The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SAINT JOSEPH HOSPITAL 1375 EAST 19TH AVENUE DENVER, CO 80218 Aug. 23, 2016
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on interviews and document reviews the facility failed to provide training or education for nurses regarding the classification of a patient's allergy or adverse drug reaction.

This failure created the potential for patients to have an adverse reaction to drugs received in the facility.

FINDINGS:

POLICY

According to the policy Adverse Drug Events, an adverse drug reaction (ADR) is any unexpected, unintended, undesired, or excessive response to a medicine that: requires discontinuing the medicine, necessitates supportive treatment, negatively affects prognosis or results in temporary or permanent harm, disability, or death. Supervisors and managers of affected departments shall conduct an investigation of the occurrence and report findings via the Event Reporting System.

1. The facility failed to develop and educate nursing staff on a standard process to identify and report patient allergies.

a) Document review of Epic Training for Nursing Care Navigator provided by a Health Information Management employee (HIM) #15 revealed nursing staff were instructed to update a patient's medical record by choosing an appropriate reaction type when a patient reported an allergy. Choices of a reported allergy reaction type included allergy, intolerance, side effect or unknown. HIM #15 could not provide a policy or further education regarding how Registered Nurses (RN) were to differentiate between allergy, intolerance, side effect, or unknown.

b) On 08/17/16 at 6:00 p.m., an interview was conducted with emergency room registered nurse (RN) #8. RN#8 stated s/he chose and documented an appropriate reaction type to a patient's reported allergy. S/he stated an allergy could be considered a rash or anaphylaxis (swelling of airway). Gastrointestinal (GI) upset was considered a drug medication intolerance. RN#8 stated no education was provided by the facility regarding how to choose allergy, intolerance or side effect for a patient's stated allergy.

c) On 08/18/16 at 8:54 a.m., an interview was conducted with Interventional Radiology RN #9. S/he stated if a patient stated that a drug caused nausea and vomiting that was a side effect, not an allergy. RN#9 further stated the facility had not provided any education regarding how to choose an appropriate reaction type for a patient reported allergy.

d) On 08/18/16 at 3:06 p.m., an interview was conducted with Intermediate Care RN #7, s/he stated there had not been any education done at this facility regarding how to choose an appropriate reaction type when a patient reported an allergy. S/he stated an allergy was a reaction to a drug such as vomiting or anaphylaxis. This contradicted RN#9's statement stating vomiting was a side effect. RN #7 stated a drug intolerance was anything that did not make the person feel good, such as nausea or GI upset.

RN#7 stated s/he did not consider an allergic reaction to be an adverse drug reaction (ADR). This was in contrast to the facility's Adverse Drug Event policy. RN #7 went on to say RNs at the facility could give medications listed as a drug intolerance in a patient's medical record without contacting a provider.

e) On 08/18/16 at 9:10 a.m., an interview was conducted with Director of Interventional Radiology (Director) #10. S/he was in charge of RNs in pre and post procedural areas. Director #10 stated RNs in the pre and post procedural areas were responsible for choosing and documenting an appropriate reaction type of allergy, intolerance, or side effect in the patient's medical record. S/he further stated RNs learned how to classify drug medication intolerance versus an allergy in "Nursing 101", the facility did not educate RNs regarding this topic.

f) On 08/18/16 at 9:33 a.m., an interview was conducted with Pharmacist #11. S/he stated RNs could choose an appropriate reaction type to a patient's stated allergy. S/he further stated this was the responsibility of the staff member who conducted the initial patient assessment. Pharmacist #11 stated this was usually an RN. Pharmacist #11 stated s/he thought this process was taught in nursing school.

g) On 08/17/16 at 5:11 p.m., an interview was conducted with Chief Nursing Officer (CNO #4). S/he stated s/he was unaware RN staff chose the appropriate reaction type of a patient's stated allergy. S/he stated this should be done by providers and should be consistent throughout the facility.

During a subsequent interview with CNO #4 on 08/18/16 at 4:21 p.m., s/he stated RNs were expected to know the difference between a drug allergy, intolerance, and side effect from nursing school. This statement contradicted his/her statement the day before this interview. CNO #4 further stated nausea and vomiting could be classified as either medication intolerance or an allergic reaction. This statement was not consistent with RN #7's statement that vomiting was an allergy, RN #8's statement that GI upset was an intolerance, and RN #9's statement that nausea and vomiting was a side effect. CNO #4 stated there were no policies regarding allergy verification. Furthermore, there were no policies guiding RNs how to choose the appropriate reaction type of allergy, intolerance, side effect, or unknown when a patient reports an allergy.

No additional policies or staff education regarding patient allergy verification or classification of patient allergies were received prior to exiting on 08/23/16 at 11:51 a.m.

2. The nursing staff failed to update the medical record of Patient #13 when an allergic reaction was identified.

a) Review of Patient #13's chart revealed the following:

On 05/03/16 Patient #13 was admitted to the facility with an allergy to the antibiotic Penicillin (PCN). Patient #13 reported anaphylaxis (swelling of airway) as his/her reaction to taking PCN.

Document review revealed on 05/03/16 Patient #13 was given the antibiotic Vancomycin 2000 milligrams (mg) intravenously (IV) at 6:45 p.m. At 9:15 p.m. Patient #13 developed severe itching and hives to scalp and forehead. RN #14 stopped the Vancomycin infusion, notified the provider and administered Benadryl (a medication used to treat itching, hives and other symptoms of an allergic reaction) to Patient #13. RN #14 documented an allergic reaction to Vancomycin in the comment box of the Vancomycin order on Patient #13's Medication Administration Record (MAR) and held the 5:00 a.m. scheduled dose. The adverse drug reaction was reported to Risk Management via the occurrence reporting system.

On 05/04/16 at 8:01 p.m. RN #14 reviewed Patient #13's allergies and marked Penicillin with anaphylaxis to be Patient #13's only allergy. This review occurred after RN #14 reported Patient #13's allergic reaction to Vancomycin to Risk Management and on the MAR. Although, RN #14 documented the patient's reaction to the Vancomycin, s/he did not add the new drug reaction to the patient's documented allergy list.

Document review showed Patient #13's allergies were marked as reviewed on the following dates: 05/17/16, 05/19/16, 06/01/16, 06/07/16, 06/09/16, 06/23/16, 07/01/16, and 07/06/16 by various facility providers and staff. The only allergy listed during the times of review was PCN. Electronic chart review on 08/23/16 revealed the antibiotic Vancomycin not listed at any time as an allergy on the medical record of Patient #13. This placed the patient at risk to receive a medication which previously caused an allergic reaction.

b) During an interview on 08/17/16 at 5:11 p.m. with CNO #4, s/he stated it was the responsibility of all staff members, including the RN staff, to update and review a patient's reported and identified allergies in the patient's medical record.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 482.25, PHARMACEUTICAL SERVICES was out of compliance.

Cross-reference:

A-500 - Standard: 482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. The facility failed to ensure staff were able to identify and ensure proper review of allergies and adverse drug reactions. The facility failed to ensure a standard process was in place for identifying and classifying patients' allergies and adverse drug reactions. Additionally, the facility failed to update Patient #13's medical record after an adverse drug reaction occurred during Patient #13's hospital stay. This failure placed patients at an increased risk of adverse drug reactions to occur.

A-505 - Standard: Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use. The facility failed to ensure outdated medications were removed from a pediatric crash cart. This failure created the potential for patients to receive expired medications.

A-508 - Standard: Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital's quality assessment and performance improvement program. The facility failed to ensure a standard process for identifying and classifying adverse drug reactions and further failed to ensure complete investigation regarding patients' adverse drug reactions. These failures resulted in missed opportunities to improve patient safety and health outcomes.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on observation, document reviews and interviews the facility failed to ensure staff were able to identify and ensure proper review of allergies and adverse drug reactions. The facility failed to ensure a standard process was in place for identifying and classifying patients' allergies and adverse drug reactions. Additionally, the facility failed to update Patient #13's medical record after an adverse drug reaction had occurred during Patient #13's hospital stay.

This failure placed patients at an increased risk of adverse drug reactions to occur.

FINDINGS:

POLICY

According to the policy, Adverse Drug Events, adverse drug reaction (ADR) is any unexpected, unintended, undesired, or excessive response to a medicine that: requires discontinuing the medicine, necessitates supportive treatment, results in temporary or negatively affects prognosis or results in temporary or permanent harm, disability, or death. Supervisors and managers of affected departments shall conduct an investigation of the occurrence and report findings via the Event Reporting System.

Pharmacy staff will classify reported adverse drug events (ADE) for medication errors to determine the severity level and identify the probability that the ADR is drug-related (doubtful, possible, probable, or definite) using the Naranjo algorithm. Pharmacy complied report of ADEs for presentation to the appropriate medical staff committee for review and evaluation. Pharmacy staff will report rare, severe, or unusual ADEs to the Federal Drug Administration (FDA) in accordance with the MedWatch Program.

According to the policy Safety Event Identification, Analysis and Reporting, the Event Determination Team is a designated team at each care site that includes the Care Site Risk Manager (CSRM), Patient Safety Specialist (PSS) and various members of senior leadership. The role of this team is to determine the level of harm and to provide final determination of Serious Safety Events. A Patient Safety Event is an event not consistent with routine patient care, generally accepted performance standards, or care site procedures which either did or could have resulted in injury or loss to a patient. Safety Event Classification (SEC) is an event classification system based on degree of harm that result from a deviation from generally accepted performance standards (GAPS). Serious Reportable Event is any patient safety event that is identified as a mandatory reportable event as define by state regulations. CSRM and department leader [will] conduct [an] initial review and investigation of the event and complete follow-up. CRSM and PSS [will] determine the type of event; ensure complete and accurate documentation in online event reporting system. [They will] conduct other actions as indicated (i.e. refer to pharmacy, patient representative etc.), CRSM and PSS [will] classify the event. If the event is a possible Serious Safety Event, Sentinel Event, or Serious Reportable Event CRSM and PSS will conduct investigation/interviews. CRSM and PSS [will also] ensure complete and accurate documentation in online event reporting system. The EDT will review possible Serious Safety or Serous Reportable Events. The CRSM and PSS [will] implement the plan determined by the EDT including notifying regulatory bodies within required timeframes. The CRSM and PSS [will] ensure MedWatch report is completed.

According to the General Medical Staff Rules, p.18, the duties of the Medication Use Committee (MUC) shall develop, implement and monitor professional policies regarding the effect (including reactions and interactions) of drug usage. The MUC shall meet as often as necessary to fulfill its duties.

1. The facility failed to develop and educate nursing staff on a standard process to identify and report patient allergies.

a) Document review of Epic Training for Nursing Care Navigator provided by a Health Information Management employee (HIM) #15 revealed nursing staff were instructed to update a patient's medical record by choosing an appropriate reaction type when a patient reported an allergy. Choices of a reported allergy reaction type included allergy, intolerance, side effect or unknown. HIM #15 could not provide a policy or further education regarding how Registered Nurses (RN) were to differentiate between allergy, intolerance, side effect, or unknown.

b) On 08/17/16 at 6:00 p.m., an interview was conducted with emergency room registered nurse (RN) #8. RN#8 stated s/he chose and documented an appropriate reaction type to a patient's reported allergy. S/he stated an allergy could be considered a rash or anaphylaxis (swelling of airway). Gastrointestinal (GI) upset was considered a drug medication intolerance. RN#8 stated no education was provided by the facility regarding how to choose allergy, intolerance or side effect for a patient's stated allergy.

c) On 08/18/16 at 8:54 a.m., an interview was conducted with Interventional Radiology RN #9. S/he stated if a patient stated that a drug caused nausea and vomiting that was a side effect, not an allergy. RN#9 further stated the facility had not provided any education regarding how to choose an appropriate reaction type for a patient reported allergy.

d) On 08/18/16 at 3:06 p.m., an interview was conducted with Intermediate Care RN #7, s/he stated there had not been any education done at the facility regarding how to choose an appropriate reaction type when a patient reported an allergy. S/he stated an allergy was a reaction to a drug such as vomiting or anaphylaxis. This contradicted RN#9's statement stating vomiting was a side effect. RN #7 stated a drug intolerance was anything that did not make the person feel good, such as nausea or GI upset.

RN#7 stated s/he did not consider an allergic reaction to be an adverse drug reaction (ADR). This was in contrast to the facility's Adverse Drug Event policy. RN #7 went on to say RNs at the facility could give medications listed as a drug intolerance in a patient's medical record without contacting a provider.

e) On 08/18/2016 at 9:10 a.m., an interview was conducted with Director of Interventional Radiology (Director) #10. S/he was in charge of RNs in pre and post procedural areas. Director #10 stated RNs in the pre and post procedural areas were responsible for choosing and documenting an appropriate reaction type of allergy, intolerance, or side effect the patient's medical record. S/he further stated RNs learned how to classify drug medication intolerance versus an allergy in "Nursing 101", the facility did not educate RNs regarding this topic.

f) On 08/18/16 at 9:33 a.m., an interview was conducted with Pharmacist #11. S/he stated RNs could choose an appropriate reaction type to a patient's stated allergy. S/he further stated this was the responsibility of the staff member who conducted the initial patient assessment. Pharmacist #11 stated this was usually an RN. Pharmacist #11 stated s/he thought this process was taught in nursing school.

g) On 08/17/16 at 5:11 p.m., an interview was conducted with the Chief Nursing Officer (CNO #4). S/he stated she was unaware RN staff chose the appropriate reaction type of a patient's stated allergy. S/he stated this should be done by providers and should be consistent throughout the facility.

During a subsequent interview with CNO #4 on 08/18/16 at 4:21 p.m., s/he stated RNs were expected to know the difference between a drug allergy, intolerance, and side effect from nursing school. This statement contradicted his/her statement the day before this interview. CNO #4 further stated nausea and vomiting could be classified as either medication intolerance or an allergic reaction. This statement was not consistent with RN #7's statement that vomiting was an allergy, RN #8's statement that GI upset was an intolerance, and RN #9's statement that nausea and vomiting was a side effect. CNO #4 stated there were no policies regarding allergy verification. Furthermore, there were no policies guiding RNs how to choose the appropriate reaction type of allergy, intolerance, side effect, or unknown when a patient reports an allergy.

No additional policies or staff education regarding patient allergy verification or classification of patient allergies were received prior to exiting on 08/23/16 at 11:51 a.m.

2. The facility failed to update the medical record of Patient #13 when an allergic reaction was identified.

a) Review of Patient #13's chart revealed the following:

On 05/03/16 Patient #13 was admitted to the facility with an allergy to the antibiotic Penicillin (PCN). Patient #13 reported anaphylaxis (swelling of airway) as his/her reaction to taking PCN.

Document review revealed on 05/03/16 Patient #13 was given the antibiotic Vancomycin 2000 milligrams (mg) intravenously (IV) at 6:45 p.m. At 9:15 p.m.. Patient #13 developed severe itching and hives to scalp and forehead. RN #14 stopped the Vancomycin infusion, notified the provider and administered Benadryl (a medication used to treat itching, hives and other symptoms of an allergic reaction) to Patient #13. RN #14 documented an allergic reaction to Vancomycin in the comment box of the Vancomycin order on Patient #13's Medication Administration Record (MAR) and held the 5:00 a.m. scheduled dose. The adverse drug reaction was reported to Risk Management via the occurrence reporting system.

On 05/04/16 at 8:01 p.m. RN #14 reviewed Patient #13's allergies and marked Penicillin with anaphylaxis to be Patient #13's only allergy. This review occurred after RN #14 reported Patient #13's allergic reaction to Vancomycin to Risk Management and on the MAR. Although, RN #14 documented the patient's reaction to the Vancomycin, s/he did not add the new drug reaction to the patient's documented allergy list.

Document review showed Patient #13's allergies were marked as reviewed on the following dates: 05/17/16, 05/19/16, 06/01/16, 06/07/16, 06/09/16, 06/23/16, 07/01/16, and 07/06/16 by various facility providers and staff. The only allergy listed during the times of review was PCN. Electronic chart review on 08/23/16 revealed the antibiotic Vancomycin not listed at any time as an allergy on the medical record of Patient #13. This placed the patient at risk to receive a medication which previously caused an allergic reaction.

b) During an interview on 08/17/16 at 5:11 p.m. with CNO #4, s/he stated it was the responsibility of all staff members, including the RN staff, to update and review a patient's reported and identified allergies in the patient's medical record.

3. The pharmacy failed to identify that Patient #15's Adverse Drug Reaction (ADR) was a drug-related event.

a) Review of Patient #15's chart revealed the following:

Document review of Patient #15's medical record, dated 11/30/15, revealed on 01/18/11 morphine was added to his/her list of allergies. The medical record revealed Patient #15 experienced a rash, redness, itching, and pain when given morphine and had received Benadryl for treatment. Further document review of Patient #15's medical record revealed on 04/18/11 oxycodone was added to his/her list of allergies. The medical record revealed Patient #15 experienced itching when given oxycodone.

On 11/30/15 Patient #15 was admitted for an outpatient surgical procedure. At 7:27 a.m. on 11/30/15 the Anesthesia Record listed drug allergies included Percocet, Penicillin, Morphine, Droperidol, Prechlroperazine, and Compazine. Patient #15 was prescribed Percocet 5-325 milligrams (mg) tablet to take by mouth every four hours as needed for severe pain at home after the procedure on 11/30/15. Warning override history of Patient #15's chart reviewed on 08/23/16 revealed a drug allergy alert was overridden on 11/30/15 at 10:56 a.m. by Provider #1 with the reason "Medical Doctor aware/notified", no further documentation could be provided regarding Patient #15's potential for an adverse drug reaction to Percocet.

On 12/01/15 at 5:52 p.m., a post-anesthesia care unit nurse documented a phone conversation with Patient #15. According to this documentation Patient #15 discussed his/her allergy to Percocet with the surgeon and the resident prior to discharge the day before. The resident suggested Patient #15 take Benadryl for his/her symptoms. Patient #15 reported that s/he woke with swollen eyes and itching all over after taking Percocet at home for pain. No mention if s/he took Benadryl with Percocet as verbally directed. Patient #15 stated s/he had to call her attending provider to switch pain medication.

Review of Patient #15 medical record, dated 11/30/15 did not reveal any documentation regarding education provided to Patient #15 regarding Percocet's potential adverse drug reaction or the use of Benadryl when taking Percocet.

b) On 08/23/16 documentation review of the MUC meeting minutes revealed Pharmacist #2 presented ADR's at the 03/10/16 meeting. ADR report revealed "patient with allergy to oxycodone listed, reaction stated to be itching. It was noted Oxycodone was prescribed with Benadryl for outpatient use. Post discharge the patient was still itching and states eyes were swollen. Patient was given new prescription for a different pain medication. The committee did not feel it had enough information to pass judgment. The patient received large amounts of fluids during hospital procedure and could potentially have caused swollen eyes prior to discharge. Inappropriate labeling of medication allergies versus medication side effects was a common occurrence in the hospital and important to distinguish these differences at the time of medication history in order to prevent similar situation from happening in the frame."

Patient #15's chart review revealed no documentation of swollen eyes during his/her post-operative assessments. Review of Patient #15's ADR at MUC meetings occurred 3 months after the event. ADR report revealed the specific event type to be "Known Allergy but Medication Ordered." No further investigation or Naranjo Algorithm was completed for this event. This was in contrast to the facility's Adverse Drug Events policy.

Review of Medical Executive Committee (MEC) meeting minutes from 04/12/16 revealed the MUC meeting minutes from 03/10/16 were reviewed. No action was noted to be executed regarding the "inappropriate labeling of medication allergies versus medication side effects as a common occurrence in the hospital and the importance to distinguish these differences at the time of medication history in order to prevent similar situation from happening."

c) During an interview with Pharmacist #3 on 08/18/16 at 1:22 p.m., s/he stated no investigation, action plan, or staff education had been done regarding the inappropriate labeling of medication allergies versus medication side effects. S/he further stated a Naranjo Algorithm score to determine the severity level of the event was not found for this ADR. This was in contrast to the facility's Adverse Drug Events policy.

d) During an interview with the Director of Pharmacy (Director #5), on 08/17/16 at 2:59 p.m., s/he stated inappropriate labeling of medication allergies versus medication side effects was a common occurrence in the hospital. Director #5 could not provide additional education or procedures implemented to prevent inappropriate labeling of medications from occurring. Director #5 expected registered nurses (RN) and pharmacists to know how this was done from school.

Document review of the facility's Adverse Drug Events policy revealed Pharmacist #3, a current staff member working for Director #5, to be a major contributor to the policy. During an interview on 08/17/16 at 2:59 p.m., Director #5 stated s/he was unaware if an Adverse Drug Event policy existed. S/he thought this would be a nursing responsibility. According to the General Medical Staff Rules, the MUC shall develop, implement, and monitor professional policies regarding the effect (including reactions and interactions) of drug usage. Director #5 was a member of the MUC and expected his/her staff to follow the Medical Staff Rules.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interviews, and document review, the facility failed to ensure outdated medications and supplies were removed from stock.

This failure created the potential for patients to receive expired medications and outdated supplies to be used leading to an increased risk of poor patient outcomes.

FINDINGS:

POLICY

According to policy, Medication Management, LIP, RN, RPh, Radiology technician, MA [will] verify the medication is stable based on visual examination prior to administration by checking for: discoloration, particulate matter and expiration date.

1. The facility failed to remove expired medications from the emergency room (ER) Pediatric Code Cart.

a) During a tour of the ER on 08/15/16 at 11:06 a.m., it was noted the pediatric code cart had the following expired items:

(3) Infant Plus Heartstart Pads used for resuscitation of patients less the 10 kilograms (kg) expired on ,d+[DATE], 06/16, and 07/16.

(1) Adult/Child Heartstart Pads used for resuscitation of patients greater than 10 kg expired on ,d+[DATE].

(3) 25% Dextrose injection of 2.5 grams expired 08/01/16.

b) On 08/15/16 at 11:28 a.m., an interview was conducted with Pharmacist #17. S/he stated a pharmacist should have checked the Pharmacy Keeper Program to track expired medications in the code carts. The Pharmacy Keeper program alerted a pharmacist if a medication in the code (resuscitation) cart had expired. Pharmacist #17 noted a pharmacist must log onto the program monthly to check the expiration dates of medications in the resuscitation carts.

c) On 08/15/16 at 11:36 a.m., an interview was conducted with Pharmacist #18. S/he stated the Pharmacy Keeper should have been checked once a month before the 20th of each month to ensure medication was not expired or due to expire the next month. If a medication was expired, it should have been removed and replaced.

d) On 08/15/16 at 3:07 p.m., an interview was conducted with Director of Pharmacy (Director) #5. S/he stated that a pharmacist was dedicated to the area where the code care should have been located. Director #5 stated any pharmacist had the ability to change the location of a cart physically or in the computer system. S/he stated this code cart should have been located in the "green area" of the ER, but was located in the "blue area". Director #5 explained if a code cart was labeled in the computer as located in the "blue area" and was not physically in the "blue area" the cart check could be missed by the pharmacist. Director #5 stated this was known as the Swiss Cheese Effect and the code cart with the expired items had not been checked for expired items.
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and document review, the facility failed to ensure proper reporting, investigation and review of adverse drug reactions.

These failures created the potential for similar events to reoccur placing a patient at an increased risk for an adverse drug reaction.

FINDINGS:

POLICY

According to the policy, Adverse Drug Events, adverse drug reaction (ADR) is any unexpected, unintended, undesired, or excessive response to a medicine that: requires discontinuing the medicine, necessitates supportive treatment, results in temporary or negatively affects prognosis or results in temporary or permanent harm, disability, or death. Pharmacy staff will classify reported adverse drug events (ADE) for medication errors to determine the severity level and identify the probability that the ADR is drug-related (doubtful, possible, probable, or definite) using the Naranjo algorithm. Pharmacy complied report of ADEs for presentation to the appropriate medical staff committee for review and evaluation. Pharmacy staff will report rare, severe, or unusual ADEs to the Federal Drug Administration (FDA) in accordance with the MedWatch Program.

According to the policy Safety Event Identification, Analysis and Reporting, the Event Determination Team is a designated team at each care site that includes the Care Site Risk Manager (CSRM), Patient Safety Specialist (PSS) and various members of senior leadership. The role of this team is to determine the level of harm and to provide final determination of Serious Safety Events. A Patient Safety Event is an event not consistent with routine patient care, generally accepted performance standards, or care site procedures which either did or could have resulted in injury or loss to a patient. Safety Event Classification (SEC) is an event classification system based on degree of harm that result from a deviation from generally accepted performance standards (GAPS). Serious Reportable Event is any patient safety event that is identified as a mandatory reportable event as define by state regulations. CSRM and department leader [will] conduct [an] initial review and investigation of the event and complete follow-up. CRSM and PSS [will] determine the type of event; ensure complete and accurate documentation in online event reporting system. [They will] conduct other actions as indicated (i.e. refer to pharmacy, patient representative etc.), CRSM and PSS [will] classify the event. If the event is a possible Serious Safety Event, Sentinel Event, or Serious Reportable Event CRSM and PSS will conduct investigation/interviews. CRSM and PSS [will also] ensure complete and accurate documentation in online event reporting system. The EDT will review possible Serious Safety or Serous Reportable Events. The CRSM and PSS [will] implement the plan determined by the EDT including notifying regulatory bodies within required timeframes. The CRSM and PSS [will] ensure MedWatch report is completed.

According to the General Medical Staff Rules, p.18, the duties of the Medication Use Committee (MUC) shall develop, implement and monitor professional policies regarding the effect (including reactions and interactions) of drug usage. The MUC shall meet as often as necessary to fulfill its duties.

REFERENCES

According to the MedWatch website, an adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is: death resulting from an adverse event.
http://www.fda.gov/Safety/MedWatch/HowToReport/ucm 7.htm

1. The facility failed to conduct a complete investigation regarding Patient #4's ADR.

a) Review of Patient #4's chart revealed the following:

Patient #4 was admitted on [DATE] for an elective surgery. Allergies reported included Cranberries with a reported reaction of swelling and PCN with a known reaction of nausea and vomiting.

On 12/10/15 Patient #4 was prescribed Ceftriaxone 0.5 grams (g) intravenously (IV). On 12/10/15 at 2:25 p.m. it was documented the drug was administered. Within 20 minutes of the infusion start time Patient #4 reported that his/her airway was closing and the RN reported Patient #4's oxygenation saturation was dropping. At 2:45 p.m. Patient #4 stopped breathing and became pulseless, a code for resuscitation was called. Patient #4 was then placed on life support and transferred to the Intensive Care Unit. Patient #4 subsequently passed away.

b) Document review of the Adverse Drug Reaction Event revealed the event was reported to Risk Management on 12/11/15 via the computerized occurrence reporting system. Document review of this occurrence report revealed Patient #4 suffered an anaphylactic reaction to Ceftriaxone, an unknown allergy. Follow-up of event performed by Risk Manager #13 determined this event to be "not a Safety Event pending evaluation by Pharmacy." Pharmacy evaluation was requested at time of survey. No evaluation by Pharmacy could be provided. No additional investigation or actions were taken regarding this ADR resulting in Patient #4's death.

c) On 08/18/16 at 3:03 p.m., an interview was conducted with Manager of Patient Safety #12. S/he stated that daily safety huddles were done to discuss occurrences reported for the last 24 hours to ensure accurate reporting and proper follow-up

Document review of Daily Safety Huddles for 12/10/15 - 12/15/15 revealed no mention of Patient #4's reported occurrence entered on 12/11/15.

d) On 08/18/16 at 1:22 p.m., an interview was conducted with Pharmacist #3. S/he stated ADRs should have been reviewed during the MUC meetings on a monthly basis. S/he went on to state there was a lapse in ADR reporting from 12/15-02/16 as well as 04/16-8/16 due to time restraints of the MUC meetings.

e) On 08/1/16 at 2:59 p.m., an interview was conducted with Director of Pharmacy #5. Director #5 stated s/he was unsure of a policy related to ADRs. S/he further stated an investigation was conducted; however, was unable to provide any documentation of the investigation or elaborate on what the investigative findings included. Director #5 further stated this event was not reviewed at the MUC. No further action was taken and no education was completed regarding Patient #4's ADR event resulting in death. Director #5 stated Patient #4's reaction was rare, severe and unusual. According to the facility's ADR policy, duties of the MUC according to the General Medical Staff Rules, and FDA guidelines rare, severe and unusual reactions to medications should be reported to the FDA. Director #5 further stated s/he did not report this reaction because s/he stated death was a known reaction to Ceftriaxone.

f) Document review of Serious Safety Events provided by Risk Manager #13 revealed the Event Determination Team met on 12/14/15 to discuss Patient #4's ADR. The team determined this event was not a safety event. This determination was made without pharmacy investigation being completed. Documentation regarding the review and investigation of Patient #4's ADR resulting in death could not be provided by the facility upon request during survey.

On 08/18/16 at 12:12 p.m., an interview was conducted with Risk Manager #13. S/he stated Patient #4's event would not have been investigated further once it was determined to not be a serious safety event and would not be reviewed by the MEC. This was in contrast to the facility's Safety Event Identification, Analysis and Reporting policy regarding Serious Reportable Events.

g) During an interview on 08/18/16 at 12:27 p.m., Physician #6, a member of the MEC, stated staff was expected to know and follow facility policy regarding ADRs. S/he was unaware an investigation was not completed by Pharmacy regarding Patient #4's ADR, which contradicted medical staff rules and facility policy.

2. The pharmacy failed to identify that Patient #15's Adverse Drug Reaction (ADR) was a drug-related event.

a) Review of Patient #15's chart revealed the following:

Document review of Patient #15's medical record, dated 11/30/15, revealed on 01/18/11 morphine was added to his/her list of allergies. The medical record revealed Patient #15 experienced a rash, redness, itching, and pain when given morphine and had received Benadryl for treatment. Further document review of Patient #15's medical record revealed on 04/18/11 oxycodone was added to his/her list of allergies. The medical record revealed Patient #15 experienced itching when given oxycodone.

On 11/30/15 Patient #15 was admitted for an outpatient surgical procedure. At 7:27 a.m. on 11/30/15 the Anesthesia Record listed drug allergies included Percocet, Penicillin, Morphine, Droperidol, Prechlroperazine, and Compazine. Patient #15 was prescribed Percocet 5-325 milligrams (mg) tablet to take by mouth every four hours as needed for severe pain at home after the procedure on 11/30/15.

Warning override history of Patient #15's chart reviewed on 08/23/16 revealed a drug allergy alert was overridden on 11/30/15 at 10:56 a.m. by Provider #1 with the reason "Medical Doctor aware/notified", no further documentation could be provided regarding Patient #15's potential for an adverse drug reaction to Percocet.

On 12/01/15 at 5:52 p.m., a Post-Anesthesia Care Unit nurse documented a phone conversation with Patient #15. According the documentation, Patient #15 discussed his/her allergy to Percocet with the surgeon and the resident prior to discharge the day before. The resident suggested Patient #15 take Benadryl for his/her symptoms. Patient #15 reported that s/he woke with swollen eyes and itching all over after taking the Percocet at home for pain. There was no mention if s/he took Benadryl with Percocet as verbally directed. Patient #15 stated s/he had to call her attending provider to switch pain medication.

Review of Patient #15's medical record, dated 11/30/15, did not reveal any documentation regarding education provided to Patient #15 regarding Percocet's potential adverse drug reaction or the use of Benadryl when taking Percocet.

b) On 08/23/16 documentation review of the MUC meeting minutes revealed Pharmacist #2 presented ADR's at the 03/10/16 meeting. The ADR report revealed "patient with allergy to oxycodone listed, reaction stated to be itching. It was noted Oxycodone was prescribed with Benadryl for outpatient use. Post discharge the patient was still itching and states eyes were swollen. Patient was given new prescription for a different pain medication. The committee did not feel it had enough information to pass judgment. The patient received large amounts of fluids during hospital procedure and could potentially have caused swollen eyes prior to discharge. Inappropriate labeling of medication allergies versus medication side effects was a common occurrence in the hospital and important to distinguish these differences at the time of medication history in order to prevent similar situation from happening in the frame."

Patient #15's chart review revealed no documentation of swollen eyes during his/her post-operative assessments. Review of Patient #15's ADR at MUC meetings occurred 3 months after the event. The ADR report revealed the specific event type to be "Known Allergy but Medication Ordered." No further investigation or Naranjo Algorithm was completed for this event. This was in contrast to the facility's Adverse Drug Events policy.

Review of Medical Executive Committee (MEC) meeting minutes from 04/12/16 revealed the MUC meeting minutes from 03/10/16 were reviewed. No action was noted to be executed regarding the "inappropriate labeling of medication allergies versus medication side effects as a common occurrence in the hospital and the importance to distinguish these differences at the time of medication history in order to prevent similar situation from happening."

c) During an interview with Pharmacist #3 on 08/18/16 at 1:22 p.m., s/he stated no investigation, action plan, or staff education had been done regarding the inappropriate labeling of medication allergies versus medication side effects. S/he further stated a Naranjo Algorithm score to determine the severity level of the event was not found for this ADR. This was in contrast to the Adverse Drug Events policy.

d) During an interview with the Director of Pharmacy #5, on 08/17/16 at 2:59 p.m., s/he stated inappropriate labeling of medication allergies versus medication side effects was a common occurrence in the hospital. Director #5 could not provide additional education or procedures implemented to prevent inappropriate labeling of medications from occurring. Director #5 expected registered nurses (RN) and pharmacists to know how this was done from school.

Document review of the facility's Adverse Drug Events policy revealed Pharmacist #3, a current staff member working for Director #5, to be a major contributor to the policy. During an interview on 08/17/16 at 2:59 p.m., Director #5 stated s/he was unaware if an Adverse Drug Event policy existed. S/he thought this would be a nursing responsibility. According to the General Medical Staff Rules, the MUC shall develop, implement, and monitor professional policies regarding the effect (including reactions and interactions) of drug usage. Director #5 was a member of the MUC and expected his/her staff to follow the Medical Staff Rules.

3. The pharmacy failed to perform a complete investigation and update the medical record of Patient #13's ADR event.

a) Review of Patient #13's chart revealed the following:

On 05/03/16 Patient #13 was admitted to the facility with an allergy to the antibiotic Penicillin (PCN). Patient #13 reported anaphylaxis, throat and tongue swelling, as his/her reaction to taking PCN.

Document review revealed on 05/03/16 Patient #13 was given the antibiotic Vancomycin 2000 milligrams (mg) intravenously (IV) at 6:45 p.m. At 9:15p.m. Patient #13 developed severe itching and hives to scalp and forehead. RN #14 stopped the Vancomycin infusion, notified the provider and administered Benadryl (a medication used to treat itching, hives and other symptoms of an allergic reaction) to Patient #13. RN #14 documented an allergic reaction to Vancomycin in the comment box of the Vancomycin order on Patient #13's Medication Administration Record (MAR) and held the 5:00 a.m. scheduled dose. The adverse drug reaction was reported to Risk Management via the occurrence reporting system.

On 05/04/16 at 8:01 p.m. RN #14 reviewed Patient #13's allergies and marked Penicillin with anaphylaxis to be Patient #13's only allergy. This review occurred after RN #14 reported Patient #13's allergic reaction to Vancomycin to Risk Management and on the MAR. Although, RN #14 documented the patient's reaction to the Vancomycin, s/he did not add the new drug reaction to the patient's documented allergy list.

Document review showed Patient #13's allergies were marked as reviewed on the following dates: 05/17/16, 05/19/16, 06/01/16, 06/07/16, 06/09/16, 06/23/16, 07/01/16, and 07/06/16 by various facility providers and staff. The only allergy listed during the times of review was PCN. Electronic chart review on 08/23/16 revealed the antibiotic Vancomycin not listed at any time as an allergy on the medical record of Patient #13. This placed the patient at risk to receive a medication which previously caused an allergic reaction.

b) On 08/18/16 at 1:22 p.m., an interview was conducted with Pharmacist #3. S/he stated all ADRs were to receive a Naranjo algorithm score and the reports were then reviewed at the MUC's monthly meetings. Review of the ADR report for Patient #13 revealed an incomplete report with no Naranjo score. Pharmacist #3 further stated s/he could not provide a Naranjo algorithm scores for any ADRs at the time of survey. Pharmacist #3 stated that ADRs had not been reported to MUC since 03/10/16 due to there not being enough time at the meetings.

c) During an interview on 08/17/16 at 5:11 p.m. with CNO #4, s/he stated it was the responsibility of all staff members, including the RN staff, to update and review a patient's reported and identified allergies.