Unity Health Newport

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 review of the 2025 CMS Casper Reports 0153D and 0155D, and the American Proficiency Institute (API) proficiency testing results, the laboratory failed to have initial successful participation in proficiency testing for the analyte compatibility testing. 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 as cited at D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 -- (e) Failure to achieve an overall testing event score of satisfactory for 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 2025 CMS Casper Reports 0153D and 0155D, and the American Proficiency Institute (API) proficiency testing results, the laboratory failed to achieve satisfactory performance in two consecutive proficiency testing events for the analyte compatibility testing as evidenced by: A. The Laboratory received a score of 80% for compatibility testing in the first proficiency testing event of 2025. B. The Laboratory received a score of 80% for compatibility testing in the second proficiency testing event of 2025. 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 CMS 0155D, 0153D reports and API performance evaluation for 2025 the laboratory director failed to provide overall management and direction to the lab for successful participation in proficiency testing. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on record review of CMS 0155D, 0153D, and API performance evaluation from 2025, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for compatibility testing. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Review of the CMS 209 form, lack of documentation and interviews with laboratory staff, determined the laboratory failed to assess employee competency as directed in personnel requirements. Survey findings follow: A) Review of the CMS 209 form submitted by the laboratory revealed that the Technical Consultant (TC) #1 on the CMS 209 form was also listed as the General Supervisor (GS). B) Review of personnel records for TC #1 on the CMS 209 form, revealed that no competency evaluation for the position of General Supervisor was present. C) Upon request, the laboratory was unable to provide documentation of competency determinations for calendar year 2023 or 2024 for the position of General Supervisor for the personnel identified above. D) In an interview at 11:25 a.m. on 8/27/2024, the technical consultant #1 on the form CMS 209, confirmed that competency determinations have not been performed on the personnel designated as general supervisor. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. 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 -- This STANDARD is not met as evidenced by: Based on a review of the manufacturer's instruction, the laboratory's procedure manual, patient test records, and interview with staff the laboratory failed to ensure 10 of 24 examined patient ammonia samples were centrifuged within 15 minutes of collection and 5 of 56 examined lactic acid samples were centrifuged within 30 minutes of collection from June through July of 2024. 1- A) A review of the manufacturer's instructions ("Ammonia Ultra" from Abbott, REF 6K89-30, 307237 /RO4, rev.-7/2017) for the ammonia analysis performed in the laboratory, stated: "Rapid separation of plamsa from blood cells is critical for obtaining reliable results. The standard recommendation is no more than 15 minutes from sample collection to start of centrifugation." B) The Laboratory's Quality Control (QC) Policy manual did not contain specific policies for ammonia, but stated "Unity Health Newport will follow the testing procedures set forth by Abbott, the manufacturers of the c4000, and ci4100 analyzers in the published IFU, SOP and Package inserts." C) A sampling of ammonia patient test records from June and July revealed: Sample ID 705238; Collected : 6/12/24 14:12, Analyzed: 6/12/24 15:21 Sample ID 718101; Collected : 6 /20/24 09:42, Analyzed: 6/20/24 11:02 Sample ID 758356; Collected : 7/16/24 17:40, Analyzed: 7/16/24 22:13 Sample ID 771382; Collected : 7/25/24 04:10, Analyzed: 7 /25/24 05:34 Sample ID 781200; Collected : 7/31/24 10:15, Analyzed: 7/31/24 11:04 D) During interview, the Technical Consultant (as listed on the CMS-209 form) confirmed that the lab documented collection times and report times; but not centrifuge times for ammonia testing. 2- A) A review of the manufacturer's instructions ("Lactic Acid2" from Abbott, REF 04T3020, H06713R02, rev.-9/2022) for the Lactic acid analysis performed in the laboratory, stated: "Separate the plasma by centrifugation within 30 minutes of sample collection." B) The Laboratory's QC Policy manual did not contain specific policies for lactic acid, but stated "Unity Health Newport will follow the testing procedures set forth by Abbott, the manufacturers of the c4000, and ci4100 analyzers in the published IFU, SOP and Package inserts." C) A sampling of lactic acid patient test records from June and July revealed: Sample ID 687521; Collected : 6/2/24 04:45, Analyzed: 6/2/24 05:26 Sample ID 690547; Collected : 6/4/24 00:04, Analyzed: 6/4/24 01:08 Sample ID 708760; Collected : 6/14/24 12:00, Analyzed: 6/14/24 13:29 Sample ID 711547; Collected : 6/17/24 00:27, Analyzed: 6/17/24 01:41 Sample ID 749031; Collected : 7 /10/24 16:30, Analyzed: 7/10/24 18:42 D) During interview, the Technical Consultant (as listed on the CMS-209 form) confirmed that the lab documented collection times and report times; but not centrifuge times for lactic acid testing. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Through review of the laboratory's policy and procedure for "Quality Control" (QC), review of quality control Levy-Jennings charts for March through July 2024, review of QA review notes, lack of documentation and interview it was determined that the laboratory failed to recognize or take

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Through review of proficiency testing attestation forms and interview it was determined that the laboratory's testing personnel failed to sign attestation forms for three of twenty American Proficiency Institue (API) proficiency testing events reviewed. Findings follow, A. Through review of proficiency testing doumentation for 2021 and 2022 it was determined that testing attestation forms were not signed by all testing personnel for API Hematology/Coagulation 1st event of 2021, API Chemistry Core 1st Event of 2021, and API Hematology/Coagulation 2nd event of 2022. B. In an interview on 11/9/22 at 2:15 pm, the laboratory testing personnel identified as number 2 on the CMS 209 form verified that the attestation forms were not signed by the testing personnel. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: 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 -- Through observations made during a tour of the laboratory, a review of manufacturer's package inserts, and interviews with laboratory staff, it was determined the laboratory failed to label reagents with expiration dates. Survey findings include: A. A review of manufacturer's package inserts for the Triage D-dimer and Cardiac test cartridges revealed the cartridges must be stored at refrigerator temperature (2 - 8 degrees Celsius) or may be kept at room temperature for 14 days. B. During a tour of the laboratory, at 10:18 a.m. on 11/8/2022, the surveyor observed 9 each of Triage D- Dimer cartridges (lot T13203 expiration 10/17/23), and 2 each of Triage Cardiac cartridges (lot T13048 expiration 10/20/22) stored on the counter top at room temperature. The cartridges were not labeled with the date that they had been stored at room temperature or with the expiration date (14 days after placed at room temperature). C. During an interview, at 10:18 a.m. on 11/8/2022, laboratory employee #1 confirmed the Triage cartridges were stored at room temperature and were not labeled with the new expiration date. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through review of the manufacturer's instrument manuals, lack of documentation, and interview it was determined that the laboratory failed to monitor required appropriate operating humidity levels in the room in which instruments used for hematology and chemistry testing with an operating humidity requirement were utilized. Findings follow: A) Review of the manufacturer's instrument manuals revealed the following humidity requirements for instruments in use in the laboratory; the AU 480 chemistry analyzer 15% to 90%, the Sysmex XN 1000 Hematology analyzer 20% to 80% and the Elite Coagulation analyzer less than 90%. B) Upon request the laboratory could not produce humidity level records for the calendar year of 2020. C) In an interview on 11/5/20 at approximately 09:45 AM, the laboratory staff member, identified as number two on the CMS 209 form, stated that the laboratory does not record the laboratory humidity level. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observation, and interview it was determined that phlebotomy supplies that had exceeded their date of expiration were present and available for use on one of two phlebotomy trays in the outpatient phlebotomy area. Findings follow: A) During a tour of the laboratory on 11/5/20 at approximately 11:00 AM twelve BD EDTA blood collection tubes lot # 9126972 expiration date 2020-08-31 and twelve BD EDTA blood collection tubes lot # 9184902 expiration date 2020-10-31 were observed on one of two phlebotomy trays in the outpatient phlebotomy area . B) In an interview on 11/5/20 at approximately 11:00 AM, the laboratory staff member, identified as number two on the CMS 209 form, confirmed that the items identified above had expired and were available for use. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory 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: Through a review of the manufacturer's Maintenance Schedule List for the Beckman Coulter AU480, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document required daily maintenance on one of thirty days in September 2020 and two of thirty-one days in October 2020. Survey findings include: A. The manufacturer's Maintenance Schedule List for the Beckman Coulter AU480 includes the following required daily maintenance: Inspect the Syringes for leaks; Inspect the Wash Solution Roller Pump for Leaks; Inspect, Clean, and Prime the Sample Probe, Reagent Probe, and Mix Bars; Inspect the Wash Solution and Replenish; Inspect the Printer and Printer Paper; Replace the DI water or diluent in the Pre-dilution Bottle; ISE Cleaning; and ISE Calibration. B. On the following dates in September and October 2020 the daily maintenance listed above was not documented: September 30,2020; October 1, 2020; and October 8, 2020. C. In an interview on 11/5/2020 at 10:00 a.m., employee #2 (as listed on the form CMS- 209) confirmed that the laboratory was unable to produce documentation that daily maintenance was performed on the AU480 chemistry analyzer on the days listed. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. -- 2 of 5 -- This STANDARD is not met as evidenced by: Through a review of quality control records for March, July, and September 2020 for the RapidPoint 500 blood gas analyzer, lack of documentation, and interviews with laboratory staff, it was determined the laboratory had no documentation of monitoring over time the accuracy and precision of blood gas quality control results. Survey findings include: A. Quality control records for the RapidPoint 500 blood gas analyzer consisted of printer tapes with each individual result of quality control and calibrations during the day. B. In an interview at 10:59 on 11/4/2020 the surveyor requested documentation of monitoring over time the precision an accuracy of the blood gas quality controls. At that time employee #2 (as listed on the form CMS-209) stated that he reviewed Levey-Jennings Graphs on the instrument and did not print them because the printed format was such that it was not useful for determining if shifts and trends had occurred. C. During a tour of the laboratory at 2:45 on 11/4/2020 employee #2 was asked to show the surveyor the Levey-Jennings Graphs for blood gas quality control on the RapidPoint 500 analyzer. The surveyor asked specifically to see March, July, and September of 2020. The RapidPoint 500 analyzer only had the September 2020 Levey-Jennings Graphs (one of three months requested). D. In an interview at 10:00 on 11/5/2020 employee #2 confirmed he was unable to obtain Levey-Jennings Graphs from any months prior to August 2020. 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: . Through a review of laboratory policy and procedures manual, quality control data, patient testing logs, lack of documentation, as well as interview with staff, it was determined the laboratory failed to perform positive and negative controls on days when patients were analyzed. Survey Findings Follow: A. A review of the laboratory quality control policy for MedTox Drugs of abuse test revealed "perform external positive and negative liquid controls per day of testing and with new box." B. A review of quality control data for March, July and September (three of nine months) of 2020 revealed on July 1, 2020 MedTox Control 2 for the test of Opiates and Amphetamines produce a control results of "invalid." There was no documentation that the laboratory repeated MedTox Control 2: on July 10, 2020 (one of thirty days) the laboratory had no Quality Control documentation for MedTox drug of abuse test: on July 29, 2020 MedTox Control 1 for the test of THC (Tetrahydrocannabinol), PCP (Phencyclidine) and COC (Cocaine) produce a control result of "invalid" for Positive Control. There was no documentation that the laboratory repeated MedTox Control 1. C.A review of patient testing logs for the July 2020 ( one of seven months) revealed on July 1, 2020 the following patients had urine drug screens performed and reported: patient # 60265, patient #60885, patient #61282 and patient # 62311; on July 10, 2020 the following patients had urine drug screens performed and reported without documentation of quality control: patient # 74757 and patient #74732: on July 29, 2020 the following patients had urine drug screens performed and reported: patient -- 3 of 5 -- #08807, patient #08960, patient #09158, patient #09856, patient #10645, patient # 10868 and patient #10262. D. In an interview on 11/4/2020 at 10:00, laboratory personnel #2 (as listed on form CMS 209) confirmed patients were tested and reported for urine drug screens on July 1 and 29, 2020 with only one level of quality control documented and on July 10, 2020 without documentation of quality control. D5783

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of Media QC sheets for media received in 2017 and 2018, through lack of documentation, and through interviews with laboratory staff, it was determined the laboratory failed to check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response. Survey findings include: A. Media QC sheets for TSA (Trypticase Soy Agar) include media received on 3/28/2017, 5/12/2017, 6/13/2017, 7 /18/2017, 9/9/2017, 9/14/2017, 10/11/2017, 11/3/2017, 11/27/2017, 1/4/2018, 1/11 /2018, 2/2/2018, 2/22/2018, 3/8/2018, 3/29/2018, 4/20/2018, and 5/2/2018. The laboratory documented growth of E. coli and beta hemolysis by Strep pyogenes on lots received 6/13/2017 and 7/18/2017 (two of seventeen shipments of TSA). B. Media QC sheets for Maconkey Agar include media received on 2/9/2017, 3/28/2017, 5/12/2017, 6/20/2017, 8/23/2017, 9/1/2017, 10/11/2017,10/20/2017, 11/6/2017, 11/27 /2017, 1/4/2018, 1/18/2018, 2/2/2018, 3/8/2018, 4/11/2018, and 5/2/2018. The laboratory documented growth of E. coli, inhibition of Proteus mirabilis, and inhibition of Enterococcus faecalis on the lot received 5/12/2017 (one of sixteen shipments of Maconkey Agar). C. Media QC sheets for Chocolate Agar include media received on 2/9/2017, 3/28/2017, 5/19/2017, 7/24/2017, 9/13/2017, 11/6/2017, 1/4 /2018, and 2/22/2018. The laboratory did not document growth of Neisseria 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 -- gonorrhoeae or Haemopholus influenzae (zero of eight shipments of Maconkey Agar). D. In an interview at 1:51 p.m. on 5/16/2018, laboratory employee #2 (as listed on the form CMS-209) confirmed the laboratory does not perform quality control cultures on each lot and shipment of media and further confirmed the laboratory did not have an Individualized Quality Control Plan for bacteriological media quality control. -- 2 of 2 --