Nevada Regional Medical Center

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of BioRad quality control (QC), lack of quality control package inserts, and interview with the general supervisor (GS) #1, the laboratory failed to retain QC package inserts from January 2022 to April 2024. Findings: 1. Review of chemistry QC showed the laboratory used BioRad assayed chemistry QC for the analytes: ammonia, ethanol, acetaminophen, B-hcg, carbamazepine, digoxin, ferritin, free T4, gentamycin, tpsa, phenytoin, salicylates, thyroid stimulating hormone, valproic acid, vancomycin, lithium, theophylline, phenobartibol, vitamin B12, folate, tobramycin, troponin HS, myoglobin, CKMB, nt-pro-bnp, urine microalbumin, urine protein, urine sodium, urine creatinine, hemoglobin A1C, vitamin D, direct bilirubin, total bilirubin, rcrp, spinal fluid glucose, spinal fluid total protein, and procalcitonin. 2. Lack of quality control package inserts showed the laboratory failed to retain QC package inserts from January 2022 to April 2024. 3. Interview with the GS #1 on April 22, 2025 at 1:30 PM, confirmed the laboratory failed to retain chemistry QC package inserts for the last 2 years. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 on observations and record review the laboratory failed to meet the condition of analytic systems for hematology, chemistry, histology, and microbiology. The laboratory failed to follow the written procedure for gram stains (Refer to D5401); the laboratory failed to provide a procedure for replacing stains used for frozen sections (Refer to D5403); the laboratory failed to verify the correct lot number and expiration date was entered into the coagulation analyzer for the ISI value in use (Refer to D5411); the laboratory failed to include two controls materials of different concentrations each day of patient testing on the Dimension EXL-200 (Refer to D5447); the laboratory failed to document how criteria was established for acceptability of control materials providing quantitative results for 26 analytes (Refer to D5469); the laboratory failed to document the quality of the staining materials on day of use for frozen sections (Refer to D5473); and the laboratory failed to ensure all control materials for the Dimension EXL-200 were accurate before reporting patient test results (Refer to D5481). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 review of laboratory procedures, gram stain quality control (QC) records for April, May and June 2024, patient testing log, and interview the general supervisor (GS) #1, the laboratory failed to follow the written procedure for gram stains for 6 of 28 testing days in 2024. Findings: 1. Review of laboratory procedure "Gram Satin" states "The gram staining procedure is checked and recorded for each new batch of stains and daily when a gram stain is performed." 2. Review of gram stain QC records for April, May and June 2024 showed no gram stain QC documented on April 24, 2024, April 25, 2024, May 13, 2024, June 2, 2024, June 10, 2024, and June 24, 2025. 3. Review of patient testing logs showed the laboratory performed eight patient gram stains while QC was not performed. 4. Interview with the general supervisor (GS) #1 on April 22, 2025 at 1:00 PM confirmed the laboratory failed to follow the written procedure for gram stains. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of -- 2 of 6 -- results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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 Siemens Dimension EXL with LM chemistry quality control (QC) records, and interview with the general supervisor (GS) #1, the laboratory failed to establish criteria for acceptability of control materials providing quantitative results. Findings: 1. Review of the Siemens Dimension EXL with LM QC records showed the laboratory did not establish, document, and define statistical parameter criteria (mean and standard deviations) for acceptability of quantitative chemistry QC. 2. Review of Siemens Dimension EXL with LM analyzer showed alkaline phosphatase level 1 QC range of 93-133 U/L. The laboratory could not provide documentation for establishment of the QC range. 3. Review of Siemens Dimension EXL with LM analyzer showed alkaline phosphatase level 2 QC range of 400-440 U/L. The laboratory could not provide documentation for establishment of the QC range. 4. Review of Siemens Dimension EXL with LM analyzer showed total bilirubin level 1 QC range of 1.06-1.34 mg/dl. The laboratory could not provide documentation for 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 -- establishment of the QC range. 5. Review of Siemens Dimension EXL with LM analyzer showed total bilirubin level 2 QC range of 4.61-5.21 mg/dl. The laboratory could not provide documentation for establishment of the QC range. 6. Interview with the GS #1 on August 15, 2023 at 1:00 PM confirmed the laboratory failed to establish criteria for acceptability of control materials providing quantitative results. -- 2 of 2 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's "Quality Control Action Plan", June, July, and August 2021 quality control records and interview with the technical supervisor (TS) #1, the laboratory failed to follow quality control (QC) procedure before reporting patient's test results. Findings: 1. Review of the laboratory's "Quality Control Action Plan", states " 2-2S violation (2 consecutive controls exceed the mean by 2 SD.) is an unacceptable quality control result." 2. Review August quality control results for total bilirubin showed the 2 standard deviation (SD) range in Cerner database for total bilirubin Liquichek 1 lot # 56950 QC was 0.99-1.27. On 08/02/2021 the quality control value was 1.30 and on 08/03/2021 was 1.30. Three patients test results had been reported on 08/03/2021 after an unacceptable quality control result on 08/03 /2021 with no remedial QC actions taken. 3. Interview with TS #1 on August 31, 2021 at 11:00 AM confirmed the laboratory did not follow procedure and run acceptable quality control prior to reporting patient test results. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. 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 -- This STANDARD is not met as evidenced by: Based on lack of documentation of 2020 and 2021 Gem Premier 3000 blood gas quality control (QC) logs and interview with the Technical Supervisor (TS) #1, the laboratory failed to test one sample of control material each 8 hours of patient testing. Findings: 1. Review of Gem Premier 3000 blood gas QC showed no documentation of blood gas QC every 8 hours of patient testing. Review of QC from January 1, 2020 to date August 31, 2021 showed 442 patient test results were reported when QC was not documented. 2. Interview with the TS #1 on August 31, 2021 at 10:30 AM confirmed the laboratory failed to document one sample of blood gas control material each 8 hours of patient testing. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on the lack of documentation of blood gas quality control (QC), lack of monthly review of blood gas statistical reports and interview with the technical supervisor (TS) #1, the laboratory director failed to ensure the quality control (QC) programs are established and maintained to assure the quality of laboratory services and to identify failures in quality as they occur in 2019/2020 and to date August 31, 2021. Findings: 1. Review of the laboratory's "Quality Control Action Plan "stated that "will be collated monthly and statistical reports will be generated. Statistical report variance such as standard deviations (SD) and coefficient of variance (CV), and /or other data comparison will be reviewed." 2. Lack of documentation of monthly review for 2019/2020 and to date August 31, 2021 blood gas QC showed no review by the laboratory director to assure the quality of the testing and to identify failures in quality. 3. Interview with the TS #1 on August 31, 2021 at 11:00 AM confirmed, the laboratory director failed to ensure the QC programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 2 of 2 --

Summary Statement of Deficiencies D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require