Platinum Management Llc

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) (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 record review and interview with testing personnel #2, the laboratory failed to ensure its activated clotting time (ACT) testing results were reported and documented as part of the test report for two (Patients #3 and #4) of nine patient test reports reviewed. Findings include: 1. A review of the laboratory's "Movi Preference Card ACT Testing" patient testing logs revealed the following patients received ACT testing: a. Patient #3 received an ACT test on 11/19/24 with a result of 178. b. Patient #4 received an ACT test on 9/14/24 with a result of 140. 2. A review of the laboratory's test reports for Patients #3 and #4 listed above lacked ACT testing results. 3. An interview on 5/19/25 at 10:00 am with testing personnel #2 confirmed ACT testing results for the patients listed above were not documented on the test reports. 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 D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #2, the laboratory failed to ensure its Hemachron Activated Clotting Time test system's accuracy, precision, and reportable range met performance specifications for 6 (March 2023 to October 2023) of 6 months since the laboratory started testing. Findings include: 1. A review of the laboratory's "Method Validation Plan Policy" revealed a section stating, "For each unmodified FDA-cleared method the laboratory will demonstrate, prior to reporting patient test results that it can obtain the performance specifications for accuracy, precision and reportable range, comparable to those established by the manufacturer. The laboratory will also verify that the manufacturer's reference range is appropriate for the laboratory's patient population." 2. A review of the laboratory's EP Evaluator Simple Precision documentation revealed the laboratory performed its precision study using two levels of quality control materials and performed testing 10 times each on both samples. The range for acceptability of the low control was 135.2 to 187.2. The precision data revealed the sixth run had a result of 131. 3. The surveyor requested