Hospital District No 6 Of Harper County

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based upon a complaint, review of the manufacturer's instructions, lack of documented patient results, lack of documented quality control (QC), lack of documented internal QC results, failure of testing personnel to perform testing utilizing the test analyzer for the determination of test results and interview with the Emergency Department (ED) nurse manager, the laboratory failed to perform the SARS-CoV-2 & Flu A+B assay according to the manufacturer's instructions changing this test system to high complexity. See Conditional Findings: Analytic Systems. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based upon the review of the manufacturer's instructions, lack of approved test procedure, lack of test system verification, lack of documented quality control (QC), Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- lack of documented patient results, and interview with the Emergency Department (ED) nurse manager and technical consultant (TC) #1, the laboratory failed to monitor and evaluate the modified BD Veritor system for SARS-SoV-2 & Flu A+B and correct identified problems for the testing performed. (See D5401, D5423, D5449, D5787) D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of a written procedure for the modified BD Veritor SARS-CoV-2 & Flu A+B test system, assay results in the patient EMR and interview with the ED nurse manager, the laboratory failed to provide a written procedure available to and followed by testing personnel in the ED. Findings: 1. Request was made to the ED nurse manager for the procedure used to perform the modified BD Veritor SARS- CoV-2 & Flu A+B test in the ED. No documentation was provided by the ED or the laboratory. 2. The surveyor asked the ED nurse manager if the ED staff utilized the manufacturer's testing instructions. The response was the ED staff did not use the manufacturer's testing instructions. 3. The surveyor asked the ED nurse manager how the ED were able to perform the assay. The ED nurse manager stated that another nurse who performed this assay at a different clinical site showed the ED staff how to perform the test. 4. The laboratory director stated they did not provide a written procedure to the ED because the laboratory was not informed that the ED had started performing this assay. 5. Review of a spreadsheet titled "Covid/Flu Tests Performed by BD Machine in PHC Emergency Room" with patient treatment information revealed 319 patients had 957 tests performed. from 2/8/22 to 8/25/23. 6. Interview with the ED nurse manager on 10/10/23 at 10:35 a.m. confirmed, the laboratory failed provide a written procedure available to and followed by testing personnel in the ED. . D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on statements made by the ED nurse manager, review of the manufacturer's instructions, lack of performance verification documentation and interview, the -- 2 of 4 -- laboratory failed to verify test performance of the modified BD Veritor SARS CoV-2 & Flu A+B test system prior to use in patient testing. Findings: 1. The surveyor asked the ED nurse manager if the BD Veritor SARS CoV-2 & Flu A+B test was performed using the BD analyzer. The ED nurse manager stated that the test cartridges were read manually, and use of the analyzer was optional. 2. The surveyor asked if the ED test documentation included whether the analyzer was used or not. The ED nurse manager stated she did not know if the analyzer's use was documented and most testing was read visually by the ED staff. 3. Review of the manufacturer's instructions for the BD Veritor SARS CoV-2 & Flu A+B test system revealed on page 1, under warnings and precautions the following: "DO NOT read the test results visually." 4. Failure to perform a waived test according to manufacturer's instructions changes the test to high complexity. The surveyor asked for the verification study. No verification study documentation for the modified BD Veritor SARS CoV-2 & Flu A+B test system was provided at survey. 5. The technical consultant (TC) #1 stated the laboratory was not informed that the ED staff were performing this assay and did not know that the ED staff did not follow the manufacturer's instructions. Testing was stopped upon discovery by laboratory personnel on 9/1/23. 6. Interview with TC #1 on 10/10/23 at 10:55 a.m. confirmed the laboratory failed to verify test performance of the modified BD Veritor SARS CoV-2 & Flu A+B test system prior to use in patient testing. 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 the use of a modified test system, lack of quality control (QC) documentation, and interview with the ED nurse manager, the laboratory failed to ensure that positive and negative QC was performed each day of patient testing for the modified BD Veritor SARS CoV-2 & Flu A+B test system used by ED testing personnel. Findings: 1. The ED staff performed testing for COVID Sar CoV-2, Flu A and Flu B using a modified test system, which changed the testing to high complexity. High complexity testing must have QC performed each day of patient testing. 2. The surveyor requested QC logs for patient testing performed from 2/8/22 to 8/25/23. No documentation of QC was provided at the time of survey. 3. The ED nurse manager stated that QC was performed periodically, but no documentation for it could be found. 4. Interview with the ED nurse manager on 10/10/23 at 10:35 a.m. confirmed the laboratory failed to ensure that positive and negative QC was performed each day of patient testing for the modified BD Veritor SARS CoV-2 & Flu A+B test system used by ED testing personnel. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) -- 3 of 4 -- The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on the review of the ED test records for the modified BD Veritor SARS CoV-2 & Flu A+B test system, and interview with the ED nurse manager, the laboratory failed to ensure that the test records included documentation for positive identification of the specimen, date and time of receipt, analyte results, dates of testing and identity of the personnel who performed the test(s) for the modified BD Veritor SARS CoV-2 & Flu A+B performed in the ED from 2/8/22 to 8/25/23. Findings: 1. Request was made for the test records for the modified BD Veritor SARS CoV-2 & Flu A+B test system used in the ED. The surveyor was provided with a one page document named "Lab Exchange" containing eight patient entries from 7/8/23 to 8/25/23. No documentation of 311 patient test records for this test system was provided at the time of survey. 2. The ED provided a spreadsheet that was constructed from patient information taken from EMR records. This was a compilation document not used at the time of testing and provided to document treatment and patient harm concerns. It did not include specific patient results for each analyte. 3. Review of the "Lab Exchange" document for 8 of 319 patients tested of revealed: a. No positive identification for one of eight entries (only one identifier). b. No time for the receipt of the sample for eight of eight entries. c. No record of the individual analyte (COVID, Flu A, Flu B) results for six of eight results d. No record of the identity of the personnel who performed the tests for eight of eight entries 4. The surveyor asked for the remaining 311 patient test records. The ER nurse manager stated that once the log page was full and a new page started, the old document was shredded. 5. TC #1 stated that the laboratory had not been provided with the completed test records or copies and was unable to review them. 6. Interview with the ED nurse manager confirmed, the laboratory failed to ensure that the test records included documentation for positive identification of the specimen, date and time of receipt, analyte results, dates of testing and identity of the personnel who performed the test(s) for the modified BD Veritor SARS CoV-2 & Flu A+B performed in the ED from 2/8/22 to 8 /25/23. -- 4 of 4 --

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 for the analyte: Cell identification or White blood cell differential for two out of three consecutive proficiency testing events: 2020 Event 3 and 2021 Event 2 (refer to D2131). D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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: A PT desk review and phone interview on 10/19/21 revealed the laboratory failed to successfully particiate in PT from API for the analyte: Cell identification or White blood cell differential. Findings: 1. Review of the 2020 API 3rd Event revealed a score of 68% for Cell identification or White blood cell differential. 2. Review of the 2021 API 2nd Event revealed a score of 64% for Cell identification or White blood cell differential. 3. Phone interview 10/19/21 at 8:20 a.m. with the general supervisor confirmed, the laboratory failed to successfully particiate in PT from API for the analyte: Cell identification or White blood cell differential. -- 2 of 2 --

Summary Statement of Deficiencies D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of