Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records, review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with laboratory manager, the laboratory failed to allow testing personnel (TP) who routinely perform complete blood count testing (CBC) on patient samples to participate in four of four proficiency testing events. Findings include: 1. Review of proficiency records since the last survey revealed the 3rd event of 2023 and all 3 events of 2024 were performed by the laboratory manager who does not perform CBCs on patient specimens. TP #1, TP #2 and TP #3 as listed on the CMS 209 form perform CBC testing on patients but did not participate in four of four proficiency testing events. 2. An interview with the laboratory manager on 11/7/2024 at 2:00 p.m., revealed the laboratory manager that performed proficiency testing for the 3rd event of 2023 and all 3 events of 2024 do not routinely perform CBC testing on patients. All CBC testing on patient samples is performed by the testing personnel listed on the CMS 209 form. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. 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 -- This STANDARD is not met as evidenced by: Based on interview with testing personnel (TP) #2 and #3 as listed on the Centers for Medicaid and Medicare Services (CMS) 209 form, review of one Complete Blood Count (CBC) final report along with the corresponding patient purple top tube and the laboratory's labeling policy, the laboratory failed to follow their policy to ensure positive identification of the patient specimen from the time of collection through testing and reporting for CBC results. Findings include: 1. Interview with TP #2 and TP #3 indicated that only the chart number is written on the purple top tube after collection. Testing personnel also confirmed the name and chart number are entered into the Medonic hematology analyzer for CBC testing. The CBC report is then given to the provider. 2. Surveyor observation of 4 of 4 purple top tubes tested on the day of survey contained only the chart number written on the tubes. Surveyor observed 1 of 4 CBC reports to correspond with a purple top tube that had the same number written on it. 3. The laboratory's labeling policy states "All specimens must be labeled with (2) identifiers. At Friendship Medical Clinic the specimens for lab testing must be labeled with the patient's name, chart number, and date of birth". This policy was not being followed. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of laboratory testing personnel (TP) records, the Centers for Medicare and Medicaid Services (CMS) 209 form and interview with the laboratory manager, the laboratory director had not ensured that two of three testing personnel as listed on the CMS 209 personnel form had received the appropriate documented training prior to performing and reporting all testing in the laboratory to include complete blood count (CBC) testing on the Medonic hematology analyzer. Findings Include: 1. Review of laboratory personnel records and lack of training documentation available the day of survey, revealed the following TP had no initial documented training for moderate complexity CBC testing prior to performing testing on patients. a. TP #2 - hire date of 7/24 b. TP #3 - hire date of 8/24 2. Interview with the laboratory manager on 11/7/2024 at 2:00 p.m., confirmed the personnel records for two of three testing personnel containing initial laboratory training was not available for review the day of survey. -- 2 of 2 --