Herington Hospital, Inc

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 the review of proficiency testing (PT) records from American Proficiency Institute (API), the laboratory failed to successfully participate in PT under the specialty Routine chemistry for the regulated analyte: pO2 blood gas. (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 desk review of proficiency testing (PT) from the provider API for Chemistry, and phone interview, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analyte: pO2 blood gas. Findings: 1. Review of API PT scores for 2022 Event 3 revealed a 60% performance score for pO2 blood gas. 2. Review of the API PT scores for 2023 Event 1 revealed a 60% performance score for pO2 blood gas. 3. Phone interview with the lab manager on 4/4/23at 7:55 a.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analyte: pO2 blood gas. -- 2 of 2 --

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 the lack of documentation of performance verifications, non-waived test list, and interview with the Laboratory Director (LD) and Laboratory Manager, the laboratory failed to perform a validation/verification on Quidel's Solana analyzer performance specifications prior to reporting patient test results. Findings: 1. Request was made to review the performance verifications of two of two Quidel's Solana analyzer analytes; serial number (S/N) 20022051. No documentation of verification of the manufacturer's performance characteristics for accuracy, precision, reportable range, and normal values appropriate for the laboratory's patient population were made available for two of two analytes performed on the analyzer at the time of survey. 2. Non waived analytes performed were: Group B Screen (GBS) and Clostridioides difficile (C.diff). Laboratory Manager stated the laboratory began reporting patient test results on the analyzer as of 10/21/21. 3. Patient results were released for 12 tests on 12 patients from 10/21/21 to date of survey. 4. Interview with the LD and the Laboratory Manager on 6/6/22 at 10:34 p.m. confirmed, the laboratory failed to perform a verification/validation for Quidel's Solana analyzer performance specifications prior to reporting patient test results. 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 --