Psh Hampden Medical Center Poct

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 and interviews with the laboratory coordinator point of care (LC-POC) #1 and laboratory coordinator point of care (LC-POC) #2, 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 chemistry, diagnostic immunology and hematology testing were performed from 10/21/2021 to the date of the survey. 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. The laboratory performs patient testing Monday through Sunday from 12:00 am to 11:59 pm according to the information in the CMS-116 form. 3. Review of the laboratory personnel report (Pennsylvania State) form on 09/28/2023 showed that the personnel #2, personnel #3 and personnel #4 act as the general supervisor for the laboratory. 4. On the day of the survey, 09/28/2023 at 11:55 am, during an interview, the LC-POC #1 and LC-POC#2 stated that the laboratory did not have a qualified supervisor onsite for every hour of patient testing according to chapter 5 section 5.23 of the Pennsylvania State regulations for clinical laboratories. 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 review of the Abbott istat analyzer validation records and interview with technical consultant (TC) #1, the laboratory failed to demonstrate and document the performance specifications of precision and accuracy for chemistry analytes performed on the Abbott istat Chem 8+ Cartridges used from 10/01/2021 to 10/21 /2021. Findings Include: 1. On the day of survey, 10/21/2021, review of the Abbott istat Chem 8+ Cartridge validation records revealed, the validation performed on 08/31 /2021 did not include performance specifications for precision and accuracy. 2. From 10/01/2021 to 10/21/2021, 53 patients were analyzed on the Abbot istat. 3. TC #1 confirmed the finding above on 10/21/2021 around 09:55 a.m. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure and interview with Technical Consultant (TC)#1, the laboratory failed to establish a procedure to evaluate biannual relationship between 7 of 7 Abbott Istat analyzers using the chem8+ cartridges from 10/1/2021 to 10/21/2021 Findings include; 1. On the day of survey 10/21/2021, the laboratory could not provide a procedure to evaluate the biannual relationship between 7 of 7 Abbott Istat analyzers from 10/01/2021 to 10/21/2021. 2. The TC#1 confirmed the finding above on 10/21/2021 at 10:05 a.m. -- 2 of 2 --