Greater Regional Health

Summary Statement of Deficiencies 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 review of DrugCheck Dip Drug Test records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 3: 30 pm on 5/24/2023, the laboratory failed to establish the performance specifications of analytical sensitivity and analytical specificity for the DrugCheck Dip Drug Testing. The findings include: 1. Laboratory Personnel identifier #1, confirmed the laboratory used the DrugCheck Dip Drug Test for patient drug screening. 2. The DrugCheck Dip Drug Test has not been approved by the Food and Drug Administration (FDA). 3. In May 2023, the laboratory established the performance specifications of accuracy and precision. 4. The laboratory did not establish the performance specifications of analytical sensitivity and analytical specificity. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory 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 -- must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the Performance Testing of Serofuge and Cell Washer procedure and blood bank logs and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 5/24/23, the laboratory failed to document the daily volume check for the blood bank cell washer for 28 out of 28 days from 2/1/2023 - 2/28/2023. The findings include: 1. The Performance Testing of Serofuge and Cell Washer procedures states, "On a daily basis, the cell washer's dispense volume must be checked. The target value for this volume is 40 mls, per manufacturer's recommendation. The results of this check are recorded on the blood bank preventive mainenace chart." 2. At the time of the survey, the laboratory did not record the daily volume check for the blood bank cell washer from 2/1/2023 - 2 /28/2023. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of blood bank procedures, lack of cell washer maintenance records and confirmed by laboratory personnel identifer #1 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 5/24/2023, the laboratory failed to define the frequency for performing the optimum spin time function check on the cell washer. In addition, the laboratory failed to perform the optimum spin time function check on the cell washer from 1/1/2022 - 5/24/2023. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of an Individualized Quality Control Plan (IQCP), review of quality -- 2 of 3 -- control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 3:30 pm on 5/24/2023, the laboratory failed to perform a positive and negative control each day of patient testing for the Rupture of the Membranes (ROM Plus) and DrugCheck Dip Drug Test for 28 out of 28 days from 2/1/2023 - 2/28/2023. The findings include: 1. For the ROM Plus and DrugCheck Dip Drug Test, the laboratory performed QC with each new lot and/or shipment of test kits. 2. Laboratory personnel identifier #1 indicated that the laboratory intended to follow manufacturer's instructions for performing QC. 3. At the time of the survey, the laboratory did not have an IQCP for the either of the test kits. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the laboratory test volume form and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1: 00 pm on 5/24/23, the laboratory failed to perform twice annual comparison testing for three out of three time periods from 1/1/2022 - 5/24/2023 for the analytes: influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV). The findings include: 1. The laboratory performed influenza A, influenza B, SARS-CoV- 2, and RSV testing using both the Biofire and Cepheid test systems. 2. The laboratory did not perform comparison testing for influenza A, influenza B, SARS-CoV-2, and RSV from 1/1/2022 - 5/24/2023. -- 3 of 3 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Vitros 7600 chemistry analyzer instructions for use (IFU), quality control (QC) records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report), the laboratory failed to appropriately establish criteria for acceptability of amylase and lipase control materials for two out of two lot numbers of QC used from 07/11/2021- 07/17/2021. The findings include: 1. The laboratory uses Bio-Rad Liquid Unassayed Multiqual QC for amylase and lipase controls and during the week of 07/11/2021- 07/17/2021, the laboratory used lot 56631, expiration 2022-04-30 (level 1) and lot 56633, expiration 2022-04-30 (level 3). 3. Review of the Vitros amylase slide IFU indicated that the instrument's reportable range for amylase is 30-1200 U/L. 4. For level 1 QC (lot 56631, expiration 2022-04- 30), the laboratory established the following acceptable range for amylase testing: 26.6- 36.6 U/L. 5. Review of the Vitros lipase slide IFU indicated that the instrument's reportable range for lipase is 10-2000 U/L. 6. For level 3 QC (lot 56633, expiration 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 -- 2022-04-30), personnel identifier #2 stated that during establishment of the acceptable QC range for lipase testing, the laboratory never achieved results below 2000 U/L. Because they exceeded the instrument's reportable range, the results of each run were always ">2000 U/L" and a range could not be established. 7. Personnel identifier #2 confirmed that the laboratory's established amylase and lipase QC ranges listed above for lot 56631, expiration 2022-04-30 (level 1) and lot 56633, expiration 2022-04-30 (level 3) exceeded the reportable ranges for the Vitros instrument and were not appropriately established. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of quality control records and interview with laboratory personnel identifier #2 (refer to the Laboratory Personnel Report), the laboratory director failed to meet responsibility requirements including: ensuring testing personnel are performing test methods as required as specified in D6087; ensuring a quality control program is established and maintained as specified in D6093; ensuring a quality assessment program is established and maintained as specified in D6094; ensuring the laboratory has taken and documented

Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifiers #1 and #13 (refer to the Laboratory Personnel Report) at approximately 8:30 am on 06/30/2021, the laboratory failed to take and document

Summary Statement of Deficiencies D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on lack of Insulin-line growth factor binding protein-1 procedures and test records and confirmed by laboratory personnel #2 (refer to the Laboratory Personnel Report) at approximately 2:30 pm on 4/24/19, the laboratory failed to meet the endocrinology requirements for: performing twice annual verification as specified in D5217; having a written procedure as specified in D5403; defining and documenting criteria for proper storage of reagents as specified in D5413, verifying the performance specifications as specified in D5421; performing a positive and negative control material as specified in D5449; and maintaining a record system as specified in D5787. 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 review of the Laboratory Test List & Annual Volume form and confirmed by laboratory personnel #2 (refer to the Laboratory Personnel Report) at approximately 2:30 on 4/24/2019, the laboratory failed to verify the accuracy twice annually for the analyte, Insulin-line growth factor binding protein-1 (IGFBP-1). The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- findings include: 1. Laboratory personnel #2 confirmed that nursing staff started testing patients for the analyte, IGFBP-1 using the Actim Prom test kit sometime after the last Clinical Laboratory Improvement Amendments (CLIA) survey performed on 3 /23/2017 (an exact implementation date could not be determined). 2. At the time of the survey, the laboratory did not have records indicating the twice annual verification of the analyte, IGFBP-1. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)