West Loop Laboratory

Summary Statement of Deficiencies 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 review of laboratory policies, review of accuracy assessment records, and confirmed in interview of laboratory personnel, the laboratory failed to have a policy that defined acceptance criteria for performing split sample accuracy assessments with a reference laboratory. The findings included: Note: There is no commercially available proficiency testing material. Therefore, the laboratory must verify the accuracy of tests that do not have compatible proficiency testing samples offered. 1. Review of the laboratory's policies found no policy available that defined acceptance criteria for evaluating accuracy performed when the laboratory performed split sample accuracy assessments. 2. Review of the laboratory's accuracy assessments from September 2021 through December 2021 found the laboratory performed an in-house CBC and would perform a split sample with a reference laboratory. However, the results were not evaluated against any acceptable criteria to determine if results were accurate. 3. An interview with the testing person on January 26, 2022 at 11:00 hours in the office confirmed the findings. Upon her review of the records, she agreed there was no established acceptance criteria for evaluating the data. D5485 CONTROL PROCEDURES CFR(s): 493.1256(h) If control materials are not available, the laboratory must have an alternative mechanism to detect immediate errors and monitor test system performance over time. 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 -- The performance of alternative control procedures must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory policies, quality control records, patient records, and confirmed in interview of laboratory personnel, the laboratory failed to have a mechanism in place to (A) detect immediate errors and (B) monitor test system performance over time for 150 patients tested for CBC (complete blood count) from August 1, 2021 through January 5, 2022. The findings included: A. No mechanism in place to detect immediate errors 1. Review of laboratory policy titled, "Quality Assurance Reviews" stated, "The nurse shall make sure controls on the QBC are run daily and appropriately documented. She shall also document the patient results and if the results are awry, she should re-run the test and appropriately so document. The results should be immediately available to the physician..." 2. Review of quality control records found the laboratory did not have an alternate mechanism in place to detect immediate errors from August 1, 2022 through January 5, 2022. 3. Review of patient records from August 1, 2022 through January 5, 2022 found the laboratory tested 150 patients when it did not have an alternate mechanism in place to detect immediate errors (see patient alias list - QBC Autoread Results of Patients Run from August 1, 2021 through January 5, 2022). 4. An interview with the testing person on January 26, 2022 at 10:30 hours in the office confirmed the findings. She stated that she does periodic split samples with a reference laboratory and thought that covered the alternate mechanism. B. No mechanism in place to monitor the test system's performance over time 1. Review of laboratory policy titled, "Quality Assurance Reviews" stated, "Each month the nurse should review all aspects of quality control and quality assurance and she should document any problems encountered and how they were resolved on the quality assurance. 2. The laboratory did not perform at least two levels of quality control testing each day of patient testing. Therefore, there were no records that could be reviewed monthly. a. The laboratory did not have a mechanism in place to detect errors over time. 3. The laboratory was asked to provide documentation of having a mechanism in place to detect errors over time. No documentation was provided. 4. An interview with the testing person on January 26,2022 at 10:00 hours in the office confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: . Based on review of College of American Pathologists (CAP) proficiency testing (PT) documentation for 2019, confirmed by staff interview, the laboratory failed to participate in PT for hematology in the 1st event of 2019. Findings: 1. During document preparation for the survey, it was noted that no PT results for hematology were available for the first event of 2019. 2. On inquiry, testing person 1 (CMS form 209) stated that in a telephone conversation with the vendor supplying PT near the end of the previous year, she had given verbal authorization to continue purchase of CAP PT for 2019, and that the vendor had failed to complete the order to reenroll. 3. In an interview at the site on 07-24-2019, testing person 1 confirmed that no PT for hematology was performed for the 1st event of 2019. . D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance 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 -- (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on review of CAP PT documentation for 2017 and 2018, confirmed by staff interview, the laboratory failed to verify the accuracy of hematology testing assigned proficiency testing scores that did not reflect laboratory test performance. Findings: 1. CAP hematology PT results for the 3rd event of 2017 and 1st, 2nd and 3rd events of 2018 were reviewed. In all events for Centrifugal Hematology, scores for White Blood Cell Count, Hemoglobin, Hematocrit and Platelet Count were graded with a coded result, (20). 2. Review of the evaluation cover sheets for the above testing events revealed the following notation: LEGEND: Exception codes appearing in this evaluation: (20)=No appropriate target/response cannot be graded. 3. Review of the evaluation reports for the above testing events showed that in each case the number of laboratories participating was less that 10. A minimum of 10 reporting participants is required for PT providers to score any analyte. 4. In an interview at the site on 07-24- 2019, testing person 1 stated that she was unaware of the requirement to verify the accuracy of unscored PT results. No alternate method was employed for accuracy verification of the analytes not scored. . D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: . Based on surveyor observation, review of CAP PT documentation for 2019 and staff interview, the laboratory director (CMS form 209) failed to ensure the laboratory was enrolled in an approved proficiency testing program for hematology in the first event of 2019. Refer to D2123. -- 2 of 2 --