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ANNA JAQUES HOSPITAL 25 HIGHLAND AVENUE NEWBURYPORT, MA 01950 April 12, 2011
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on record review, physician and staff interview, a significant medication error for one of one applicable Patients (#1)occurred in October 2010. A continuous Heparin infusion was administered for an undetermined amount of time without appropriate intervention by the nursing staff. The Hospital failed to adequately address and implement a Hospital wide corrective action plan to prevent the reoccurrence of a significant medication error.

The findings are as follow:

The Hospital submitted a response letter to Patient #1's family dated 03/24/11which included a corrective action plan to require mandatory re-education for all nurses, changes to the verification process for high alert medications and changes to the labeling and confirmation process.

The Director of CCSU was interviewed by telephone on 04/28/11 at 10 AM via conference call the the Hospital's Risk Manager. The Director of CCSU said there was no mandatory re-education of all nurses nor presented hospital-wide. The Director of CCSU said the nursing staff were spoken too individually. The Director of CCSU said there were no additional policy changes made to high alert medications. The Director of CCSU said the nursing staff were instructed that the best practice was to use a single pump for the administration of multiple intravenous medications. The Director of CCSU said RN #3 reported the error may have occurred during the addition of the D 5 and 1/2 Normal Saline with the Potassium Chloride 40 mEq additive.

The Director of Pharmacy and Nurse Educator were interviewed on 04/12/11 at 9:44 AM and 1 PM respectively. The Director of Pharmacy said that color coded labels were ordered for application to intravenous lines for high risk medications. The Nurse Educator said there were no formal re-education programs offered to the nursing staff following the Heparin medication error. The Nurse Educator said the nursing staff were provided orientation at the time of hire regarding high risk medications. The Director of Pharmacy said that medication errors were reviewed at the Medication Task Force Committee Meetings however there were no minutes documented for any meetings for review by the Surveyor.

On tour of the inpatient unit and interview with the nursing staff indicated there were no labels available for application to the intravenous lines for high risk medications.

There was no documented evidence the Hospital ensured mandatory re-education was conducted as outlined in the complaint letter sent to Patient #1's family. There was no evidence that there were changes implemented to the verification process for high alert medications nor color coded labels made available for use with high alert medications; as outlined in the response letter to Patient #1's family complaint letter.
VIOLATION: HOSPITAL PROCEDURES Tag No: A0410
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, physician and staff interview two medication errors occurred for one of one applicable Patients (#1) in October 2010. Heparin was incorrectly administered by a continuous infusion pump at the wrong rate for an undermined amount of time. During the course of the survey an additional medication error was discovered without evidence of investigation by the Hospital for Patient #1. A second intravenous medication Potassium Chloride had contradictory entries for the dosage and no documented start time for the administration.

The findings are as follow:

Patient #1 evidenced symptoms of [DIAGNOSES REDACTED]

(1) HEPARIN MEDICATION ERROR:

Review of the Telephone Physician Orders dated 10/04/10 at 10:15 PM indicated Physician #2 ordered the
administration of Heparin by a bolus injection, followed with a Heparin continuous drip and to follow Heparin Protocol. The Heparin Nomogram (physician order protocol) for Non-Pulmonary Embolism/Deep Vein Thrombosis dated 10/04/10 at 9:15 PM indicated Heparin 5000 units by intravenous injection was to be administered followed by a continuous Heparin infusion of 25,000 units in 500 militers of D5W at a rate of one thousand units per hour (via an infusion pump at 20 ml/hr). Laboratory tests included partial thromboplastin time (PTT) to be drawn every six hours and after any change in the Heparin infusion rate. The Heparin Nomogram orders indicated; if the PTT results were in excess of 150, the Heparin infusion was to be stopped for 60 minutes, then resume the infusion and reduce the rate by 150 units/hr. The Heparin Nomogram indicated the physician was then to be notified.

Physician #2 was interviewed in person on 04/11/11 at 4 PM. Physician #2 was the covering physician for the Attending Physician. Physician #2 said Patient #1 had an earlier episode of [DIAGNOSES REDACTED]on 10/03/10. Physician #2 was called during the evening of 10/04/10 and Heparin was ordered per protocol. Physician #2 ordered the Heparin in part for a concern for an embolic stroke.

Review of the Heparin Medication/Nomogram Record indicated on 10/05/10 at 12 AM Heparin 5000 unit bolus by intravenous injection was administered. The Heparin Medication/Nomogram Record further indicated on 10/05/10 (incorrectly dated 10/04/10) was initiated at 12 AM at a rate of 20 ml/hr for the administration of one thousand units per hour. The Heparin Medication/Nomogram Record indicated both RN #1 and RN #2 witnessed the imitation of the Heparin continuous infusion via an infusion pump.

Registered Nurses (RN) #1 and #2 were interviewed on 04/12/11 at 7:30 AM and 7:45 AM respectively. RN #2 administered the Heparin injection and initiated continuous Heparin infusion with RN #1. RN #2 said there was no secondary infusion as it was policy to run Heparin exclusive of any other intravenous medications. RN #2 said since the Heparin error, the nursing staff were instructed to run Heparin on it's own pump. RN #1 was not clear given the length of time since Patient #1 had been hospitalized ; as to who hung the Heparin and who programmed the infusion pump. Both RN #1 and the oncoming RN #3 documented on the Heparin Medication/ Nomogram Record the rate was verified at 20 ml/hr at the change of shift on 10/05/10 at 7 AM.

On 10/05/10 Patient #1's laboratory PTT results drawn at 7:29 AM were recorded as elevated at 249. Review of the literature indicated PTT test is used to access the intrinsic pathway of clot formation. The PTT helps to regulate the appropriate dosage for the administration of Heparin. The laboratory results were in the critical value range which required the laboratory technician to immediately notify the nurse on the inpatient unit. The laboratory technician called the critical results to RN #3 at 8:54 AM.

Review of the Heparin Medication/Nomogram Record indicated the Heparin infusion continued until 10/05/10 at 9:00 AM and then the infusion was stopped as per protocol for a PTT value in excess of 150. RN #3 discontinued the Heparin infusion for 60 minutes.

The Heparin Medication/Nomogram Record had the initials of RN #3 but lacked the initials of a second RN as a witness to stopping the Heparin infusion.

Continued review of the Heparin Medication/Nomogram Record indicated at 10 AM Heparin drip infusion was restarted at a rate of 17 ml/hr for an administration dose of 850 units per hour. RN #3 decreased the infusion rate by 150 units/hr as per protocol. RN #3 initialed for the resumption of the Heparin infusion with RN #4 as witness.

Continued review of the Heparin Medication Record indicated the Heparin infusion continued at a rate of 17 ml/hr with the administration of 850 units per hour.

Review of the Pharmacy Records indicated RN #3 removed a bag of Heparin 25,000 units in 500 militers from the Omnicell/pharmacy refrigerator and charged the medication to Patient #1. It was not clear as to why a new bag of Heparin was pulled from the Omnicell when the first bag hung on 10/05/10 at 12 AM was to run for approximately 25 hours. RN #3 did not document the new bag of Heparin was hung.

On 10/05/10 at 3:30 PM, RN #5 assumed the care of Patient #1. Both RN #3 and RN #5 were interviewed on 04/11/11 at 1 PM and at 2:50 PM respectively. RN #3 said the Heparin infusion was running at one thousand units per hour at a rate of 20 ml/hr until 9 AM on 10/05/10. RN #3 said the Heparin was then stopped for 60 minutes and restarted as per protocol. RN #3 said when the Heparin infusion was resumed an hour later, the rate of infusion of the Heparin was decreased to 17 ml/hr for the administration of 850 units of Heparin per hour. RN #3 was unaware when the Heparin infusion had been checked prior to the transfer of care to RN #5. Both RN #3 and RN #5 said Patient #1's Heparin infusion was not verified at the change of shift on 10/05/10 at 3 PM as required per protocol.

RN #5 said a PTT was drawn on 10/05/10 at 5 PM. RN #5 called the laboratory for the PTT results at 7 PM. RN #5 said Patient #1's PTT was elevated to a critical level of 249. RN #5 said the Heparin was turned off. Instead, review of the Heparin Medication Record/Nomogram dated 10/05/10 at 7:30 PM indicated the Heparin infusion was reduced by another 150 units to 700 units/hour. RN #5 said the entry onto the Heparin Medication Record/Nomogram was made in error. Review of the Laboratory Results for the PTT dated 10/05/10 drawn at 5 PM indicated the laboratory technician called and spoke to RN #5 at 7:33 PM. RN #5 denied being called by the laboratory technician. RN #5 said the Charge Nurse/RN #6 was called to Patient #1's room to witness the incorrect Heparin delivery rate. RN #5 said one of the two infusion lines had the Heparin running at 75 ml/hr instead of 17 ml/hr.

RN #5 did not reconcile the amount of Heparin infused to Patient #1 at the discovery of the error.

Review head CT dated 10/05/10 at 8:10 PM indicated there was no intracranial hemorrhage and no midline shift. There was extensive deep cerebra white matter ischemia/gliotic change.

RN #6 was interviewed in person on 04/12/10 at 3:23 PM. RN #6 said on 10/05/10 RN #5 requested assistance in Patient #1's room. RN #6 went to Patient #1's room at 8 PM to verify Heparin drip ( a half an hour after the critical value laboratory results of the PTT was called to RN #5). RN #6 said the primary line (the A line) was incorrectly infusing 20 mEg of Potassium Chloride in D 5 1/2 strength Normal Saline as a rate of 17 ml/hr. RN #6 said the primary A line should have had the Heparin drip. RN #6 said the secondary piggy back line (or the B line) had the Heparin infusion incorrectly running at a rate of 75 ml/hr. RN #6 could not specifically recall the amount of Heparin infused or what was remaining in the bag. RN #6 said the Heparin bag had been recently hung but RN #6 was not able to determine the specific time. RN #6 said RN #5 denied changing the rate and that the Heparin was okay at the change of shift at approximately 3:30 PM. RN #6 contradicted RN #5 and reported the verification had been done at the change of shift at 3 PM. RN #6 arrived to work at 7 PM. RN #6 said Patient #1's PTT was drawn a couple of hours later and remained high.

Review of the Telephone Physician's Orders dated 10/05/10 at 8 PM indicated Attending Physician #1 ordered that the Heparin be stopped and hourly PTT levels drawn. A Neurologist was called on 10/05/10 at 8:27 PM, who ordered to resume Heparin at 17 ml/hr without a bolus; if the PTT normal (or less than 60).

Attending Physician #1 was interviewed in person on 04/12/11 at 8 AM. Attending Physician #1 was notified of the medication error and high dosage delivery rate on 10/05/10. Attending Physician #1 said a repeat head CT scan was ordered and negative for any bleeding. Attending Physician #1 said Patient #1 had a prolonged hospitalization without any complications secondary to the Heparin error. Attending Physician #1 said the Heparin administration resumed the next morning on 10/06/11. Attending Physician #1 said patients can be very sensitive to the administration of Heparin and any error needed to be taken seriously. Attending Physician #1 said the VP of Patient Care/CNO said the error would be investigated and staff re-educated. Attending Physician #1 said Patient #1's family were told of the error and that there were no complications.

Review of the PTT Laboratory Data dated 10/05/10 at 9 PM, 10:42 PM, 11:30 PM and 12:35 AM on 10/06/10 were all recorded at 249. Patient #1's Heparin drip remained off until 10/06/10 at 3:30 AM.

Review of the Occurrence Report dated 10/06/10 indicated a medication error occurred on 10/05/10 at 7:59 PM whereby Heparin infusion lines were crossed and the Heparin ran rapidly at a rate of 75 ml/hr.

The nursing staff failed to remove both the bag of Heparin and the solution containing the Potassium Chloride and the infusion pump in order to reconcile the specific delivery amount for both infusions.

The Director of CCSU was interviewed by telephone on 04/28/11 at 10 AM via conference call the the Hospital's Risk Manager. The Director of CCSU said there was no mandatory re-education of all nurses nor presented hospital-wide. The Director of CCSU said the nursing staff were spoken too individually. The Director of CCSU said there were no additional policy changes made to high alert medications. The Director of CCSU said the nursing staff were instructed that the best practice was to use a single pump for the administration of multiple intravenous medications. The Director of CCSU said RN #3 reported the error may have occurred during the addition of the D 5 and 1/2 Normal Saline with the Potassium Chloride 40 mEq additive.

(2) POTASSIUM CHLORIDE MEDICATION ERROR:

Review of the Physician Orders dated 10/05/10 at 9 AM indicated Attending Physician #1 ordered an additional intravenous infusion of D5and 1/2 strength Normal Saline with 40 mEq of Potassium Chloride to run at a rate of 75 cc/hr.

Review of the Intravenous Fluid and Medication Sheets dated 10/05/10 indicated RN #3 hung D 5and 1/2 strength Normal Saline with Potassium Chloride (specific additive dosage amount was written over with the number 40 millequivelemts) at a rate of 75 cc/hr. RN #3 failed to document the time the infusion of D 5 1/2 strength with Potassium Chloride 40 meq was hung.

RN #5 said the delivery rate for the solution with the 20 mEq's of Potassium Chloride was running at 17 ml/hr. (The physician's order was for D 5and 1/2 Normal Saline with 40 mEg's of potassium chloride). RN #5 said RN #6 called Attending Physician #1, Nursing Supervisor and a Neurologist to notify them of the Heparin medication error.

RN #6 said RN #5 requested a witness to the Heparin medication error. RN #6 said the infusion lines were changed and then restarted the 20 mEg Potassium Chloride in D 5 1/2 strength Normal Saline to 75 ml/hr. RN #6 said the Potassium Chloride bag was fairly full. RN #6 said if the Potassium Chloride had been hung at 10 AM or 10:30 AM, the bag would have been ready to be replaced and near empty at 8 PM.

Both RN #5 and RN #6 said 20 mEq/hr of Potassium Chloride was administered instead of ordered dose of 40 meg/hr.

The Occurrence Report lacked any investigation or acknowledgement of the secondl medication error: There was no documentation for the inappropriate administration of the Potassium Chloride nor the discrepancy in the dosage for the Potassium Chloride addressed as a medication error

The nursing staff failed to adequately monitor the Heparin drip infusion and consistently verify the order and rate of infusion with the hand-off to the oncoming nurse as required per policy. The nursing staff failed to observe the infusion program including the appropriateness of the delivery and secondary intravenous infusion of Potassium Chloride and Patient #1's response to the delivery of the Heparin.

There were no documented complications nor ill effect to Patient #1 as a result of the Heparin medication error.

There was insufficient documentation that both the Heparin and Potassium Chloride infusion medication errors were adequately investigated by the Hospital to ensure hospital wide compliance and patient safety.