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Based on observation, interviews and document review, the facility failed to provide continuous pulse oximetry monitoring for a patient with Obstructive Sleep Apnea (OSA), who was also receiving large amount of Opiate pain medication.

The failure prevented timely alerting of staff for intervention when Patient #1 had a change in condition. On hospital day 2, the patient was found unresponsive, did not respond to resuscitation efforts and expired.

FINDINGS:

FACILITY POLICY

According to Hospital Policy and Procedure Obstructive Seep Apnea: Screening and Management, effective 08/19/13, the policy applies to all hospital inpatient and outpatient facilities caring for patients with Obstructive Sleep Apnea (OSA). The policy states that oxygen saturation monitoring is a prudent supplemental assessment measure for patient who have or screen positive for OSA and are receiving opioids or other medications that cause sedation. The policy states that inpatients who have OSA or screen positive for it should be monitored with pulse oximetry (preferably continuous if available) until opioids and other medications that cause sedation are discontinued.

According to Hospital Policy and Procedure Continuous Oxygen Saturation Monitoring, effective 03/01/15, the policy states that patients with a diagnosis of OSA will be placed on continuous pulse oximetry.
NOTE: Although the most recent review of the policy/procedure was after the January, 2015 care of Patient #1, Staff #2 and Staff #3 clarified on 03/09/15 at 12:10 p.m. that these expectations were in found in prior version that was in effect in January 2015.


1. On 01/10/15, at the time of admission, the facility failed to place Patient #1 on continuous pulse oximetry, despite the patient having a diagnosis of OSA and receiving frequent doses of oral and intravenous (IV) opiates for pain control. There was some evidence that the patient might have been placed on continuous monitoring for a few hours during the first night, but the patient was not placed on continuous pulse oximetry throughout the hospital period. There was evidence that the patient's oxygen saturation was checked periodically after admission, in the course of doing routine vital signs. The patient was discovered unresponsive late on the night of 01/11/15, resuscitation efforts were not successful and the patient expired at that time.

a) Review of the medical record for Patient #1 revealed that the patient was initial seen in the Emergency Department on 01/10/15 for acute abdominal pain with a known right ovarian cyst, with elective surgery planned for April, 2015. The had an abdominal/pelvic ultrasound and CT scan, surgical consultation and surgery was scheduled for 01/12/15. The patient was admitted for observation and acute pain management prior to surgery. The patient was receiving oral immediate release oxycodone (Oxy IR) and IV Dilaudid for pain. The patient had a diagnosis of OSA and used a Continuous Positive Airway Pressure (CPAP) machine with supplemental oxygen at home and during the hospitalization.

Further review of the admission history and physical indicated that the patient had the past medical history of:
"1. Hypothyroidism with multinodular goiter, has thyroidectomy surgery planned next month.
2. Type 2 diabetes with gastroparesis and peripheral neuropathy.
3. Obstructive sleep apnea, on CPAP and 2L of oxygen at night.
4. GERD (gastroesophageal reflux disease).
5. Gout.
6. History of upper extremity DVT's x 3, most recently in 2012.
7. History of subdural hematoma in 2003.
8. Hypertension.
9. COPD (chronic obstructive pulmonary disease).
10. Congestive heart failure. However, last echocardiogram in our system, done in 2013, was limited due to body habitus, but showed a normal ejection fraction.
11. Pulmonary hypertension.
12. Chronic lower extremity edema."
The report contained a past surgical history, which stated:
"C1 laminectomy, L1 to L3 laminectomy, appendectomy, cholecystectomy, multiple knee surgeries, including bilateral knee replacements, intestinal bypass that was later reversed and hysterectomy."
The history report also indicated that the patient was taking an antidepressant for diagnosis of depression and that the patient had diagnosis of morbid obesity with BMI of 51.

The record indicated that the patient had pulse oximetery readings done at the following times:
01/10/15 at 20:45 - 91% on 1 liter of oxygen per minute/nasal cannula
01/11/15 at 00:05 - 92% on 1 liter of oxygen per minute/nasal cannula
01/11/15 at 04:00 - 91% on 2 liters of oxygen per minute/nasal cannula
01/11/15 at 07:00 - 91% on 2 liters of oxygen per minute/nasal cannula
01/11/15 at 11:28 - 95% on 2 liters of oxygen per minute/nasal cannula
01/11/15 at 15:15 - 91% on 2 liters of oxygen per minute/nasal cannula
01/11/15 at 20:00 - 92% on 2 liters of oxygen per minute/nasal cannula

A nursing note dated 01/12/15 at 05:44 stated that the patient had been assessed at 22:00 on 01/11/15 prior to receiving bedtime dose of medications and IV Dilaudid and patient had a pulse oximetry reading of 93% on 2 liters of oxygen per minute/nasal cannula. The note also describe the circumstances of the patient being found unreponsive at 23:14 and subsequent resuscitation efforts and actives conducted after the patient was pronounced dead by a physician involved in resuscitation efforts at 23:34.

The records also contained a copy of the autopsy report, provided by a coroner, which stated the cause of death was "cardiomegaly and old myocardial fibrosis." "Comment: Opiate levels are within normal limits. Myocardial fibrosis indicates that the decedent had a previous heart attack that scarred the heart muscle." The report included a diagnosis of morbid obesity with a weight of 310 pounds.

b) Review of facility event review documents revealed that the facility had determined that the patient had not been on continuous pulse oximetry monitoring, as required per policies/procedures related to patients with OSA and those taking large doses of narcotic pain medication. The review also determined that equipment to provide continuous pulse oximetry monitoring of the patient was available for use at the time of the patient's hospitalization.

c) On 03/09/15 at 12:10 a.m., an interview was conducted with staff members #2 and #3 related to the documentation of Patient #1's care during the hospitalization. They confirmed that facility review of the documentation and other investigation activities revealed that the patient had not been on maintained on continuous pulse oximetry monitoring as required by policies and procedures and that equipment to do so had been available at the time. They clarified that the patient had received treatment in the former hospital location and that the facility had just moved to the new campus on the previous week (3/3/15). They stated all rooms on the new inpatient medical-surgical floor (4 North and 4 South) have built in pulse oximetry equipment in every room, making it readily available for continuous pulse oximetry and/or telemetry monitoring.

d) On 03/09/15 at 3:35 p.m., an interview was conducted with Staff #4, one of the nurses that cared for Patient #1 on 01011/15. The nurse confirmed that the patient had been assessed frequently and although drowsy, the patient's pulse oximetry readings were good during the time s/he cared for the patient. The nurse stated that s/he tried to encourage the patient to try take less medication, but the patient insisted s/he had significant pain and wanted everything s/he could have. The patient did agree to hold one evening medication due to some drowsiness after a discussion with the nurse. The nurse confirmed that the patient was assessed frequently by nursing and ancillary staff and appeared to be doing well, but that patient had not been on continuous pulse oximetry monitoring. The nurse had not been aware that it was required and s/he stated that sometimes the equipment was not readily available.

e) On 03/10/15 at 8:55 a.m., and interview was conducted with Staff #6, an ancillary staff member who cared for Patient #1 on 01/10/15 and 01/11/15. The staff member stated that the patient was checked by nurses and ancillary staff frequently and the patient was sleepy at times. but independent and able to get up to the bathroom on his/her own. The patient was frequently removing her CPAP and supplemental oxygen and had to be reminded to put it back on. The staff member stated that the patient was on the phone to family a lot, particularly on 01/11/15 and that s/he had last interacted with the patient to refill the water pitcher, at patient's request, approximately 10 minutes prior to the patient being found unresponsive. S/he stated that the patient looked fine and was on the phone talking to family at that contact. The staff member did confirm that the patient was not on continuous pulse oximetry monitoring, but did have vital signs, including pulse oximetry, at the times listed above from the medical record.

f) On 03/10/15 at 9:30 a.m., an interview was conducted with Staff #7, a nurse that cared for Patient #1 on 01/10/15 and 01/11/15. The nurse confirmed that the patient was very insistent about being in control of when s/he received the pain medication and was afraid if s/he didn't take enough, the pain would get out of control like it had been the night of 01/10/15. The nurse stated that s/he frequently assessed the patient and even though s/he was sleepy, the patient was frequently on the phone with family and getting up to the bathroom with staff as a standby. The nurse stated that s/he had placed continuous pulse oximetry on the patient the night of 01/10-11/15 after the patient had gotten CPAP hooked up and finally ready for bed at about 2:00 a.m., after the bedtime medications had finally arrived. The nurse stated that s/he had planned to place the patient on continuous pulse oximetry again during the night of 01/11-12/15 after the respiratory therapist had checked out the CPAP machine for the night and the patient had put it on and was ready to go to bed. The nurse state that the respiratory therapist had fixed the CPAP machine for bedtime, but the patient was still on the phone. S/he planned to approach the patient again about setting up the overnight continuous monitoring after the nurse had finished giving other patient medications and when patient done with phone calls, when s/he got the notification that patient had been found unresponsive an a CODE was called for full cardiac resuscitation. The nurse stated that s/he would have initiated continuous pulse oximetry monitoring if there had been any indication that the patient was not being adequately oxygenated. S/he stated the patient had looked good, remained active and pulse oximetry readings were stable. S/he had not been aware that continuous pulse oximetry monitoring was mandatory for this patient.

g) During an interview with Staff #3 on 03/11/15 at 10:10 a.m., the staff member provide a copy of an audit conducted at the facility from 01/16/15-03/2/15 indicating that the nursing medical-surgical units (which was where patient #1 had received care) had conducted an audit of continuous pulse oximetry monitoring on OSA patient and found them to be 100% compliant.

h) On 03/10/15 at 9:40 p.m., during a tour of the medical surgical-units, Patient #11, who had been identified by the charge nurse, Staff #13, as a patient with OSA. The patient observed to have a finger probe taped on to right hand for pulse oximetry, but the monitoring had been activated at the unit at the head of the bed. The charge nurse immediately activated the monitoring and stated the patient was a newly admitted patient. Review of the patient's medical record reviewed that the patient had been on the unit for more than an hour and was settled in his/her bed with spouse visiting.

Based on observation, interviews and document review, the facility failed to ensure that a nurse obtained a physician order to hold a medication prescribed to prevent the development of a Deep Vein Thrombosis (DVT) in a patient with a prior history of developing DVT's.

The failure prevented the administration of the medication, as intended by the physician, for Patient #1, who had a history of Deep Vein Thrombosis (DVT) development that the physician was attempting to manage with anticoagulant therapy prior to surgery.

FINDINGS:

FACILITY POLICY

According to Hospital Policy and Procedure Orders for Patient Care, last reviewed 03/01/15, orders for administration of drugs and biologicals must be prescribed by a physician or other licensed independent practitioner (LIP).
NOTE: Although the most recent review of the policy/procedure was after the January, 2015 care of Patient #1, Staff #10 clarified on 03/10/15 at 4:00 p.m. that these expectations were found in the prior version that was in effect in January 2015.

According to Hospital Policy and Procedure Medication Administration Monitoring, last reviewed 03/01/15, during the medication order verification process, if a nurse encounters any errors, concerns or questions about a medication order, the nurse is expected to contact the ordering physician/LIP for clarification. A medication hold order is written by the physician/LIP. If a medication is not given in the timeframe ordered, the prescribing physician/LIP should be notified and the circumstances documented.
NOTE: Although the most recent review of the policy/procedure was after the January, 2015 care of Patient #1, Staff #10 clarified on 03/10/15 at 4:00 p.m. that these expectations were found in the prior version that was in effect in January, 2015.

1. On 01/11/15, Staff #7, a nurse that provided care to Patient #1, made the decision to hold the dose of Lovenox that was scheduled to be given to Patient #1 at 21:00 for prevention of a Deep Vein Thrombosis (DVT) because of a prior history of developing DVT's. The nurse allegedly believed that it was standard practice to suspend use of an anticoagulant medication just prior to surgery to prevent uncontrolled bleeding in the surgery. The nurse did not have an approved/ordered protocol to allow the medication to be held. The nurse did not contact the physician to get an order to hold the medication in question, as required by facility policies/procedures regarding medication orders.

a) On 03/10/15, a review of the medical record of Patient #1 revealed that the patient with multiple medical problems, including a history of DVT's in upper extremities was seen in the Emergency Department (ED) on 01/10/15 for severe abdominal pain, was scheduled for abdominal surgery surgery on 01/12/15 for a suspected ovarian torsion and an ovarian cyst. The patient was admitted for inpatient care, including administration of intravenous and oral narcotic pain medication, The patient was admitted to the hospital with a sub-therapeutic level of anticoagulant medication. The patient's physicians ordered doses of an injectable anticoagulant (Lovenox) to prevent DVT's that were to be given prior to surgery. The orders sent from the pharmacy scheduled a dose of Lovenox to be administered on 01/11/15 at 21:00. The nurse held the order, but did not call the ordering physician to clarify the situation/provide an order to hold the dose at 21:00, as required by facility policies/procedures.

b) On 03/10/15 at 9:30 a.m., Staff #7 was interviewed and confirmed that the 21:00 Lovenox dose that was scheduled to be given on 01/11/15 was held. The nurse confirmed that the decision to hold the dose was based on his/her belief that it was a standard of care and usual practice to hold the anticoagulant medication just prior to surgery to prevent uncontrolled bleeding during surgery. When asked if there was a hold order specific to the patient or an order protocol that provided that direction, s/he was unable to provide anything specific that provided that directive. The nurse also confirmed that s/he did not call the physician to get an order to hold the medication.

c) On 03/10/15 at 4:00 p.m., Staff #10, who was a supervisor of Staff #7, confirmed that the policies that were in effect in January 2015 and currently require that a nurse needed to have or should have acquired an order from a physician to hold the 21:00 dose of Lovenox that the nurse was supposed to give on 01/11/15.

d) On 03/09/15 at 12:10 p.m., Staff #2 and Staff #3 stated that Staff #7 did incorrectly hold the 21:00 dose of Lovenox on 01/11/15 without getting a physician order, as required by hospital policies/procedures.