Wilbarger General Hospital Laboratory

Summary Statement of Deficiencies D0000 As a result of the CLIA recertification inspection performed on June 11, 2019, the laboratory is not in compliance with the following Conditions of Participation required for certification in the CLIA program at 42 CFR: D5026 - 42 C.F.R. 493.1217 Condition: Immunohematology; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6063 - 42 C.F.R. 493.1412 Condition: Laboratories performing moderate complexity testing; testing personnel; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on review of the CMS 155D proficiency testing reports, review of the laboratory's College of American Pathologists proficiency testing records from 2018 and 2019 (4 of 4 events reviewed) and staff interview, the laboratory failed to ensure proficiency testing data was released to HHS. The findings were: 1. A review of the laboratory's CMS 155D proficiency testing reports revealed proficiency testing data was not being collected by CMS. 2. A review of the laboratory's College of American Pathologists proficiency testing records from 2018 (events 1, 2, and 3) and 2019 (event 1) revealed the proficiency testing agency was not sending data to HHS. In the proficiency testing instructions, the proficiency testing company wrote the following: "1. All laboratories subject to Clinical Laboratory Improvement Amendments (CLIA) regulations: If your laboratory is beginning or discontinuing testing on any CMS- regulated analyte, you must check your CMS Analyte Reporting Selections to ensure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 20 -- no changes are needed. You can maintain your laboratory's current reporting preferences by accessing the application via e-LAB Solutions Suite under Proficiency Testing/Quality Management." 3. An interview with the Respiratory Therapy Manager on 06/11/2019 at 12:47 hours revealed she was unaware that HHS was not receiving the proficiency testing data as required. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Review of proficiency testing records and interview of facility personnel, the laboratory failed to test proficiency samples the same number of times as it tests patient specimens for the assay 25-0H Vitamin D- on the first event of 2019 (3 events per calendar year) for 3 of 3 proficiency samples. Findings included: 1. Review of The American Proficiency Institute (API) proficiency testing records for the first event of 2019 found that the laboratory tested proficiency specimens IAS-01, IAS-02, and IAS- 03 in duplicate on 4/29/2019. 2. Interview of the Laboratory Manager conducted on June 11, 2019 at 10:06 am in the laboratory confirmed that the laboratory tested 3 of 3 proficiency specimens two times each and that patient specimens were not tested two times each. 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 hospital policies and confirmed in interview, the facility failed to ensure end user nursing personnel were adequately trained on detecting and alerting on possible transfusion reactions to ensure prompt identification of transfusion reactions for all hospital patients receiving blood or blood components. The findings included: 1. Review of facility policy "Blood and Blood Component Administration" (PolicySTAT ID: 5481135) on page 2 stated, "13. Suspected adverse blood transfusion reactions will be communicated to the ordering physician, laboratory /laboratory director, and nursing supervisor, and documented in the patient's medical record." 2. Further review of the policy on page 8 provided an example of a Febrile Non-Hemolytic Transfusion Reaction (FNHTR). The policy defined FNHTR as, "Within 1-2 hours and up to 4 hours: AND EITHER (Fever greater than or equal to 38 degrees Celsius/100.4 Fahrenheit oral and a change of at least 1 degree Celsius/1.8 -- 2 of 20 -- degrees Fahrenheit from pre-transfusion value OR Chills/rigors are present." 3. Random review of duplicate transfusion forms stored in the laboratory found the following 1 of 30 patients from May 2018 to June 2019 with vital signs documentation. The vital signs included temperature documenation: Patient Identification: Account #707281 (Transfused: 12-02-2018) Time Temp Stats 1750 98.4 (baseline) 15 minute check @ 1805 98.6 30 minute check @ 1820 98.6 First Hour @ 1850 98.1 Second Hour @ 1950 101.1 (increase of 2.7 degrees Fahrenheit from baseline) Third Hour @ 2050 101.8 (increase of 3.4 degrees Fahrenheit from baseline) Blood Discontinued @ 2105 101.3 (increase of 2.5 degrees Fahrenheit from baseline) 4. Review of patient chart records found that in the patient's progress notes at 19:50 it stated, "Second Hour Check: No changes from previous assessment, no signs or symptoms of transfusion reaction. Lung sounds clear bilaterally." -Note: Patient's Progress Notes and the duplicate form that is sent to the lab do not match. The duplicate form indicated that the patient had a fever of greater than 100.4 with a 2.7 degree Fahrenheit increase in temperature from the baseline. The increase in patient's temperature was not documented in the Progress Notes until 21:05 (1 hour and 15 minutes later). a. There was no documentation that the facility followed its policy to notify the ordering physician, laboratory director/laboratory, and the nursing supervisor. 5. Review of the patient's progress notes at 20:50 stated, "Third Hour Check: No changes from previous assessment, no signs or symptoms of transfusion reaction. Lung sounds clear bilaterally." -Note: Patient's Progress Notes and the duplicate form that is sent to the lab do not match. The duplicate form indicated that the patient had a fever of greater than 100.4 with a 3.4 degree Fahrenheit increase in temperature from the baseline. The increase in patient's temperature was not documented in the Progress Notes until 21:05 (15 minutes later). a. There was no documentation that the laboratory followed its policy to notify the ordering physician, laboratory director/laboratory and the nursing supervisor. 6. Review of the patient's progress notes at 21:05 stated, "Febrile Reaction > Degrees Rise in Temp: 101.1 2d hour at right temple, 101.8 3d hour at right temple, 101.3 at transfusion end at right temple, 100.8 at left forehead and 100.6 at right forehead. There was no documentation that the facility followed its own policy to contact the ordering physician, laboratory/laboratory director, and the nursing supervisor. 7. Interview with the Infection Preventionist (scribe) on June 11, 2019 confirmed the findings. After her review of the records she agreed that the transfusion should have been stopped and further instructions obtained. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor's review of Immunohematology records, patient records, and interviews, the laboratory failed to meet applicable requirements in the specialty of Immunohematology (refer to D5559). D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that -- 3 of 20 -- occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on review of hospital policies, review of patient transfusion records, and confirmed in interview, the laboratory failed to implement a system to identify and document problems that occurred when a breakdown in communication occurred between the provider and the laboratory. The findings included: 1. Review of facility policy "Blood and Blood Component Administration" (PolicySTAT ID: 5481135) on page 2 stated, "13. Suspected adverse blood transfusion reactions will be communicated to the ordering physician, laboratory/laboratory director, and nursing supervisor, and documented in the patient's medical record." 2. Further review of the policy on page 8 provided an example of a Transfusion Associated Circulatory Overload (TACO). The policy defined a TACO as, "Onset or exacerbation within 1-2 hours and up to 6 hours: -Dyspnea -Orthopnea -Hypertension (increase in 30 mm hg) - Increased BNP -Radiographic evidence of pulmonary edema -Evidence of left heart failure -Increased CVP -Gallop -JVD -New ST-segment and T-wave changes in EKG - Elevated serum Troponin -Increased BP characterized by widening of pulse pressure - Radiographs show a widened cardio thoracic ratio" 3. Review of transfusion vital signs ("Record of Patient's Response") found on duplicate forms located in the laboratory revealed the following 1 of 30 patients with documentation as follows: Patient ID: Last four digits of Account #: 9952 (Patient Date of Birth: 02-11-1945) According to the "Record of Patient's Response" for the 2nd unit of blood (Donor Unit #W0910 19 108821), the following vital signs were documented by the RN (registered nurse): Time Temp Blood Pressure Oxygen Saturation Prior to transfusion 14:05 97.7 101/62 93% 15 minute check 15:00 97.7 104/68 94% 30 minute check 15: 15 97.8 127/80 100% First hour 15:45 98.1 105/75 99% Second hour 16:45 97.7 148 /100 61% Blood discontinued 16:50 97.9 152/100 60% "Was there a reaction to blood? Yes" and "If so, was blood reaction form completed and lab notified? Yes." 4. The area on the form where nursing staff are to document which laboratory technologist was notified was left blank. 5. Review of the patient chart records in the "Discharge Summary" stated, " ...ED Physician 1 (alias) was notified of the critical status of the patient. He came up and took over care and intubated patient successfully. Patient was started on albumin and epinephrine drip to help stabilize her blood pressure. Hospital 2 (alias) was called and accepted transfer. Air Evacuation Service 1 (alias) will transport patient to Hospital 2 (alias)." 6. Review of patient post- transfusion laboratory test results revealed the following: Troponin = 0.27 ng/mL (hc) (Reference Range = 0.0 - 0.02 ng/mL) Date and Time Resulted: 02-28-2019 @ 1726 BNP = 1440 pg/mL (Reference Range = 0 - 100 pg/mL) Date and Time Resulted: 02- 28-2019 @ 1726 Urinalysis Blood = 2+ (Reference Range = Negative) 7. Interview with testing personnel two (as listed on CMS-Form 209) on June 11, 2019 at 14:45 hours in the laboratory confirmed the findings. He revealed that he presented to the floor where the patient was and that ED Physician 1 (alias) told him not to work up as a transfusion reaction because the patient's reaction was due to giving the blood too fast and not a transfusion reaction. Testing Personnel two went on to say that based on the information he was given a transfusion reaction investigation was not performed. 8. Interview with the Laboratory Director, Chief Executive Officer, Nurse Practitioner 1, Laboratory Manager, Respiratory Therapy Manager, and scribes on June 11, 2019 at 17:20 hours confirmed that as of the exit conference, the facility did not know the patient's outcome. Key: mm hg - millimeters mercury BNP - Brain Natriuretic Peptide CVP - Central Venous Pressure JVD - Jugular Vein Distention EKG - Electrocardiogram BP - Blood Pressure ED - Emergency Department ng/ml - -- 4 of 20 -- nanograms per milliliter hc - high critical pg/ml - picograms per milliliter CMS - Centers for Medicare and Medicaid Services 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)