Summary:
Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Citation One: Based on observation of the laboratory, review of the laboratory procedure manual, quality control (QC) records, patient test records, and staff interview the laboratory failed to follow the procedure for printing and retaining cumulative complete blood count (CBC) QC records for one of four lots reviewed in 2023. The findings include: 1. Observation of the laboratory on 03/27/2024 at 9:30 am revealed a Cell Dyn Emerald CBC instrument used for patient testing. 2. A review of the laboratory procedure titled "Policy for Changing Control Values in the Emerald Cell Dyn" revealed when the laboratory received a new lot of QC for the CBC instrument, the current lot of QC (low, normal, and high) would be printed from the CBC instrument and placed in the QC binder behind the manufacturer package insert for that lot number. 3. A review of the laboratory QC records revealed the use of lot number 3093 from 04/29/2023 to 07/10/2023. There was no documentation that the cumulative QC was printed and maintained for lot 3093. 4. A review of the laboratory patient data logs revealed the following dates that patient CBCs were reported from 04 /29/2023 through 07/10/2023: 05/01/2023 Fifteen patients reported 05/25/2023 Eight 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 -- patients reported 06/01/2023 Ten patients reported 06/14/2023 Nine patients reported 07/05/2023 Ten patients reported 5. Interview on 03/27/2024 at 1:45 pm with the technical consultant confirmed the laboratory failed to follow the procedure for printing and retaining cumulative QC data for control lot 3093 in 2023. Citation Two: Based on observation of the laboratory, review of the laboratory procedure manual, lack of records, patient test records, and staff interview, the laboratory failed to follow the procedure for performing CBC QC before patient testing on 01/11/2024 (one of five dates reviewed). The findings include: 1. Observation of the laboratory on 03/27 /2024 at 9:30 am revealed a Cell Dyn Emerald CBC instrument used for patient testing. 2. A review of the laboratory procedures revealed the following: "Quality Control Program" procedure stated that three levels of quality control are performed daily and two levels must be within confidence limits prior to patient testing. 3. A review of the patient test records revealed patient number one had a CBC reported on 01/11/2024. 4. QC records for 01/11/2024 were not available on the date of the survey (03/27/2024). 5. Interview on 03/27/2024 at 1:45 pm with the technical consultant confirmed the laboratory failed to follow the procedure for performing QC before patient testing on 01/11/2024. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of final patient test reports and staff interview, the laboratory failed to ensure final patient test results for the CBC analyte hematocrit (Hct) percent (%) were accurately transcribed from the CBC instrument printout to the electronic medical record (EMR) for one of five patients reviewed. The findings include: 1. A random review of patient test reports revealed patient number two reported on 11/16 /2022 at 10:33 am. The Hct % result on the instrument printout was 37.5%; the Hct % result which was manually entered into the EMR was 97.5%. 2. Interview on 03/27 /2024 at 1:45 pm with the technical consultant confirmed the laboratory failed to ensure the Hct % results were accurately entered into the patient EMR for patient number two in 2022. -- 2 of 2 --