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Based on review of Committee Minutes, Medication Error Reports and staff interview, it was determined that the Hospital failed to ensure that there was an effective hospital wide quality program to identify opportunities for improvement that would decrease medication errors (A276) and failed to ensure that there was a medication safety committee that meets regularly to evaluate data collected on medication errors (A277). The cumulative effect of these systemic problems resulted in the Hospital's inability to maintain an effective quality assessment and performance improvement (QAPI). As a result, it was determined that the Condition for QAPI was not in compliance.

A. Based on a review of medication error reports and staff interview, it was determined that the Hospital failed to ensure, for 3 of 3 years reviewed (2008, 2009 and 2010) all medication errors were evaluated and opportunities for improvement were identified by the Hospital Quality/Safety Committee that would decrease medication errors.

Findings include:

1. On 3/29/10 and 3/30/10, data from medication error reports for 2008, 2009 and 2010 was reviewed at approximately 10:30AM and 3:00PM. The medication error reports for 2008 indicated that the Hospital had a total of 474 medication errors. The total medication errors increased to 597 in 2009. The total errors for 2010 (January through March) were 148. Upon review of the Hospital Wide Quality Minutes for 2008, 2009 and 2010, the minutes lacked documentation that the errors were analyzed to identify changes that would lead to a decrease in medication errors.
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Examples of medication errors are as follows:

* On 1/19/09 Potassium Chloride was hung on the wrong patient resulting in increased monitoring.

* On 3/1/09 medication route was incorrect and two medications (Aricept and Nameda) were transcribed on the MAR that were not intended for the Pt. resulting in increased monitoring of the patient.

*3/10/09 Medication sheets in the ED were documented incorrectly. As a result, Cartizem was not given twice a day and albuterol was given orally instead of by nebulizer for the entire hospitalization requiring increased monitoring of the Pt.

*On 4/3/09 30 units of insulin was given when the physician ordered the insulin decreased to 20 units.

*4/19/09 the order was for Amrinone (vasodilator) but pharmacy read the order as amiodarone( antiarrhythmic) which was given to the Pt. as a continuous infusion. The Pt. required increased monitoring.

*5/9/09 the physician ordered 1 gram of magnesium sulphate with lidocaine to run over one hr. The IV was labeled correctly. However, a curious nurse peeled back the label to discovered that pharmacy dispensed Integrilin (inhibits platelet formation). The Pt. required monitoring for any bleeding. The pharmacist was unable to identify who prepared the medication.

*On 5/1/09 Heparin was not infused according to protocol. As a result, the patient's bleeding time (PTT(bleeding time)) was greater than 200 (reference range 21 to 31).

* On 5/30/09 during a pediatric code, the incorrect percentage dose of sodium bicarbonate was in the crash cart. The correct dosage was given to the infant.

* On 6/30/09 a 101 year old female patient was found lethargic and difficult to arouse due to an overdose of Morphine that required a reversal drug. The order was for MS every 6 hours as needed. The Pt. received a dose at 0015 and again at 5:25AM including a dose of xanax. This incident was classified as a near death event.

* On 1/23/10 Epidural Morphine was given instead of Fentanyl due to a discrepancy to the narcotic count.

* On 2/2/10 IV sodium chloride was infused instead of Dextrose in water resulting in elevated Pt. sodium levels. This incident was categorized as "an event occurred that resulted in need of treatment- caused temporary harm"

* A student nurse with a preceptor administered the incorrect drug (Plavix) instead of aspirin on 2/23/10.

*On 2/16/10 A patient received intravenous potassium chloride instead of Dextrose and water.

2. The above findings were confirmed by Accreditation Manager during an interview on 3/30/10 at approximately 2:45PM.

A. Based on a review of Hospital Quality and Safety Committee Minutes, review of Nursing/Pharmacy Minutes, a review of the Hospital's Quality Improvement Plan and staff interview, it was determined that the Governing Body failed to ensure that there was a Medication Safety Committee that meets regularly to evaluate data collected on medication errors.

Findings include:

1. The monthly Hospital Quality and Safety Committee Minutes for 2009 and 2010 did not have a set agenda for reviewing all medication errors or discussion for implementing corrective actions. As a result, it could not be determined exactly how the Hospital Quality and Safety Committee Minutes addresses deficient medication practices and follow up actions.

2. On 3/29/10 at approximately 2:00PM, the "Nursing/Pharmacy Meeting Minutes were reviewed for 2009. The Committee would meet once a month to discuss "system wide problems" related to medication errors. The Committee last convened on 4/6/09. It could not be determined why the Committee disbanded.

3. The Hospital's Quality Improvement Plan, dated 2009-2010 was reviewed on 3/29/10 at approximately 2:00PM. The plan did not define specific responsibilities for medication error evaluation, frequency of meetings or a reporting calendar. Although the plan included, " ...will use information from data analysis and implement changes that will improve the quality of care, treatment, services and patient safety...", it could not be determined exactly how the Hospital implemented changes to improve patient safety relative to medication errors.

4. The Accreditation Manager was interviewed on 3/30/10 at approximately 2:45PM. The Manager stated that medication variances reports are presented by pharmacy twice a year to the Hospital Quality and Safety Committee. The last report was presented in November 2009 to the Hospital Quality and Safety Committee. The report included medication variance data. However, there was no documentation that the Hospital Quality/Safety Committee evaluated the medication errors or recommended corrective actions to reduce the errors.

4. The above finding was confirmed by the Accreditation Manager during an interview on 3/30/10 at approximately 3:00PM.

A. Based on clinical record reviewed and staff interview, it was determined that for 1 of 4 (Pt. #8) open clinical records reviewed on the 2 West Unit, the Hospital failed to ensure medication orders were properly transcribed.

Findings include:

1. The clinical record for Pt. #8 was reviewed on 3/30/10 at approximately 11:25 A.M. This was an 80-year-old female, admitted 3/24/10 with diagnoses of Nosebleed and Pancytopenia. The record included a physician's order dated 3/25/10 for Zosyn 2.25 gm (antibiotic) intravenously every 6 hours. The medication administration record (MAR) for Pt. #8 dated 3/25/10 included a handwritten transcription for Zosyn 2.25 mg (milligrams) intravenously every 6 hours instead of 2.25 gm (grams) as ordered.

2. In an interview with the Director of Pharmacy on 3/30/10, the Director stated the Zosyn is available in prepackaged doses of 2.25 grams, 3.375 grams and 4.5 grams.

3. The above finding was confirmed with the Director of Quality on 3/30/10 at approximately 2:00 P.M.


B. Based on a review of Hospital policy, Hospital stated practice, observation and clinical record review on the 2 West Unit,, and staff interview, it was determined that for 4 of 4 (Pt. #s 7-10) open clinical records reviewed, the Hospital failed to ensure intravenous fluids were labeled as required.

Findings include:

1. Hospital policy #7.0 entitled, "Peripheral Intravenous (IV) Therapy, Adult" was reviewed on 3/30/10 at approximately 1:00 P.M. The policy requires "Verify physician order for fluid orders... Complete appropriate label."

2. Hospital practice as stated by 2 West Manager is to label intravenous fluids with a label taken from the Pyxis machine which includes: Patient name and id number, type of intravenous fluid and dose.

A tour was conducted of the 2 West Unit on 3/30/10 from 9:15 A.M. - 12:00 P.M and observations were conducted.

3. On 3/30/10 at approximately 9:15AM, Patient #7 was observed with intravenous (IV) fluids that did not contain a label.. The clinical record for Pt. #7 was reviewed on 3/30/10 at approximately 11:00 A.M. This was a 57-year-old female, admitted 3/29/10 with diagnoses of Chest Pain and High Blood Pressure. The record included a physician's order dated 3/29/10 for Nitroglycerin 5 mcg/hr and 0.9 normal saline @ 75 mL/hr.

4. On 3/30/10 at approximately 9:45AM Patient #8 was observed with unlabeled IV fluids. The clinical record for Pt. #8 was reviewed 11:25 A.M. This was an 80-year-old female, admitted 3/24/10 with diagnoses of Nosebleed and Pancytopenia. The record included a physician's order dated 3/25/10 for Zosyn 2.25 gm (antibiotic) intravenously every 6 hours and an order dated 3/24/10 for 0.9 normal saline at 100 mL/hr.

5. On 3/30/10 at approximately 9:50AM Patient #9 was observed with unlabeled IV fluids. The clinical record for Pt. #9 was reviewed on 3/30/10 at approximately 10:30 A.M. This was an 83-year-old female admitted on 3/19/10 with a diagnosis of Hemorrhagic Cystitis, Hematuria, and Urinary Tract Infection. The record included a physician's order dated 3/28/10 for N (normal) Saline 75 mL/hr. The order failed to indicate the strength or percentage of normal saline. The record lacked documentation to indicate that the order was clarified with physician prior to administering 0.9 normal saline. The medication administration record (MAR) included that sodium chloride (normal saline) 0.9 % was dispensed by pharmacy.

6. On 3/30/10 at approximately 10:00AM Patient #10 was observed with unlabeled IV fluids. The clinical record for Pt. #10 was reviewed on 3/30/10 at approximately 12:00 P.M. This was an 82-year-old female, admitted 3/27/10 with diagnoses of Hyperkalemia and Renal Insufficiency. The record included a physician's order dated 3/29/10 for Magnesium Sulfate 2 gm intravenously and 0.9 NaCl @ 40 mL/hr.

7. The above findings were confirmed during an interview with the 2 West Unit Manager and Unit Director on 3/30/10 at approximately 12:15 P.M.

A. Based on review of Hospital Policy, clinical record review, incident report review and staff interview it was determined that for 2 of 5 (Pt. #1 and 8 ) clinical records reviewed from 2 West - Telemetry unit, the Hospital failed to ensure medications were administered accurately as ordered by the physician.

Findings include:

1. The Hospital policy titled "Medication Administration" was reviewed on 3/30/10 at 9:00 AM. The policy included "Purpose: To provide guidelines for administering medications safely and accurately. 1. Medications are administered with a physicians order...2. The five rights are observed in giving each medication: ...the right time, the right medication...".

2. The clinical record of Pt. #1 was reviewed on 3/29/10 at 9:30 AM. Pt. #1 was a 42 year old male admitted on 3/30/09 with the diagnosis of Left Upper Arm Pain. The clinical record included a physician order dated 3/29/09 at 9:56 PM written in the Emergency Department (ED) for a Heparin drip (blood thinning medication) to be started. The Heparin was documented as being initiated intravenously for continuous dosing at 10:10 PM by E#1 (ED RN).

3. Pt. #1 was admitted to the 2 West, Telemetry Unit at 12:15 AM on 3/30/09 by E#2 (Telemetry RN) with a Heparin intravenous infusion running. However, E#2 indicated that she reviewed the physician orders and noticed Pt. #1 was receiving a nitroglycerin drip instead of Heparin. E#2 immediately discontinued the Nitroglycerin and notified the nursing supervisor and the physician of the error. The documentation indicated that the Heparin had been given continuously from 10:10 PM on 3/29/09 until 2:15 AM on 3/30/09 (4 hours and 5 minutes).

4. The incident report dated 3/30/09 was reviewed on 3/29/10 at 11:00 AM. The report written by E#1 included, "patient was to be placed on a heparin drip. Both medications are in the same area. I grabbed Nitroglycerin instead of Heparin. Patient went to floor. Nurse from floor discontinued the Nitroglycerin and called the physician ". Pt. #1 therefore never received the Heparin drip and had taken the nitroglycerine drip (wrong medication) for 4 hours and 5 minutes.

5. The above findings were confirmed with the Risk Manager on 3/30/10 at 8:00 AM, during an interview.







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6. The clinical record for Pt. #8 was reviewed on 3/30/10 at approximately 11:25 A.M. This was an 80-year-old female, admitted 3/24/10 with diagnoses of Nosebleed and Pancytopenia. The record included a physician's order dated 3/25/10 for Zosyn 2.25 gm (antibiotic) intravenously every 6 hours. The medication administration record (MAR) for Pt. #8 indicated that the patient failed to receive Zosyn at the ordered time interval. Examples are as follows:

* Zosyn dose was administered on 3/25/10 at 12:00 P.M., 6:00 P.M., and 3/26/10 at 3:30 A.M. (9.5 hours after the last dose).

* After 3/26/10 at 3:30 A.M., the next dose administered was on 3/26/10 at 2:00 P.M. (10.5 hours after the last dose.

* The next dose of Zosyn was administered on 3/26/10 at 10:05 P.M. (8 hours after the previous dose).

* The following dose of Zosyn was administered on 3/27/10 at 2:00 A.M. (4 hours after the last dose)

7. The above findings were confirmed during an interview with the 2 West Unit Manager and Unit Director on 3/30/10 at approximately 11:30 A.M.

A. Based on a review of Hospital policy, clinical record review, and staff interview it was determined that, in 1 of 4 records reviewed on 2 West (Pt. #9), the Hospital failed to ensure orders were clarified as needed prior to administration of intravenous fluids.

Findings include:

1. Hospital policy #13.1 entitled, "Medication Administration," was reviewed on 3/30/10 at approximately 2:40 P.M. The policy requires, "Pharmacy is responsible for contacting the physician... when... there is a question about the order..."

2. On 3/30/10 at approximately 10:30 A.M., the clinical record for Pt. #9 was reviewed.. This was an 83-year-old female admitted on 3/19/10 with diagnoses of Hemorrhagic Cystitis, Hematuria, and Urinary Tract Infection. The record included a physician's order dated 3/28/10 for N (normal) Saline 75 mL/hr. The order failed to indicate the strength or percentage of normal saline. The record lacked documentation to indicate that the order was clarified with physician prior to administering 0.9 normal saline. The medication administration record (MAR) included that sodium chloride (normal saline) 0.9 % was dispensed by pharmacy.

3. The above finding was confirmed during an interview with the 2 West Unit Manager and Unit Director on 3/30/10 at approximately 10:30 A.M.