Gothenburg Memorial Hospital

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's procedures, review of the laboratory's new analyzer, and interview with the laboratory manager on 9/5/2024 at 12:43 PM, the laboratory failed to have a procedure signed by the laboratory director for the laboratory's new chemistry analyzer. 1. Surveyor review of the laboratory's procedures revealed a procedure for the laboratory's previous chemistry analyzer. 2. Review of the laboratory's new analyzer revealed the laboratory began using the new chemistry analyzer on 4/1/2024. 3. Interview with the laboratory manager, confirmed the laboratory did not have a procedure signed by the laboratory director for the new chemistry analyzer. 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 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of list of tests performed, surveyor review of proficiency testing (PT) records, a lack of any verification records, an interview with the laboratory supervisor, the laboratory failed to have a system for verifying the accuracy of the testing for vaginal wet preparations, potassium hydroxide (KOH) preparations, and direct antiglobulin test (DAT). The findings include: 1. Review of the laboratory's list of tests performed revealed the laboratory had performed testing for vaginal wet preparations, KOH preparations, and DAT in 2019 and 2020. 2. The laboratory's proficiency test results for 2019 and 2020 did not include testing for vaginal wet preparations, KOH preparations, and DAT. 3. Interview with the general supervisor on 5/6/2021 at 10:29 AM confirmed the laboratory had not enrolled in PT for vaginal wet preparations, KOH preparations, and DAT, nor had the laboratory performed accuracy verification for these analytes. 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 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 desk review of proficiency testing for 2019, this laboratory had unsatisfactory performance for the sub specialty of endocrinology with the overall scores for the first event 2019 (score 73%) and the second event 2019 (score 73%). See D2099. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory 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 -- performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review and the laboratory's graded PT results from American Proficiency Institute, the laboratory failed to attain an overall testing event score of at least 80%. Findings include: 1. 2019 first event, subspecialty - endocrinology, score of 73% 2. 2019 second event, subspecialty - endocrinology, score of 73% -- 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 review of the demonstration of performance specifications and an interview with the general supervisor at 12:25 PM on 9/11/2018, the laboratory failed to demonstrate the accuracy for a new erithrocite sedimentation rate (ESR) instrument. Findings are: 1. Review of the validation of performance specifications for a new ESR instrument (started on 9/29/2017) revealed no checks for accuracy had been included in the instrument validation. 2. Interview with the general supervisor confirmed a test comparison with another laboratory or instrument had not been performed prior to patient testing. D6085 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3) The laboratory director must ensure that the test methodologies selected have the capability of providing the quality of results required for patient care. This STANDARD is not met as evidenced by: Based on a lack of procedure, a review of manufacturer's instructions and an interview 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 -- with the general supervisor at 1:25 PM on 9/11/2018, the laboratory failed to have adequate newborn testing procedures. Findings include: 1. No procedure could be presented at the time of survey for the steps taken for newborn screening for Rh/D negative mothers. 2. Review of the manufacturer's instructions for the Micro Typing System used by the laboratory revealed that it was unable to detect weak D antigen. 3. The general supervisor stated routine follow up testing was not routinely performed for fetal maternal bleeding on Rh positive babies born to Rh negative mothers unless the physician suspected a larger than normal bleed and ordered it specifically. The general supervisor also stated that weak D testing had not been sent out on Rh negative babies born to Rh negative mothers. -- 2 of 2 --