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Based on interview and record review, the Condition of Participation for Quality Assessment and Performance Improvement Program (QAPI) {42 CFR 482.21} was determined to be NOT MET when the hospital failed to measure, analyze, and track quality indicators for High Alert Medications such as Heparin {blood thinner] and Fentanyl [pain medication]) for three of 16 sampled patients (Patients 1, 12, & 16). [Refer to A286]

The cumulative effect of these systematic problems resulted the facility's inability to ensure the provision of quality patient care in a safe environment for all patients receiving care at the facility.





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Based on interview, and record review, the Condition of Participation for Nursing Services (42 CFR 482.23) was determined to be NOT MET when the hospital failed to provide nursing care by trained and qualified staff to ensure the provision of nursing care according to the hospital's policies and procedures when:

1. Registered Nurse (RN) 3 and RN 5, who were not qualified in the management of Heparin (blood thinner) administration, were assigned to one of 16 sampled patients(Pt 1) and failed to administer this medication correctly (refer to A397); and

2. One of 16 sampled patients (Patient 12) was administered fentanyl (medication used to treat severe pain) on 10 consecutive dates, from 5/31/20 to 6/10/20, that were not in accordance with the Nurse Practitioner's (NP- A registered nurse who has completed advanced education and training in the diagnosis and management of common medical conditions) order (refer to A405, findings 1 & 2)

The cumulative effect of these systematic problems resulted the facility's inability to ensure the provision of quality patient care in a safe environment for all patients receiving care at the facility.

Based on observations, interviews and document reviews the hospital failed to provide Pharmaceutical Services that meet the needs of the patients as evidenced by:

1. The hospital pharmacy failed to appropriately monitor and accurately dose Heparin for Patient 1 which resulted in four medication errors which included RN 4 did not administer a bolus dose as prescribed; RN 4 initiated a starting rate that exceeded the maximum allowable rate; RN 5 administered a rate change that exceeded the maximum rate change; and RN 3 increasing the rate instead of stopping the infusion which resulted in hospitalization due to a gastrointestinal (GI) bleeding. (See A-500)

2. The hospital pharmacy failed to appropriately monitor and accurately dose Heparin for Patient 16 that resulted in two medication errors, which included RN 1 initiating an incorrect lower starting rate then what was prescribed; and RN 2 delaying the administration of a Heparin rate change by 3.5 hours. (See A-500)

3. The hospital pharmacy failed to appropriately monitor and accurately dose Fentanyl for Patient 12 that resulted a medication error in which RN 6 administered Fentanyl for ten days that was at a higher rate then what was prescribed. (See A-500)

The cumulative effect of these systematic problems resulted the facility's inability to ensure the provision of quality patient care in a safe environment for all patients receiving care at the facility.

Based on interview and document review, the hospital failed to ensure quality indicators for High Alert Medications (drugs that bear a heightened risk of causing significant patient harm when they are used in error) were measured, analyzed, and tracked for three of 16 sampled patients (Patient 1, Patient 12, and Patient 16).

This failure resulted in repeated medication errors which caused Patient 1 to have gastrointestinal [GI] bleeding [bleeding from the stomach, intestines, or rectum); placed Patient 12 at risk for increased sedation or potential overdose, and placed Patient 16 at risk for potentially life-threatening blood clot.

Findings:

1. During a review of Patient 1's clinical record indicated that on 5/23/2020, Patient 1 had a clotted arteriovenous fistula (abnormal connection between an artery and a vein) on the left upper arm. The physician's order dated 5/23/2020, included an order for intravenous (IV- through the vein) Heparin per protocol.

During an interview on 06/09/20 at 2 p.m., the Director of Pharmacy (DOP) stated Patient 1 had been administered intravenous (IV- given through the vein) Heparin with multiple medication errors. The DOP stated that one of the errors resulted in Patient 1 to have a GI bleeding. The DOP stated four Heparin infusion errors had occurred in the past: 1) A Heparin bolus dose (single dose of Heparin given over a short period of time) was not administered as prescribed, 2) The starting infusion rate exceeded the maximum rate, 3) The nurse administered a dose that exceeded the maximum rate; and, 4) The nurse increased the rate of Heparin infusion instead of decreasing the rate of infusion, which then resulted in a GI bleed on 5/28/20.

During a review of Patient 1's "Physician's Order (PO)" dated 5/23/2020, the PO indicated the expected doses of Heparin to be administered at the following times:
*5/23/20 at 7:00 p.m. Initiation of Heparin-Bolus 8,360 units
*5/23/20 at 7:00 p.m. Start the rate at a maximum of 1500 units/hour (hr)
*5/27/20 at 12:42 a.m. Increase rate by 4 units/kg/hr by a maximum 400 units/hr
*5/28/20 at 8:30 a.m. stop Heparin infusion

During a review of Patient 1's "Nursing Administration Flow Sheet (NAFS) between 5/23/20 and 5/27/20, the NAFS indicated the actual administration rates of the IV heparin infusion was not in accordance with the PO:
*5/23/20 at 7:00 p.m. No Heparin Bolus administered
*5/23/20 Starting Heparin rate was 1881 units/hour (rate exceeded maximum initiation rate of 1500 units/hour)
*5/27/20 at 12:42 a.m. Rate increased by 425 units/hour (rate exceeded maximum rate change)
*5/28/20 at 8:30 a.m. Rate increased to 291 units/hour (protocol required to stop Heparin infusion)
*5/28/20 at 10:00 a.m. IV Heparin infusion stopped
*5/28/20 after the IV Heparin infusion stopped, Pt 1 had a visible GI Bleed. The blood was found in Patient 1's bed. The clinical record had missing information and the exact time of the bleed was not documented.

During an interview on 6/11/20 at 9:00 a.m. Registered Nurse (RN) 4 stated she made the medication errors on 5/23/20 at 7:00 p.m. RN 4 did not bolus the Heparin but changed the initial rate to exceed the maximum. RN 4 stated she made the mistake because she was busy and did not check to see if the Heparin initial rate was appropriate. RN 4 stated she did not verify the Heparin dosing with Pharmacy.

During an interview on 6/11/20 at 9:45 a.m., the DOP stated RN 5, who made the medication error on 5/27/20 at 12:42 a.m., no longer worked at the hospital. RN 5 was not available for an interview during the time of the survey.

During an interview on 6/11/20 at 9:20 a.m. with RN 3, RN 3 stated she was never trained to administer IV Heparin infusion. RN 3 also stated she made the medication error on 5/28/20 at 8:30 a.m.. RN 3 stated she should have stopped the infusion instead of increasing Patient 1's IV Heparin infusion rate to 291 units/hour. She stated she never verified the dosing with Pharmacy, and she did not know that she had to verify the Heparin dosing with Pharmacy.

During an interview on 6/10/20 at 2:54 p.m. with Physician 1, he stated he was asked to see Patient 1 because of the medication error on 5/28/20 at 8:30 a.m. Physician 1 also stated that when he saw Patient 1, he observed about 300 milliliter (ml-unit of measurement) in Patient 1's stool in the bed. Physician 1 stated he was concerned about the Heparin medication error and ordered the Heparin antidote (Protamine) to reverse the effects of Heparin. Physician 1 stated the Heparin was a contributing factor to Patient 1's GI Bleed.

During a review of the hospital policy titled ,"Anticoagulant Management" dated 3/2013 and revised on 1/2020 indicated, "Pharmacy is to proactively monitor heparin drip...Laboratory will provide PTT (Partial Thromboplastin Time, a blood test that looks at how long it takes for blood to clot) results directly to pharmacy ..."

During an interview on 6/10/20 at 3:03 p.m., Registered Pharmacist 1 (Rph 1) stated activated partial thromboplastin time (aPTT) was used per protocol to change the rate of the Heparin. Rph 1 stated a PTT tests blood clotting and the test was used to measure how Patient 1 was responding to the IV Heparin infusion. Rph 1 stated that she had not received direct communication from the hospital laboratory services regarding aPTTs.

During an interview on 6/9/20 at 3:30 p.m., the Director of Laboratory Services (DLS) stated that they did not provide aPTT directly to pharmacy. The DLS also stated that no direct communication was made to the pharmacy regarding aPTTs. The DLS stated they would call the charge nurse with the aPTT results and not the Pharmacy.

During an interview on 6/9/20 at 3:26 p.m., PM Clinical Pharmacist (CP) 1 stated that the Pharmacy was not receiving aPTT results directly from the laboratory services. CP 1 stated there was a plan in the past for the lab to provide direct aPTT results but it was never implemented.

A review of the "American Society of Health-System Pharmacists (ASHP)Guidelines: Minimum Standard for Pharmacies in Hospitals" indicated, "These guidelines outline a minimum level of services that most hospital pharmacy departments should consistently provide...Standard VII. Monitoring Medication Use...Medication therapy monitoring shall be conducted by pharmacists. Medication therapy monitoring includes...an assessment of...c. The appropriateness of the dose of the medication...f. Adverse drug reactions and other undesired effects...h. Clinical...laboratory data to evaluate the efficacy and safety of medication therapy and to anticipate toxicity and adverse effects..."

A review on 6/9/20 of the hospital policy dated 3/2013 and revised on 01/2020 entitled Anticoagulant Management indicated, "Pharmacy is to proactively monitor Heparin drip...pharmacy will be monitoring the aPTT of patient...Pharmacy will contact nursing to adjust heparin drip per protocol..."

During an interview on 6/9/20 at 3:26 p.m., Clinical Pharmacist (CP) 1 stated that Pharmacy did not proactively monitor Heparin drip, did not monitor aPTT, and did not contact nursing to adjust Patient 1's Heparin drip. CP 1 Patient 1 who had a GI bleeding, did not have proactive Pharmacy monitoring and dosage adjustments by a Pharmacist.

During an interview on 6/9/20 at 3:30 p.m., CP 1 stated proactive monitoring and dosing by Pharmacy did not happen because it was forgotten due to the infrequent use of Heparin drip. CP 1 stated that after generating a report, there were only three patients that had been on Heparin drip and none were proactively monitored and dosed by Pharmacy despite the hospital policy requirement.

During an interview on 6/9/20 at 3:26 p.m. CP 1 stated that if there had been proactive monitoring and dosing by a Pharmacist, Patient 1's medication error that resulted in a GI bleed would not have happened.

2. A review of Patient 12's clinical record indicated Patient 12 was prescribed intravenous (IV - through the vein) Fentanyl (pain medication) 25-50 mcg/hr by Nurse Practitioner (NP) 1 for pain and to alleviate agitation due to being on the ventilator. The following are Patient 12's Fentanyl infusion times and rates:
*5/31/20 at 3:30 p.m. Fentanyl 25 microgram (mcg - unit of measurement)/hour
*5/31/20 at 3:40 p.m. Fentanyl 50 mcg/hr
*5/31/20 at 3:50 p.m. Fentanyl 75 mcg/hr (Continued at this rate which exceeded the prescribed orders for 25-50 mcg/hr for about 10 days); medication error by RN 6
*6/10/20 at 6:36 a.m. discontinued

During an interview on 6/11/20 at 11:08 a.m., NP stated she ordered the Fentanyl 25-50 mcg/hr on 5/31/20 and had not made any changes to the Fentanyl order on 5/31/20. NP 1 also stated she signed the verbal order the next day for 25-50 mcg/hr.

The above order indicated that RN 6 increased the Fentanyl to 75 mcg/hr and was not following the prescriber orders. This medication error continued for 10 days. During an interview on 6/11/20 at 10:45 a.m., the Chief Clinical Officer (CCO) stated RN 6 was not available to interview during the time of the survey.

During an interview on 6/11/20 at 11:25 a.m., the Director of Pharmacy (DOP) stated the Pharmacy had not been monitoring Patient 12's IV Fentanyl drip. The DOP also stated the Pharmacy's primary function was to distribute medications. The DOP stated there would be a plan moving forward for Pharmacists to monitor and recommend appropriate dosing for patients on IV Fentanyl.

3. A review of Pt 16's clinical record indicated Pt 16 was prescribed on 4/13/20 to continue Heparin dose from previous hospital and then to receive dosage per hospital protocol for Deep Vein Thrombosis prophylaxis (prevention of clots in veins). The initial Heparin prescribed starting rate was 891 units/hour, but RN 1 documented she administered 1100 units/hour. During an interview on 6/10/20 at 12:30 p.m., RN 1 stated she did not recall what rate she administered to Pt 16. RN 1 did not deny that she made a medication error but she also stated that she could not recall.

During a review of the hospital policy titled titled Medications: Standard Administration Times dated 3/2013 the policy indicated, "Time-Critical Scheduled Medications should be administered within 30 minutes before or after the scheduled time..." During an interview with the DOP on 6/11/20 at 9:42 a.m., the DOP stated IV Heparin infusion would be considered a time-critical medication because if it is not administered timely a patient may get a life threatening blood clot.

During an interview on 6/10/20 at 11:20 a.m., CP 1 stated there was also another medication error that involved Patient 16. CP 1 stated RN 2 delayed administration of IV Heparin drip by greater than 3.5 hours without a physician order. CP 1 stated RN 2 should have administered the dose at 6:50 a.m. on 4/14/20 instead of 10:30 a.m. on 4/14/20. CP 1 validated there was no documented reason for the late administration of Heparin in Patient 16's clinical record.

During an interview on 6/10/20, at 11:45 a.m., RN 2 stated she could not recall why there was a delay. RN 2 also stated she did not request a delay from the prescriber. She acknowledged that delaying administration of a Heparin rate change could have caused Pt 16 to have excessive bleeding or a life threatening blood clot.

During an interview on 6/10/20 at 2:25 p.m. with the DOP, the DOP stated there were no proactive monitoring and interventions for patients on IV Heparin drip. The DOP stated the pharmacy had not been following hospital policy. The DOP stated that moving forward Pharmacy would be following hospital policy and be proactive in monitoring and dosing of Heparin drips. The DOP acknowledged that the Pharmacy services needed to improve to prevent medication errors that could harm the patients.

During an interview on 06/11/20 at 11:45 a.m. with the Director of Pharmacy (DOP), the DOP stated the hospital did not measure, analyze, and track quality indicators for High Alert Medications such as IV Heparin and Fentanyl. The DOP stated there were no quality studies addressing IV Heparin and Fentanyl, despite having a history of medication errors with High Alert Medications. The DOP stated, in the future, he would ensure that the hospital would be measuring, analyzing, and tracking for High Alert Medications in the future to improve medication safety. The DOP stated, "We have to do better, and we will."

The hospital did not provide evidence of measuring, analyzing, and tracking quality indicator for High Alert Medications during the time of the survey.

A review of the Institute of Safe Medication Practice (ISMP), a nationally recognized medication resource that focuses on medication error prevention and safe medication use, indicated in the entitled document ISMP's List of High Alert Medications, "High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors." The list included Heparin (a medication used to prevent blood clots).

Based on interview and record review, the hospital failed to ensure qualified nursing personnel were assigned to care for one of 16 sampled patients (Patient 1) when Registered Nurse (RN) 3 and RN 5, who lacked training in the administration of IV (intravenous - into the vein) Heparin (blood thinner) infusions, were assigned and administered incorrect doses of IV Heparin to Patient 1.

This failure resulted in Patient 1 developing GI (gastrointestinal- a series of organs that form a continuous passage from the mouth to the anus) bleeding, which required transfer to a higher level of care, and had the potential to place Patient 1 at risk for serious harm due to medication errors.

Findings:

During a review of Patient (Pt)1's "Physician Progress Note" (PPN), dated 5/24/20, the PPN indicated, Pt 1 was diagnosed with a clotted (obstruction) arteriovenous fistula (connection between an artery and a vein) in the left upper arm on 5/23/20. The PPN indicated an IV heparin infusion was ordered to treat the clot per protocol (specific set of orders) on 5/23/20.

During a concurrent interview and record review, on 6/9/20, at 2:15 p.m., with the Chief Clinical Officer (CCO), Pt 1's Nursing Administration Flow Sheet from 5/26/20 to 5/28/20 was reviewed. This document indicated, and the CCO confirmed, on 5/27/20 at 12:42 a.m., the IV Heparin infusion rate was increased by 425 units/hour, which exceeded the maximum rate change of 400 units/hour. This document indicated, and the CCO confirmed, on 5/28/20, at 8:30 a.m., RN 3 increased the rate to 291 units/hour, although the protocol required for the infusion to be stopped and the infusion ran this way until it was stopped at 10 a.m. The CCO stated, "[RN 3] should not have been assigned to [Pt 1] because [RN 3] has no qualifications or training related to heparin drips [infusions]." The CCO stated RN 3 had been an RN for three months and had not been trained and had no prior experience with Heparin drips. The CCO stated that Heparin is a high-risk (involving or exposed to a high level of danger) medication.

During a concurrent interview and record review, on 6/10/20, at 1:33 p.m., with RN 5, RN 5 stated he cared for Pt 1 from 5/26/20 at 11 p.m. to 5/27/20 at 7 a.m.; he stated it was his first experience with a Heparin drip and he received no in-depth training on Heparin drips prior to caring for Pt 1. Pt 1's physician orders for the Heparin protocol, dated 5/23/20 - 5/27/20, were reviewed. The initial order, on 5/23/20, indicated and RN 5 confirmed, that, if the aPPT (activated partial thromboplastin time - blood test that characterizes coagulation or clotting of the blood) was less than 35 seconds, to increase the rate by 4 units/kg (kilogram- units of measure related to a person's weight)/hr to a maximum of 400 units/hr. A review of the laboratory report dated 5/26/20 indicated and RN 5 confirmed that Pt 1's aPPT was 31.6 seconds. RN 5 confirmed the nursing administration flowsheet dated 5/27/20 at 12:42 a.m. indicated he increased the Heparin rate by 425 units/hr rate, which exceeded the maximum rate change of 400 units/hr.

During an interview with Medical Doctor (MD) 1, on 6/10/20 at 2:54 p.m., MD 1 stated he was asked to see Pt 1 because of the medication error that occurred on 5/28/20 at 8:30 a.m. MD 1 stated, when he saw Pt 1, he observed Pt 1 in bed with 300 ml (milliliters - unit of measurement) of blood in Pt 1's stool. MD 1 stated he was concerned about the Heparin medication error and ordered the Heparin antidote (reversal agent) to reverse the effects of the Heparin error. MD 1 stated the Heparin was a contributing factor to Pt 1's GI bleed.

During an interview on 6/11/20 at 9:20 a.m., with RN 3, RN 3 stated she was never trained to administer IV Heparin infusions. RN 3 confirmed she made the Heparin medication error on 5/28/20 at 8:30 a.m.; she stated she should have stopped Pt 1's heparin infusion, instead of increasing the rate of infusion to 291 units/hour.

During a review of Pt 1's "EMERGENCY INTERFACILITY TRANSFER FORM [EITF]," dated 5/28/20 at 1:30 p.m., the EITF indicated, Pt 1 was "on a Heparin drip, miscalculated drip, Heparin dcd [discontinued] the MD [Medical Doctor] contacted ... Pt (1) had hemorrhage (bleeding) from rectum, MD ordered to send out" to a higher level of care.

During a review of the hospital's Policy & Procedure (P&P) titled, "Pharmacy Heparin Drip Monitoring [Protocol]," dated 1/6/20, the P&P indicated, for a PPT Value less than 35 seconds... increase the infusion rate by 4 units/kg/hr (Maximum 400 units/hr)..."

During a review of the hospital's P&P titled, "ACUITY STAFFING," dated 2/2020, indicated, "PURPOSE: To standardize a process for providing an adequate number of nursing staff members to address the individualized care needs of patients ...POLICY: ...B ...Staff members will not be asked to perform duties for which they are not qualified or have not been trained and unable to demonstrate competency ..."

Based on interview and record review, the hospital failed to administer medications as ordered when:

1. Two of 16 sampled patients (Patients 1 and 16) were administered IV (intravenous - into the vein) Heparin (blood thinner) infusions on several occasions that were not in accordance with the physician's order; and

2. One of 16 sampled patients (Patient 12) was administered fentanyl (medication used to treat severe pain) on 10 consecutive dates, from 5/31/20 to 6/10/20, that were not in accordance with the Nurse Practitioner's (NP- A registered nurse who has completed advanced education and training in the diagnosis and management of common medical conditions) order.

These failures resulted in medication errors for Pts 1, 12, and 16 and actual harm to Pt 1, who developed gastrointestinal (GI - a series of organs that form a continuous passage from the mouth to the anus) bleeding and had to be transferred to an acute care hospital for a higher level of care and had the potential for serious and potentially fatal medication errors to any other patients at the facility with heparin and fentanyl orders including risk of bleeding and respiratory distress (at the time of the occurrence, these three patients were the only ones with these kinds of orders).

Findings:

1. During a review of Pt 1's "Physician Progress Note" (PPN), dated 5/24/20, the PPN indicated, Pt 1 was diagnosed with a clotted (obstruction) arteriovenous fistula (connection between an artery and a vein) in the left upper arm on 5/23/20. The PPN indicated the IV heparin infusion was ordered to treat the clot per protocol (specific set of orders) on 5/23/20.

During a concurrent interview and record review, on 6/9/20 at 2 p.m., with the Chief Clinical Officer (CCO), Pt 1's "Progress Notes (PN)," dated 5/23/20 was reviewed. The PN indicated and the CCO confirmed on 5/23/20, Pt 1 weighed 104.5 kg (kilograms-unit of measurement) and a heparin drip rate was started at 37.62 ml (milliliters - unit of measurement)/hr (per hour). The CCO stated, " ...The initial rate was not started at the correct rate." The CCO validated the rate should have been started at 30 ml/hr.

During a concurrent interview and record review, on 6/9/20, at 2:15 p.m., with the Chief Clinical Officer (CCO), Pt 1's " Progress Notes (PN)," dated 5/28/20, were reviewed. The PN indicated, at 7:07 a.m., "Bedside report was given to [RN 3]." The record review indicated and the CCO confirmed, there was a physician order to stop the heparin infusion at 8:30 am; however, instead of stopping it, RN 3 increased the infusion to 291 units (measurement of quantity)/hr (per hour) . The CCO stated, "[RN 3] should not have been assigned to [Pt 1] because [RN 3] has no qualifications or training related to heparin drips [infusions]." The CCO stated RN 3 had been an RN for three months and had not been trained and had no prior experience with heparin drips. The CCO stated that heparin is a high-risk (involving or exposed to a high level of danger) medication.

During an interview on 6/10/20, at 11:20 a.m., with the Clinical Pharmacist (CP) 1, the CP 1 stated there was a medication error for the administration of heparin for Pt 16. CP 1 stated RN 2 had delayed the administration of IV heparin drip by three and a half hours (3.5) hours without a physician order. CP 1 stated RN 2 should have administered the dose on 4/14/20 at 6:50 a.m. and not at 10:30 a.m. CP 1 stated there was no documented reason for the late administration in Pt 16's clinical record.

During a concurrent interview and record review, on 6/10/20, at 12:30 p.m., with RN 1, Pt 16's "Clinical Records (CR)," dated 4/13/20, was reviewed. The CR indicated and RN 1 confirmed, Pt 16 was to continue on heparin dose from previous hospital and then dose per hospital protocol for Deep Vein Thrombosis (clotting of blood) prophylaxis (action taken to prevent). The CR indicated and RN 1 confirmed the initial heparin prescribed starting rate was 891 units/hour (unit of measurement) but instead RN 1 administered 1100 units/hour, exceeding the prescribed dose by 209 units/ hour.

During an interview on 6/10/20, at 12:45 p.m. with RN 2, RN 2 stated he could not recall why there was a 3.5 hour delay in administering the heparin for Pt 16. RN 2 stated, she did not request a delay from the prescriber for the heparin. RN 2 acknowledged that, when a heparin rate change is delayed, the harm could have resulted in Pt 16 to have excessive bleeding or a life threatening blood clot.

During a concurrent interview and record review, on 6/10/20, at 1:33 p.m., with RN 5, RN 5 confirmed he cared for Pt 1 from 5/26/20 at 11 p.m. to 5/27/20 at 7 a.m.; he stated it was his first experience with a heparin drip and he received no in-depth training on heparin drips prior to caring for Pt 1. Pt 1's physician orders for the heparin protocol, dated 5/23/20 - 5/27/20, were reviewed. The initial order, on 5/23/20, indicated and RN 5 confirmed, that, if the aPPT (activated partial thromboplastin time-blood test that characterizes coagulation or clotting of the blood) was less than 35 seconds, to increase the rate by 4 units/kg (kilogram- units of measure related to a person's weight)/hr (per hour) to a maximum of 400 units/hr. A review of the laboratory report dated 5/26/20 indicated and RN 5 confirmed that Pt 1's aPPT was 31.6 seconds. The nursing administration flowsheet dated 5/27/20 at 12:42 a.m. indicated and RN 5 confirmed he increased the heparin rate by 425 units/hr rate, which exceeded the maximum rate change of 400 units/hr.


During a concurrent interview and record review on 6/10/20, at 3:45 p.m., with RN 3, Pt 1's "PN" dated 5/28/20 was reviewed. The PN for Pt 1 indicated, RN 3 was to " ...Hold infusion for 1 hr. [hour] start @ [at] 0830 [8:30 a.m.]... Decrease rate by... 2.8 units/hr... " RN 3 stated, " ...I had never taken care of a patient on heparin drip before ... I was not comfortable with heparin drips..."

During a concurrent interview and hospital's policy and procedure (P&P) review on 6/11/20, at 9:42 a.m., with the DOP, the P&P titled, "Medications: Standard Administration Times (MSAT)," dated 3/2013, was reviewed. The MSAT indicated, "Time-Critical Scheduled Medications should be administered within 30 minutes before or after the scheduled time ..." The DOP stated IV heparin infusion would be considered a time critical medication.

During a review of the hospital's P&P titled, "ACUITY STAFFING," dated 2/2020, indicated, "PURPOSE: To standardize a process for providing an adequate number of nursing staff members to address the individualized care needs of patients ...POLICY: ...B ...Staff members will not be asked to perform duties for which they are not qualified or have not been trained and unable to demonstrate competency ..."

During a review of the hospital's P&P titled, "Pharmacy Heparin Drip Monitoring [Protocol]," dated 1/6/20, the P&P indicated, " ...Loading Dose Heparin ... concentration 5000 units/mL ...Dose: 80 units/kg IV bolus [the administration of a discrete amount of medication within a specific time, generally 1 - 30 minutes, in order to raise its concentration in blood to an effective level] (MAX: 10,000 units) ... Heparin PREMIX 25,000 units/ 500 mL ...Concentration 50 units/mL ...Continuous infusion ... Initial rate: 18 units/kg/hr (MAX: 1,500 units/hr) ..."

2. During a review of Pt 12's clinical record, the document titled, "History and Physical," indicated Pt 12 was admitted to the facility on 5/12/2020 for rehabilitation following the repair of a fractured left femur (thigh bone).

During a review of Pt 12's "Medical Administration Record [MAR- a report that serves as a legal record of the drugs administered to a patient]," dated 5/31/20, the MAR indicated, "...fentanyl/Dextrose 5% in Water (D5W- an IV sugar solution that delivers fluids directly into a vein) IV drip 400 microgram (mcg-unit of measurement)/100 ml ... Instructions: 25-50 mcg/hr (or [medical doctor] order) goal: Richmond Agitation-Sedation Scale [RASS- a medical scale used to measure the agitation or sedation level of a person] -3 [moderate sedation] to -4 [deep sedation] ... Ordered: 5/31/20 at 2:28 p.m. by [NP 1]."

During a review of Pt 12's MAR from 5/31/20 thru 6/10/21, the document indicated the following were recorded as Pt 12's fentanyl infusion times and rates:

5/31/20 at 3:50 p.m. rate at 18.75 ml/hr dose: 75 mcg/hr (25 mcg over the prescribed dose)
6/1/20 at 12 a.m. rate at 18.75 ml/hr dose: 75 mcg/hr (25 mcg over the prescribed dose)
6/2/20 at 12 a.m. rate at 18.75 ml/hr dose: 75 mcg/hr (25 mcg over the prescribed dose)
6/3/20 at 12 a.m. rate at 18.75 ml/hr dose: 75 mcg/hr (25 mcg over the prescribed dose)
6/4/20 at 12 a.m. rate at 18.75 ml/hr dose: 75 mcg/hr (25 mcg over the prescribed dose)
6/5/20 at 12:10 a.m. rate at 18.75 ml/hr dose: 75 mcg/hr (25 mcg over the prescribed dose)
6/6/20 at 2:52 a.m. rate at 18.75 ml/hr dose: 75 mcg/hr (25 mcg over the prescribed dose)
6/7/20 at 12 a.m. rate at 18.75 ml/hr dose: 75 mcg/hr (25 mcg over the prescribed dose)
6/8/20 at 12 a.m. rate at 18.75 ml/hr dose: 75 mcg/hr (25 mcg over the prescribed dose)
6/9/20 at 12 a.m. rate at 18.75 ml/hr dose: 75 mcg/hr (25 mcg over the prescribed dose)
6/10/20 at 12 a.m. rate at 18.75 ml/hr dose: 75 mcg/hr (25 mcg over the prescribed dose)
6/10/20 at 6:36 a.m. fentanyl was discontinued

During a concurrent interview and record review on 6/10/20, at 3:30 p.m., with RN 8, the charge nurse, Pt 12's MARs dated 5/31/20 thru 6/10/20 were reviewed. RN 8 validated the prescribed dose of Fentanyl 25-50 mcg/hr was not followed. RN 8 validated the administered doses exceeded the prescribed dose of 25 mcg/hr for 11 days and NP's order for Fentanyl were not followed and should been. RN 8 reviewed Pt 12's chart all of the orders from 5/31/20 thru 6/10/20 and confirmed he was not able to find an NP or physician's order for fentanyl to be given at 75 mcg/hr during this period of time.

During an interview on 6/11/20 at 11:08 a.m. the NP stated she had ordered Fentanyl 25-50 mcg/hr on 5/31/20 and had not made any changes to the fentanyl order from 5/31/20.

During a concurrent interview and record review on 6/11/20, at 3:26 p.m., with RN 6, the hospital's P&P titled, "Moderate Sedation," dated 9/30/19, was reviewed. The P&P indicated, "...all loading doses and initial infusion rates must be specifically ordered by the physician and reflected on the order..." RN 6 stated she was not aware of the hospital's policy. RN 6 stated she received a verbal order for fentanyl with a goal of RASS -3 to -4. RN 6 stated the NP did not order a titration (increase or decrease in increments) rate. RN 6 stated on 5/31/20 at 3:50 p.m., she titrated the fentanyl infusion to 75 mcg/hr (25 mcg above the prescribed dose). RN 6 stated Pt 12 could have experienced respiratory distress (trouble breathing) as a result of the incorrect dose.

During a concurrent interview and record review, on 6/12/20, at 9:51 a.m., with RN 7, the MAR for Pt 12 was reviewed. RN 7 validated the prescribed fentanyl order was 25-50 mcg/hr. RN 7 stated Pt 12's fentanyl rate was set at 75 mcg/hr (25 mcg over the prescribed dose) on 6/6/20. RN 7 stated she did not check the prescribed order of Fentanyl at 25-50 mcg/hr. RN 7 stated she should have checked the fentanyl order. RN 7 stated she did not follow the prescribed order for fentanyl.

During a review of the hospital's P&P titled, "Medication Administration" dated 4/19, the P&P indicated, "...Purpose: To ensure the safe preparation and administration of medications...21. Follow the 6 Rights of medication administration - Administer... 3. In the right dose..."

During a review of the Institute of Safe Medication Practice (ISMP), a nationally recognized medication resource which focused on medication error prevention and safe medication use, indicated, "...High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors." The list included fentanyl.

Based on interview and record review, the hospital failed to ensure verbal orders were used infrequently by physicians when three of 16 sampled patients (Patients 1, 12, and 16) had verbal order rates ranging from 38.7% to 64.7% from 6/2/20 through 6/11/20.

This failure had the potential to increase the risk of miscommunication and increased medication errors for all patients with verbal orders at the facility.

Finding:

During an interview on 6/12/20 at 10:43 a.m., with RN (Registered Nurse) 9, a staff nurse, RN 9 stated physicians were not placing their own orders. RN 9 stated the physicians give verbal orders to nurses to enter into the electronic medical records.

During a concurrent interview and record review on 6/12/20, at 9:37 a.m., with the Director of Pharmacy (DOP), pharmacy order reports for verbal orders were reviewed from 6/2/20 through 6/11/20; the reports indicated, and the DOP confirmed, Pt 1 had a total of 222 physician orders, of which 86 were verbal orders, for a rate of 38.7%; Pt 12 had a total of 51 physician orders, of which 33 were verbal orders, for a rate of 64.7%; and Pt 16 had a total of 93 physician orders, of which 52 were verbal orders, for a rate of 55.9%.

During a concurrent interview and record review on 6/12/20, at 11:12 a.m., with MD (Medical Doctor) 2, the pharmacy order reports for verbal orders from 6/2/20 to 6/11/20 were reviewed. MD 2 stated, "...Verbal orders should be very few and there were quite a bit of verbal orders and it needs to change...I need to see which physicians are doing the verbal orders and have individual discussions with each doctor to help reduce the amount of verbal orders." MD 2 stated verbal orders were a problem and he will take responsibility for "correcting this issue."

During a review of the hospital's policy and procedure titled, "Medication Administration" dated 4/19, the policy and procedure indicated, "PURPOSE: To ensure the safe preparation and administration of medications... POLICY: 3. Telephone [verbal] orders are to be taken only in an emergency or when another alternative exist and are to be written on the Physician's Order Sheet..."

Based on interview and record review, the hospital pharmacy failed to proactively monitor and make dosage adjustments to prevent, identify and minimize patient harm and medication errors, for patients on high alert medications (e.g. Heparin (blood thinner) and Fentanyl (pain medication and mild sedative) in accordance with hospital policy and professional standards of practice, for three of four sampled patients (Patients 1, 12, and 16) when:

1. The hospital pharmacy failed to appropriately monitor and accurately dose heparin for Patient (Pt) 1 which resulted in four medication errors which included: Registered Nurse (RN) 4 did not administer a bolus dose as prescribed; RN 4 initiated a starting rate that exceeded the maximum allowable rate; RN 5 administered a rate change that exceeded the maximum rate change; and RN 3 increased the rate instead of stopping the infusion which resulted in hospitalization due to a gastrointestinal (GI) bleeding.

2. The hospital pharmacy failed to appropriately monitor and accurately dose Fentanyl for Pt 12, which resulted in a medication error in which RN 6 administered Fentanyl for ten days at a higher rate than what was prescribed.

3. The hospital pharmacy failed to appropriately monitor and accurately dose heparin for Pt 16. This failure resulted in two medication errors, which included RN 1 initiating an incorrect, lower starting rate than what was prescribed; and RN 2 delaying the administration of a Heparin rate change by 3.5 hours.

Findings:

1. During a review of Patient 1's clinical record indicated that on 5/23/2020, Patient 1 had a clotted arteriovenous fistula (abnormal connection between an artery and a vein) on the left upper arm. The physician's order dated 5/23/2020, included an order for intravenous (IV- through the vein) Heparin per protocol.

During an interview on 06/09/20 at 2 p.m., the Director of Pharmacy (DOP) stated Patient 1 had been administered intravenous (IV- given through the vein) Heparin with multiple medication errors. The DOP stated that one of the errors resulted in Patient 1 to have a GI bleeding. The DOP stated four Heparin infusion errors had occurred in the past: 1) A Heparin bolus dose (single dose of Heparin given over a short period of time) was not administered as prescribed, 2) The starting infusion rate exceeded the maximum rate, 3) The nurse administered a dose that exceeded the maximum rate; and, 4) The nurse increased the rate of Heparin infusion instead of decreasing the rate of infusion, which then resulted in a GI bleed on 5/28/20.

During a review of Patient 1's "Physician's Order (PO)" dated 5/23/2020, the PO indicated the expected doses of Heparin to be administered at the following times:
*5/23/20 at 7:00 p.m. Initiation of Heparin-Bolus 8,360 units
*5/23/20 at 7:00 p.m. Start the rate at a maximum of 1500 units/hour (hr)
*5/27/20 at 12:42 a.m. Increase rate by 4 units/kg/hr by a maximum 400 units/hr
*5/28/20 at 8:30 a.m. stop Heparin infusion

During a review of Patient 1's "Nursing Administration Flow Sheet (NAFS) between 5/23/20 and 5/27/20, the NAFS indicated the actual administration rates of the IV heparin infusion was not in accordance with the PO:
*5/23/20 at 7:00 p.m. No Heparin Bolus administered
*5/23/20 Starting Heparin rate was 1881 units/hour (rate exceeded maximum initiation rate of 1500 units/hour)
*5/27/20 at 12:42 a.m. Rate increased by 425 units/hour (rate exceeded maximum rate change)
*5/28/20 at 8:30 a.m. Rate increased to 291 units/hour (protocol required to stop Heparin infusion)
*5/28/20 at 10:00 a.m. IV Heparin infusion stopped
*5/28/20 after the IV Heparin infusion stopped, Pt 1 had a visible GI Bleed. The blood was found in Patient 1's bed. The clinical record had missing information and the exact time of the bleed was not documented.

During an interview on 6/11/20 at 9:00 a.m. Registered Nurse (RN) 4 stated she made the medication errors on 5/23/20 at 7:00 p.m. RN 4 did not bolus the Heparin but changed the initial rate to exceed the maximum. RN 4 stated she made the mistake because she was busy and did not check to see if the Heparin initial rate was appropriate. RN 4 stated she did not verify the Heparin dosing with Pharmacy.

During an interview on 6/11/20 at 9:45 a.m., the DOP stated RN 5, who made the medication error on 5/27/20 at 12:42 a.m., no longer worked at the hospital. RN 5 was not available for an interview during the time of the survey.

During an interview on 6/11/20 at 9:20 a.m. with RN 3, RN 3 stated she was never trained to administer IV Heparin infusion. RN 3 also stated she made the medication error on 5/28/20 at 8:30 a.m.. RN 3 stated she should have stopped the infusion instead of increasing Patient 1's IV Heparin infusion rate to 291 units/hour. She stated she never verified the dosing with Pharmacy, and she did not know that she had to verify the Heparin dosing with Pharmacy.

During an interview on 6/10/20 at 2:54 p.m. with Physician 1, he stated he was asked to see Patient 1 because of the medication error on 5/28/20 at 8:30 a.m. Physician 1 also stated that when he saw Patient 1, he observed about 300 milliliter (ml-unit of measurement) in Patient 1's stool in the bed. Physician 1 stated he was concerned about the Heparin medication error and ordered the Heparin antidote (Protamine) to reverse the effects of Heparin. Physician 1 stated the Heparin was a contributing factor to Patient 1's GI Bleed.

During a review of the hospital policy titled ,"Anticoagulant Management" dated 3/2013 and revised on 1/2020 indicated, "Pharmacy is to proactively monitor heparin drip...Laboratory will provide PTT (Partial Thromboplastin Time, a blood test that looks at how long it takes for blood to clot) results directly to pharmacy ..."

During an interview on 6/10/20 at 3:03 p.m., Registered Pharmacist 1 (Rph 1) stated activated partial thromboplastin time (aPTT) was used per protocol to change the rate of the Heparin. Rph 1 stated a PTT tests blood clotting and the test was used to measure how Patient 1 was responding to the IV Heparin infusion. Rph 1 stated that she had not received direct communication from the hospital laboratory services regarding aPTTs.

During an interview on 6/9/20 at 3:30 p.m., the Director of Laboratory Services (DLS) stated that they did not provide aPTT directly to pharmacy. The DLS also stated that no direct communication was made to the pharmacy regarding aPTTs. The DLS stated they would call the charge nurse with the aPTT results and not the Pharmacy.

During an interview on 6/9/20 at 3:26 p.m., PM Clinical Pharmacist (CP) 1 stated that the Pharmacy was not receiving aPTT results directly from the laboratory services. CP 1 stated there was a plan in the past for the lab to provide direct aPTT results but it was never implemented.

A review of the "American Society of Health-System Pharmacists (ASHP)Guidelines: Minimum Standard for Pharmacies in Hospitals" indicated, "These guidelines outline a minimum level of services that most hospital pharmacy departments should consistently provide...Standard VII. Monitoring Medication Use...Medication therapy monitoring shall be conducted by pharmacists. Medication therapy monitoring includes...an assessment of...c. The appropriateness of the dose of the medication...f. Adverse drug reactions and other undesired effects...h. Clinical...laboratory data to evaluate the efficacy and safety of medication therapy and to anticipate toxicity and adverse effects..."

A review on 6/9/20 of the hospital policy dated 3/2013 and revised on 01/2020 entitled Anticoagulant Management indicated, "Pharmacy is to proactively monitor Heparin drip...pharmacy will be monitoring the aPTT of patient...Pharmacy will contact nursing to adjust heparin drip per protocol..."

During an interview on 6/9/20 at 3:26 p.m., Clinical Pharmacist (CP) 1 stated that Pharmacy did not proactively monitor Heparin drip, did not monitor aPTT, and did not contact nursing to adjust Patient 1's Heparin drip. CP 1 Patient 1 who had a GI bleeding, did not have proactive Pharmacy monitoring and dosage adjustments by a Pharmacist.

During an interview on 6/9/20 at 3:30 p.m., CP 1 stated proactive monitoring and dosing by Pharmacy did not happen because it was forgotten due to the infrequent use of Heparin drip. CP 1 stated that after generating a report, there were only three patients that had been on Heparin drip and none were proactively monitored and dosed by Pharmacy despite the hospital policy requirement.

During an interview on 6/9/20 at 3:26 p.m. CP 1 stated that if there had been proactive monitoring and dosing by a Pharmacist, Patient 1's medication error that resulted in a GI bleed would not have happened.

2. A review of Patient 12's clinical record indicated Patient 12 was prescribed intravenous (IV - through the vein) Fentanyl (pain medication) 25-50 mcg/hr by Nurse Practitioner (NP) 1 for pain and to alleviate agitation due to being on the ventilator. The following are Patient 12's Fentanyl infusion times and rates:
*5/31/20 at 3:30 p.m. Fentanyl 25 microgram (mcg - unit of measurement)/hour
*5/31/20 at 3:40 p.m. Fentanyl 50 mcg/hr
*5/31/20 at 3:50 p.m. Fentanyl 75 mcg/hr (Continued at this rate which exceeded the prescribed orders for 25-50 mcg/hr for about 10 days); medication error by RN 6
*6/10/20 at 6:36 a.m. discontinued

During an interview on 6/11/20 at 11:08 a.m., NP stated she ordered the Fentanyl 25-50 mcg/hr on 5/31/20 and had not made any changes to the Fentanyl order on 5/31/20. NP 1 also stated she signed the verbal order the next day for 25-50 mcg/hr.

The above order indicated that RN 6 increased the Fentanyl to 75 mcg/hr and was not following the prescriber orders. This medication error continued for 10 days. During an interview on 6/11/20 at 10:45 a.m., the Chief Clinical Officer (CCO) stated RN 6 was not available to interview during the time of the survey.

During an interview on 6/11/20 at 11:25 a.m., the Director of Pharmacy (DOP) stated the Pharmacy had not been monitoring Patient 12's IV Fentanyl drip. The DOP also stated the Pharmacy's primary function was to distribute medications. The DOP stated there would be a plan moving forward for Pharmacists to monitor and recommend appropriate dosing for patients on IV Fentanyl.

3. A review of Pt 16's clinical record indicated Pt 16 was prescribed on 4/13/20 to continue Heparin dose from previous hospital and then to receive dosage per hospital protocol for Deep Vein Thrombosis prophylaxis (prevention of clots in veins). The initial Heparin prescribed starting rate was 891 units/hour, but RN 1 documented she administered 1100 units/hour. During an interview on 6/10/20 at 12:30 p.m., RN 1 stated she did not recall what rate she administered to Pt 16. RN 1 did not deny that she made a medication error but she also stated that she could not recall.

During a review of the hospital policy titled titled Medications: Standard Administration Times dated 3/2013 the policy indicated, "Time-Critical Scheduled Medications should be administered within 30 minutes before or after the scheduled time..." During an interview with the DOP on 6/11/20 at 9:42 a.m., the DOP stated IV Heparin infusion would be considered a time-critical medication because if it is not administered timely a patient may get a life threatening blood clot.

During an interview on 6/10/20 at 11:20 a.m., CP 1 stated there was also another medication error that involved Patient 16. CP 1 stated RN 2 delayed administration of IV Heparin drip by greater than 3.5 hours without a physician order. CP 1 stated RN 2 should have administered the dose at 6:50 a.m. on 4/14/20 instead of 10:30 a.m. on 4/14/20. CP 1 validated there was no documented reason for the late administration of Heparin in Patient 16's clinical record.

During an interview on 6/10/20, at 11:45 a.m., RN 2 stated she could not recall why there was a delay. RN 2 also stated she did not request a delay from the prescriber. She acknowledged that delaying administration of a Heparin rate change could have caused Pt 16 to have excessive bleeding or a life threatening blood clot.

During an interview on 6/10/20 at 2:25 p.m. with the DOP, the DOP stated there were no proactive monitoring and interventions for patients on IV Heparin drip. The DOP stated the pharmacy had not been following hospital policy. The DOP stated that moving forward Pharmacy would be following hospital policy and be proactive in monitoring and dosing of Heparin drips. The DOP acknowledged that the Pharmacy services needed to improve to prevent medication errors that could harm the patients.

During an interview on 06/11/20 at 11:45 a.m. with the Director of Pharmacy (DOP), the DOP stated the hospital did not measure, analyze, and track quality indicators for High Alert Medications such as IV Heparin and Fentanyl. The DOP stated there were no quality studies addressing IV Heparin and Fentanyl, despite having a history of medication errors with High Alert Medications. The DOP stated, in the future, he would ensure that the hospital would be measuring, analyzing, and tracking for High Alert Medications in the future to improve medication safety. The DOP stated, "We have to do better, and we will."

The hospital did not provide evidence of measuring, analyzing, and tracking quality indicator for High Alert Medications during the time of the survey.

A review of the Institute of Safe Medication Practice (ISMP), a nationally recognized medication resource that focuses on medication error prevention and safe medication use, indicated in the entitled document ISMP's List of High Alert Medications, "High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors." The list included Heparin (a medication used to prevent blood clots).