Wellspan Poc Testing

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) records and interview with the nurse navigator (NN) , the laboratory failed to provide 4 of 6 PT attestation statements for routine chemistry signed by the laboratory director or designee in 2021 and 2022. Findings Include: 1. On the day of the survey, 02/03/2023 at 10:15 am, The following AAB PT attestation statements were not signed by the laboratory director or designee in 2021 and 2022. - Routine Chemistry: i-STAT Chemistry : - 2021 Event #2. - 2022 Event #1 - 2022 Event # 2 - 2022 Event # 3 2. The NN confirmed the findings above on 02/03/2023 around 11:30 a.m. 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 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 -- 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 lack of documentation and interview with the nurse navigator (NN), the laboratory failed to determine that the performance specifications for 1 of 1 Abbott iSTAT Chem 8+ Cartridges used for routine chemistry specimens from May 2021 to February 2023 were not affected by the relocation of the laboratory. Findings Include: 1. On the day of survey, 02/03/2023 at 10:00 am, the laboratory could not provide documentation showing that the performance specifications of 1 of 1 Abbot iSTAT were not affected by the relocation of the laboratory from May 2021 to February 2023. 2. From 01/01/2022 to 12/31/2022, 840 patients were analyzed on the Abbot iSTAT Chem 8+ cartridges. 3. The NN confirmed the finding above on 02/03/2023 around 11:30 am. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on lack of competency assessment (CA) records and interview with the nurse navigator (NN), the technical consultant (TC) failed to assess the competency of 4 of 5 testing personnel (TP) for routine chemistry examinations in 2022. Finding Include: 1. On the day of the survey, 02/03/2023 at 09:30 am, the NN could not provide CA records for 4 of 5 TP (CMS 209 personnel #2, #3, #4, and #6) who performed routine chemistry examinations using the iSTAT Chem 8+ cartridges in 2022. 2. The NN confirmed the findings above on 02/03/2023 around 11:30 am. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte Urea Nitrogen (BUN). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in a proficiency testing for the analyte: Urea Nitrogen (BUN), which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 2nd event of 2021 and the 1st event of 2022. Findings include: Analyte Year Event Score BUN 2021 2 20%. BUN 2022 1 0%. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the istat quality control (QC) records, and interview with the manager of point of care testing, PoC team leader, testing personnel (TP) #1, TP#8 and TP#9, the laboratory failed to document QC procedures performed each day of patient testing on 2 of 12 days the Abbott istat chem 8 cartridges were in use during the month of February 2021. Findings include: 1. On the day of survey, 03/25/2021, review of the istat chem 8 cartridge QC records revealed, the laboratory did not document QC procedures performed each day of patient testing in February 2021 (2 of 12 days). 2. The laboratory was aware of the days QC was not performed, but failed to document a