Baptist Memorial Hospital - Calhoun

Summary Statement of Deficiencies 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 7/31/18 through 11 /5/20 and blood bank procedure manual and interview with the laboratory supervisor at 3:00 pm on the day of survey (11/5/20), the laboratory failed to inspect the blood bank refrigerator Jewett alarm system quarterly according to the blood bank procedure manual to ensure appropriate temperature conditions for proper blood and blood product storage were maintained. Findings include: 1. Review of the blood bank procedure manual requires the refrigerator Jewett alarm system to be checked quarterly by laboratory staff. The laboratory's written procedure for checking for High Activation and Low Activation alarm check states the low temperature of activation should no colder that 1 degree C (Celsius) and the high temperature of activation should be no higher than 6 degrees C. It also states to record the low temperature of activation, the high temperature, initial, date and time on the equipment log sheet. 2.. Interview with the laboratory supervisor at 3:00 pm confirmed the blood bank refrigerator was monitored and temperatures were documented manually and digitally but no quarterly alarm check was performed on the Jewett alarm system since the last survey. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of respiratory personnel records from last survey on 7/31/18 through day of survey, 11/5/20, the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interview with the technical consultant and Respiratory Supervisor at 10:30 am on the day of survey, the technical consultant (TC) failed to evaluate and document the performance of respiratory testing personnel (TP) #13 and #14 responsible for performing blood gas testing at least semiannually during the first year of employment. A semiannual evaluation must be performed during the first year of employment by the technical consultant. Findings include: 1. Review of the personnel records for TP #13 and #14 revealed the 6 month evaluation/competency available the day of survey was documented as performed by the department supervisor instead of the technical consultant. The semiannual evaluation/competency for TP #13 available the day of survey was documented on 2/22/19 by the department supervisor. The semiannual evaluation/competency performed on TP#14 was documented on 6/19 by the department supervisor. 2. Interview with the laboratory TC and respiratory department supervisor and staff at 10:30 am confirmed the 6 month evaluation and competency performed on TP #13 and #14 was completed by the department supervisor not the TC delegated on CMS 209 form. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of respiratory personnel records from the previous survey on 7/31/18 through day of survey, 11/5/20, the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interview with the technical consultant (TC) and Respiratory Supervisor at 10:30 am on the day of survey, the technical consultant failed to evaluate annually and document the performance of respiratory testing personnel (TP) #8, #9, #10, #11, #12, #13 and #14 responsible for performing blood gas testing. An annual evaluation/competency must be performed each year of employment by the technical consultant. Findings include: 1. Review of the respiratory personnel records for 2018 revealed annual evaluation/competencies available for review for TP #8, #9, and #12 were not performed by the technical consultant. 2. Review of the respiratory personnel records for 2019 revealed annual evaluation/competencies available for review on TP #8, #9, #10, # 11 and #12 were not performed by the technical consultant. 3. Review of the respiratory personnel records for 2020 revealed annual evaluation/competencies available for review on TP #8, #9, #10, #11, #12, #13 and #14 were not performed by the technical consultant. 4. Interview with the TC and respiratory supervisor and staff at 10:30 am on the day of the survey confirmed the annual evaluation/competencies for TP #8, #9, #10, #11, #12, #13 and #14 performed for the years 2018, 2019 and 2020 were all performed by staff other than the technical consultant. -- 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 the Sysmex CA 600 maintenance form from 11/1/16 to 7/31/18, it was determined the laboratory failed to document as performed the weekly maintenance required by the manufacturer's instructions on the Sysmex CA 600 coagulation analyzer. The following maintenance was not documented as performed: Weekly Maintenance: Clean DI H2O rinse bottle with alcohol -10/17, 11/17, 12/17, 1 /18, 2/18, 3/18 THIS IS A REPEAT DEFICIENCY 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 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 -- 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 12/8/16 through 7/30/18, and confirmation with staff at 11:30am on 7/30/18, the laboratory failed to perform calibration verification on the Dimension EXL 250 chemistry analyzer every 6 months. Findings include: Review of laboratory chemistry calibration records, revealed Sodium (NA), Potassium (K), and Chloride (CL) calibrates on the Dimension EXL 250 analyzer every 2 hours but does not yield 3 points, a minimal value, a mid-point value and a maximum, value. Calibration verification was peformed on 12/8/16, 9/8/17 and 6/28/18. This time frame exceeds the 6 month requirement. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on review of quality control (QC) records and patient test records for serum pregnancy testing with the Quick Vue hCG Combo Cassette from 4/10/17 through 7 /30/18, and interview with general supervisor at 1:30 pm on 7/30/18, the lab failed to include two levels of control material each day of patient testing when approximately 27 patient serum pregnancy results were reported. There was no documentation of an Individualized Quality Control Plan (IQCP), required after 1/1/16, if two levels of QC are not done each day of testing Findings include: On the following days patient serum pregnancy tests were performed without a positive and negative control: 4/10 /17 - 1 patient tested 6/4/17 - 1 patient tested 6/23/17 - 1 patient tested 7/22/17 - 1 patient tested 9/5/17- 9/7/17 - 7 patients tested 9/21/17 - 1 patient tested 9/30/17 - 1 patient tested 10/2/17 - 1 patient tested 10/5/17 - 1 patient tested 10/17/17 - 1 patient tested 10/21/17 - 1 patient tested 11/2/17 - 2 patients tested 12/19/17 - 1 patient tested 2/14/18 - 1 patient tested 2/16/18 - 1 patient tested 6/2/18 - 1 patient tested 6/8/18 - 1 patient tested 7/1/18 - 1 patient tested 7/12/18 - 1 patient tested 7/22/18 - 1 patient tested B. Based on review of quality control (QC) records, IQCP(Individualized Quality Control Plan), and patient test records for blood gas testing on the Gem Premier 4000 Blood Gas Analyzer, from 1/13/17 through 7/31/18, and interview with laboratory staff at 3:30 pm on 7/31/18, the Blood Gas Department failed to include two levels of external control material each day of patient testing from 1/13/17 through 7/31/18 or follow their IQCP that included testing external liquid controls monthly and with each pack change. Approximately 182 patient blood gas results were reported during this time period. Findings include: Review of quality control -- 2 of 4 -- records and patient test records for blood gas testing with the Gem Premier blood gas analyzer from 1/13/17 through 7/31/18 revealed approximately 182 patient blood gas results were reported during this time frame with no documentation of performance of at least two levels of quality control (QC) each day of patient testing or with the change of the iQM cassette pack each month according to the manufacturer's instructions. The IQCP, required after 1/1/16 if two levels of control are not included each day of patient testing, was written to include two levels of QC with each new cartridge prior to patient testing and monthly, but no external liquid QC material was tested. CVP (Calibration Valuation Product) was tested per the manufacturer as part of the calibration process--in an interview on 7/31/18 at 3:30 pm the blood gas staff confirmed CVP was run monthly and with each pack change, but no external liquid controls were run. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory procedure for microbiology (blood cultures) and lack of documentation of control records or an IQCP, the laboratory failed to check each lot or shipment of blood culture media for sterility, for its ability to support growth, or document physical characteristics of the media when compromised. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of