Greenwood Leflore Hospital

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing program. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing) D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 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 -- (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 8/14/2024, the laboratory failed to achieve satisfactory performance in two of three testing events (2023-Event 3 and 2024-Event 1) resulting in unsuccessful participation in the subspecialty of Routine Chemistry for the analyte Sodium (0475). Refer to D2096. 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 8/14/2024, the laboratory has not successfully performed proficiency testing in the subspecialty of Routine Chemistry for the analyte Sodium (0475) in two of three 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 Sodium (0475): Sodium: Year 2023-3rd Event 0% Year 2024-1st Event 60% 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 surveyor desk review of the laboratory proficiency testing 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 8/14 /2024, the laboratory director failed to provide overall management and direction of the laboratory services. 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: -- 2 of 3 -- Based on surveyor desk review of the laboratory proficiency testing records (graded copies from the College of American Pathologists (CAP) and CASPER report 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 8/14 /2024, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 quality control (QC) records for Fetal fibronectin testing on the Hologic fFN test system from 1/1/2023 through 11/30/2023, patient test count reports, interview with the technical consultant on 12/6/2023 at 2:05 p.m., and the laboratory's written Individualized Quality Control Plan (IQCP), the laboratory failed to follow its written IQCP for performing two levels of external quality control each month of patient testing for five of eleven months, when a total of 6 patient fetal fibronectin results were reported. Findings include: 1. The laboratory's IQCP for fetal fibronectin testing on the Hologic fFN test system states that one external positive and one external negative control will be performed per new lot or new shipment or every 30 days. There was one level of external control performed for each month for January through April 2023. For September 2023 there was no documentation of external controls. There was no documentation of test kit lot number with received shipment date or external control lot number and expiration date. 2. Review of QC records for fetal fibronectin testing on the Hologic fFN test system from 1/1/2023 through 11/30 /2023 revealed no documentation of performance of both positive and negative external controls for January through April 2023 and September 2023, five months of the eleven-month time frame reviewed. 3. Review of patient test count reports for January through April 2023 and September 2023, revealed a total of 6 patient fetal fibronectin results reported during these five months. 4. In an interview on 12/6/2023 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- at 2:05 p.m., the technical consultant confirmed the external positive and negative controls for fetal fibronectin testing were not performed as required in January through April 2023 and September 2023. 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: Based on an interview at 11:00 a.m. on 12/5/2023 with the technical consultant and hematology testing personnel, observation of the Sysmex hematology quality control vials (QC) in use by the laboratory on 12/5/2023 at 11:00 a.m., and review of the manufacturer's package insert for the quality control, the laboratory failed to follow the manufacturer's instructions for open vial stability of the QC material. Findings include: 1. The manufacturer's package insert for Sysmex XN CHECK states the vials will retain stability for 7 days after opening if stored at 2-8 degrees Celsius. The Sysmex XN CHECK BF manufacturer's package insert states controls are stable for 30 days after opening when stored at 2-8 degrees Celsius. Observation of five open vials of hematology controls in use on the day of survey revealed there was no open date on the vials to ensure the controls were not used beyond the stability date. 2. Direct observation of the QC vials in the hematology refrigerator on 12/5/2023 at 11: 00 a.m. revealed the following vials with no open date documented: XN CHECK L1 lot # 33141101 Exp 1/28/2024 XN CHECK L2 lot # 33141102 Exp 1/28/2024 XN CHECK L3 lot # 33141103 Exp 1/28/2024 XN CHECK BF L1 lot # 33111301 Exp 1 /28/2024 XN CHECK BF L2 lot # 33111302 Exp 1/28/2024 3. In an interview at 11: 00 a.m. on 12/5/2023, the technical consultant confirmed there was no "open vial" date on the QC listed above to determine when the five vials of controls were opened. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to -- 2 of 3 -- identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on the review of Vitros XT 7600 records to include assay package inserts, procedures, and calibration records form 1/6/2023 through 12/6/2023 and confirmation from the laboratory manager during an interview at 3:00 p.m. on 12/6 /2023, the laboratory failed to perform calibration verification on the Vitros XT 7600 (West) every 6 months for Procalcitonin (PCT). There were 0 of 2 expected calibration verifications documented as performed. Findings include: 1. Review of the Vitros XT 7600 procedures indicated that Procalcitonin (PCT) is calibrated using less than 3 calibrator levels. 2. Calibration verification is required every 6 months on any assays which are calibrated with less than 3 calibration levels. 3. Review of the Vitros XT 7600 (West) calibration records revealed no records of calibration verification on Procalcitonin for 2023 for 0 of 2 expected verifications documented as performed 4. The laboratory manager confirmed in an interview at 3:00 p.m. on 12/6/2023 that calibration verifications had not been performed for Procalcitonin performed on the Vitros XT 7600. -- 3 of 3 --