Memorial Hospital

Summary Statement of Deficiencies D0000 An onsite unannounced complaint investigation was performed September 13 - 14, 2022 to investigate allegations made for complaint TX00429186. The complaint was substantiated and the laboratory failed to meet the following conditions:The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780. 493. 1100 Condition: Facility administration; 493. 1441 Condition: Laboratory director. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of policies and procedures, laboratory records, transfusion records and interview of facility personal the laboratory failed to meet the requirements for transfusion services as specified in 493.1101 through 493.1105. (refer to D 3023 and D3025) D3023 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(2) The facility must establish and follow policies to ensure positive identification of a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- blood or blood product recipient. This STANDARD is not met as evidenced by: Review of laboratory and nursing policies and procedures, transfusion records,

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 16, 2021, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts proficiency testing records, the facility failed to achieve successful Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- performance in two of two consecutive testing events in 2021 for the specialty Routine Chemistry for the analyte Lactate Dehydrogenase, Total (LDH), resulting in unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Association of Bioanalysts Comparative Evaluations, the facility failed to attain a score of at least 80 percent for the analyte Lactate Dehydrogenase, Total (LDH) in two of two consecutive testing events in 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte Lactate Dehydrogenase, Total (LDH) in the specialty of Routine Chemistry in two of two consecutive events: 2021 AAB 2nd event 0% 2021 AAB 3rd event 0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analytes specialty Routine Chemistry for the analyte Lactate Dehydrogenase, Total (LDH), Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Lactate Dehydrogenase, Total (LDH), in the specialty of Routine Chemistry for two of two events in 2021. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Review of laboratory records and interview facility personnel found that the laboratory used expired CVP (calibration verification product) to verify the performance of the Gem Premier blood gas analyzer in October 2017. The findings included: 1. Review of CVP sample reports for 2017 found that the laboratory used expired CVP in one of 12 months. The laboratory used CVP lot 1826 with an expiration date of September 2017 on October 18, 2017 to verify the performance of the analyzer. 2. Review of patient test records found that the laboratory tested 12 patient specimens between October 1 and November 1, 2018 when lot 1834 was placed into use. 3. Interview the technical consultant conducted on August 14, 2018 at 9:27 AM confirmed that the expired CVP material was used to verify the accuracy of the machine. D6114 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(1) The technical supervisor is responsible for selection of the test methodology that is appropriate for the clinical use of the test results. This STANDARD is not met as evidenced by: Observations, review of operators guides and package inserts and interview facility personnel found that the technical supervisor failed to select the appropriate blood 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 -- glucose monitoring system for use in the emergency room, nursery, operating room and nurses unit. The findings included: 1. Observations made during the tour the facility found four Contour Next blood glucose monitoring devices in use. Emergency room- Contour next blood glucose monitoring device serial number 84635987358 with blood glucose test strips lot DW8APEF088 expiration January 31, 2020. Nursery- Contour Next blood glucose monitoring device serial number 84636657358 with blood glucose strips lot DW8CPEG 11B expiration March 31, 2020. Nursing unit - Contour Next blood glucose monitoring device serial number 84635027358 with blood glucose strips lot DW8CPEG 11B expiration March 31, 2020. Operating room - Contour Next blood glucose monitoring device serial number 80704427358 with blood glucose test strips lot DW7H PEG14A expiration August 31, 2019. 2. Review of the operator's guide for the Contour Next blood glucose monitoring system found under the heading indications for use: "The contour next blood glucose monitoring system is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single patient use only, and should not be shared. The system is intended for self testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The contour next blood glucose monitoring system is not intended for the diagnosis or screening for diabetes mellitus and is not intended for use on neonates." Review of the package insert for the Contour Next blood glucose test strips found under the heading intended use: "Contour Next test strips are an over-the-counter (OTC) product and are intended for self testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples. The Contour Next blood glucose monitoring systems are not intended for the diagnosis of or screening for diabetes mellitus." Under the heading caution: "the meter in Lansing device are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients!" 3. Review of patient test records found 66 patient specimens tested in the nursery and 23 patients tested in the emergency room using the Contour Next blood glucose monitoring device. Patient test records for the operating room were requested but not provided. 4. Interview of the laboratory director and technical supervisor conducted on August 16, 2018 at 11:10 AM confirmed that the laboratory director and technical supervisor were not consulted in the choosing of the blood glucose meters. It was confirmed that when the hospital built the new ER and labor and delivery in early 2018 these meters were purchased and placed into use without their knowledge. -- 2 of 2 --