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Based on document review and interview, the QAPI (quality assessment and performance improvement) program failed to document and review an adverse event identified during a medical record (MR) review for 1 of 10 MRs reviewed (Patient #5).

Findings include:

1. Review of the policy/procedure Organization-Wide Quality Assessment and Performance Improvement Program 2017 (approved 4-17) indicated the following: "Appendix I. Blood Utilization Review & Screening Plan ...When an opportunity to improve the performance of key processes in the use of blood and blood components has been identified, the Laboratory Administrative Director in conjunction with the Laboratory Medical Director, (Pathologist) and any other physician or staff will take actions for improvement...the Blood Utilization Review Plan will be reviewed annually...[to assure its]...effectiveness of the efforts taken to continually improve performance and safety of all processes in the use of blood and blood components..."

2. Review of the MR for Patient #5 indicated on 7-16-17 around 2000 hours the patient experienced cardiac arrest, the Burn Center Physician MD12, ordered type O Rh-negative blood for emergency transfusion pending a blood type and crossmatch and 4 units of type O Rh-positive blood were released by the Blood Bank staff, MT21, and administered to the patient. The (4) Emergency Blood Request/Emergent Blood Release forms failed to indicate MD12 or their associate Physician MD11 signed the verbal order form(s) within 24 hours of the order and the (4) Record(s) of Blood Transfusion lacked documentation indicating each unit of blood was checked by at least one Registered Nurse and a second licensed nurse prior to initiating the transfusion and/or a starting time with pre-transfusion vital signs and/or or a stop time with post-transfusion vital signs recorded on the form(s) or in the EMR (electronic MR) under the section titled Transfusion Record.

3. Review of documentation titled Quality Tracking Form initiated 7-17-17 by Laboratory Manager, A7 regarding the 7-16-17 Emergency Blood Release event involving Patient #5 indicated that Blood Bank staff MT21 prepared 4 units of type O Rh positive blood for emergency transfusion after MT21 failed to confirm the 53 year old patient was less than 55 years of age. The Quality Tracking Form indicated MT21 transported the units of type O Rh-positive blood to the Burn Center and failed to obtain a blood specimen from the patient for blood type and cross-match compatibility testing before leaving the nursing unit and lacked documentation any recommendations or actions were implemented including the staff was counseled and/or re-educated by the Laboratory Director, A4 or staff A7 on the policy requirements for Emergency Issue of Blood Components.

4. On 6-4-19 at 1310 hours, the Laboratory Manager, A7 confirmed the above and confirmed no other documentation indicating MT21 was counseled and/or re-educated about the policy requirements for Emergency Issue of Blood Components was available.


5. Review of the 7-19-17 Pathology Operations committee minutes indicated a discussion of events involving Pt#5 were presented and reviewed. The documentation indicated the Laboratory Medical Director, MD14 believed the Pathology Operations committee was not the best venue for investigating the event, staff A4 reported that a SWOT analysis was scheduled for later on that month with follow-up responsibility by a committee other than Pathology Operations and no other documentation was provided to indicate the adverse patient event was analyzed by a SWOT Team, Patient Safety or Quality Improvement Team and/or preventive actions were implemented to prevent a similar event in the future.

6. On 6-4-19 at 1310 hours, staff A7 confirmed the above and confirmed no other documentation indicating a Patient Safety or Quality Improvement analysis of the 7-16-17 event involving Patient #5 was available.

Based on document review and interview, the facility failed to follow its policy/procedures for blood administration for 1 of 10 medical records (MR) reviewed (Patient #5).

Findings include:

1. Review of the policy/procedure Emergency Issue of Blood Components (approved 3-16) indicated the following: "The procurement of a specimen for compatibility testing should be obtained before transfusion is initiated to limit blood typing discrepancies...1. Begin preparing one set of "O" negative red blood cells for emergency issue as soon as the blood bank is notified of an in house emergency. 2. If a second set of red blood cells is needed before the patient is identified and typed, and the emergent patient has been identified as a male or a female greater than 55 years of age, type "O Rh Positive" red blood cells may be issued...Collect a specimen when you drop off the cooler with the units and band the patient."

2. Review of the MR for Patient #5 indicated on 7-16-17 the Physician MD12 ordered type O Rh-negative blood for emergency transfusion pending results of blood type and cross-match compatibility testing for the (less than 55 year old) patient and indicated 4 units of type O Rh-positive blood were issued by the Blood Bank staff MT21 for emergency transfusion to the patient.

3. On 6-4-19 at 1310 hours, the Laboratory Manager A7 confirmed that MT21 did not follow the age requirements identified in the Emergency Issue of Blood Components policy and failed to release units of type O Rh-negative blood on 7-16-17 as needed until the blood type and cross-match compatibility testing was completed.

4. Review of the policy/procedure Blood Administration (revised 1-17) indicated the following: "1.H. Blood products must be identified at the bedside, against the blood transfusion log form and the patient armband, by one Registered Nurse (RN) and a second licensed nurse (this process must be documented in the EMR [electronic MR] or the transfusion log if EMR unavailable...2. Documentation Requirements...11. Pre-transfusion/baseline vital signs. 12. Blood start time...16. Stop time vital signs. 17. Blood stop time...For rapid infusion, document start and stop times and all applicable vital signs.

5. Review of the MR for Patient #5 indicated on 7-16-19 at approximately 2000 hours the patient experienced cardiac arrest and emergency resuscitative measures were implemented in response including an order to transfuse 4 units of type O Rh-negative blood. The MR indicated the Blood Bank issued 4 units of type O Rh-positive blood in response and no MR documentation indicated each unit of blood was checked by at least one RN and a second licensed nurse prior to initiating the transfusion, or a starting time with pre-transfusion vital signs, or a stop time with post-transfusion vital signs were recorded in the EMR or on the Record of Blood Transfusion document issued with each unit of blood.

6. On 6-4-19 at 1030 hours, the Chief Quality Officer, A3 and the Director of Clinical Outcomes, A11 confirmed the MR for Patient #5 lacked the indicated documentation.

Based on document review and interview, the facility failed to ensure that verbal and telephone orders for blood administration were authenticated by a physician within 24 hours for 1 of 10 medical records (MR) reviewed (Patient #5).

Findings include:

1. Review of the policy/procedure Verbal and Telephone Orders and CPOE (Computerized Physican Order Entry) approved 9-15, indicated the following: "Verbal and telephone orders for restraint, code status, and blood must be signed within 24 hours."

2. Review of the MR for Patient #5 indicated on 7-16-17 that Physician MD12 ordered type O Rh-negative blood for emergency transfusion and review of the (4) Emergency Blood Request/Emergent Blood Release forms failed to indicate MD12 or their associate Physician MD11 signed the verbal order form(s) within 24 hours of the order.

3. On 6-4-17 at 1310 hours, the Laboratory Manager A7 confirmed the (4) Emergency Blood Request/Emergent Blood Release verbal order forms dated 7-16-17 for Patient #5 lacked documentation indicating a physician signed the orders within 24 hours.