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Based on staff interview, clinical record, administrative document and professional standard review, the governing body failed to have a system in place to ensure the safe administration of high risk, high alert medications such as heparin (a medication used to thin the blood). Medical Doctor (MD) 1 administered 25,000 units of heparin in 250 milliliters (ml) of Normal Saline (NS) instead of the intended 1000 units of heparin in 500 ml NS. Without clarifying the verbal order, Registered Nurse (RN) 1 provided an intravenous (IV) bag of normal saline (NS) with 25,000 units of heparin in 250 milliliters (ml) and IV tubing to Medical Doctor (MD) 1 who administered the heparinized saline used in the declotting (removing blood clots) procedure for Patient (Pt) 1. This failure resulted in the avoidable overdose of Heparin to Pt 1 and directly led to the cause of death which was listed on the Hospitalist Death Summary as " massive blood loss " . The overdose of heparin occurred on 11/22/16 at 5:35 p.m. and Pt 1 expired on 11/23/16 at 2:17 a.m. (refer to A 405, A 408).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on staff interview, clinical record, administrative document and professional standard review, the facility failed to have a system in place to ensure the safe administration of high risk, high alert medications such as heparin (a medication used to thin the blood). Medical Doctor (MD) 1 administered 25,000 units of heparin in 250 milliliters (ml) of Normal Saline (NS) instead of the intended 1000 units of heparin in 500 ml NS. Without clarifying the verbal order, Registered Nurse (RN) 1 provided an intravenous (IV) bag of normal saline (NS) with 25,000 units of heparin in 250 milliliters (ml) and IV tubing to Medical Doctor (MD) 1 who administered the heparinized saline used in the declotting (removing blood clots) procedure for Patient (Pt) 1. This failure resulted in the avoidable overdose of Heparin to Pt 1 and directly led to the cause of death which was listed on the Hospitalist Death Summary as " massive blood loss " . The overdose of heparin occurred on 11/22/16 at 5:35 p.m. and Pt 1 expired on 11/23/16 at 2:17 a.m. (refer to A 405)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on staff interview, clinical record, administrative document and professional standard review, the hospital failed to adhere to accepted standards of practice and follow hospital policy and procedures for the administration of the high risk drug, Heparin (medication used to thin the blood). Without clarifying the verbal order, Registered Nurse (RN) 1 provided an intravenous (IV) bag of normal saline (NS) with 25,000 units of heparin in 250 milliliters (ml) and IV tubing to Medical Doctor (MD) 1 who administered the 250 ml of heparinized saline used in the declotting (removing blood clots) procedure for Patient (Pt) 1. The intended dose of heparin was 1,000 units of heparin in 500 ml of NS.

This failure resulted in the overdose of Heparin to Pt 1 and directly led to the cause of death which was listed on the Hospitalist Death Summary as "massive blood loss" . The overdose of heparin occurred on 11/22/16 at 5:35 p.m. and Pt 1 expired on 11/23/16 at 2:17 a.m.

Findings:

The clinical record indicated Pt 1 was admitted to the hospital on 11/20/16 for altered mental status and renal failure (the kidneys inability to remove waste from the body) requiring hemodialysis (the process of filtering the blood with an external mechanical device). On admission Pt 1 had an arteriovenous (AV) fistula (a surgically placed connection between an artery and a vein in order to facilitate hemodialysis) which was clotted and dialysis staff was no longer able to access for hemodialysis treatments due to the blood clots. Pt 1's medical plan included a right upper arm fistulagram (a specialized procedure to visualize inside the vein and artery) and declotting of the AV fistula on 11/22/16 in Interventional Radiology (IR) (the specialized area of the hospital for image guided procedures).

On 12/6/16 at 2:15 p.m., during an interview, RN 1 stated she was working in IR on 11/22/16 when Pt 1 arrived for her procedure at 3:30 p.m. RN 1 stated she was aware of the reason for Pt 1's admission to the hospital and the reason for the IR procedure. RN 1 stated half way through the procedure, MD 1 gave a verbal order for an IV (into the vein) heparin drip. MD 1 asked for the heparin drip to be in a pressure bag (an inflatable cuff that fits around an IV fluid bag and can be manually inflated to a desired level of pressure to regulate the flow of fluid). RN 1 stated she remembered asking MD 1, "25,000 units of heparin in 250 ml bag of NS"? RN 1 stated she remembered MD 1 stated "yes" . When asked if she double checked and verified the medication order with another healthcare professional, RN 1 stated "no" . When asked whether she clarified the dose of heparin to be administered, RN 1 stated "no" . When asked whether or not the 25,000 units of heparin in 250 ml NS in a pressurized cuff was excessive for the procedure, she stated she would not have put it on the table if she knew how he was going to use it. During the interview RN 1 described the sequence of activities she performed in providing the 25,000 units of heparin in 250 ml of NS. After hearing the verbal order from MD 1, RN 1 walked approximately five feet from the foot of the bed to a locked cabinet where the heparin was stored, reached and grabbed 250 ml bag of NS with 25,000 units of heparin. RN 1 stated she fit the inflatable cuff over the IV bag. RN 1 stated she dropped the IV tubing onto the sterile field (an area free of germs), holding on to the pointed end connecting it to the bag of heparinized saline which was in the pressure bag. RN 1 stated, MD 1 manually controlled the rate of the drip with a roller clamp. When asked if she double checked the verbal order, she stated "no" .

On 12/6/16 at 3:30 p.m., during an interview, RN 2 stated she was working in the procedure room with RN 1 and she was at the head of the bed monitoring the patient and administering sedation (medication used during procedures to lower the patient ' patient's awareness to external stimulation such as pain). RN 2 stated she was "doing her thing" and didn't hear an order for a heparin drip, "I wasn't paying attention." RN 2 stated she saw a pressure bag but didn't look at what was in it. When asked whether 25,000 units of heparin was excessive for the procedure, RN 2 stated "yes" . RN 2 stated the usual dose of heparin for this type of procedure was 1,000 units in 500 ml of NS.

On 12/7/16 at 9:10 a.m., during an interview and concurrent document review, RN 3 stated she was in the monitor room recording the events of the procedure. RN 3 stated she heard RN 1 call out heparin drip via right arm fistula. RN 3 documented in the Procedure Log at 4:09 p.m. "heparin drip via right arm fistula access side port of sheath per MD 1" . RN 3 stated she did not question the order without a specific dosage because it was common to use 1,000 units of heparin in 500 ml of NS for this procedure. After the procedure, the Radiology Technician (RT) 1 showed her an empty 250 ml bag which had contained 25,000 units of heparin. RN 3 said when she saw the empty bag, and realized Pt 1 received 25,000 units of heparin, she told everyone in the room "this is bad," referring to the extremely high amount of heparin Pt 1 received.

On 12/7/16 at 11:55 a.m., MD 1 stated he asked RN 1 for a heparin drip in a pressure bag to keep the vein free of blood clots. MD 1 stated RN 1 asked if he wanted heparin and MD 1 said "yes" . MD 1 stated he was unaware RN 1 provided a pre-mixed bag of 250 ml of NS with 25,000 units of heparin for the drip and did not visualize the bag provided by RN 1 prior to administering the heparinized saline. MD 1 stated his intended verbal order was for 1,000 units of heparin in 500 ml of NS. MD 1 stated when he was administering the heparinized saline he was unaware he was infusing 25,000 units of heparin. MD 1 stated his normal practice is to use a heparinized saline drip to maintain patency of the vein and he controls how much is infused. MD 1 stated he realized after the procedure when RN 4 addressed the room, that Pt 1 received 25,000 units of heparinized saline.

On 12/6/16 at 1 p.m., during an interview RN 4 stated she was in the Intensive Care Unit (ICU) when she received report from RN 3 regarding Pt 1's condition. RN 4 stated she was told that Pt 1 had a large hematoma (collection of blood outside the blood vessels under the skin) growing at the fistula site while attempting to declot. RN 4 stated she was informed that Pt 1's blood pressure was low and was having difficulty breathing and needed to return to ICU immediately. RN 4 stated Pt 1 was transferred from IR by two nurses, two technicians and MD 1. On Pt 1's return to ICU at 5:50 p.m., RN 4 stated she was informed Pt 1 had received 25,000 units of heparin during the procedure. At 7 p.m. Pt 1's right arm was assessed and blood was noted to be pooling (a collection of blood) behind the patient. The right arm was elevated and pressure applied to the sites that were bleeding and right arm dressing was applied.

On 11/22/16 Pt 1 received a hemodialysis treatment that began at 7:15 p.m. and ended at 10:15 p.m. Review of the Hemodialysis Summary of Treatment written by RN 5, dated 11/22/16 at 10:53 p.m., indicated "Hemodialysis Arteriovenous (AV) access right upper arm, status post fistulagram, bleeding on the access with big hematoma, right arm is swollen and cool to touch, radial pulse is not palpable (felt)" .

Review of Care Team Note dated 11/23/16 at 2:45 a.m., indicated at 11 p.m. an attempt was made to start an IV line to administer blood, however due to the severity of the hematoma and the high PTT (partial thromboplastin time, a test to determine the time it takes blood to clot) which was greater than 200 seconds (normal range 25 - 35 seconds), they were unable to start the blood transfusion. At 12 a.m. Pt 1's swelling in her upper right arm had increased. Pt 1's time of death was 2:17 a.m., eight hours and thirty five minutes after the heparin overdose was identified.

On 12/6/16 at 3 p.m., during an interview and concurrent record review, IR Manager stated it was the expectation of her staff to double check all heparin administered and the documentation should have been accurate and complete. The record indicated the nurse monitoring the procedure documented the heparin drip without identifying a dose. The IR Manager stated the expectation of staff was to clearly identify the heparin units per hour and should have read back the order. The IR Manager stated, when the verbal order was given, the nurse should have verified MD 1's response of yes by clarifying the dosage of heparin requested.

On 12/8/16 at 2 p.m., an interview was conducted with members of the Governing Body which consisted of the Chief Nurse Executive (CNE), Chief Medical Executive (CME), Chief Executive Officer (CEO), Chief of Staff (COS) and Chief Operating Officer (COO). The CME stated they were notified by Risk Management on 11/23/16 at 12 p.m., that a patient had received a significant overdose of heparin in IR. The CEO stated that on 11/28/16 the Governing Body decided it was a serious safety event. The CME stated he thought someone from Risk Management had interviewed MD 1 regarding the incident. When asked if a Medical Doctor interviewed MD 1 about the incident, the CME said "no" . When asked if a Root Cause Analysis (RCA) had been completed, the CME said "no" . The CME stated the RCA had been started but was not complete.

Review of the "Hospitalist Death Summary" dated, 11/23/16 at 8:53 a.m., indicated "the causes of death were Hypovolemic Shock (a life-threatening condition that results when you lose more than 20 percent of your body's blood supply) and Iatrogenic (caused by hospital staff) Massive Bleed status post (after) Fistulagram Declot" .

The Hospital Policy and Procedure titled, "Medication: Administration of" dated 10/14/16, indicated, "... POLICY: ... C. The healthcare professional's responsibility must include knowledge of the drug's action, usual dose, route of administration, untoward effects. ... PROCEDURE: ... D. The nurse must know the classification, action, usual dosage, contraindications and incompatibilities of intravenous medication... I... 1. Verifies that the medication selected for administration is the correct one based on the medication order and the product label... W. High risk medications such as heparin ... must be checked by two qualified healthcare professionals for the dose... Y... the licensed nurse will show the physician the medication vial, container, etc. from which the medication was drawn..."

The Hospital Policy and Procedure titled, "Medication: High Risk (High Alert)" dated 7/15/16, indicated "... POLICY: ...G. High risk medication such as ... heparin ... must be checked by two qualified healthcare professionals..."

Based on interview and document review, the hospital failed to ensure the master formula for oral suspension compounded (medications mixed together in the exact strength and dose) by the hospital pharmacy matched the compounding formulation in the drug reference used by the hospital. The hospital master formula for clonidine (medication used to treat high blood pressure) and tacrolimus (medication used to prevent organ rejection) oral suspensions did not match the compounding reference used for expiration date. This failure had a potential to result in patients' exposure to medications that may no longer be effective.

Findings:
On 12/7/16 at 1:25 p.m., during an observation in the main pharmacy, one brown plastic bottle of prepared clonidine 0.01 mg/ml (milligram per milliliter) 100 ml and two brown plastic bottles of prepared tacrolimus 0.5 mg/ml 60 ml were observed on the liquid medication shelf. The master formula record for the pharmacy prepared clonidine oral suspension and the tacrolimus oral suspension was reviewed. When asked, Inpatient Pharmacy Supervisor 1 stated the hospital used Lexicomp as a compounding reference for the master formula expiration dates for both the clonidine and tacrolimus oral suspensions.
Lexicomp is a nationally recognized drug reference widely used by healthcare professionals.
Review of the Lexicomp online (provided by the hospital) against the hospital master formula showed as follows:
For clonidine: Lexicomp used 100% of Ora-Blend (1:1 mixture of Ora-Plus: Ora-Sweet) as the suspending solution, however the hospital used about 93 % of Oral-Plus and about 6% of cherry syrup instead. The hospital prepared suspension was labeled with the same expiration date of 91 days as the reference though the formulation was not the same.
For tacrolimus oral suspension: Lexicomp used 1:1 mixture of Ora-Plus and simple syrup as the suspending solution, however the hospital used 6:5:1 mixture of simple syrup, Ora-Plus and sterile water instead. The hospital prepared suspension also used the same expiration date of 56 days as the reference.
During an interview on 12/8/16 at 10:00 a.m., the Pharmacy Clinical Coordinator stated she was responsible for the sterile compounding and the Inpatient Pharmacy Supervisors were responsible for the non-sterile compounding. The Clinical Coordinator stated she was not sure who added the two formulations in the master formula that were different from the Lexicomp formulations. The Inpatient Pharmacy Supervisor 1 was not sure when the clonidine and tacrolimus master formulations were put together and was not aware the formulations were different from the Lexicomp references. The Director of Pharmacy (DOP) acknowledged their master formula for clonidine and tacrolimus oral suspensions did not match the Lexicomp references expiration dates being used.

Based on interview and document review, the hospital failed to ensure competency evaluation was implemented for a new pharmacy technician prior to allowing the Pharmacy Technician (PT) 1 to compound sterile preparation.
This failure had potential to result in the patients' exposure to preventable infections from potentially contaminated IV (intravenous - through vein) medications.

Findings:
Review of the hospital policy and procedure titled "Orientation and Ongoing Education, Training and Competency Assessment of Pharmacy personnel" revised 7/12, read in part "Pharmacy staff shall be skilled and competent to perform the duties and responsibilities required of their position ... Initial and ongoing training and competency education and assessment will be provided to achieve this objective ... Periodic skills assessment and competency testing will take place for all employees ... IV admixture [sterile solution prepared by certified pharmacy technician for intravenous use to patients]/sterile compounding will be included in the competency assessments ..."
USP (United States Pharmacopoeia) is a scientific, non-profit organization that sets the quality, purity, identity and strength standards for medications ... manufactured and consumed worldwide. USP is federally recognized as an authoritative source regarding minimum standards of safe practice applicable to both sterile and non-sterile compounding. USP <797> (USP chapter 797) establishes the minimum standard of practice applicable when preparing, storing, and transporting CSPs (Compounded Sterile Preparations) to be followed by all health care personnel in any setting.
According to USP <797>, all compounding personnel shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (zero colony forming unit, cfu) no less than three times before initially being allowed to compound CSPs for human use.
On 12/8/16 at 09:30 a.m. pharmacy staff competency was reviewed for CSPs in the presence of the DOP. Pharmacy Technician 1 started working at the hospital in 2014, CSP competency assessment was initiated and a gloved fingertip/thumb sampling was completed on 12/30/15. The gloved fingertip/thumb sampling grew one cfu. The hospital was unable to show any follow up done after this single fingertip/thumb sampling. Further, the hospital was unable to show PT 1 had at least three fingertip/thumb sampling completed with zero cfu in each of the sample before initially being allowed to compound CSPs.
The Director of Pharmacy (DOP) acknowledged the hospital was unable to show any follow up done after the single fingertip/thumb sampling. Further, the hospital was unable to show PT 1 had at least three fingertip/thumb sampling completed with zero cfu in each of the sample before initially being allowed to compound CSPs and stated he was not aware of this USP <797> requirement at the time PT 1 was being evaluated for CSP competency.

Based on observation, interview, and document review, the hospital failed to ensure outdated medical supplies were not available in the emergency crash cart (used for storing medications and medical supplies needed during a medical emergency) for patients' use. This failure had the potential to expose patients to preventable infections.

Findings:

Review of the hospital policy and procedure titled "Crash Cart Check (Adult and Pediatric)" revised 3/15/16, read in part "Initial completion of stock supplies to the crash cart will be done by Central Supply ...The crash cart expiration date can be found in the left upper corner of the Central Supply sheet, indicating first item to expire in locked cart ..."

On 12/07/16 at 10:50 a.m., during an observation and concurrent interview on 3 South Cardiac Telemetry unit, the emergency crash cart was identified by the 3 South Charge Nurse. Inspection of the crash cart showed two IV (intravenous - through vein) start kit with expiration dates of 8/16, two arterial blood sampling kit (for gases and electrolytes) with expiration date of 9/16 and an oral tracheal tube with an expiration date of 10/16. The expiration date documented on the crash cart Central Supply sheet was 2/17. The 3 South Charge Nurse acknowledged the IV start kit, arterial blood sampling kit, and oral tracheal tube were expired.

During an interview on 12/07/16 at 11:05 a.m., the Central Supply Manager and the Central Supply Supervisor acknowledged the findings. The Central Supply Supervisor checked the crash cart and the central supply sheet. She stated the supply sheet on the crash cart was not the correct central supply sheet, the crash cart number on the Central Supply sheet with the expiration date of 2/17 did not match the number on the crash cart.