Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bons Secours Maryview Medical Outpatient Infusion Center on January 17, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of the laboratory's 2017 and 2018 hematology proficiency testing (PT) documentation, and an interview, the laboratory failed to retain the attestation statement signed by the laboratory director (LD) for one (1) of six (6) events reviewed. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT documentation, a total of 6 events, revealed no LD attestation statement for the 2018 Event 1. The inspector requested to review the attestation documentation. No documentation was available for review. 2. In an exit interview with the Point of Care Coordinators, Practice Manager, and Laboratory Administrator at approximately 2:00 PM , it was confirmed the findings as outlined above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 a review of proficiency testing (PT) records and an interview, the laboratory failed to attain a score of at least eighty (80) percent (%) of acceptable responses for three (3) out of six (6) hematology analytes on the 2018 third (3rd) testing event. Findings include: 1. Review of the laboratory's 2017 and 2018 American Proficiency Institute (API) PT records (a total of 6 events reviewed) revealed scores of less than 80 % for the following hematology analytes in the 2018 3rd event: 60% Score -Red Blood Cell count (RBC): HSY -13 unacceptable, HSY-14 unacceptable; 60% Score- Hematocrit (HCT): HSY-13 unacceptable, HSY-14 unacceptable; 60% Score- Hemoglobin (HGB): HSY -13 unacceptable, HSY-14 unacceptable. 2. In an interview with the Point of Care Coordinators, Practice Manager, and Laboratory Administrator at approximately 2:00 PM , it was confirmed that the laboratory received unsatisfactory scores as outlined above. 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, 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 a review of the proficiency testing (PT) records, procedure manual, and an interview, the laboratory failed to document remedial action taken for the unsatisfactory third (3rd) Hematology testing event in calendar year 2018. Findings include: 1. Review of 2017 and 2018 American Proficiency Institute (API) hematology PT test result documentation (a total of six events) revealed no evidence of remedial action for the following unsatisfactory analyte scores on the 2018 3rd Event: 60% Red Blood Cell count (RBC): HSY -13 unacceptable, HSY-14 unacceptable; 60% Hematocrit (HCT): HSY-13 unacceptable, HSY-14 unacceptable; 60% Hemoglobin (HGB): HSY -13 unacceptable, HSY-14 unacceptable; with an overall unsatisfactory Hematology event score of 76%. 2. Review of the laboratory's procedure manual revealed a policy (Policy Number OPIC.0012 Version 1.3 Evaluating Proficiency Testing Results) which stated, "document the causes and