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Based on staff interview and review of medical records and laboratory blood component release logsheets, the facility failed to ensure 2 of 7 units of pRBCs released for emergency transfusion (patient #8) were authorized in writing by the requesting physician. The facility further failed to ensure appropriate procedures were in place to prevent errors in identifying the correct unit number of pRBCs released for 2 of 13 sample patients. The findings were:

Transfusion-related information found in patient medical records and laboratory blood release logsheets were reviewed on 4/1/10 and 4/2/10. The following problems were found:

1. Medical record review showed patient #8 received treatment in the ED on 3/23/10 for trauma resulting from a motor vehicle accident. The treatment included transfusions of two units of uncrossmatched group O, Rh negative pRBCs. Detailed review of the medical record failed to show a release form signed by a physician acknowledging that the blood had not been crossmatched for the patient prior to transfusion. After reviewing the medical record on 4/2/10 at 10:12 AM, the DON confirmed written authorization by the ED physician for emergency transfusion had not been completed.

2. The laboratory blood release logsheet for 12/26/09 showed pRBC unit # W0423 09 060790 was removed from the blood bank at 10:35 AM for transfusion to patient #4. However, the patient's medical record showed nursing staff incorrectly listed the unit as #W0423 09 063842. The medical record further revealed signatures from two RNs attesting the unit information was correct prior beginning the transfusion from the incorrectly identified unit. A post-dated entry from 1/4/10 noted the incorrect unit number resulted from a transcription error; however, the entry failed to clarify how the incorrect unit number was initially entered into the record, or how two separate RNs independently attested in writing that the pRBC unit information was correct.

3. The laboratory blood release logsheet for 3/14/10 showed pRBC unit #W0423 10 012660 was removed from the blood bank at 3:08 PM for patient #13. The logsheet include a second annotation showing the wrong unit number was taken from the blood bank by nursing personnel; the unit was subsequently returned to the blood bank unused.

Interview with the DON on 4/2/10 at 9:45 AM revealed her expectation that nursing staff correctly identify all blood unit information, to include the unit identification number, prior to transfusion. She further stated she was aware of the incident involving an incorrect pRBC unit number with patient #4, but was not aware the problem recurred more recently with patient #13.

Based on medical record review, staff interview, and review of policies and procedures, the facility failed to ensure staff were aware of, and followed, their policy related to possible blood transfusion reactions for 1 of 1 sample patients (#11) who exhibited signs and symptoms of an adverse event. The findings were:

According to the facility's current policy and procedure, "Suspected Transfusion Reaction," fever during a transfusion "is defined as an increase in temperature of 1 degree C [Centigrade] or 2 degrees F [Fahrenheit], unless increase brings patient temperature up to normal..." Further review showed, "If the blood product is still being infused, the transfusion must be discontinued immediately." Review of the attached procedural steps for a fever showed, "Stop transfusion. Keep IV open." Failure to be aware of and follow the policy was identified as follows:
a. During an interview on 4/1/10 at 1:40 PM, RN #1 stated she was unaware of any standard number of degrees increase in a patient's temperature that would automatically require staff to stop the transfusion. She further stated staff would use their own judgment.
b. Medical record review showed patient #11 was admitted to the facility on 3/17/10 and received a blood transfusion. Review of the transfusion record showed the patient's baseline temperature at 12:45 PM was 97.4 degrees F, and the blood transfusion was started at 1 PM. At 1:15 PM staff documented the patient's temperature as 100.8 degrees F (a 3.4 degree increase), and at 1:30 PM it was recorded as 104.6 degrees F, an increase of 7.2 degrees from baseline. Signs and symptoms of a transfusion reaction were listed on the transfusion form, these signs included an increase in the patient's temperature of 2 degrees F. Detailed review of the entire medical record showed no evidence the blood transfusion was stopped.
c. On 4/2/10 at 1:30 PM the DON confirmed the policy and procedure for monitoring patients during transfusions for possible adverse events had not been followed in the aforementioned cases.

Based on review of medical records, staff interview, and review of policies and procedures, the facility failed to reduce verbal orders to writing for 3 of 3 sample ED patients (# 5, #6, and #8) whose records were reviewed for blood transfusions. In addition, staff failed to clarify unclear orders for 2 of 13 sample patients (#7 and #11). The findings were:

1. Review of medical records for patients #5, #6, and #8 revealed all three were treated in the ED for trauma related to motor vehicle accidents. Each was documented as having received several treatments and medications, including blood transfusions, and each was ultimately transferred from the facility. However, each of the patient records lacked any physician orders.

Interview with the DON on 4/2/10 at 1:20 PM confirmed both written and verbal orders were lacking. The DON stated she thought the physicians' dictated reports covered the orders. Review of the records showed the dictated report for patient #5 did not include all administered medications or any medication dosages. Patient #6 was seen on 10/20/09, but the dictation was not signed until 1/27/10. The dictated report for patient #8 who was seen on 3/23/10 had not been signed.

Review of the facility's 2003 policy and procedure, "Verbal orders," number 3010-5(B), showed the facility encouraged physicians to write orders when present in the area. If unavailable and verbal orders were obtained, the person taking the order "should write down the order and read it back verbatim to the practitioner..." The order "...should be recorded directly on the order sheet...dated, timed, and signed."

2. According to the medical record, patient #7 was admitted on 2/6/10 with orders for two units of pRBCs to be transfused, each over ninety minutes. Another order later that day was "Transfuse 2 units of PRBC over 4 hours." Although it was unclear whether each unit was to be infused over four hours or whether both units were to be infused in a single four hour period, the record lacked evidence that staff clarified the order prior to transfusion. On 4/2/10 at 1:30 PM, the DON stated the RN on duty asked her (DON) about the order. The DON stated both she and the RN on duty interpreted the order as two units to be infused over four hours, but verified that neither nurse clarified the order with the requesting physician.

According to Smith, Duell, and Martin, 2008 "Clinical Nursing Skills Basic to Advanced Skills" seventh edition: "If a written order is...questionable for any reason, the physician must be notified for clarification."

3. Medical record review showed patient #11 was admitted on 3/17/10 with orders for Tylenol two capsules orally and Benadryl 25 milligrams IV. Neither of these orders included the information necessary for an appropriate order; the dosage of Tylenol and the time or frequency it was to be given were lacking, and the time Benadryl was to be administered was not included in the order. According to Elkin, Perry, and Potter, 2007 "Nursing Interventions & Clinical Skills" 4th Editin: all orders should include the name of the medication, the dose, the route, the frequency, and the physician's signature.

Based on observation, medical record review, staff interview, and review of policies and procedures, the facility failed to develop, revise, and implement care plans for 3 of 3 sample patients (#7, #11, #12) reviewed for inpatient care plans. The findings were:

During an interview on 4/2/10 at 8:50 AM, the DON stated an initiative to review and revise patient care plans had been ongoing for approximately one month. She further stated her efforts included training nursing staff to follow current policies and procedures related to care plans. Review of the facility's policy and procedure entitled "Standard of Practice - Implementation of Plan of Care" required each patient to "...receive individualized nursing care via implementation of documented plan of care...The professional nurse will be responsible for the on-going assessment and updating of the...plan of care." Failure to implement this policy was identified in the following 3 instances:


a. Observation on 4/1/10 at 1:40 PM showed patient #12 was receiving a blood transfusion. According to the admission orders, the patient was to receive two units of blood in eight hours that day. Review of the medical record on 4/2/10 at 8 AM showed the patient was admitted the previous day at 12 PM, but nineteen hours later the record failed to include a care plan addressing concerns related to the transfusions. After reviewing the patient's care plan on 4/2/10 at 8 AM, the DON confirmed it failed to address issues related to blood transfusions.
b. According to the physician's orders, patient #11 was admitted on 3/17/10 with diagnoses including cancer and fever. The patient received two units of blood the day of admission, with an additional unit infused on 3/26/10. Review of the medical record showed the patient underwent removal of an implanted vascular access device and various treatments in addition to the transfusions. Review of the care plan showed these later procedures and treatments were not addressed. The DON confirmed the lack of a comprehensive care plan for this patient on 4/2/10 at 1:30 PM.
c. Review of the admission orders dated 2/6/10 showed patient #7 received two units of blood that morning for a diagnosis of anemia secondary to profuse bleeding. Further review showed a third unit was infused that night with a fourth unit was transfused early the next morning. Review of the nursing file for care plans showed treatments and laboratory tests were documented, but further care plan issues had not been addressed. On 4/2/10 at 8:50 AM the DON confirmed the absence of a comprehensive care plan for this patient.

Based on staff interview and review of medical records, the facility failed to ensure each record contained complete and accurate entries for 6 of 13 sample patients (#1, #2, #4, #5, #10 and #11) that received blood transfusions while admitted to the facility. The findings were:

1. Medical record review revealed the following problems related to transfusions:

a. Patient #1 received seven units of blood in January 2010. Two of these transfusion events lacked documentation to show the time transfusions were started or completed. A third transfusion event documented a total volume of 848 milliliters (mL) of blood transfused from a single unit of pRBCs. However, pRBC production restricts total volume to 250-350 mL per unit. The laboratory manager confirmed in interview on 4/1/10 at 4:05 PM the blood bank did not store or release oversized units of pRBCs or whole blood.

b. Patient #2 was transfused two units of blood on 12/2/09. The medical record contained an unresolved discrepancy for the start time of the first transfusion: one nursing entry noted the transfusion started at 12:50 PM, while a second note stated the transfusion began at 11:56 AM, 54 minutes earlier.

c. Patient #4 was transfused seven units of blood in December 2009. During one of the transfusions, the medical record failed to include a specific stop time or the volume transfused. This patient's record also contained an unresolved error in identifying a blood unit number (refer to C205 for details).

d. Patient #5 was seen in the ED on 10/20/09 and received five units of blood. However, the record lacked transfer forms, vital signs, orders, and nursing documentation related to the blood transfusions.

e. Patient #10 received two units of blood on 11/9/09. Documentation of the first transfusion included several attempts to correct time entries. The crossed-out and written-over entries were illegible.

f. Patient #11 was transfused with two units of blood on 3/17/10, but information on the transfusion form was scratched out in two places, overwritten once, and left blank once.

2. The DON stated in interview on 4/2/10 at 10:15 AM that nursing staff were required to enter all required information, such as vital signs, start and stop times, volumes, and any adverse events accurately and legibly. She acknowledged the record entries noted were unacceptable..

Based on review of medical records, staff interview, and review of policies and procedures, the facility failed to ensure staff documented specific verbal orders in writing for 3 of 3 sample ED patients whose records (# 5, #6, and #8) were reviewed for blood transfusions. The findings were:

Refer to C297 for details related to the lack of orders for patients #5, #6, and #8.

Based on medical record review, staff interview, and review of training information and policies and procedures, the facility failed to ensure anesthesia was administered by qualified personnel for 1 of 4 sample patients (#8) who received an anesthetic agent. The findings were:

Medical record review showed patient #8 was treated in the ED for injuries sustained in a motor vehicle accident on 3/23/10. The patient was noted as nonresponsive when brought into the ED at 2:06 PM. At 2:11 PM the DON administered the anesthetic agent, propofol, 100 milligrams IV. The following concerns with this practice were identified:
a. On 4/2/10 at 8:50 AM the DON confirmed she administered the medication even though the anesthetist was present. She stated she had completed the facility's course on administration of conscious sedation and thought she was now authorized to administer propofol. Review of training information verified she completed the course in 2004.
b. Review of the facility's policy and procedure entitled "Conscious/Moderate Sedation" number 2200 - 224A, last revised in February 2003, showed "Nurses...may use conscious sedation under the direct supervision of a physician when anesthesia is unavailable..." Propofol was not included among the medications listed in the facility's policy and procedure for conscious sedation.
c. The DON was unaware propofol could not be administered by the nursing staff.

Based on staff interview and review of medical records, blood component release logsheets, and QA documents, the faculty failed to develop, implement, and monitor effective actions to promote safe transfusion practices. The findings were:

1. On 4/2/10 the facility's QA program and ongoing projects were reviewed in detail. None of the areas selected by the facility for monitoring and intervention addressed the following problems:
a. Incomplete, inaccurate, and illegible documentation was discovered in 6 of 13 (46%) sample patient records (#1, #2, #4, #5, #10 and #11). The sample included 29 transfusion events and spanned a six-month time period (October 2009 through March 2010).
b. The current QA monitors failed to address review of transfusion-related documentation and identify problem areas for further evaluation.
c. Twice in six months (patient #4 on 12/26/09 and patient #13 on 3/14/10), laboratory blood release records showed nursing services took a different unit of pRBCs than the one identified in the blood bank logbook. According to the medical record, the error in unit identification for blood released on 12/26/09 for patient #4 occured despite two RN reviews prior to the actual transfusion.The DON stated in interview on 4/1/10 at 2:50 PM she initiated a "rapid-fix" project on February 2010 to monitor the use of preprinted barcode blood unit identification labels; this was explained by the DON as an effort to prevent misidentification errors. the DON stated in a subsepuent interview on 4/2/10 at 9:40 AM that the "rapid-fix" project failed to prevent the second incident of unit misidentification that occured on 3/14/10. The administrator confirmed in interview on 4/2/10 at 11:40 AM that, in light of the repeat incident, the nursing "rapid-fix" initiative did not correct the problem of unit misidentification.
d. According to interview on 4/1/10 at 4:20 PM with the laboratory manager, blood was routinely released from the blood bank by a single individual; there was no system in place to ensure two qualified individuals confirmed unit information prior to release. The DON acknowledged the frequent lack of a second qualified individual to assist at the time of release in an interview on 4/1/10 at 4:40 PM. These two interviews confirmed the absence of a process to prevent misidentification of blood units at the time blood was released from the laboratory.

2. The administrator confirmed in interview on 4/2/10 at 11:10 AM the need to enhance existing QA processes to ensure safe and well-documented transfusion practices.