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Based upon review of the facility Organization-wide Quality Improvement Program, and interview with the facility Chief Quality Officer, the hospital failed to ensure the Clinical Lab component of the hospital met the Conditions of Participation for Clinical Laboratories. A CLIA (Clinical Laboratory Improvement Amendments) complaint survey was conducted on the same dates of 1/27/16 through 1/29/16 (CCR#2016000094, FL00075901). The CLIA inspection found ongoing immediate jeopardy with 3 laboratory Conditions of Participation, Facility Administration 493.1100, Analytic Systems 493.1250 and Laboratory Director 493.1441. The laboratory's analytic systems quality assessment failed to identify that the blood bank procedures manual was missing required procedures for reporting and recording of test results, and failed to identify that all procedures were not updated with required recent changes. The Laboratory Director failed to ensure compliance with the requirement to ensure that blood bank personnel perform testing according to required procedures, failed to ensure that a quality assessment program was maintained to assure the quality of laboratory services, and failed to ensure that testing personnel maintained competency to perform test procedures and report test results accurately.

The cumulative effect of these systemic problems were the result of the hospital's failure to evaluate the effectiveness of the Laboratory's required Quality Assurance program to prevent potential errors with possible life threatening outcomes, and to correct existing laboratory blood testing processes related to identified accuracy and reliability of blood bank patient test results.

The determination of ongoing immediate jeopardy in the hospital clinical laboratory led to a determination of ongoing immediate jeopardy at the CoP of QAPI.

The findings include:

Refer to A0286: Based upon review of the facility Organization-wide Quality Improvement Program (QAPI), interview with the facility Chief Quality Officer, review of the facility's self-report of an adverse event of 12/14/15, Root Cause Analysis of said event, and findings of the Clinical Laboratory complaint survey (CCR#2016000094, FL00075901) conducted on 1/27/16 - 1/29/16, the hospital failed to ensure the Clinical Lab component of the hospital integrated the required Quality Assurance process in sufficient detail to measure, track, and analyze adverse patient events for 2 of 2 sampled patients with blood bank errors (#1 and #2). QAPI failed to evaluate the effectiveness of the Laboratory's required Quality Assurance program to prevent potential errors with possible life threatening outcomes, and to correct existing laboratory blood testing processes related to identified accuracy and reliability of blood bank patient test results. This led to a determination of ongoing immediate jeopardy.

Based upon review of the facility Organization-wide Quality Improvement Program (QAPI), interview with the facility Chief Quality Officer, review of the facility's self-report of an adverse event of 12/14/15, Root Cause Analysis of said event, and findings of the Clinical Laboratory complaint survey (CCR#2016000094, FL00075901) conducted on 1/27/16 - 1/29/16, the hospital failed to ensure the Clinical Lab component of the hospital integrated the required Quality Assurance process in sufficient detail to measure, track, and analyze adverse patient events for 2 of 2 sampled patients with blood bank errors (#1 and #2). QAPI failed to evaluate the effectiveness of the Laboratory's required Quality Assurance program to prevent potential errors with possible life threatening outcomes, and to correct existing laboratory blood testing processes related to identified accuracy and reliability of blood bank patient test results. This led to a determination of ongoing immediate jeopardy.

The findings are:

On 12/14/15 the facility reported an incident which occurred in the facility's Emergency Department (ED). The incident was related to a 77 year old male patient (patient #2) being treated in the ED for shortness of breath, chronic obstructive pulmonary disorder, heart failure, anemia, and community acquired pneumonia. The ED physician determined that the patient required a blood transfusion to treat the anemia. The ED physician ordered for the patient's blood to be typed and crossed and for packed red blood cells (PRBC) to be prepared for transfusion. The blood bank of the hospital (a section in the hospital's clinical laboratory) examined the sample, identified the blood type, and prepared the PRBCs for infusion. The blood bank had determined the blood type of the patient to be type A+ blood. A nurse from the ED went to the blood bank and reviewed the label of the PRBCs, to include the blood type and patient identity, then signed documentation accepting the blood for administration to patient #2. The nurse returned to the ED and followed procedures to have another nurse verify the label of the PRBCs, and the identity of the patient and his lab reported blood type to be A+. The nurse began the blood transfusion, administration of the PRBCs to patient #2. Approximately 7 minutes after the infusion began, the patient complained of increased difficulty in breathing, followed by chest pain. The physician was interviewed at approximately 2:50 pm on 1/29/16 and he stated he told the nurse to stop the blood transfusion and move the patient to the trauma room for possible intubation. The physician further stated that upon arriving in the trauma room, the patient "coded" and staff began resuscitation efforts. The patient expired after several attempts at resuscitation. A review of the adverse incident report submitted by the facility indicated the blood type of A+ for patient #2 was wrongly identified. A subsequent testing of the patient's blood sample, by a second blood bank technician was determined to be blood type O+.

The Chief Quality Officer of the hospital (CQO) conducted an investigation and determined certain "gaps" existed contributing to the error in identification of the appropriate blood type for patient #2. Three "gaps" were identified, and corrective actions were developed for each "gap".

The CQO was interviewed on 1/27/16 at approximately 1:20 pm. The CQO stated that corrective actions related to the event include:

Current policy modified to give added emphasis to one tube in the testing rack and specimen identification verification during all phases of testing. All laboratory testing personnel are required to review the policy and sign an attestation that they understand and will follow the policy.

The blood type (ABO) re-check policy was revised to include a requirement that the patient ABO re-check testing will be completed prior to the release of any blood products for any patient without a prior blood bank history. The policy includes how this confirmation will be documented on the blood product disposition log. The blood bank history check with the ABO re-check will be confirmed during the blood product disposition check performed by the blood bank tech (BBT) and nurse when dispensing a blood product from the blood bank. All laboratory testing personnel are required to review the policy and sign an attestation that they understand and will follow the policy.

The blood administration policy has been revised to include the reinforcement of the IV (intravenous) pump setting for the first 30 ML (milliliters) of blood administered during the first 15 minutes of the transfusion, if the patient has any change in status as compared to the patient's baseline status just prior to the transfusion; and the requirement that a transfusion reaction be initiated anytime a patient expires while receiving a blood product. All nursing personnel who may be involved with the transfusion of blood products are required to review the policy, complete a transfusion reaction quiz, and sign an attestation that they understand and will follow the blood administration policy.

The CQO stated that actual observation of staff ability (both nursing staff and blood bank staff), or demonstration of skills is expected to meet the standards of correction determined by the Root Cause Analysis (RCA).

The Hospital's "Organization-wide Quality Improvement program for 2015 was reviewed.

Review of the "Performance Assessment & Improvement Plan," revised 6/1/12, showed that the lab tracked "Blood Utilization and Administration" in the blood banking area. There were no other assessments performed to assure the quality of the laboratory's blood bank written procedures and accuracy of blood bank reporting. During an interview on 1/29/16 at 12:10 PM, the laboratory supervisor confirmed that there was no additional blood banking quality assessment programs.

Review of personnel records for Blood bank technologist #1 revealed a pattern of blood bank errors. Technologist #1 made a computer entry error on the blood type for patient #8 on 8/18/15 that was not discovered until 1/3/16 when the patient returned to the hospital and was retested. Blood bank technologist #1 failed to follow the procedure to use one tube of blood when performing blood typing and crossmatch procedures for transfusion on 12/14/15 on patient #2. During an interview on 1/29/16 at 10:58 AM, the laboratory supervisor confirmed that there is no mechanism to continually monitor the competency of personnel regarding proper testing procedures and accurate reporting of computer results when compared to their written results in the blood bank.

During an interview on 1/29/16 at 10:55 AM, the laboratory supervisor confirmed that the lab quality assessment procedures do not include a mechanism to identify when computer data entries are inaccurate when compared to written results of blood types in the blood bank records.

The laboratory failed to retain original patient testing records of blood typing, antibody screening, and compatibility testing. Observations of the testing procedures in the laboratory's blood bank area on 1/28/16 at 9:45 AM by the CLIA surveyor showed that the blood bank technologist #3 recorded results of a patient's blood typing,
antibody screening, and compatibility testing of two units of blood on the lab requisition slip. Requisition slips were being placed in a plastic bin following transcribing of the results on the patient history card and on the transfusion record sheet and reporting of the patient's results in the computer. During an interview on 1/28/16 at 9:50 AM, the
laboratory supervisor stated that the requisition slips that have the original patient results
recorded on them are not saved. The supervisor stated that they shred the requisition slips after a few days of saving them in the plastic bin in the blood bank lab.

Review of the laboratory's procedures, "Compatibility Testing - ID-MTS Gel System," revised 6-1-12, and "Compatibility Test (Crossmatch), Manual," revised 6-1-12, showed that the lab has still not revised the procedures to add steps to ensure that only one patient tube of blood is used at one time and there are no steps added in the procedures to ensure that the patient tube is correctly identified. Review of the lab's procedures, "Issuing Compatible Blood," approved by the director on 6/1/12, and "Request and Release of Blood Products," revised and approved 6/1/12, showed that the procedures do not include the new procedure that was in effect as of 12/17/15 to include a "Stop" sign on units of blood to indicate that the unit should not be issued because the ABO type recheck still needs to be performed on the patient's blood sample. During an interview on 1/29/16 at 10:40 AM, the laboratory supervisor confirmed that all procedures are not updated and that the "Stop" tag procedure on units of blood that require ABO type recheck needs to be added to the procedures for issue and releasing of blood.

An interview was conducted with the hospital CQO on 1/29/16 at approximately 3:00 pm during a review of the process improvements utilized by the hospital. The CQO provided data for all of the areas the process improvement plan for the hospital clinical laboratory during the recent plan year. Tech specimen handling compliance rates exist only for the current month of January 2016, and not for the year 2015. Additionally, each employee was rated at 100% compliance. The requirement for compliance established in the plan is "at least one Direct Observation" is completed per month. The CQO confirmed that there is no documentation of time, date, or person providing the Direct Observation of specimen handling. The CQO also confirmed that there is also no documentation that ABO re-check compliance has been performed in the past plan year, or in the current month.