Ummc - Gulf Coast Pediatrics

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the College of American Pathologists (CAP) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8/30/2023, the laboratory failed to maintain satisfactory performance in two of two testing events (2023-Event 1 and 2023-Event 2) resulting in unsuccessful participation in Routine Chemistry for the analyte Glucose. Refer to D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the College of American Pathologists (CAP) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8/30/2023, the laboratory has not successfully performed proficiency testing for Glucose in two of two testing events. Findings include: A review of the laboratory records from the College of American Pathologists (CAP) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for Glucose: Glucose: Year 2023- 1st Event 20% Year 2023-2nd Event 20% -- 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 quality control (QC) results for the Ortho Clinical Diagnostics Vitros 350 chemistry system from 3/1/2023 through 4/28/2023, manufacturer's instructions for Performance Verifier I, Lot #D8955, and Performance Verifier II, Lot #K9589, put in use on 3/1/2023, the patient test log for glucose, and interview with the technical consultant on 5/11/2023 at 11:30 a.m., the laboratory failed to ensure results for at least two levels of control materials met the laboratory's criteria for acceptability for glucose testing for 32 of 37 testing days, during this timeframe, when a total of 79 patient glucose tests were performed and reported. Findings include: 1. In an interview on 5/11/2023 at 11:30 a.m., the technical consultant stated the laboratory's policy for establishing an acceptable range for Performance Verifier (PV) I and Performance Verifier (PV) II, used for quality control testing on the Vitros 350 chemistry system, is to calculate the mean for each analyte after repeated testing and to establish a range of two standard deviations above and below the mean with the manufacturer's suggested standard deviation from the package insert for each lot of PV I and PV II. 2. Review of QC results for the Ortho Clinical Diagnostics Vitros 350 chemistry system from 3/1/2023 through 4/28/2023, manufacturer's instructions for Performance Verifier I, Lot #D8955, and Performance Verifier II, Lot #K9589, put in use on 3/1/2023, and the patient test log for glucose revealed at least one of two levels of control materials failed to meet the laboratory's acceptable range of two standard deviations above and below the established mean for glucose testing for the following 32 of 37 testing days, during this timeframe, when a total of 79 patient glucose tests were performed and reported: 3/2/23--1 patient result reported. 3/3/23--1 patient result 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 -- reported. 3/7/23--5 patient results reported. 3/8/23--1 patient result reported. 3/13/23-- 3 patient results reported. 3/14/23--4 patient results reported. 3/15/23--2 patient results reported. 3/16/23--2 patient results reported. 3/17/23--2 patient results reported. 3/20 /23--6 patient results reported. 3/21/23--4 patient results reported. 3/23/23--2 patient results reported. 3/24/23--2 patient results reported. 3/27/23--2 patient results reported. 3/28/23--2 patient results reported. 3/29/23--2 patient results reported. 3/30 /23--2 patient results reported. 4/4/23--5 patient results reported. 4/5/23--2 patient results reported. 4/10/23--1 patient result reported. 4/11/23--4 patient results reported. 4/12/23--1 patient result reported. 4/14/23--1 patient result reported. 4/17/23--3 patient results reported. 4/18/23--3 patient results reported. 4/20/23--1 patient result reported. 4/21/23--2 patient results reported. 4/24/23--2 patient results reported. 4/25 /23--3 patient results reported. 4/26/23--2 patient results reported. 4/27/23--3 patient results reported. 4/28/23--3 patient results reported. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of quality control (QC) results for the Ortho Clinical Diagnostics Vitros 350 chemistry system from 3/1/2023 through 4/28/2023, manufacturer's instructions for Performance Verifier I, Lot #D8955, and Performance Verifier II, Lot #K9589, put in use on 3/1/2023, the patient test log for glucose, and interview with the technical consultant on 5/11/2023 at 11:30 a.m., the technical consultant failed to ensure acceptable levels of analytic performance were maintained throughout the entire testing process when at least one of two levels of control materials failed to meet the laboratory's criteria for acceptability for glucose testing for 32 of 37 testing days, during this timeframe, when a total of 79 patient glucose tests were performed and reported. Refer to D5481 (Failure to ensure two levels of control met criteria for acceptability each day of patient testing.) -- 2 of 2 --