Claiborne County Hospital Dba Claiborne Co Med Ctr

Summary Statement of Deficiencies 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: Based on review of quality control (QC) logs, patient testing logs and interview with the laboratory general supervisor (GS) as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to include a positive and negative control on each day of patient testing for the Consult Combo HCG Pregnancy test performed for five of fifteen serum samples. The Consult Combo hCG Pregnancy test is categorized as moderate complexity when used with serum samples. Findings Include: 1. Review of the Consult Combo HCG patient test log and QC log from 1/5/2023 through 10/17/2024 revealed that on the 5 days listed below, pregnancy tests were performed on serum samples. Five of fifteen hCG patient tests were performed without quality control on these days. 4/22/2023 - 1 patient tested 4/30 /2023 - 1 patient tested 6/22/2023 - 1 patient tested 2/09/2024 - 1 patient tested 3/25 /2024 - 1 patient tested 2. Interview with GS on 10/17/2024 at 1:00 p.m., confirmed that testing personnel (TP) were not performing two levels of QC (positive or negative) each day of patient testing with the Consult Combo HCG test kit as required for moderate complexity testing. 3. There was no IQCP (Individualized Quality Control Plan) available for review on the day of survey. As IQCP is required after 1/1 /2016 if two levels of quality control (QC) are not performed each day of use for moderate/high complexity testing. 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 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: A. Based on review of the laboratory Blood Bank Procedure Manual, the Blood Bank checklist log from 11/1/18 through 4/14/21, and confirmation with the general supervisor (GS) listed on the Centers for Medicare & Medicaid Services (CMS) 209 form at 1:00 pm on 4/15/21, the laboratory did not follow their blood bank procedure for performing the serofuge RPM and timer checks since the last survey on 10/31/18. Findings include: 1. Review of the Blood Bank Procedure Manual revealed the serofuge RPM and timer used for centrifugation in Blood Bank is to be checked quarterly. 2. Review of the Blood Bank maintenance checklist from 11/1/18 through 4 /15/21 revealed the serofuge RPM and timer check had not been documented as performed since 10/31/18. 3. Interview with the GS listed on the CMS-209 personnel form at 1:00 pm on the day of survey confirmed that the Blood Bank serofuge RPM and timer check had not been documented as performed since 10/31/18. B. Based on the review of the laboratory Blood Bank Procedure Manual, the Blood Bank checklist log from 11/1/18 through 4/15/21 and confirmation with the GS at 1:00 pm on the 4/15 /21, the laboratory did not follow the blood bank procedure for performing the serofuge calibration. 1. Review of the Blood Bank Procedure Manual revealed calibration must be performed on the serofuge at 20, 30 and 45 seconds for saline, albumin, AHG and washing stage every 6 months. 2. Review of the Blood Bank maintenance checklist from 11/1/18 through 4/15/21 revealed the serofuge calibration had not been documented as performed since 10/31/18. 3. Interview with the GS at 1: 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 -- 00 pm on the day of survey, confirmed the the Blood Bank serofuge had not been documented as calibrated since 10/31/18. This timeframe exceeds the 6 month intervals required by the laboratory procedure manual. 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: Based on review of quality control (QC) logs, patient testing logs and interview with the laboratory general supervisor (GS) as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form on 4/15/21 at 1:00 pm, the laboratory failed to include a positive and negative control on each day of patient testing for the Consult Combo HCG Pregnancy test when performed with serum samples between 12 /27/19 and 3/21/21. The Consult Combo hCG Pregnancy test is categorized as moderate complexity when used with serum samples. Findings Include: 1. Interview with GS on 4/15/21 at 1:00 pm confirmed that testing personnel (TP) were not performing two levels of QC (positive or negative) each day of patient testing with the Consult Combo HCG test kit as required for moderate complexity testing. 2. There was no IQCP (Individualized Quality Control Plan) available for review on the day of survey. An IQCP is required after 1/1/16 if two levels of quality control (QC) are not performed each day of use for moderate/high complexity testing. 3. Review of the Consult Combo HCG patient test log and QC log from 12/27/19 through 3/21/21 revealed that on the 5 days listed below, pregnancy tests were performed on serum samples. No QC was performed on these days. 05/20/2020 - 1 patient tested 12/10 /2020 - 1 patient tested 01/03/2021 - 1 patient tested 02/13/2021 - 1 patient tested 03 /22/2021 - 1 patient tested -- 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: Based on review of laboratory personnel documented annual evaluations/competency and interview with the technical consultant, the laboratory failed to follow written policies to assess employees and technical consultant competency at least annually since employment of the new technical consultant in April 2017. On the day of survey, there was no competency evaluation for the technical consultant performed by the laboratory director. 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 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 -- 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 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 review of chemistry laboratory records from 2/3/17 through the day of survey, and confirmation with staff at 1:30 pm on 10/31/18, the laboratory failed to perform calibration verification on the Dimension EXL 200 chemistry analyzer every 6 months. Calibration verification should be performed using at least 3 levels of calibrator every 6 months as per the regulations. Findings include: Review of laboratory chemistry calibration records, revealed Sodium (NA), Potassium (K), and Chloride (CL) calibrate on the Dimension EXL 250 analyzer every 2 hours but does not yield 3 points. The last calibration verification was performed on 2/3/17. This time frame does not meet the calibration verification requirements specified in the regulations. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of immunohematology (blood bank) records from 1/1/17 through 10 /31/18, the laboratory failed to have available evidence of monthly inspections of the Jewett refrigerator alarm system to ensure appropriate temperature conditions for blood and blood product storage were maintained. Findings include: Review of blood bank records and alarm recorder log, from 1/1/17 through 10/31/18 revealed the laboratory performed monthly Jewett temperature alarm system checks, but the actual recorder graphs did not reveal at what temperature the alarm was activated. There was no obvious peak indicated on the graph paper representing a low and high activation of the alarm system. The laboratory's written procedure for Hi/Lo alarm check state the high temperature activation is set at 6.0 degrees Celsius and the low temperature activation is set at 1.0 degree Celsius. This could not be supported by the documentation on the recorder graphs. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of laboratory records (including quality control, calibrations, temperature logs, maintenance logs and proficiency testing results), since the last survey, 12/7/16, through the day of survey, 10/31/18, and confirmation with staff at 3: 30 pm, the Technical Consultant (TC) listed on the CMS-209 (Centers of Medicare and Medicaid) form or the TC appointed at the time failed to document as reviewed the following laboratory records: 1. Horiba AB Pentra 60 + hematology calibrations from 12/7/16 through 6/27/18 2. Horiba AB Pentra 60 + hematology maintenance from 1/1/17 through 10/29/18 3. Dimension EXL 200 chemistry Quality Control records from 2/1/17 through 10/30/18 4. Dimension EXL 200 chemistry maintenance 1/1/17 through 10/30/18 5. Dimension EXL 200 chemistry calibrations 1/31/17 through 10/18/18 6. iSTAT blood gas calibration verification 6/7/17 through 6/28/18 -- 3 of 3 --