Goldenpoint Solutions Llc

Summary Statement of Deficiencies D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) results from the College of American Pathologists (CAP), and interviews with the Technical consultant (TC) #1, TC #2, and with Testing personnel (TP) #1, the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Iron, an analyte in the specialty Chemistry. The laboratory failed two consecutive PT events in 2024 and 2025, resulting in an initial unsuccessful proficiency testing performance. The findings include: 1. A review of CAP PT results revealed the laboratory received failing scores for Iron in two consecutive PT events, as follows: a) 2025 Survey - Chemistry Event 3: 60% Iron b) 2026 Survey - Chemistry Event 1: 60% Iron 2. The above findings were confirmed during an interview with the TC #1, TC #2, and TP #1 on 8/6/26 at 5:00pm. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor review of maintenance records for the Cobas c501 and the Cobas 6000 Chemistry analyzers, and an interview with Testing personnel (TP) #1, the 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 -- laboratory failed to document monthly maintenance for the Cobas c501 and Cobas 6000 and the weekly maintenance for the Cobas 6000. Weekly maintenance for the Cobas 6000 was not documented for 19 of 25 months reviewed in 2024 through 2026. Monthly maintenance for 2024-2026 was not documented as follows: a) Cobas c501 for 3 of 25 months, b) Cobas 6000 for 4 of 25 months. The findings include: 1. A review of the maintenance records for the Cobas c501 revealed no documentation of monthly maintenance for the following months: a) December 2024 b) August 2025 c) November 2025 2. A review of the maintenance records for the Cobas 6000 revealed no documentation of monthly maintenance for the following months: a) December 2024 b) January and April 2025 c) July 2026 3. A review of the maintenance records for the Cobas 6000 revealed no documentation of weekly maintenance for the following months:: a) December 2024 b) January to July, and September to December 2025 c) January to July 2026 4. The above findings were confirmed during an interview with the TP #1 8/6/26 at 3:00pm. -- 2 of 2 --

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 --