St Vincent Morrilton Lab

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. 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 establish a policy to ensure 2 of 19 patient lactate samples were centrifuged within 15 minutes of collection from 2/21/25 though 3/4/25. A) Manufacturer's instructions ("Siemens Dimension Clinical Chemistry System Flex Reagent Cartridges" Lactate, REF DF16, Issue Date 2019-04-01) for the lactate analysis performed in the laboratory, stated:" Blood is best collected without stasis in a container of sodium fluoride/potassium oxalate, followed by immediate chilling of the specimen and separation of the cells within 15 minutes." B) The Laboratory's General Policy manual did not contain specfic policies for lactate, but referred to "following manufacturer's instructions and /or package inserts". C) A query of Lactate sample turnaround time records from 2/21 /25 through 3/4/25 revealed 2 of 19 samples took longer than 15 minutes from collection to result. Centrifuge times were not documented. D) During interview 3/5 /25 at 2:53pm, the General Supervisor (as listed on the CMS-209 form) confirmed that the lab documented collection times and report times; but not centrifuge times. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- (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: Based on observation and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 3/5/25 at 2:37pm, one (of one) container of Siemens Ictotest Reagent Tablets (lot (10)284115A, SMN 10337316, Siemens, expiration date 12/31/24) was observed in the laboratory, available for use beyond the expiraton date. B) During a tour of the laboratory on 3/5/25 at 2:32pm, six (of six) Sofia RSV test kits (lot 160853, Item 1197500 RSV FIA, Quidel, expiration date 12/29/24) was observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 3/5 /25 at 2:37pm testing personnel #7 (as listed on the CMS-209 form), confirmed that the items, identified above, had exceeded their expiration dates and were available for use in the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on review of review of Sysmex CA-600 Maintenance Checklists for 2022 and 2023 and interviews with laboratory staff, the laboratory failed to perform monthly maintenance on the Sysmex CA-600 in nine of 16 months reviewed. Survey findings include: A. The Sysmex CA-600 Maintenance Checklist includes a required Monthly "Clean Di H2O Rinse Bottle With Alcohol". B. The Monthly "Clean Di H2O Rinse Bottle With Alcohol" was not documented in the following months in 2022: January, April, May, September, October, and December. C. The Monthly "Clean Di H2O Rinse Bottle With Alcohol" was not documented in the following months in 2023: January, March, and April. D. In an interview, at 2:30 p.m. on 5/25/23, laboratory employee #3 (as listed on the form CMS-209) confirmed the monthly maintenance for the Sysmex CA-600 was not documented each month in 2022 and 2023. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 2020 and 2021 CMS Casper Reports 155D, 153D and the American Proficiency Institute(API) proficiency testing results, it was determined the laboratory failed to have successful participation in proficiency testing for ABO/RH and D(Rho) Type testing as evidenced by: Failure to attain a testing event score of at least 100 percent in ABO/RH and D(Rho) type testing is unsatisfactory performance as cited at 2153. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(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 2 -- Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of 2020 and 2021 CMS Casper Reports 155D, 153D and the American Proficiency Institute(API) proficiency testing results, it was determined the laboratory failed to have successful participation in proficiency testing for ABO/RH and D(Rho) type testing as evidenced by: A. A review of the proficiency testing results revealed the laboratory received a score of 80% for the test of D(Rho) type testing and 90% for ABO/RH testing in the third proficiency testing event of 2020. B. A review of the proficiency testing results revealed the laboratory failed to participate in the second proficiency testing event of 2021 resulting in a score of 0 % for the test of ABO/RH and D(Rho) type testing. 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 a review of the 2020 and 2021 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. 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: . Based on review of 2020 and 2021 proficiency testing event results, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the test D(Rho) type. Refer to D2153 -- 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 manufacturer's package insert, observation, lack of documentation and interview it was determined that the laboratory failed to note the date and time of one of one container of innovin (thromboplastin reagent) placed on the Siemens CA 660 coagulation analyzer. Findings follow: A) On a tour of the laboratory on 5/25/21 at 01:30 PM one of one vials of Dade Innovin, lot # 549758, was observed in use in a container on the Siemens CA 660 instrument without a date and time of being placed into use. B) Review of the manufacturer's package insert for Dade Innovin revealed that once reconstituted and placed into the instrument the product would expire in twenty-four hours. C) Upon request, the laboratory was unable to provide documentation of the date and time the Innovin was placed into use. D) In an interview on 5/25/21 at 01:30 PM the laboratory staff member, identified as number 5 on the CMS 209 form, confirmed that there was no documentation of when the Innovin , identified above, had been placed into use on the instrument. D5783