Summary:
Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) records and an interview with the laboratory director and the testing person, the testing personnel failed to adhere to the laboratory's policy for the acceptance of QC material tested on the Beckman Coulter AcT Diff. Findings Include: It was confirmed with the laboratory director and testing person on April 25, 2019, at approximately 12:10 PM that the testing personnel failed to follow the laboratory's written QC policy and have all three levels of QC material come within acceptable range prior to patient testing. On the following days, the following parameters were out of acceptable range, on two days controls were not tested and remediation was not performed. November 15, 2018 - Platelets & WBC - 7 patients tested; March 26, 28 & 2, 2019 - Platelets - 46 patients tested; High Control: March 19, 21, April 22 & 25, 2019 - Platelets - 25 patients tested; March 26 & April 2, 2019 - Control not tested Approximately 78 patient samples were tested and results reported during this time. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on a review of patient test records, and an interview with the laboratory director and testing person, the laboratory failed to have records that identify the person who performed the hematology test using the Coulter Beckman AcT Diff. Findings Include: On April 25, 2019, at approximately 2:15 pm and confirmed with the laboratory director and testing person, six of six electronic test reports reviewed failed to maintain a record system that includes the identity of the person who performs hematology patient testing. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) records and an interview with the laboratory director and the testing person, the director failed ensure that the QC program for hematology was maintained to assure quality laboratory services. Refer to D5481 D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of patient charts and an interview with the laboratory director and testing person, the director failed to have the laboratory maintain an information or record system that includes the identity of the person who performs patient testing. Refer to D5787 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 -- 2 of 3 -- 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 a review of personnel records and an interview with the laboratory director and testing person, it was found on April 25, 2019, at approximately 11:15 am, the laboratory director failed to ensure that appropriate training was documented for one of two testing personnel who performs the moderate complexity test for hematology. 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's review of hematology QC records, and an interview with the laboratory director and testing person, the testing personnel failed to adhere to the laboratory's established QC procedures for hematology testing. Findings: It was confirmed with the laboratory director and testing person on April 25, 2019, at approximately 12:10 PM, that the testing personnel failed to follow the laboratory established QC criteria to have all three levels of QC material to come within acceptable range prior to patient testing. -- 3 of 3 --