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Based on record review, observation, and interview, the hospital failed to ensure patients were provided a safe environment of care by ensuring pharmaceutical services met the needs of the patients, nursing services documented allergic/adverse reactions (including naivety) to medications, and medical staff were accountable for the medical care provided to patients. A patient with known and documented allergy to a certain drug was administered the drug by nursing staff which ended to the patient demise. After revieiwing the medical record of the patient, the Pharmacist informed the surveyors that the drug should not have been administered


This failed practice contributed to the death of Patient #4, posed an immediate jeopardy to patient safety and placed any patient with a known or potential allergic/adverse reaction to a medication in an unsafe environment with the likelihood of harm, serious injury or death.


On 05/14/18 at 3:30 pm, the surveyors identified immediate jeopardy for 482.13 Patient's Rights - failure to provide a safe environment. This failed practice contributed to the death of Patient #4, posed an immediate jeopardy to patient safety and placed any patient with a known or potential allergic/adverse reaction to a medication in an unsafe environment with the likelihood of harm, serious injury or death.


(Refer to A-0144)



On 05/15/18 at 10:30 am, the Oklahoma State Department of Health notified the CMS Regional Office of the immediate jeopardy findings.

On 05/15/18 at 2:30 pm, the Director of Pharmacy, Director of Medical Staff, Chief Nursing Officer and Chief Nursing Educator were notified of the immediate jeopardy findings.


On 05/16/18 at 4:00 pm, a plan of removal of immediate jeopardy was submitted which included:

1. Review of all current patients with medication overrides with an allergic/adverse reaction status to include documentation of the conversation between the pharmacist and physician/provider regarding the override of the medication.

2. Develop standardized severity level definitions.

3. Change in hospital policy with education provided to nurses, pharmacists and physicians/providers of completed education prior to the start of their shift.


On 05/17/18 at 10:00 am, the surveyors accepted the plan of removal.


On 05/17/18 at 10:45 am, surveyors verified the removal of the immediacy by:

a. Reviewed a list of all current patients with medication overrides with an allergic/adverse reaction. Confirmed by document review that the conversations between the physician/provider and pharmacist were held and documented.

b. The standardized severity level definitions were observed on the home screen of computers being utilized by staff. Interviews with staff confirmed their knowledge of the definitions and the location of the definitions.

c. The updated hospital policy was reviewed by surveyors, sign in sheets for education were reviewed, and staff interviewed confirmed their knowledge of the change in hospital policy.

Based on record review, observation, and interview, the hospital failed to:

a. provide pharmaceutical services that met the needs of the patients.

b. provide safe, competent nursing care for patients with documented allergies or adverse reactions, including opioid naivety.

c. ensure medical staff followed hospital approved bylaws (including rules and regulations) and were accountable for medical care provided to patients.

These deficient practices posed an immediate jeopardy to patients' health and safety and placed patients at risk for the likelihood of serious harm, serious injury and possibly subsequent death.


Findings:

a. A review of Patient #4's record showed on 11/23/17 at 8:41 am, Patient #4 received an opiate medication, Dilaudid (a derivative of morphine) prior to an MRI procedure. A note in the MAR (medication administration record) indicated that the physician was aware of the allergy to morphine. There was no severity level indicated and no documentation of a conversation between the physician and the pharmacist regarding therapeutic appropriateness of the medication.

05/15/18 at 11:45 am, Staff WW (PharmD) stated the policy utilized for use and handling of medications essential to patient care was titled Medication Management #PHARM004. The policy did not address opiate naïve/opiate tolerant patients, nor did it address the severity levels, the overriding process and the process of documenting ordering providers' awareness of allergic/susceptible reactions to medications. No additional policies and procedures were provided.

05/08/18 at 11:30 am, Staff PPP (RN) stated that nurses would use a different screen to see a reaction, but could see there was an allergy when scanning the patient's bracelet. Nursing could override an allergy.

05/08/18 at 12:00 pm Staff WW (PharmD) stated there wasn't anything built into Pyxis to alert nursing of an allergy. Pyxis allowed nursing to "get out what you need". When nursing scanned the bracelet, a flag would alert nursing of an allergy, but nursing could override the alert.


b. The Electronic Medical Record (EMR) showed:

1. On 11/21/17, Patient #4 had an allergy to Morphine and "Pt states he goes to sleep and they have to reverse it"

2. On 11/23/17, Staff QQQ (MD) ordered Hydromorph 2 mg IV "before MRI".

3. On 11/23/17 at 8:41 am, Staff KKKK administered 2 mg IV Dilaudid as ordered,

4. On 11/23/17 at 8:52 am, Patient #4 was transported to MRI by a transport tech (without an RN present),

5. On 11/23/17 at 9:37 am, Patient #4 returned to room by transport tech,

5. On 11/23/17 at 10:10 am, Staff KKKK documented patient was in respiratory distress, Rapid Response Team and Staff QQQ were notified,

6. On 11/23/17 at10:20 am, code blue initiated and

7. On 11/23/17 at 10:56 am, efforts ended and patient was pronounced deceased.


A policy "Medication Management", effective 02/2018, showed that the individual administering the medication was also responsible for reviewing allergy information prior to medication administration.


During a phone interview on 5/17/18 at 1:00 pm, Staff KKKK stated "if staff clicks on the allergy it shows the reaction". He/she did not recall notifying the physician regarding Patient #4's allergy to Morphine. Staff KKKK also stated he/she did not ask patients their reaction to Morphine.


c. The hospital documentation system allowed documentation of allergic reactions to medications, including the use of severity levels. There was no definition/criteria for severity levels. The staff (nursing, pharmacy and physicians) stated they assigned the severity level based on patient statements or observation of patient reactions.


Patient #4 required pain medication prior to an MRI. Staff QQQ (MD) ordered the opiate Dilaudid (a derivative of morphine) and overrode the morphine allergy. There was no documentation of communication with the pharmacy regarding the patient's CNS dysfunction and requiring "reversal agent".


The record showed Staff QQQ (MD) approved the Dilaudid, it did not show the reaction severity level or reversal agent requirement. There were no documented orders to counteract a possible reaction and no additional precautions were taken when the medication was administered. Patient #4 returned from MRI, a Code Blue was initiated and after approximately 20 minutes, the patient was pronounced deceased.


On 05/10/18 at 10:30 am, Staff R (MD) stated the chart had not been reviewed nor had an investigation been conducted prior to the survey. After reviewing the chart, Staff R acknowledged the Dilaudid should not have been ordered; there was no documented conversation with the Pharmacy department regarding the medication or severity level of the allergic reaction.

Based on record review and interview, the hospital failed to ensure medical staff followed hospital approved bylaws (including rules and regulations) and were accountable for medical care provided to patients by ensuring approval of hospital policies/procedures and a safe consistent documentation process for patient allergies/adverse reactions to medications.


Patient #4 required pain medication prior to an MRI. Staff QQQ (MD) ordered the opiate Dilaudid (a derivative of morphine) and overrode the morphine allergy. There was no documentation of communication with the pharmacy regarding the patient's CNS dysfunction and requiring "reversal agent".


The record showed Staff QQQ (MD) approved the Dilaudid, it did not show the reaction severity level or reversal agent requirement. There were no documented orders to counteract a possible reaction and no additional precautions were taken when the medication was administered. Patient #4 went into cardiac arrest and died.


The deficient practice contributed to the death of Patient #4, posed an immediate jeopardy to patient safety and placed the opiate naïve or opiate tolerant patients in an unsafe environment with the likelihood of harm, serious injury or death due to a lack of a safe, consistent documentation process for patient allergies/adverse reactions to medications.


(Refer to A-0347)



On 05/14/18 at 3:30 pm, the surveyors identified immediate jeopardy (IJ) for Medical Staff.

On 05/15/18 at 2:30 pm, surveyors notified the facility of the IJ.


On 05/16/18 at 4:00 pm, a plan of removal of the IJ was submitted which included:

1. Physicians and providers were provided education regarding change in hospital policy and procedure requiring a conversation and confirmation of overrides of allergic/adverse reactions to medications before the medication could be given to a patient.

2. The conversation between the physician/provider and the pharmacist would be documented in the electronic medical record, and would be visible to the nursing staff administering the medication.

3. Develop standardized severity level definitions.



On 05/17/18 at 10:00 am, the surveyors accepted the plan of removal.

On 05/17/18 at 10:45 am, surveyors verified the removal of the immediacy by:

1. The updated hospital policy was reviewed and staff interviewed confirmed their knowledge of the change in hospital policy.

b. The conversations regarding overrides were documented by both physician/provider and pharmacist. Surveyors observed the documentation was visible in the electronic medical record and visible to the nursing staff.

c. The standardized severity level definitions were observed on the home screen of computers being utilized by staff. Interviews with staff confirmed their knowledge of the definitions and the location of the definitions.

Based on document review and interview, the hospital failed to ensure medical staff were accountable for approval of policies and procedures related to opiate naïve or opiate tolerant patients, and determination of a safe consistent documentation process for patient allergies/adverse reactions to medications.

This failed practice contributed to the death of patient #4, posed an immediate jeopardy to patients' health and safety, and placed patients at risk for the likelihood of serious harm, serious injury and possibly subsequent death.

Findings:

Patient #4 was an 88 year old male who presented to the emergency room following a fall at home. He complained of neck pain and was later determined to have cervical fractures. The ER physician documented "CNS dysfunction" requiring "reversal agent" when patient given morphine.

The hospital documentation system allowed documentation of allergic reactions to medications, including the use of severity levels. There was no definition/criteria for severity levels. The staff (nursing, pharmacy and physicians) stated they assigned the severity level based on patient statements or observation of patient reactions.

Patient #4 required pain medication prior to an MRI. Staff QQQ (MD) ordered the opiate Dilaudid (a derivative of morphine) and overrode the morphine allergy. There was no documentation of communication with the pharmacy regarding the patient's CNS dysfunction and requiring "reversal agent".

The record showed Staff QQQ (MD) approved the Dilaudid, it did not show the reaction severity level or reversal agent requirement. There were no documented orders to counteract a possible reaction and no additional precautions were taken when the medication was administered. Patient #4 returned from MRI, a Code Blue was initiated and after approximately 20 minutes, the patient was pronounced deceased.

Surveyors requested policies and procedures regarding opiate naïve and opiate tolerant patients, processes to determine severity levels of allergic reactions, and overrides of medications; none were provided.

The Medical Staff Rules and Regulations stated "A sentinel event is an event that results in an unanticipated death ..." "An investigation and report regarding a sentinel event shall be conducted as part of a Peer Review Process."

On 05/10/18 at 10:30 am, Staff R (MD) stated the chart had not been reviewed nor had an investigation been conducted prior to the survey. After reviewing the chart, Staff R acknowledged the Dilaudid should not have been ordered; there was no documented conversation with the Pharmacy department regarding the medication or severity level of the allergic reaction.

Based on record review, interview, and observation, the hospital failed to:

A. provide safe, competent nursing care for Patient #4 who had a documented allergies/adverse reactions, including opioid naivety. (Refer to A-0395)

B. ensure Patient #4, who received an opioid analgesic, was monitored for early identification of adverse effects and timely initiation of appropriate corrective actions. (Refer to A-0405)

On 11/23/17 at 8:41 am, Patient #4 received an opiate medication, Dilaudid (a derivative of morphine) prior to an MRI procedure. A note in the MAR (medication administration record) indicated that the physician was aware of the allergy to morphine. There was no severity level indicated and no documentation of a conversation between the physician and the pharmacist regarding therapeutic appropriateness of the medication. Patient #4 went into cardiac arrest and died.


On 05/14/18 at 3:30 pm, the surveyors identified immediate jeopardy (IJ) for Nursing Services.

On 05/15/18 at 2:30 pm, surveyors notified the facility of the IJ.


On 05/16/18 at 4:00 pm , a plan of removal of the IJ was submitted and included:

1. Develop standardized severity level definitions.

2. Change in hospital policy with education provided to nurses, pharmacists and physicians/providers with completed education prior to the start of their shift.

3. Review of all current patients with medication overrides with an allergic/adverse reaction status to include documentation of the conversation between the pharmacist and physician/provider regarding the override and the documentation visible to nursing staff.


On 05/17/18 at 10:00 am, the surveyors accepted the plan of removal.

On 05/17/18 at 10:45 am, surveyors verified the removal by:

a. The standardized severity level definitions were observed on the home screen of computers being utilized by staff. Interviews with staff confirmed their knowledge of the definitions and the location of the definitions.

b. The updated hospital policy was reviewed by surveyors, sign in sheets for education were reviewed, and staff interviewed confirmed their knowledge of the change in hospital policy.

c. Surveyors reviewed a list of all current patients with medication overrides with an allergic/adverse reaction. Confirmed by record review that the conversations between the physician/provider and pharmacist were held, documented and visible to the nursing staff.

Based on record review and interview, the hospital failed to provide safe, competent nursing care for patients with documented allergies or adverse reactions, including opioid naivety.

This failed practiceresulted in one patient (#4) of 20 records reviewed, who had a documented allergy to Morphine, being transported to MRI (magnetic resonance imaging) after receiving 2 mg (milligrams) of IV (intravenous) Dilaudid. On 11/23/17 at 8:41 am, Patient #4 received an opiate medication, Dilaudid (a derivative of morphine) prior to an MRI procedure. A note in the MAR (medication administration record) indicated that the physician was aware of the allergy to morphine. There was no severity level indicated and no documentation of a conversation between the physician and the pharmacist regarding therapeutic appropriateness of the medication.

The deficient practice posed an immediate jeopardy to patients' health and safety and placed patients at risk for the likelihood of serious harm, serious injury and possibly subsequent death.


Findings:

The Electronic Medical Record (EMR) of patient #4 showed:

I. On 11/21/2017:

A. An untitled document showed provider from transferring facility documented: Allergies Morphine, "Pt states he goes to sleep and they have to reverse it"

B. 5:22 pm: "Coded Allergies: morphine "Severity: (Unknown 11/21/17)"

C. 11:23 pm: "patient reports he is sensitive to Morphine, will easily fall asleep requiring reversal agents"


II. On 11/22/2017:

A. 12:26 am: 1 mg Dilaudid given IV "ADMIN CONFLICTS: Allergies/ADRs (adverse drug reactions)reviewed"

B. 1:04 am: "patient not given morphine due to allergy"


III. On 11/23/2017:

A. 7:22 am: Staff QQQ (MD) ordered Hydromorph 2 mg IV "before MRI"

B. 7:30 am: Staff KKKK (RN) documented patient allergy band on

C. 8:21 am: vital signs were Pulse 61, Respirations 16, Blood pressure 133/68, Pulse oximetry (saturation of oxygen content in the blood) 95%, patient's level of consciousness was "Alert"

D. 8:41 am: Staff KKKK administered 2 mg IV Dilaudid as ordered

E. 8:52 am: patient transported to MRI by transport tech (without an RN present)

F. 9:37 am: patient transported back to room by transport tech

G. 10:00 am: vital signs were Pulse 103, Respirations 32, Blood pressure 111/68, Pulse oximetry 90%, Oxygen on via Non-Rebreather (concentration not documented)

H. 10:10 am, Staff KKKK documented patient was in respiratory distress, Rapid Response Team and Staff QQQ were notified

I. 10:10 am: patient blue in color

J. 10:20 am: code blue initiated

K.10:56 am: efforts ended, patient deceased


A policy "Medication Management", effective 02/2018, showed:

1. The individual administering the medication was also responsible for reviewing allergy information prior to medication administration.

2. The hospital staff administering the medication was responsible for checking allergy information if an initial dose of medication was obtained from floor-stock supplies (Dilaudid was a floor-stock supply).


On 5/10/18 at 10:30 am, Staff R (MD) stated the expectation would have been for nurses to have a reversal agent immediately available when administering opioids.


5/11/18 at 10:45 am, Staff B (RN) stated nursing staff did not "normally" accompany patients to MRI, but there were situations, "such as this one, that they should."


On 5/16/18 Staff R provided surveyors with a document, "Equinalgesic Conversion Table", which showed a conversion equation utilized in prescribing opioids and other analgesics. He/she stated it was not currently available to nursing staff.


During a phone interview on 5/17/18 at 1:00 pm Staff KKKK stated "if staff clicks on the allergy it shows the reaction". He/she did not recall notifying the physician regarding Patient #4's allergy to Morphine. Staff KKKK also stated he/she did not ask patients their reaction to Morphine.


A Safety Alert from The Institute for Safe Medication Practices 2007, "Hydromorphone Alert" showed:

"The intravenous starting dose for Dilaudid has been reduced to 0.2mg-1mg (previously 1-2mg)."


The Institute for Safe Medication Practices, Medication Safety Alert 2018 showed:

1. "Dilaudid has sedative properties and has been attributed to many errors"

2. "Best practice ...nurses have assessed the patient after every intervention of administration of Dilaudid; arousability, vital signs, possibly pulse oximetry."

3. "after each intervention a nurse is required to re-assess their patient"

4. "Pharmacy and Nursing should not accept opiate orders without knowing if the patient is 'opiate naïve or tolerant'".

5. "Monitoring a patient's response and any adverse effects is critical for obtaining a safe outcome"

6. "Medical surgical units should be using a standardized sedation scale for all patients receiving opiates."

Based on record review and interview, the hospital failed to ensure patients who received opioid analgesics were monitored for early identification of adverse effects, opiod naivety, and timely initiation of appropriate corrective action.

The deficient practice posed an immediate jeopardy to patients' health and safety and placed patients at risk for the likelihood of serious harm, serious injury and possibly subsequent death.

Finding:

On 11/23/17 at 8:41 am, Patient #4 received an opiate medication, Dilaudid (a derivative of morphine) prior to an MRI procedure. A note in the MAR (medication administration record) indicated that the physician was aware of the allergy to morphine. There was no severity level indicated and no documentation of a conversation between the physician and the pharmacist regarding therapeutic appropriateness of the medication.

Staff B (RN) stated nursing staff did not "normally" accompany patients to MRI, but there were situations, "such as this one, that they should."


(Refer also to Tag A-0395)

Based on record review and interview, the hospital failed to:

A. develop policies and procedures to standardize the severity levels of allergic/adverse reactions to medications, and the override process of the medications that resulted in Patient #4 receiving an opiod medication resulting in his/her death. (Refer to A-0491)

B. establish a process for discussions of questions with the prescribing practitioner, the outcomes and documentation of the discussions in Patient #4's medical record regarding therapeutic appropriateness of a medication, and real or potential allergies or sensitivities to medications, including opiates resulting in his/her death. (Refer to A-0500)

On 11/23/17 at 8:41 am, Patient #4 received an opiate medication, Dilaudid (a derivative of morphine) prior to an MRI procedure. A note in the MAR (medication administration record) indicated that the physician was aware of the allergy. There was no severity level indicated and no documentation of a conversation between the physician and the pharmacist regarding therapeutic appropriateness of the medication. Hospital policy titled "Medication Management" stated under "Medication Allergy Information" that "Prior to dispensing ...the pharmacist is responsible for review of the patient medication allergy information." Patient #4 was given Dilaudid, went into cardiac arrest, and died.


On 05/14/18 at 3:30 pm, the surveyors identified immediate jeopardy (IJ) for Pharmaceutical Services.


On 05/15/18 at 2:30 pm, surveyors notified the facility of the IJ.


On 05/16/18 at 4:00 pm, a plan of removal of IJ was submitted which included:

1. Review of all current patients with medication overrides with an allergic/adverse reaction status to include documentation of the conversation between the pharmacist and physician/provider regarding the override.

2. Develop standardized severity level definitions.

3. Change in hospital policy with education provided to nurses, pharmacists and physicians/providers with completed education prior to the start of their shift.


On 05/17/18 at 10:00 am, the surveyors accepted the plan of removal.


On 05/17/18 at 3:00 pm, surveyors verified the removal of the immediacy by:

a. Reviewed a list of all current patients with medication overrides with an allergic/adverse reaction. Confirmed through record review that the conversations between the physician/provider and pharmacist were held, documented and visible to the nursing staff.

b. The standardized severity level definitions were observed on the home screen of computers being utilized by staff. Interviews with staff confirmed their knowledge of the definitions and the location of the definitions.

c. The updated hospital policy was reviewed by surveyors, sign in sheets for education were reviewed, and staff interviewed confirmed their knowledge of the change in hospital policy.

Based on record review and interview, the hospital failed to develop policies and procedures to standardize severity levels of allergic/adverse reactions to medications, and the override process of the medications.

This failed practice had the likelihood to affect opiate naïve or opiate tolerant patients due to unsafe, understandable, and consistent processes for the prevention of medication errors. This failed practice resulted in the death of one patient (#4) of 20 records reviewed.

Findings:

11/23/17 at 8:41 am, Patient #4 received an opiate medication, Dilaudid (a derivative of morphine) prior to an MRI procedure. A note in the MAR (medication administration record) indicated that the physician was aware of the allergy to morphine. There was no severity level indicated and no documentation of a conversation between the physician and the pharmacist regarding therapeutic appropriateness of the medication.

05/15/18 at 11:45 am, Staff WW (PharmD) stated the policy utilized for use and handling of medications essential to patient care was titled Medication Management #PHARM004. The policy did not address opiate naïve/opiate tolerant patients, nor did it address the severity levels, the overriding process and the process of documenting ordering providers' awareness of allergic/susceptible reactions to medications. No additional policies and procedures were provided.

05/08/18 at 11:30 am, Staff PPP (RN) stated that nurses would use a different screen to see a reaction, but could see there was an allergy when scanning the patient's bracelet. Nursing could override an allergy.

05/08/18 at 12:00 pm, Staff OOO (RN) stated nursing would call the pharmacy and ask the type of reaction if a severity level was listed as severe. A severity level was not always shown in the medical record.

05/08/18 at 12:00 pm, Staff NNN (RN) stated the severity level was based on clinical judgement and anyone could place it into the record. There was no policy.

05/08/18 at 12:00 pm Staff WW (PharmD) stated there wasn't anything built into Pyxis to alert nursing of an allergy. Pyxis allowed nursing to "get out what you need". When nursing scanned the bracelet, a flag would alert nursing of an allergy, but nursing could override the alert.

05/10/18 at 1:00 pm, Staff K stated that under allergies in the medical record, nursing could click onto the screen and see the reactions; but it wasn't always there.

05/10/18 at 1:15 pm, Staff X (RN) stated he/she wasn't sure if nurses could put in symptoms of allergic reactions. The doctor could choose severity level. The screen "should" indicate severity and reaction type. "I think admitting nurses put in the severity levels and nurses can override allergies".

5/14/18 at 1:00 pm, Staff Y (RN) stated he/she assumed there was a hard stop in the computer system so staff would have to enter a severity level.

5/14/18 at 1:30 pm, Staff A stated the severity field was required and could be free texted. The adverse reaction was the severity field and was required. A nurse could enter an allergy and pharmacy could verify.

05/15/18 at 11:45 am, Staff Y (RN) stated that nursing entered the severity code based on what the patient reported or the reaction observed. Sometimes the computer would indicate exactly what the reaction was; pharmacy could edit allergies.

Based on record review and interview, the hospital failed to establish a process for discussions of questions with the prescribing practitioner, the outcomes and documentation of the discussions in the patient's medical record regarding therapeutic appropriateness of a medication, and real or potential allergies or sensitivities to medications, including opiates.


This failed practice contributed to the death of Patient #4, posed an immediate jeopardy to patient safety and placed any patient with a known or potential allergic/adverse reaction to a medication in an unsafe environment with the likelihood of harm, serious injury or death.


Findings:

On 11/21/17 at 11:23 pm, the Emergency Room (ER) physician noted under allergies that Patient #4 had CNS dysfunction and "requires reversal agent" when given morphine.


On 11/23/17 at 8:41 am, Patient #4 received an opiate medication, Dilaudid (a derivative of morphine) prior to an MRI procedure. A note in the MAR (medication administration record) indicated that the physician was aware of the allergy. There was no severity level indicated and no documentation of a conversation between the physician and the pharmacist regarding therapeutic appropriateness of the medication.


Hospital policy titled "Medication Management" stated under "Medication Allergy Information" that "Prior to dispensing ...the pharmacist is responsible for review of the patient medication allergy information."


On 05/15/18 at 11:46 am, Staff WW (PharmD) stated that the process was for nursing staff to enter allergies into the computer and pharmacy would verify with the ordering provider. The severity level documentation was subjective and could be entered by physician, nursing or pharmacy. Staff V (RPh) stated if the physician was aware of the allergy and ordered the medication, it was "OK to dispense".