Hereford Regional Medical Center

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted June 4, 2024 through June 5, 2024, found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 laboratory policy, laboratory blood culture worksheets, patient final reports, and confirmed in interview, the laboratory failed to follow policy for the subculture and identification of positive blood culture vials for 12 of 17 sets of cultures on patients that had a previously positive identified on the BD Bactec FX40 blood culture analyzer for records reviewed in 2023. The findings included: 1. Review of the laboratory policy titled "Automated Blood Culture Instrument Procedure BD Bactec FX40" stated the following under section "I. Principle": "When positive vials are identified, the lab technologist pulls them from the instrument for confirmation of results, and for isolation and identification of the organism." 2. In review of patient final reports for blood cultures that had been identified as positive the surveyor noted the following statement on occasional final reports: "See paired result." Surveyor asked for clarification on the statement and the microbiology technical supervisor stated that when one of the two bottles from a set (aerobic and anaerobic bottles) with the same accession number, or one bottle from a paired set (separate accession number same patient) was identified as a positive, the subsequent positive bottles identified from the same accession number, or paired set, would not be cultured for bacterial identification. 3. Review of laboratory blood culture worksheets and patient final reports for 2023 included the following 12 blood cultures identified as positive 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 the BD Bactec FX40 blood culture analyzer that were not cultured for the identification of bacterial organism: Collection Date MRN Accession Number 01/14 /2023 280180 24-23-014-0067 03/22/2023 30568 24-23-081-0010 04/24/2023 80028501 24-23-114-0151 09/06/2023 80023094 24-23-249-0174 09/23/2024 29413 24-23-266-0045 10/11/2023 35100 24-23-284-0142 11/08/2023 21237 24-23-314- 0159 11/24/2023 24106 24-23-328-0086 12/04/2023 80018826 24-23-338-0031 12/08 /2023 36239 24-23-342-0131 12/11/2023 22808 24-23-345-0196 12/15/2023 26235 24-23-349-0051 3. In an interview on 6/5/2024 at 10:20, in the office, the technical supervisor (TS)2 confirmed the above positive blood culture bottled were not subcultured for the identification of the bacterial organism. 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 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 laboratory policy, manufacturer instructions, calibration verification records, and interview with laboratory personnel, the laboratory failed to perform calibration verification at least every six months for nine months between July 2023 and April 2024 for the analyte Fibrinogen on the coagulation analyzer. The findings included: 1. Based on review of the policy "Fibrinogen Standard Curve", effective 5/22/2023, the policy stated: "Policy: Fibrinogen reagent needs to be calibrated yearly an as needed to have QC within range." 2. Based on review of the manufacturer's instructions "Sysmex CA-600 Series Lot Rollover Information", on page 3 of 6, the instructions stated "Calibrated Assays: A calibration is required with reagent lot number change. Calibration/calibration verification is required every six (6) months per CLIA. Calibration may be required after major preventive maintenance or replacement of critical parts. Calibration may be required with control shift, trend, or outside acceptable limits. Ensure analyzer is performing properly before recalibration." 3. Based on review of calibration records, the fibrinogen reagent was calibrated on 7/13/2023 and 4/5/2024. The elapsed time between calibrations was 8 months and 23 days. 4. In an interview at 15:00 hours on 6/5/2024 in the office, the Laboratory Manager confirmed the laboratory had not performed calibration -- 2 of 4 -- verification studies on the fibrinogen reagent at least every six months or calibrated at least every six months with at least a three-part calibration. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of laboratory policy, laboratory blood culture worksheets, final patient reports, and confirmed in interview, the laboratory failed to include the site of culture for 35 of 37 blood cultures reviewed in 2023. The findings included: 1. Review of the laboratory policy titled "Automated Blood Culture Instrument Procedure BD Bactec FX40", section "III Specimen" had the following collection instructions: "A. Collection 1. Site Selection a. Select a different body site for each culture [set] drawn." 2. Review of laboratory blood culture worksheets included the site from which the blood culture set (aerobic and anaerobic bottles) was drawn from the patient which was not included on the patient final report: Date of Collection MRN Accession Site 01/14/2023 at 21:19 280180 24-23-014-0067 "L AC" 01/14 /2023 at 21:19 280180 24-23-014-0070 "R AC" 03/22/2023 at 07:27 30568 24-23- 081-0010 "L AC" 03/22/2023 at 07:27 30568 24-23-081-0011 "R Arm" 04/24/2023 at 22:21 80028501 24-23-114-0151 "central line" 04/24/2023 at 22:25 80028501 24-23- 114-0152 "R Hand" 05/12/2023 at 22:30 35737 24-23-132-0164 "L Arm" 05/12/2023 at 22:50 35737 24-23-123-0165 "R Arm" 08/03/2023 at 09:45 80024930 24-23-215- 0040 "R AC" 08/03/2023 at 10:26 80024930 24-23-215-0041 "L AC" 09/01/2023 at 17:21 80031221 24-23-244-0131 "R AC" 09/01/2023 at 1715 80031221 24-23-244- 0130 "L AC" 09/06/2023 at 16:30 80023094 24-23-249-0174 "L AC" 09/06/2023 at 16:30 80023094 24-23-249-0177 "R AC" 09/23/2024 at 23:15 29413 24-23-266-0045 "R hand" 09/23/2024 at 23:20 29413 24-23-266-0046 "R arm" 10/11/2023 at 21:55 35100 24-23-284-0142 "R Hand" 10/11/2023 at 21:55 35100 24-23-284-0139 "R Arm" 10/27/2023 at 07:38 80024527 24-23-300-0025 "L AC" 10/28/2023 at 06:23 80024527 24-23-301-0006 "L Hand" 10/28/2023 at 06:53 80024527 24-23-301-0005 "L AC" 10/31/2023 at 10:20 80024527 24-23-304-0058 "not indicated" 10/31/2023 at 10:20 80024527 24-23-304-0059 "not indicated" 11/08/2023 at 21:10 21237 24-23- 312-0156 "R AC" 11/08/2023 at 22:00 21237 24-23-314-0159 "R AC" 11/10/2023 at 13:35 80031861 24-23-314-0119 "not indicated" 11/10/2023 to 13:40 80031861 24- 23-314-0122 "not indicated" 11/24/2023 at 21:43 24106 24-23-328-0086 "L AC" 11 /24/2023 at 21:53 24106 24-23-328-0087 "L Hand" 12/08/2023 at 18:19 36239 24-23- 342-0130 "RW" 12/08/2023 at 18:27 36239 24-23-342-0131 "LH" 12/11/2023 at 09: 55 22808 24-23-345-0196 "not indicated" 12/11/2023 at 09:55 22808 24-23-345-0197 "not indicated" 12/15/2023 at 12:17 26235 24-23-349-0050 "L forearm" 12/15/2023 at 14:24 26235 24-23-349-0051 "L wrist" 3. In an interview on 6/5/2024 at 09:45, in the office, the microbiology technical supervisor confirmed that the body site where the blood culture set was drawn from, was not included on the patient final report. Key: L: Left R: Right AC: Accessory Cephalic Vein RW: Right wrist LH: Left hand -- 3 of 4 -- D6098 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(8) The laboratory director must ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on laboratory policy, manufacturer's instructions for use, patient reports, and confirmed in interview, the laboratory director failed to ensure that reports of test results included pertinent information required for the interpretation of blood culture results, body site and positive vial type from set drawn (aerobic and anaerobic, or peds), for 37 patient reports reviewed in 2023. The findings included: 1. Review of the laboratory policy titled "Automated Blood Culture Instrument Procedure BD Bactec FX40", section "III Specimen" had the following collection instructions: "A. Collection 1. Site Selection a. Select a different body site for each culture [set] drawn." 2. Review of the "BD BACTEC Plus Aerobic/F Culture Vials", "BD BACTEC Plus Anaerobic/F Culture Vials", and "BD BACTEC Peds Plus/F Culture Vials" intended use stated the following for the type of microorganism recovered in each culture vial: a. "BD BACTEC Plus Aerobic/F Culture Vials Intended use: BD BACTEC Plus Aerobic/F Culture Vials are used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood." b. "BD BACTEC Plus Anaerobic/F Culture Vials Intended use: BD BACTED Plus Anaerobic/F medium is used in a qualitative procedure for the anaerobic culture of microorganisms (bacteria) from blood." c. "BD BACTEC Peds Plus/F Culture Vials Intended use: BD BACTEC Peds Plus/F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures." 3. Review of patient preliminary and final reports for blood cultures positive for growth did not include the body site from which the blood culture set was obtained, or the vial type that obtained the microorganism growth. 4. In an interview on 6/5/2024 at 09:45, in the office, the microbiology technical supervisor confirmed that the final patient reports did not include the pertinent information required for interpretation of the positive blood culture results. -- 4 of 4 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) records, instrument records, and confirmed in an interview, the laboratory failed to test proficiency testing samples with the primary method for patient testing during for Chemistry Blood Gas Analysis for one out of three events in 2021. 1. Review of the College of American Pathologist (CAP) PT records has the primary method of patient blood gas testing as the Nova Prime Plus for three out of three events in 2021. 2. In a review of the instrument printouts for 2021, the surveyor found that most of the patient blood gas testing was being performed on the i-STAT analyzer with serial number 361275. 3. In an interview on 3/29/2022 at 10:40 hours, the technical consultant confirmed that the Nova Prime Plus was purchased as the primary analyzer for patient blood gas testing, with the Nova Prime intended as the backup analyzer. The laboratory retained the Abbott i-STAT for backup testing as needed. Respiratory therapy personnel preferred using the i-STAT because "it worked better" and confirmed that testing personnel did not test proficiency testing samples the same as they tested patient samples. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: . Based on review of laboratory policy, patient transfusion records, and confirmed in interview, the laboratory failed to promptly identify, investigate, and report blood and blood product transfusion reactions for two out of twelve random patients reviewed for September 2021, and December 2021 through March 2022. The findings include: 1. Review of the hospital policy titled "Blood Transfusion Record" had the following instructions regarding transfusion reactions: "The nurse will observe the patient for signs of reaction which can include but are not limited to: Temperature increase of 1 (degree) C (Celsius) or 2(degree) F (Fahrenheit), a significant change in pulse, chest pain, chills, sweating, nausea, vomiting, precordial distress, anxiety, restlessness, headache, urticaria or hives, pallor, erythema, hematuria, oliguria, anuria, jaundice, shock, cyanosis, pulmonary edema, pruritus, pain in legs or back, rigors, bronchospasm or dyspnea, respiratory distress, a drop in BP (blood pressure) of 30mmHg in the absence of profuse blood loss. "Observation for possible adverse effects during and following the administration, with appropriate actions if such effects should occur (i.e., stopping of administration, notification of provider and the Blood Bank, take vital signs)." 2. In a random review of twelve transfusion records included the two following patients that meet the transfusion reaction workup requirements as set by the policy, that were not identified and/or called to the blood bank. Patient 70344271 Unit Number W091021454220 - Transfused 12/24/2021 Starting temperature at 10:42 hours: 30(degrees) C Temperature at 30 minutes: 33 (degrees) C Patient 70350797 Unit number W091021455011 - Transfused 1/22/2022 Pre transfusion blood pressure: 119/79 Blood pressure at 30 minutes into transfusion: 88/54 3. In an interview on 3/30/2022 at 15:30, in the office, the technical consultant and nurse, confirmed that the above two patients met the transfusion reaction workup requirements and that the blood bank was not notified as defined in their own procedure. . D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on a review of laboratory policy, instrument printouts, patient final reports, and confirmed in an interview, the laboratory failed to have a test request for results given to the providers at the time of testing for blood gas analysis for ten out of ten random patients printouts reviewed in 2021 and 2022 for the Abbott i-STAT and Nova Prime Plus blood gas analyzers: Na, K, Hct, Hb, tHb, and TCO2, A, A-aDO2 respectively. 1. Review of the laboratory policy titled "Arterial Blood Gas Analysis" section "Analysis includes" list the following tests to be performed for the ABG test: "Analysis includes: Partial pressures for carbon dioxide (pCO2) Partial pressures for -- 2 of 8 -- oxygen (pO2) Hydrogen ion concentration (pH) Oxy-hemoglobin saturation (O2Hb) (SO2) Saturation of dyshemoglobins (carboxyhemoglobin or COHb, and methemoglobin or metHb) Other calculated or derived values i.e. plasma bicarbonate and base excess/deficit." 2. Review of instrument printouts had the following analysis' given to the provider for their corresponding analyzer: i-STAT: pCO2 pO2 BEecf HCO3 TCO2 sO2 Na K Hct Hb* *Via Hct Nova Prime Plus: pH pCO2 pO2 SO2 tHb COHb TCO2 Calculated: BEecf HCO3 A A-aDO2 3. A review of ten random patient testing from 2021 to 2022 included the following blood gas analysis that included results not included as tests defined in the laboratory ABG panel. Patient 70287257 - Tested on 4/5/2021 on the i-STAT Results were provided for Na, K, Hct, and Hb that are not included as tests defined in the laboratory ABG panel. Patient 70303691 - Tested on 6/23/2021 on the i-STAT Results were provided for Na, K, Hct, and Hb that are not included as tests defined in the laboratory ABG panel. Patient 70305446 - Tested on 7/2/2021 on the i-STAT Results were provided for Na, K, Hct, and Hb that are not included as tests defined in the laboratory ABG panel. Patient 70308364 - Tested on 7/19/2021 on the i-STAT Results were provided for Na, K, Hct, and Hb that are not included as tests defined in the laboratory ABG panel. Patient 70318916 - tested on 9/4/2021 on the i-STAT Results were provided for Na, K, Hct, and Hb that are not included as tests defined in the laboratory ABG panel. Patient 70343727 - Tested on 12/22/2021 on the i-STAT Results were provided for Na, K, Hct, and Hb that are not included as tests defined in the laboratory ABG panel. Patient 70344184 - Tested on 12/23/2021 on the i-STAT Results were provided for Na, K, Hct, and Hb that are not included as tests defined in the laboratory ABG panel. Patient 70358458 - Tested 2/24/2022 on the Nova Prime Plus Analyzer Results were provided for tHb, TCO2, A, and A-aDO2 that are not included as tests defined in the laboratory ABG panel. Patient 70359527 - Tested on 3/1/2022 on the Nova Prime Plus Analyzer Results were provided for tHb, TCO2, A, and A-aDO2 that are not included as tests defined in the laboratory ABG panel. Patient 70361050 - Tested on 3/6/2022 on the Nova Prime Plus Analyzer Results were provided for tHb, TCO2, A, and A-aDO2 that are not included as tests defined in the laboratory ABG panel. 4. In an interview on 3 /29/2022 at 16:00, the respiratory therapist (RT) stated that each instrument printout is supplied to the physician at the time of analysis, and at a later time, the results are entered into the patients' chart. Surveyor queried about the results that were not included in the test analysis and patient final report, and the RT stated that those results were on the analyzer strip given to the provider, but not placed in the computer. 5. In an interview on 3/29/2022 at 16:30 hours, in the laboratory office, the technical consultant confirmed that the laboratory was providing non-ordered results to the provider for blood gas testing for the Nova Prime Plus, and the I-Stat blood gas analyzers. . . 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 a review of laboratory policy, patient transfusion flow sheets, and confirmed in interview, the laboratory failed to document information on the Blood and Blood Derived Transfusion Flow Sheet as defined by their own policy for ten out -- 3 of 8 -- of twelve random patients reviewed for September 2021, and December 2021 through March 2022. The findings include: 1. Review of the laboratory policy titled "Blood Transfusion Record" have the following instructions: "Procedure: The Nursing Services personnel will complete the Blood and Blood Derivative Transfusion Flow Sheet portion as the unit being delivered. This shall include the following steps: - Comparing the product to be delivered with the Transfusion Record received from the Blood Bank and the name band on the patient. Two (2) registered nurses or the provider and a registered nurse or an LVN must verify the correct blood product and correct patient and DOB. - Obtain vital signs immediately prior to start of administration of the product, VS must be documented by RN or LVN and monitored for changes, temperature can be documented in Celsius or Fahrenheit, 5 minutes after start of product, 15 minutes after start of product, 30 minutes after start of product, every hour and at time of discontinuation of unit and then again 1 hour after unit is completed." 2. Random review of patient Blood and Blood Derivative Transfusion Flow Sheets for September 2021, and December 2021 through March 2022 included the ten patients with missing documentation: Patient 70323126 Unit W091021355325 - Transfused 9/24/2021 Missing the second set of initials for verification that the blood bank tags match the patient record. Patient 70323126 Unit W091021346397 - Transfused 9/24/2021 Missing the second set of initials for verification that the blood bank tags match the patient record. Missing the 1 hour post-transfusion vitals Patient 70344271 Unit W091021445116 - Transfused 12/24/2021 Missing temperature documentation at 15 minutes, and 1 hour after starting the transfusion. Missing the 1 hour post-transfusion vitals. Patient 70344364 Unit W091021412458 - Transfused 12 /25/2021 Missing the 1 hour post-transfusion vitals Patient 70345138 Unit W091021453280 - Transfused 12/29/2021 Missing the 1 hour post-transfusion vitals Patient 70350797 Unit W091021459526 - Transfused 1/21/2022 Missing the 1 hour post-transfusion vitals Patient 70350797 Unit W091021455011 - Transfused 1/22 /2022 Missing the 1 hour post-transfusion vitals Patient 70354441 Unit W091021454335 - Transfused 2/8/2022 Missing the 1 hour post-transfusion vitals Patient 70354438 Unit W091021220926 - Transfused 2/9/2022 Missing the 1 hour post-transfusion vitals Patient 70365463 Unit W091022131135 - Transfused 3/30 /2022 Missing temperature documentation at 5 minutes, and 15 minutes after starting transfusion. 3. In an interview on 3/31/2022 at 12:50 hours the chief nursing office (CNO) confirmed that there was missing documentation on the Blood and blood Derivative Transfusion Flow Sheet, and that they were actively monitoring the situation. . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.1441 Condition: Laboratories Performing High Complexity Testing; laboratory director 493.1250 Condition: Analytic Systems D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratories policies and procedures, quality control records, patient test records, verification records and confirmed in interview, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283. (Refer to D 5407, D5421, D5445, D5449, and D5791) D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Review of policies and procedures and interview of facility personnel found that 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 6 -- laboratory director failed to approve, sign and date seven of seven procedures available to testing personnel for use in testing patient specimens in the cardiopulmonary department. Findings included: 1. Review of Policies and Procedures in the Cardiopulmonary Services policy and procedure manual found no documentation of the approval (including signature and date of approval) by the current laboratory director for seven of seven procedures. Procedures contained in this notebook were documented as approved by DR, CNO, PI, CEO, GB, with revision dates between 01/09/2017 and 10?29/2017. Arterial Blood Gas Analysis had an effective date of 02/25/15 and a reviewed/ revised date of 10/29/17 Arterial Blood Gas Sampling had an effective date of 05/05/09 and a reviewed/ revised date of 10/29 /17 Critical Tests and Result Reporting had an effective date of 05/12/09 and a reviewed/ revised date of 10/29/17 Capillary Blood Sampling- Infants had an effective date of 04/29/09 and a reviewed/ revised date of 10/29/17 Critical Points in Arterial Blood Gases had an effective date of 04/29/09 and a reviewed/ revised date of 10/29 /17 Blood Gasses-Capillary had an effective date of 01/09/17 and a reviewed/ revised date of 01/09/17 Quality Control (Troubleshooting) Arterial Blood Gas Analysis had an effective date of 04/29/09 and a reviewed/ revised date of 10/29/17 2. Interview of the Technical Consultant of the CMS report 209 Laboratory Personnel Report conducted on May 9, 2018 at 10:38 AM confirmed that the procedures had no documentation of approval by the current laboratory director. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observations, review of verification records and interview of facility personnel, the laboratory failed to perform a complete verification study for three of three panels tested using the BioFire Film Array prior to patient testing. Findings included: 1. Observations made during the tour of the laboratory found that the laboratory was currently using the BioFire Film Array GI panel, Respiratory Panel and the Blood Culture ID panel for testing patient specimens. 2. Review of of verification studies found that the laboratory completed verification procedures for each of the panels as follows: Respiratory Panel - Verification study approved by the laboratory director on 05/27/2016. The verification study consisted of a 3 day Daily QC study and the 20 day study as defined by the manufacturer, and a comparison of 3 specimens with another facility performing the same method. The laboratory failed to evaluate the data to determine if the results obtained met the manufacturers claims for accuracy and precision. Gastrointestinal Panel - Verification study approved by the laboratory director on 05/27/2016. The verification study consisted of a 3 day Daily QC study and the 20 day study as defined by the manufacturer, and a comparison of 3 specimens with another facility performing the same method. The laboratory failed to evaluate the data to determine if the results obtained met the manufacturers claims for accuracy and precision. Blood Culture ID Panel - Verification study approved by the laboratory director on 07/19/2016. The verification study consisted of a 3 day Daily -- 2 of 6 -- AC study and the 20 day study as defined by the manufacturer, and a comparison of 3 specimens with another facility performing the same method. The laboratory failed to evaluate the data to determine if the results obtained met the manufacturers claims for accuracy and precision. 3. Interview of the Technical Consultant conducted on May 9, 2018 at 10:40 AM confirmed that the laboratory did not evaluate the data used to verify the performance of the BioFire FilmArray panels to ensure it met the manufacturer's claims for accuracy. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of the laboratory's Quality control plan for IStat G3+ cartridges, quality control records, patient test records and interview of facility personnel found that the laboratory failed to ensure that external quality controls were tested at the frequency defined in their own written procedure. Findings included: 1. Review of the Laboratory's Quality Control Plan for the IStat G3+ Cartridges (signed by the laboratory director on 12/30/15 and 03/26/18) found that the external quality controls will be tested" upon opening a box from a new shipment or a lot number and any time there is a question about the stability of the device and at least once per month." 2. Review of Quality control records between January 10, 2018 and May 7, 2018 found that the laboratory tested iStat G3+ cartridges on the following dates using two levels of quality control material: January 11, 2018 - iStat G3+ cartridges lot 212D172431241 February 12, 2018 - iStat G3+ cartridges lot 212D172861228 March 12, 2018 - iStat G3+ cartridges lot 212D172861228 April 12, 2018 - iStat G3+ cartridges lot 212D172861228 May 7, 2018 - iStat G3+ cartridges lot 212D173200243 3. Review of patient test records found 18 patient specimens tested on iStat G3+ cartridges without documentation of testing 2 levels of external controls at least once each month prior to testing patient specimens. January 10, 2018 - patient 70036101 was tested using iStat G3+ cartridge lot 212D72431241 with no external Quality control documented prior to January 11, 2018 January 11, 2018 - patient 70033729 was tested twice using iStat G3+ cartridge lot 212D72240229 with no external quality control documented in January 2018. February 3, 2018 - Patient 70043201 was tested using iStat G3+ cartridge lot 212D172861228 with no external Quality control documented prior to February 12, 2018 February 4, 2018 - Patient 70043211 was tested twice using iStat G3+ cartridge lot 212D172861228 with no external Quality control documented prior to February 12, 2018 February 5, 2018 - Patient 70042704 was tested twice using iStat G3+ cartridge lot 212D172861228 with no external Quality control documented prior to February 12, 2018 Patient 70043211 was tested using iStat G3+ cartridge lot 212D172861228 with no external Quality control documented prior to February 12, 2018 Patient 70043475 was tested using iStat G3+ cartridge lot 212D172861228 with no external Quality control documented prior to February 12, 2018 February 7, 2018 - Patient 70044310 was tested twice -- 3 of 6 -- using iStat G3+ cartridge lot 212D172861228 with no external Quality control documented prior to February 12, 2018 February 8 , 2018 - Patient 70044386 was tested twice using iStat G3+ cartridge lot 212D172861228 with no external Quality control documented prior to February 12, 2018 Patient 70043211 was tested using iStat G3+ cartridge lot 212D172861228 with no external Quality control documented prior to February 12, 2018 May 3, 2018 - Patient 70062159 was tested using iStat G3+ cartridge lot 212D173200243 with no external quality control documented prior to May 7, 2018 May 5, 2018 - Patient 70062881 was tested twice using iStat G3+ cartridge lot 212D173200243 with no external quality control documented prior to May 7, 2018 4. Interview of the Technical Consultant conducted on May 9, 2018 at 11:49 AM confirmed that the laboratory failed to test each lot of iStat 3+ cartridges at least once each month before testing patient specimens. 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: Review of the laboratory's Quality control plan for the BioFire FilmArray GI Panel, quality control records, patient test records and interview of facility personnel found the laboratory tested 5 patient specimens between April 17 and April 24, 2018 without testing a negative and positive quality control material to ensure the quality of testing. Findings included: 1. Review of the Quality control plan for the BioFire FilmArray GI Panel (signed by the laboratory Director on 05/27/2016 and 03/26/2018 )found that the laboratory's policy was to test "external controls upon opening a box from a new shipment, lot number, and any time there is a question about the stability of the system and at least once per month ." 2. Review of Quality control records found that the laboratory tested quality control materials using the BioFire FilmArray GI Panel Lot 838318 on March 15, 2018 and Lot 862218 on April 15, 2018. 3. Review of patient test records found the laboratory tested five patient specimens between April 17 and April 24, 2018 without testing a negative and positive quality control material using panels from Lot 838318 without performing quality control procedures on this lot during the month of April, 2018. Patient 24181070089A was tested on April 17, 2018 using GI Panel lot 838318 Patient 24181100047A was tested on April 20, 2018 using GI Panel lot 838318 Patient 24181100081A was tested on April 20, 2018 using GI Panel lot 838318 Patient 24181140041A was tested on April 24, 2018 using GI Panel lot 838318 Patient 24181140056A was tested on April 24, 2018 using GI Panel lot 838318 4. Interview of the Technical Consultant conducted on May 9, 2018 at 2:10 PM confirmed that the laboratory did not test external quality control materials at least once each month for each lot of the BioFire FilmArray GI Panel used in patient testing. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems -- 4 of 6 -- identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratories policies and procedures, quality control records, patient test records, verification records, and confirmed in interview, the quality assessment system used by the laboratory failed to identify and correct problems in the analytic systems. (Refer to D 5407, D5421, D5445, D5449) 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 a review of the laboratory's quality control records, quality assessment records, record review and staff interview, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. The findings included: 1. The laboratory director failed to ensure that the verification procedures had been completed for the Bio Fire FilmArray panels used for testing patients prior to testing patient specimens. (See D6013) 2. The Laboratory Director failed to ensure that the quality control program had been established and maintained for the BioFire FilmArray panels and the iSTAT G3+ cartridges used for testing patients arterial blood gasses. ( See D6020) The Laboratory Director failed to ensure approved policies and procedures were available to all testing personnel performing Blood Gas Analysis (see D6031) D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: The laboratory director failed to ensure that the verification procedures had been completed forthree of three panels tested on the Bio Fire FilmArray instrument used for testing patients prior to testing patient specimens. (See D5421) D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 5 of 6 -- 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Review of quality control records, patient test records and interview of facility personnel found that the laboratory director failed to ensure that the quality control program for arterial blood gasses and the BioFire Film Array panels had been established and maintained. (See D5445 and D5449 ) D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual and interview of facility personnel, the Laboratory Director failed to ensure approved procedures for all aspects of Arterial blood gas testing was available to all testing personnel. ( see D5407) 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: Review of quality control records and patient test records found that the technical consultant failed to ensure that a negative and positive quality control material were tested at least once each month for each lot of the BioFire FilmArray GI Panel used in patient testing. (see D5449 ) Review of quality control records and patient test records found that the technical consultant failed to ensure that two levels of quality control materials were tested at least monthly for each lot of iSTAT G3+cartridges used in patient testing. (see D5445) -- 6 of 6 --