Raleigh Group Pc

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 observation of the laboratory, patient test record review, procedure manual review, and staff interviews, the laboratory failed to ensure the laboratory director approved the procedure manual for the Beckman Coulter DxH 500 complete blood count (CBC) instrument prior to patient testing which began on 05/30/2023. The findings include: 1. Observation of the laboratory on 01/24/2024 at 9:30 am revealed the Beckman Coulter DxH 500 CBC instrument (serial 83196896) in use for patient testing. 2. Review of patient test records revealed the first patient (patient #99384) reported on 05/30/2023. 3. Review of the operator's procedure manual "Instructions for Use" for the Beckman Coulter DxH 500 CBC instrument revealed the laboratory director had not approved the procedure. 4. Interview with the technical consultant and testing person one on 01/24/2024 at 12:30 pm, confirmed the Instructions for Use manual was used as the laboratory procedure for performance of CBC testing on the Beckman Coulter DxH and it had not been approved by the laboratory director. 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 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 observation of the laboratory, review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155), the laboratory's proficiency testing (PT) records, and interview with the technical consultant, the laboratory failed to participate in proficiency testing for complete blood count (CBC) for 2022 event one. The findings include: 1. Observation of the laboratory on 06/20/22 at 8:00 am revealed the Beckman Coulter AcT Diff CBC instrument on the counter in use for patient testing (system ID 503003). 2. Review of the form CMS 155 revealed no proficiency testing scores for 2022 event one. 3. Review of the laboratory's PT records revealed a lack of proficiency testing records for 2022 event one. 3. Interview with the technical consultant on 06/20/22 at 1 pm confirmed the laboratory failed to participate in proficiency testing for 2022 event one for CBC but was performing patient CBC testing during the period. D5459 CONTROL PROCEDURES CFR(s): 493.1256(d)(5)(g) 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 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Each electrophoretic procedure include, concurrent with patient specimens, at least one control material containing the substances being identified or measured. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory's quality control records, review of an email communication and interview with the technical consultant, the laboratory failed to verify the correct instrument was selected when entering quality control (QC) ranges in the complete blood count (CBC) instrument, resulting in the use of incorrect QC ranges from 05/04/20 to 06/20/22 with approximately 2,300 patients tested during the affected period. All lots used during the period were affected. The findings include: 1. Observation of the laboratory on 06 /20/22 at 8 am revealed the Beckman Coulter AcT Diff CBC instrument on the counter in use for patient testing (system ID number 503003). 2. Review of the laboratory's CBC quality control records, including cumulative reports and manufacturer assay sheets, from 05/04/20 to the date of the survey on 06/20/22, revealed the laboratory used the stated QC ranges for the Beckman Coulter AcT Diff 2 instead of the Beckman Coulter AcT Diff instrument. The laboratory did not verify the correct instrument QC ranges were used. All lots used during the period were affected. 3. Review of an email received from the laboratory on 06/23/22 revealed approximately 2,300 patients were tested during the period the incorrect QC ranges were in use. 4. Interview with the technical consultant on 06/20/22 at 1 pm confirmed the laboratory uses the manufacturer stated QC ranges and failed to verify the correct instrument was used when entering control ranges in the instrument, resulting in the use of incorrect quality control ranges from 05/04/20 to 06/20/22 with all lot numbers used during the period affected. -- 2 of 2 --

Summary Statement of Deficiencies D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) 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. (c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed. This STANDARD is not met as evidenced by: Based on review of the written delegation form, the proficiency testing (PT), quality control (QC), quality assessment (QA), personnel records and interview with the current technical consultant, the laboratory director failed to delegate in writing the responsibilities of the laboratory director, in 2017 and 2018. The findings include: 1) Review of the April 6, 2015 written delegation form signed by the laboratory director revealed that technical consultant number 2 was not included. 2) Review of the PT, QC, QA, and personnel records revealed that technical consultant number 2 performed the laboratory director duties beginning July 17, 2017 to March 23, 2018. 3) Interview on January 8, 2019 at 2:30 p.m. with the current technical consultant confirmed technical consultant number 2 performed the PT, QC, QA, and personnel duties of the laboratory director from July 17, 2017 to March 23, 2018 with no written delegation of duties by the laboratory director. 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 --