Baptist Minor Medical Center

Summary Statement of Deficiencies D0000 493.51 Notification requirements for laboratories issued a certificate of compliance Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director; or (5) Technical supervisor (laboratories performing high complexity only). (b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory ' s certificate of compliance, so that compliance with requirements can be determined. (c) Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance. This requirement is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209) and the Aspen Web database, and interview with the laboratory liaison, the laboratory failed to notify the state agency of change in laboratory director within 30 days in 2020. The findings include: 1. Review of the Form CMS-209 and the Aspen Web database revealed the name of a laboratory director that did not match the laboratory director of record in the Aspen Web database. 2. Interview with the laboratory liaison on June 10, 2021 at 1:00 pm confirmed the laboratory failed to notify the state agency of the change in laboratory director in 2020. The current director began performing lab director duties on March 1, 2020. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. 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 -- This CONDITION is not met as evidenced by: The laboratory failed to detect and correct problems with complete blood count quality control in 2019, 2020, and 2021. (Refer to D5293) D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

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 the 2017 and 2018 complete blood count (CBC) quality control (QC) records and interview with the office manager, the laboratory failed to maintain the CBC QC manufacturer package insert containing the acceptable control limits, in 2017 and 2018. The findings include: 1) Review of the 2017 and 2018 CBC QC records revealed only two CBC QC manufacturer package insert containing the acceptable control limits were not available for review. 2) Interview on July 10, 2017 at 12:15 p.m. with the office manager confirmed the CBC QC manufacturer package insert containing the acceptable control limits were not maintained for all the lot numbers used in 2017 and 2018. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 -- 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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the 2017 complete blood count (CBC) quality control (QC) records, the quality assessment plan, the 2017 and 2018 monthly quality assessment checklist records and interview with the office manager, the laboratory failed to assess and correct problems with the monthly quality assessment (QA) review, in 2017. The findings include: 1) Observation of the laboratory on July 10, 2017 at 9:30 a.m. revealed the Beckman Coulter AcT diff2 instrument on the counter in use for patient testing. 2) Review of the 2017 CBC QC records revealed the following expired lot numbers in use with patient CBC testing: Lot Low 067200, Lot normal 074900, Lot high 086700 with expiration date June 23, 2017 was in use June 24, 2017 to July 10, 2017; Lot low 060100, Lot normal 075300 , Lot high 087100 with expiration date August 18, 2018 was in use August 19, 2017 to August 22, 2017; Lot normal 075500, Lot high 087300 with expiration date September 17, 2017 was in use September 18, 2017 to October 29, 2017 Lot low 060300 with expiration date September 15, 2017 was in use September 16, 2017 to December 31, 2017. 3) Review of the laboratory quality assessment (QA) plan revealed, " We will perform a quality review monthly and review the controls and patient's results with the laboratory director or technical consultant for their approval. If any "NOs" are found an explanation of the problem must be written on the "Quality Assessment Checklist" with clinic resolution to the problem. All quality assessment monitoring with "NO" answers a copy should also be sent the Quality Coordinator for review. When a problem is found and resolved the office manager will then do weekly "Quality Assessment Checklists" for the next 6 months. " 4) Review of the 2017 and 2018 monthly quality assessment checklists revealed the laboratory director signed review of the monthly checklists for January 2017 to June 2018 on June 5, 2018 with no