Goldenpoint Solutions Llc

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records,

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of the installation and validation records for the Sysmex XN-1000 Hematology analyzer, and an interview with the Technical Consultant, the surveyor determined the Laboratory Director failed to document review and approval of the procedures as verification of the manufacturer's performance specifications before patient testing began. This affected one of three new instruments performing moderate-complexity tests. The findings include: 1. A review of the validation records for the Sysmex XN-1000 Hematology analyzer revealed no documentation (signature and date) of the Laboratory Director's review and approval of the procedures verifying the manufacturer's performance specifications. Patient CBC (Complete Blood Count) testing began on 9/8/2022. 2. During an interview on 10/12/2022 at 2:00 PM, the Technical Consultant stated he had signed the validation because he was the Laboratory Director's designee. The surveyor explained only the Laboratory Director can approve new test procedures; this responsibility cannot be delegated. SURVEYOR ID#32558 Licensure and Certification Surveyor 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 --