Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor record review (Application for Exception to Section 5.22(f)) and interviews with the with the Technical Consultant (TC) and Testing Personnel #4 (TP) (CMS 209 personnel #6), the laboratory failed to ensure that the State of Pennsylvania (PA) regulations were met regarding having a supervisor on site during all normal scheduled working hours in which tests are being performed. Findings include: 1. The PA regulations (5.23 (b)(1)) states: "A general supervisor who meets all the requirements of subsection (a)(1), (2) or (3) and is on the laboratory premises during all normal scheduled working hours in which tests are being performed." 2. Review of the application for Exception to Section 5.22 (f) form signed by the laboratory director (LD) on 09/12/2022 states: " the laboratory director will appoint a qualified general supervisor for each laboratory who will be on-site to oversee laboratory operations during all hours in which testing is being performed and who will review quality control records on a weekly basis". 3. On the day of survey 06/27/2023 at 11:38 am, during an interview, TC stated that the laboratory did not have a qualified supervisor onsite for every hour of patient testing as required by the State of PA. 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) 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 -- (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 review of the validation records and interviews with the Technical Consultant (TC) and Testing Personnel #4 (TP) (CMS 209 personnel #6), the laboratory failed to establish--before reporting patient test results-performance specifications at the laboratory's physical location for total protein testing using the Reichert TS Meter-DSP analyzer from 07/05/2022 to the date of the survey. Findings include: 1. On the day of survey, 06/27/2023 at 10:09 am, TC stated that "the initial validation studies for the Reichert TS Meter-DSP analyzer were performed at BioSpecComp LLC d/b/a Biolvt LLC laboratory's Colmar location." 2. The laboratory did not establish performance specifications of accuracy, precision, reportable range and reference intervals (normal values) at laboratory's physical location where the patient testing is being performed. 3. The TC and TP#4 confirmed the findings above on 06/27/2023 around 12:00 pm. -- 2 of 2 --