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|AURORA MEDICAL CTR WASHINGTON COUNTY||1032 E SUMNER ST HARTFORD, WI 53027||March 8, 2012|
|VIOLATION: PHARMACEUTICAL SERVICES||Tag No: A0490|
|Based on review of clinical records, policy and procedure review, and staff interviews, the hospital failed to follow policy and procedures to minimize medication errors in 1 of 1 patients. In 1 of 1 patients receiving anesthesia, a medication error occurred and was not recorded and appropriately tracked or reported to the attending physician as a medication error, causing an immediate jeopardy situation. The hospital administered a 3 year old patient, 7 mg of morphine. There were risks of side effects, mainly respiratory depression that could be extensive and could lead to death. The hospital's failure could potentially affect all patients receiving anesthesia.
On 1/19/2012, a 3 year old patient was admitted to facility for an outpatient surgical procedure. A student RNA calculated and administered 7 mg of morphine to the 3 year old patient. The correct calculated dose should have been 1.5 mg. The error was discovered by the CRNA when doses of medication were being recorded on the anesthesia record. The student RNA, CRNA and anesthesiologist made the decision to administer Narcan to reverse the effects of the large dose of Morphine. The medication error was not documented, reported to the attending physician or the quality assurance program. On 3/8/12 at 3:15 p.m., the DQA Pharmacy Consultant confirmed that an excessive amount of morphine being administered to a 3 year old, could have extensive side effects, mainly respiratory depression that could lead to death.
The facility's failure to report a drug administration error to the attending physician and to the quality assurance program resulted in a deficient practice. See A tag 508.
The result of this systemic failure could have caused serious patient harm.
|VIOLATION: REPORTING ADVERSE EVENTS||Tag No: A0508|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Surveyor: TREPES, CYNTHIA J.
Based on clinical record review, policy and procedure review and staff interview the hospital failed to inform the attending physician regarding 1 of 1 medication error and did not report 1 of 1 error to the hospital-wide quality assurance program. The hospital administered 1 of 1 3 year old patient 7 mg morphine. This excessive amount of morphine could lead to respiratory depression and death.
A clinical record review was conducted on 2/27/12 at 10:20 a.m. on patient (pt) #1's closed outpatient record. Pt. #1 was admitted on [DATE] at 7:00 a.m. for an Adenoidectomy and tonsillectomy (surgical removal of adenoids and tonsils). Pt. #1 is 3 years old with weight of 15.5 kilogram (kg). Pt. #1 received 2 divided doses of Morphine at 8:00 a.m., one dose was 4 milligrams (mgs) and next dose was 3 mgs. (Recommended dose per Perioperative Pediatric Dosing Guidelines is 0.05-0.1 mgs/kilogram). Per dosing guidelines pt. #1 should have received .775 mgs-1.55 mgs. Pt. #1 was given 7 mgs of Morphine. At 9:00 a.m. 3 doses of Narcan (a medication used to reverse the effects of Morphine) was administered. Medication administration form signed by MD C, staff J and K.
On 3/8/2012, at 3:15 p.m., DQA Pharmacy Consultant confirmed that this excessive amount of morphine being administered to a 3 year old, could have extensive side effects, mainly respiratory depression that could lead to death.
On 2/29/12 at 11:00 a.m., staff J stated "student RNA K was responsible to give the medication in this case, it is not our practice to confirm doses with students. I did not observe her giving the medication to patient #1. When the medication was being recorded on the anesthesia record, I questioned RN K about the Morphine dose which had been given. I would not have given that much medication initially. We (the anesthesiologist and myself) decided to administer Narcan at the end of the surgery to reverse the effects of the morphine. The patient was monitored closely, Narcan was given and it did not result in any outcome. An incident report was not needed, there was no mistake, no error, just poor judgement."
On 2/29/12 at 11:50 a.m. and 1:00 p.m., attempts made to contact staff K per phone, message left but no return call received.
Per interview on 2/29/12 at 11:51 a.m. MD C stated "the anesthesiologist is responsible for monitoring the nurse anesthetist (CRNA)." MD C also stated that "student nurse anesthetists are experienced enough to draw up and administer medication without supervision." "A medication error did occur in the drug dosing - the patient was given approximately 4-7 times the appropriate dose." "Staff J and staff K informed me, and the plan was established to use Narcan to reverse the effects and monitor the patient closely." Surveyor asked MD C if he completed a medication error form and MD C stated "Staff from anesthesiology wouldn't complete that form, the operating nurse should have completed the form."
Per Operatives Procedure Reports completed by Doctor (MD) I, no complications.
Addendum on interim operative note added per MD C states: "2/21/12 Late entry- Patient's mother and father visited on hospital floor and notified re: patient receiving large intraoperative dose intravenous Morphine, reversal (Narcan) given. Parents aware. No adverse effects."
Per interview on 2/29/12 at 11:51 a.m. MD C stated "I was concerned for the patient and went up to the observation room to check the patient and inform the family of the mistake. I did not lie but I did not tell them everything, I was not sure they could handle it and I needed them to take care of the patient."
In the same interview: MD C stated that he "notified MD I of the medication error and discussed postoperative plan for patient to be monitored closely."
In an interview with MD I on 2/29/12 at 12:56 p.m., MD I stated "I was not aware of the error until the family informed me on 1/26/12 while in my office for a post-operative visit. I asked the family to write their concerns in a letter. The family brought the letter to my office on 2/2/12. On 2/3/12 I faxed the letter to administration. MD C may have told me but I do not recall that conversation on the day of the surgery, I would not have ordered Morphine as needed for pain following surgery." MD I stated "this incident was a medication error and I should have been notified by staff, not by the family."
On 2/27/12 at 10:20 a.m. in an interview with Risk Manager (RM) F, surveyor requested Medication Error report for pt. #1, staff F informed surveyor no error form was completed. Surveyor requested root/cause analysis regarding pt. #1, Staff F stated "no analysis was completed because we know why error occurred, it did not need to be investigated." Staff F also stated that "MD C went out of his way to disclose this information to the family, our policy states disclosure to family is required if there is unexpected outcome, in this patient's case there was no unexpected outcome." RM F stated "this investigation is still in process, this involves thought and we need to act in a planned manner."
On 2/28/12 at 11:45 a.m. in an interview with MD H, surveyor asked MD H if an investigation occurred following incident, MD H stated "there was nothing to investigate, the patient received more than she should have, patient was monitored and received narcan to reverse the effects." MD H stated "the nurse aesthesis have been told to watch the students closer." Surveyor asked MD H if there was documentation that this occurred and MD H stated no.
On 2/27/12 at 11:45 a.m. in an interview with staff G and staff D, surveyor asked why no medication error form was completed and Staff G and staff D stated "there was no negative outcome, therefore the form was not needed."
On 2/27/12 at 3:45 p.m. in an interview with staff L, surveyor questioned if pharmacy thought if a medication error form should have been completed and staff L stated, "A high dose of morphine was given and the patient needed to be monitored, a form should have been completed."
Review of current hospital policy on 2/28/12 at 11:00 a.m. entitled "Medication Safety" dated 10/11 states I. Policy: "It is the policy of Aurora Health Care Metro/Mid Market to provide medications to our patients in a manner that optimizes safety to allow for the best possible outcomes." III. E. "As part of the medication administration process; the nurse or other designated personnel will ensure that the right patient, right drug, right dose, right route and right administration times are verified before any medication is administered."
Review of current hospital policy on 2/28/12 at 11:10 a.m. entitled "Medication Event Reporting" dated 1/09 states II. Policy: "Medication events and subsequent reporting thereof are deemed to be components of the performance improvement process and should be tracked, trended, and analyzed by disciplines involved in the medication use process."
In the same policy, III. Definitions: "Medication event is an act occurring in prescribing, dispensing, transcribing, administering, or monitoring of medication that resulted in or could have resulted in deviation in the intended care of the patient. An error results when the act reaches the patient."
In the same policy, IV. Procedure: A.1. "The patients physician should be contacted if the error reached the patient, may change the patient's plan of care, or could require additional assessments."
In the same policy, IV. C. "Health care providers are expected to report a medication event on the electronic medication event report form on the day the event occurred or was detected."
Review of current hospital policy on 2/27/12 at 2:00 p.m. entitled "Incident Reporting/Sentinel Event Management Policy" dated 2/11 states under 3. F. "Significant event: A patient care error that may result in an unanticipated patient outcome, but does not reach the level of sentinel event. A significant event may have the systems implications of a sentinel event."
In the same policy, IV. Policy Statement: "To achieve the safest patient care and to establish the best health care practices. . .manage and learn from actual and potential risks to patient safety, with the ultimate goal of preventing patient care error. All components of the incident reporting/sentinel event process, including, but not limited to, incident reports, near misses, sentinel and significant events, root cause analysis, and the Event Review and Executive Event Review Committees, the review process, discussion, and documentation thereof, are conducted by Aurora Health Care as part of its health care services review process."