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CUERO REGIONAL HOSPITAL
ADMINISTRATION OF DRUGS
Tag No.: A0405
Based on record review and interview, the facility failed to ensure administered medications where appropriately assessed and monitored to evaluate toxicity and adverse effects. Specifically, on 11/3/14 Patient #1 was administered a combination of medications which included Dilaudid (an opioid medication), Ativan (benzodiazepine), Phenergan (antihistamine used for anti-nausea), Zofran (antiemetic), and Topamax (anticonvulsant used for migraines); and there was not appropriate monitoring of respiratory status to include oxygenation, and/or timely interventions by nursing staff upon an identified change in condition of shallow breathing. As a result, Patient #1 expired due to multi-drug toxicity.
Findings included:
Review of the Complaint Investigation Report (CIR) dated 03/31/16, TX 00247287, completed on behalf of Patient #1 by a family member revealed the following allegations in part, against the facility:
The facility may lack a written policy, or have insufficient policies in place, to safeguard against mistakes made by medical professionals in patient care, including written requirements for staff to safely care for patients, or a system of checks and balances/review between staff/team members in coordinating patient care, especially where a supervisor-subordinate relationship exists. For example: LVN #1 entered in her notes that she observed shallow breathing prior to Patient #1's death, but she did not alert any other professionals, or take any further actions to mitigate Patient #1's deteriorating condition caused by the medications administered to her prior to her death.
The complainant further indicated that the Medical Examiner concluded that Patient #1 died of as of a result of "mixed drug toxicity". Further review revealed, the Medical Examiner's Toxicology Report and Supplemental Toxicology Report confirmed the presence of controlled substances prescribed by the facility and clinic.
Review of Patient #1's Physician Admission Progress note revealed on 11/3/14 Patient #1 was admitted with a long-standing history of severe migraine headaches. Her present headache has been in place now for approximately 4-5 days. She was seen Thursday for her headache. She was seen on Friday for her headache. She was seen twice today for her headache, and she has had failed outpatient therapy. She has been treated with Demerol. She has been treated with Nubain. She has had Phenergan for her nausea. She has just not done well. PA #1 saw her this morning and then saw her again this afternoon, and we felt she needed to be admitted as she had not responded to treatment.
Review of Patient #1's Physician Orders (PO) dated 11/3/14 at 15:00 by Physician Assistant (PA) #1 ordered hospital admission for 23 hour observation with diagnosis of "Intractable migraine."
Medications ordered were:
Zofran 4 milligrams (mg) IV (Intravenous) ever (q) 8 hours (hrs) as needed (prn) for nausea,
Benadryl 25mg IV q 4 hrs prn for nausea,
Dilaudid 4mg IV q 4-6 hrs prn for pain, and
Ativan 2mg IV on admission.
Treatment: CT (Computed tomography) of head.
Review of Patient #1's Medication Administration Record (MAR) revealed the following for 11/3/14:
At 17:30 - Lorazepam (Ativan) 2mg IV administered.
At 17:33 - Ondansetron HCL (Zofran) 4mg administered.
At 18:35 - Hydromorphone (Dilaudid) 4mg IV administered.
At 21:25 - Topiramate (Topamax) 100mg tablet administered.
At 22:30 - Hydromorphone (Dilaudid) 4mg IV administered (second dose), and Promethazine 25mg (Phenergan) administered.
Review of Patient #1's Nursing notes revealed the following:
Admission Vital signs by Registered Nurse (RN) #2 on 11/3/14 at 17:13= Temperature (Temp) 99.1, No Blood Pressure (B/P) taken, Pulse (P) 106, Respirations (R) 22, and oxygen saturation percentage (02 Sat %): 99.
Vital signs by Licensed Vocational Nurse (LVN) #1 on 11/3/14 at 19:40= Temp 99.0, B/P 109/60, P 93 (lowered), R 20 (lowered), and 02 Sat %: 94 (lowered).
Nurses Note by LVN #1 on 11/3/14 at 19:40 revealed, Patient aroused "sluggish and drowsy". Denied any pain or discomfort. Skin warm and dry. Color pink. Breathing well with head of bed in high-fowlers. N/C N/V/D or HA (no complaint of nausea, vomiting, diarrhea or headache). Resting quietly in bed, "very sleepy".
Nurses Note by LVN #1 on 11/3/14 at 22:30 revealed, Patient (Pt.) awake complaint (c/o) having bad headache with nausea; noted dry heaving. States I need my pain medicine. Pt hold basin and applied cool wet cloth. Explained will medicate soon.
Hydromorphone 4mg IV administered (second dose), and Promethazine 25mg.
Nurses note by LVN #1 on 11/4/14 at 01:50 revealed, Pt aroused "drowsy and sleepy". C/O headache but "driff" back to sleep. Checked pulse and B/P manually. Pt in high fowlers position "Breathing Shallow."
Vital signs by LVN #1 on 11/4/16 at 01:50= No temp, B/P 110/60, P 80 (lowered), R 18 (lowered), and O2 Sat %: not taken (unknown) and Patient #1 received a second dose of Hydromorphone at 22:30 along with Promethazine.
Nurses note by LVN #1 on 11/4/14 at 04:40 revealed, found Pt unresponsive and lethargic. Color pale and skin cool to touch. Call Code Blue with crash cart brought in room and Cardiopulmonary Resuscitation (CPR) started. Addendum 11/5/14 at 12:42 by LVN #1, Also did sternal rub but unsuccessful with no response. Unable to obtain pulse, B/P, or respirations with head of bed up in high-fowlers position. Noted bottom of feet modeled with bluish discoloration.
Nurses note by LVN #1 on 11/4/14 at 05:00 revealed, Post mortem care given.
Nurses note by RN #1 on 11/4/14 at 05:42 revealed; at 04:42 Nurse (LVN #1) called for assistance to room that Pt was unresponsive. Code blue called and CPR initiated. Family notified of change in status and requested their presence. CPR continued per Emergency Room Doctor, EMS, ICU, and Nursing Staff. CPR continued until 04:55 when ER Doctor ceases all CPR.
During an interview on 12/5/16 at 5:30 PM with LVN #1 stated she did not identify that Patient #1's vital signs were declining from her initial vital signs on 11/3/14 at 17:13 to 11/4/14 at 01:50 because each individual set of vital signs remained normal. LVN confirmed that Patient #1's O2 Sat % went from 99 to 94 on 11/3/14 from 17:13 to 19:40. LVN #1 confirmed she observed and documented Patient #1 had "shallow breathing" along with being "drowsy and sleepy" on 11/4/14 at 01:50 and LVN #1 further confirmed that she did not take Patient #1's O2 Sat % or temperature during the vital signs obtained on 11/4/14 at 01:50 because she, "didn't get to them"; even after she observed and documented shallow breathing along with drowsiness. LVN#1 confirmed she did not notify her supervising RN on duty of the change of condition observed for Patient #1 that included shallow breathing with sluggish, drowsy, and sleepy because she did not know that she needed to notify the RN "right then;" LVN #1 thought Patient #1 was "sleepy and had received medication; didn't want to overstrain her." LVN #1 stated that on 11/3/14 at 01:50 - 02:00 she had multiple patients calling her on the "call bell" and "the phone"; including one that was being demanding, another that was challenged, and she had actually been concerned about another patient at the same time that was next to Patient #1 because the other patient's "02 Sats were dropping, his breathing was irregular, and thought he was going to crash." LVN #1 confirmed the last visual assessment for Patient #1 was documented at 01:50-02:00 on 11/4/14 and then at 04:40 is when Patient #1 was found unresponsive without vitals. LVN#1 stated during that time (11/14) that Patient rounding was to be completed every 2-4 hours.
During an interview on 12/5/16 at 06:10 PM with RN #1 stated on 11/31/4 she had "made rounds earlier in the shift" and had not noted any concerns with Patient #1. RN #1 was unable to indicate the time she made rounds and confirmed that she had not documented her rounds/assessment in Patient #1's records. RN #1 stated it was her first night working back at the facility after being away a year and a half. RN #1 stated she was "doing a lot of stuff that was not used to doing." RN #1 confirmed that LVN #1 had not notified her of any concerns of Patient #1 regarding shallow breathing or drowsy; and stated that patients "sometimes just breath shallow when resting; and [Patient #1] was on pain medicine." RN #1 confirmed that once Patient #1 was observed with shallow breathing that 02 Sats and/or lung sounds should have been assessed for respiratory depression. RN #1 stated she remembered LVN #1 coming to her and reporting Patient #1 was "not responding" and that was when she went immediately to assess and CPR was initiated.
Interview on 12/6/16 at 02:15 PM with the CQO/RN-MSN stated the physician looked at Patient #1's vital signs documented and there was not concern that Patient #1's vital signs had been declining because they were "all within normal limits." The CQO stated Patient #1 was getting pain medicine and; "would expect to see a decline in vitals" and it was determined Patient #1 was "relaxing" after getting relief from her migraine. The CQO stated that 02 Sats were "not a normal vital sign to obtain when doing vital signs."
Review of the facility's Policy at the time of this adverse event titled; Medication, Ordering, Preparing, and Administration, revised 06/11 revealed after administering any medication, especially first dose of a new medication, the health care professional will:
· Monitor the patient's response to the medication, including the patient's perception of side effects and effectiveness, by taking into account clinical information from the medical records, relevant lab values, clinical response, and medication profile.
The policy did not include specific written policy and procedures for opioid administration until further revisions by the facility in 11/15; as an action plan in response to this adverse event (11/4/14) and facility Root Cause Analysis; which included the following updates for opioid administration: Patients receiving IV dosing of Demerol, Dilaudid and Morphine will be placed on telemetry, and for patients on Patient Controlled Analgesia (PCA) Opioid Administration, will be placed on continuous pulse oximetry and telemetry.
Review of the Texas Board of Nursing findings of fact against LVN #1 dated 06/17/2016 determined the following:
7. On or about 11/4/14, while employed as a LVN at this facility; Respondent failed to intervene and notify the Supervising RN when she observed Patient #1, who had been administered Dilaudid, a medication that can cause respiratory depression, with shallow breathing. The patient was found unresponsive at 04:40, six hours after the last dose of Dilaudid, requiring a Code Blue to be initiated and was unsuccessful, and the patient expired. Respondent's conduct was likely to injure the patient in that significant changes in the patient's respiratory status may have gone undictated and prevented a timely intervention.
8. In response to this incident, in Finding of Fact in number Seven, Respondent states that the patient was given 4mg Dilaudid at 22:30 along with Phenergan and the patient was resting and asleep at 23:30. Respondent states that at approximately 01:50, the patient was still resting and had acceptable vital signs, "but her breathing was shallow." Respondent states she believed the patient had finally received relief from her migraine and that her shallow breathing was not a result of any distress. Respondent states she did not notify a supervisor of shallow breathing because that was just one of several vital signs she observed at that time, and the others were acceptable.
Review of the Centers for Medicare and Medicaid Services (CMS) Survey and Certification letter 14-15 dated 03/14/14 revealed updated regulatory guidance for hospitals titled; "Requirements for Hospital Medication Administration, Particularly Intravenous Medications and Post-Operative Care of Patients Receiving IV Opioids." CMS clarified guidance with respect to this regulatory requirement at: §482.23(c)(1), (c)(1)(i) & (c)(2) (Tag A-0405), concerning medication administration in general, to clarify that assessment and appropriate monitoring of patients receiving medications, documentation, and timely intervention when adverse reactions occur are standard components of the medication administration process.
Further review revealed the Assessment/Monitoring of Patients Receiving Medications included; observing the effects medications have on the patient is part of the multi-faceted medication administration process. Patients must be carefully monitored to determine whether the medication results in the therapeutically intended benefit, and to allow for early identification of adverse effects and timely initiation of appropriate corrective action. Depending on the medication and route/delivery mode, monitoring may need to include assessment of:
- Clinical and laboratory data to evaluate the efficacy of medication therapy, to anticipate or evaluate toxicity and adverse effects. For some medications, including opioids, this may include clinical data such as respiratory status, blood pressure, and oxygenation and carbon dioxide levels; and
- Physical signs and clinical symptoms relevant to the patient's medication therapy, including but not limited to, somnolence, confusion, agitation, unsteady gait, pruritus, etc.
Certain types of medications are considered inherently high risk for adverse drug events. Although mistakes may or may not be more common with these drugs, the consequences of errors are often harmful, sometimes fatal, to patients. (See also the discussion of high-risk medications (typically referred to as "high-alert" medications) in the guidance for §482.25(b).
Adverse patient reactions, such as anaphylaxis or opioid-induced respiratory depression, require timely and appropriate intervention, per established hospital protocols, and must also be reported immediately to the practitioner responsible for the care of the patient. (See the guidance for §482.23(c)(5) and §482.25(b)(6), concerning reporting of adverse medication-related events.
An example of vigilant post-medication administration monitoring in the case of a high-alert medication where patient factors may increase risk would be regularly checking vital signs, oxygen level via pulse oximetry, and sedation levels of a post-surgical patient who is receiving pain medication via a patient controlled analgesia (PCA) pump. Narcotic medications, such as opioids, are often used to control pain but also have a sedating effect. Patients can become overly sedated and suffer respiratory depression or arrest, which can be fatal. Timely assessment and appropriate monitoring is essential in all hospital settings in which opioids are administered, to permit intervention to counteract respiratory depression should it occur. (See also the discussion of the requirements for intravenous medications at §482.23(c)(4).
§482.23(c)(4) (Tag A-0409), concerning IV medications. The new guidance includes monitoring of patients for fluid and electrolyte balance, and patient risk assessment and appropriate monitoring to prevent over- sedation and/or respiratory depression related to post-operative patients receiving IV opioids. Hospitals are expected to develop policies and procedures that address, at a minimum, the process for patient risk assessment, including who conducts the assessments.
Hospital policies and procedures related to monitoring patients receiving IV medications are expected to address, but are not limited to, the following:
o Monitoring Patients Receiving High-alert Medications, Including IV Opioids
Policies and procedures related to IV medication administration must address those medications the hospital has identified as high-alert medications and the monitoring requirements for patients receiving such drugs intravenously.
At a minimum, hospitals are expected to address monitoring for over-sedation and respiratory depression related to IV opioids for post-operative patients.
Opioids are a class of medication used frequently in hospitals to treat pain. The sedating effects of opioids make it difficult at times to properly assess the patient's level of sedation. It can be erroneously assumed that patients are asleep when they are actually exhibiting progressive symptoms of respiratory compromise - somnolence, decreased respiratory rate, and decrease in oxygen levels. These symptoms, if unrecognized, can progress to respiratory depression and even death.
Certain characteristics, in addition to those discussed in the medication administration guidance for §§482.23(c)(1), (c)(1)(i) and (c)(2), place patients receiving opioids at higher risk for oversedation and respiratory depression. These additional factors include, but are not limited to:
o No recent opioid use or first-time use of IV opioids
o Increased opioid dose requirement or opioid habituation
o Receiving other sedating drugs, such as benzodiazepines, antihistamines, sedatives, or other central nervous system depressants
Of particular concern are patients receiving IV opioids post-operatively. The effects of IV opioids in post-operative patients must be monitored vigilantly via serial assessments of pain, respiratory status, and sedation levels.
Hospitals must have policies and procedures related to the use of high-alert medications, including IV opioids for post-operative patients. Policies and procedures must address, at a minimum, the process for patient risk assessment, including who conducts the assessments, and, based on the results of the assessment, monitoring frequency and duration, what is to be monitored, and monitoring methods. The policies and procedures must also address whether and under what circumstances practitioners prescribing IV opioids are allowed to establish protocols for IV opioid administration and monitoring that differ from the hospital-wide policies and procedures.
Regardless of the above factors, at a minimum monitoring must include the following:
o Vital signs (blood pressure, temperature, pulse, respiratory rate)
o Pain level;
o Respiratory status;
o Sedation level; sedation levels are important indicators for the clinical effects of opioids. Sedation is a useful assessment parameter to observe the effects of opioids since sedation typically precedes respiratory depression6. See the blue box below for information on sedation assessment methods.
In addition to vigilant nursing assessment at appropriate intervals, hospitals may choose to use technology to support effective monitoring of patients' respiratory rate and oxygen levels.
As part of the monitoring process, staff are expected to include the patient's reports of his/her experience of the medication's effects. Further, when monitoring requires awakening the patient in order to assess effects of the medications, the patient and/or the patient's representative must be educated about this aspect of the monitoring process. In addition, hospitals are encouraged to educate the patient and his/her representative and/or family members about notifying nursing staff promptly when there is difficulty breathing or other changes that might be a reaction to medication.
Hospital policies and procedures are expected to address how the manner and frequency of monitoring, considering patient and drug risk factors, are determined, as well as the information to be communicated at shift changes, including the hospital's requirements for the method(s) of communication.
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