. The findings were: 1) API proficiency attestation statement showed on 7/18 /2019 testing personnel #3 performed testing on proficiency samples QBC-6, QBC-7, QBC-8, QBC-9, and QBC-10. 2) API proficiency attestation statement showed on 7/18 /2019 testing personnel #2 performed testing proficiency samples QBC- 6, QBC-7, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- QBC-8, QBC-9, and QBC-10. 3) In interview on 11/14/2019 @1145 hours testing personnel #3 stated "(Testing personnel #2) does all of the PT testing, if you see our two initials we did it together. She was showing me how to do it." D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) documents the laboratory failed to maintain a copy of all records for 2018 Hematology/Coagulation - 1st Event. The findings were: 1) The surveyor requested proficiency records for 2018 Hematology/ Coagulation- 1st Event on 11/14/2019 @1000 hours. 2) API internet entry records were furnished by the laboratory director @1025. The surveyor requested raw data for the proficiency event. 3) The laboratory director returned @ 1030 hours and stated "It may be up in the attic. I will have to send an employee to look for it." 4) Requested documents were not produced by the close of survey. This is a repeat deficiency from 10/24/2017 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) documents of 2018 and 2 events of 2019 the laboratory failed to attain a score of at least 80 percent of each analyte in testing event of 2018 Hematology/Coagulation - 3rd Event for WBC. The findings were: 1. Proficiency testing results revealed that the laboratory attained a score of 60 percent for WBC on 2018 Hematology/Coagulation - 3rd Event. 2. Interview with the laboratory director on 11/14/2019 @1215 hours confirmed that the laboratory failed to attain an acceptable score of at least 80 percent. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, -- 2 of 14 -- remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute proficiency documents for 2018 and 2019 the laboratory failed to undertake and document remedial action, or provide training or technical assistance to correct problems for the unacceptable score of 60 percent in 2018 Hematology/Coagulation - 3rd Event for WBC. The findings were: 1. Proficiency testing results revealed that the laboratory attained a score of 60 percent for WBC on 2018 Hematology/Coagulation - 3rd Event. 2. Review of 2018 Hematology/Coagulation - 3rd Event Proficiency Testing Performance Evaluation showed no documentation of remedial action, training or technical assistance to correct problems associated with proficiency testing failure. 3. Documentation of remedial action was requested by the surveyor on 11/14/2019 @1215 hours. 4. In interview with the laboratory director on 11/14/2019 @ 1215 hours the laboratory director stated "I attempted to go back to rerun the samples but they had been thrown out." D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the QBC logs, QBC instrument quality control (QC) daily printouts, and in interview with staff, the laboratory failed to retain QBC instrument printout for a QC failure on 06/29/2018. Findings included: 1. Review of QBC logs for QC Level 1 (Lot #Q535-1) included a documented comment on 06/29/2018 at 11: 15 am that stated, "ERROR OUT OF RANGE" and "Repeat run in range." 2. Review of the QBC instrument quality control (QC) daily printouts for 06/29/2018 included 1 daily printout, which was the QC that was in range. The daily printout that was out of range was not available. The values of the out of range QC was unknown. The laboratory did not ensure all QC daily printouts, including out of range data, were retained for at least 2 years. 3. During the exit conference on 11/14/2019 at 4:30 pm, the laboratory director reviewed and confirmed the above findings. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory's policy manual, QBC Diagnostics Hematology Control Kit manufacturer's instructions, QBC logs, control assay sheets, QBC instrument quality control (QC) daily printouts, and patient QBC test results, the -- 3 of 14 -- laboratory failed to meet the requirements of the specialty of hematology, as evidenced by: 1. The laboratory used expired control material on the QBC analyzer and analyzed/reported 4 patient test results on 01/24/2018. Refer to D5417. 2. The laboratory reported 63 QBC hematology patient test results when results of control material did not meet the manufacturer's criteria for acceptability for 13 of 62 days from 01/04/2018 through 10/07/2019. Refer to D5481. 3. The laboratory failed to document