Kings Daughter's Medical Center

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and an interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to ensure policies and procedures were approved, signed and dated before use. This deficient practice had the potential to affect 23,240 patients tested under the specialties of Hematology and Chemistry from 06/01/2021 to 08/09/2021. Findings Include: 1. An email submitted on 04/05/2023 at 3:51 PM from the TC stated a new LD had assumed the role on 06/01/2021 but the laboratory had not submitted a Form CMS-116 notifying CMS of the change. 2. Review of the laboratory's "General Procedure Manual" table of contents provided on 04/11/2023 via electronic mail (email) revealed an LD approval signature and date of 08/09/2021. 3. During a telephone interview on 04/12/2023 at 11:20 AM, the TC confirmed policies and procedures were not approved, signed and dated by the new LD before use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 interviews with the Executive Director of Diagnostic Services (EDDS), and Testing Personnel (TP), the laboratory failed to have an adequate system in place to ensure the hematology results were accurately and reliably sent to the final test report. This deficient practice had the potential to affect 71,720 test results under the subspecialty of hematology. Findings Include: 1. Review of 2 of 2 of the laboratory's test records indicated complete blood count results reported. 2. The surveyor requested documentation of periodic verification of accurate and timely reporting of the complete blood count test results within the laboratory's information system.. 3. The EDDS and TP#1 confirmed there was no available documentation to verify results /data were accurately entered into the laboratory's information system. The interviews occurred on 05/23/2019 at 11:10 AM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --