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Based on interview, record review and policy review, the facility failed to have systemic practices in place to monitor and ensure adequate evaluation and an increased level of supervision for the nursing care needs of Patient #8, a known amphetamine (an addictive mood altering drug) and methamphetamine (a drug with more rapid and lasting effects than amphetamine, used illegally as a stimulant) user. This failure resulted in Patient #8 being found behind her locked bathroom door with an open head injury, without pulse and respirations, and with a syringe inserted into an indwelling intravenous (IV, in the vein) catheter (small, flexible tube inserted into the body) that contained a white residue. Resuscitative efforts were unsuccessful and the patient expired. Two additional syringes that each contained a white residue and a third syringe that contained one-half of an IV flush were found in her purse located on the bathroom floor. The cause of death was identified on the autopsy report as a mixed drug intoxication that included methamphetamine, hydrocodone (opioid pain medication), oxycodone (a synthetic pain medication similar to morphine), and bupropion (a drug used to treat depression).

After this death was reported, the facility also failed to prevent the potential for reoccurrence with Patient #16, when they failed to educate all staff and failed to ensure staff followed the steps listed in their "Opportunities for Improvement Action Plan" dated 11/14/18, which included that the facility would:
- Develop, educate, and implement the new hospital policy titled, "Suspected Inpatient Controlled Substance Abuse/Misuse Policy."
- Perform additional toxicology testing ordered by the provider.
- Avoid multiple line placements when possible.
- Try to ensure patient's room doors and bathroom doors remain open at all times.
- Cover IV access devices with tamper-proof sticker when not in use.

These failures had the potential to affect all patients admitted to the facility. (Refer to A-0395)

The severity and cumulative effect of these systemic practices resulted in the facility being out of compliance with 42 CFR 482.23: Condition of Participation: Nursing Services.

The facility census was 232.

Based on interview, record review and policy review, the facility failed to ensure nursing staff followed policy, identified, assessed, treated, documented and appropriately responded to the care needs for two patients (#8 and #16) of 18 patients reviewed who tested positive for street drugs or had a history of drug addiction (a chronic, relapsing disorder characterized by compulsive drug seeking) as a known risk. These failures resulted in the death of Patient #8 and placed all patients at increased risk for injury or death. The facility census was 232.

Findings include:

1. Review of the facility's policy titled, "Sitters for Patient Safety," revised 07/2018, showed:
- A sitter was an alternative method of keeping the patient free of harm to himself or others, without restricting physical activity;
- If a patient had removed a non-surgically placed device multiple times, a sitter could be considered; and,
- An assigned sitter would be responsible for total care of the patient, maintain patient safety, and be responsible to monitor and document all patient behavior.

Review of the facility's policy titled, "Tobacco-Free and No Smoking," reviewed 03/2018, showed:
- It was the expectation that all employees assisted with informing and enforcement of the policy.
- The use of tobacco and cigarette simulators was prohibited in all facilities and on all property.
- Patients and visitors were expected to follow the policy and not smoke, use tobacco, or use cigarette simulators anywhere on facility property or facilities.
- Employees, patients, and visitors were expected to refrain from smoking and/or using tobacco on all neighboring properties.

Review of Patient #8's History and Physical (H&P), showed she was a 34 year old female, that
- On 10/22/18, during dialysis (clinical purification of the blood, as a substitute for the normal function of the kidneys), became extremely ill and presented to the Emergency Department (ED) where blood cultures (a test to detect organisms such as bacteria and fungi that are present in the blood) were obtained; however, she eloped prior to evaluation by the provider.
- On 10/23/18, initial blood cultures began to show positive results (indicated bacteria or fungi was growing in her blood). She was contacted by the facility and instructed to return to the ED immediately to be evaluated and treated.
- On 10/23/18 at 12:18 PM, she presented to the Emergency Department by ambulance, where she was evaluated and subsequently admitted for sepsis (life threatening condition when the body's response to infection injures its own tissues and organs).

Review of Patient #8's Nephrology (branch of medicine that deals with the kidneys) Consultation Report dated 10/23/18, showed:
- She was a current smoker.
- She had a history of non-compliance.
- She had a history of past IV drug abuse with endocarditis (infection of the heart's lining).

Review of Patient #8's medical record showed a urine drug screen dated 10/24/18, which resulted positive for opiates (opioid, a drug with morphine-like effects), oxycodone (a synthetic pain medication similar to morphine), amphetamines (a synthetic, addictive, mood-altering drug, used illegally as a stimulant), methamphetamines (a synthetic drug with more rapid and lasting effects than amphetamines, used illegally as a stimulant), and benzodiazepines (a class of drugs that act as tranquilizers).

Review of Patient #8's Nursing Care Plans dated 10/23/18 through 10/26/18 showed that it addressed the patient's anxiety, impaired communication, developmental age (18-40 years) knowledge deficit, impaired physical mobility, pain and smoking, but did not address drug abuse.

Review of Nursing Documentation for Patient #8 showed:
- On 10/24/18 at 6:00 AM, Staff PP, Registered Nurse (RN), documented the patient was high anxiety with multiple requests for pain and anxiety medication.
- On 10/24/18 at 5:34 PM, Staff MM, RN, documented the patient asked when she would be moved out of ICU so she could go out to smoke. The patient verbalized awareness of the no-smoking policy, indicated that her car was onsite, and that she would return when finished.
- On 10/24/18 at 8:10 PM, Staff OO, RN, documented the patient was transferred to the Transitional Care Unit (TCU).
- On 10/24/18 at 8:30 PM, Staff NN, RN, documented the patient wanted to go outside, was educated regarding her status on the critical care unit and that she was unable to leave the floor. The patient's visitor became argumentative, and demanded the patient be allowed to go outside.
- On 10/25/18 at 8:50 PM, Staff NN, RN, documented Staff K, DO, was notified that the patient requested an increase in pain medications, and Staff NN requested to transfer the patient to another unit or floor, as she continuously unhooked herself from the monitors (devices used to continuously monitor a patients heart, breathing and oxygen status) and left the floor.
- On 10/26/18 at 6:00 AM, Staff NN, RN, documented the patient was noted to have been wheeled up and down the hallways by a friend, and upon return to the room, smelled of smoke. The patient continued to unhook herself from the monitors and did not reapply the monitors upon return.
- On 10/26/18 at 9:57 AM, Staff JJ, RN, documented she reassessed the patient's pain level at 9:36 AM, following pain medication administration at 9:05 AM, and her pain level was zero.
During an interview on 11/27/18 at 10:55 AM, Staff I, Vice President of Nursing Services, stated that the expectation of nursing staff would be to contact the provider when a patient was non-compliant.

During an interview on 11/27/18 at 1:58 PM, Staff K, DO, stated that if nursing staff suspected a patient was going out to smoke, they should notify security, and added that he did not usually change a patient's level of observation after a positive urine drug screen was obtained and the patient exhibited drug-seeking behaviors.

During an interview on 11/27/18 at 2:18 PM, Staff L, RN, Transitional Care Unit (TCU) Charge Nurse, stated that she began her shift on 10/26/18 at approximately 6:00 AM, and she received in report that Patient #8 left the unit frequently to go out to smoke and the physician had given permission for her to do so.

During an interview on 11/27/18 at 2:56 PM, Staff O, Nurse Tech (NT), stated that:
- On 10/26/18 at approximately 8:00 AM, she saw Patient #8 headed outside to smoke.
- Most patients did not leave the unit to smoke.
- She was unsure if Patient #8 had a physician's order to go smoke, but the physician was aware the patient went outside to smoke.
- She received in report that Patient #8 went outside frequently to smoke, and that everyone was aware the patient did this.

During an interview on 11/27/18 at 3:58 PM, Staff JJ, RN, stated that:
- On 10/26/18, she was the primary nurse for Patient #8, and it was the first day she provided her care.
- Patient #8 was not in her room during nurse-to-nurse patient report at the patient's bedside.
- During the 8:00 AM assessment, the patient stated she had gone to smoke earlier. The patient requested pain medication; however, the medication was not due until 9:00 AM.
- At approximately 9:05 AM she returned to Patient #8's room and administered insulin and the pain medication, Oxycontin. Staff JJ stated that was the last time she saw Patient #8.
- Patient #8 did not have a physician's order to go outside to smoke.

During an interview on 11/27/18 at 1:40 PM, Staff J, Housekeeper, stated that:
- On 10/26/18 at approximately 10:20 AM, she entered Patient #8's room and no one was in the room.
- She noticed the bathroom door was closed. She knocked on the door and stated, "Housekeeping"; however, she did not receive an answer.
- She assumed the patient was in the shower.

Review of Patient #8's Code Blue (emergency situation where a patient's heart or breathing stopped, and staff quickly respond with a process specific to restoring the heartbeat or breathing) Provider Note dated 10/26/18 showed:
- At approximately 10:45 AM, the patient could not be located and her door was locked.
- When the door was unlocked and opened, she was found lying face down on the floor, unresponsive, and no pulse was detected. A syringe was noted to be connected to her intravenous catheter (IV-small, flexible tube placed into a vein).
- A Code Blue was initiated immediately.
- The Code Blue was terminated after approximately 35 minutes of continued attempts to restore life, and death was pronounced at 11:32 AM.
- Due to the suspicious circumstances, the Coroner's Office and detectives with local law enforcement were notified.

During an interview on 11/27/18 at 2:44 PM, Staff N, RN, ICU Charge Nurse, stated that:
- On 10/26/18 at approximately 11:00 AM, she attended the code blue for Patient #8.
- Upon entrance to the room, she noticed "our syringe" was already connected to Patient #8's intravenous (IV, in the vein) catheter. The syringe had white residue. Another nurse handed the syringe to Staff N and she placed it into a biohazard bag.
- She searched Patient #8's purse and retrieved two additional syringes with residue and one that was one-half of an IV flush. All items were placed into the same biohazard bag for evidence.

Review of Patient #8's facility-provided summary reports titled, "Report of Autopsy" and "Toxicology Report," received from the the County Coroner's Office, showed the cause of death was drug intoxication: methamphetamine, oxycodone (opioid), hydrocodone (opioid), and bupropion (antidepressant).

During an interview on 11/27/18 at 9:30 AM, Staff H, Director of Risk Management, stated that as of 10/26/18, there wasn't a policy or procedure to implement close monitoring of patients that were admitted with a positive urine drug screen and exhibited drug-seeking behaviors.

2. Review of the facility's policy titled, "Suspected Inpatient Controlled Substance Abuse/Misuse", dated 10/30/18, showed:
- All patients would be assessed upon admission for risk of controlled substance abuse or misuse while hospitalized.
- If the RN determined the patient to be high risk, the Electronic Medical Record would automatically trigger a patient individualized plan of care and interventions to be ordered and implemented.
- High risk patient were defined as any patient identified as a potential candidate for abuse/misuse of controlled substances while admitted to the hospital, based upon clinical findings that care providers have observed or assessed.

Review of the facility's policy titled, "IV Access Devices", dated 10/30/18, showed:
- Personnel that care for patients with IV access devices must be cognizant of the potential for patients to self-administer illicit (street drugs) or controlled substances (drugs or medications that are high risk for personal consumption or abuse) through the device.
- Further actions should be considered based on results of evaluation, reports of consultants, and/or discussions with the patient. These actions may include but are not limited to; utilization of tamper-proof sticker over IV access, avoidance of multiple line placements, when possible, placement of IV in dominant arm, when possible and, removal of unnecessary supplies from the patient's room.
- Upon confirmation of actual abuse or misuse of controlled substances the provider would be immediately notified, security notified for a visual search of the patient's room and belongings, and toxicology testing per physician order. If continued suspicion, consider getting a consult for the use of a sitter.

Review of the facility's document titled "Opportunities for Improvement" showed education to clinicians on controlled substance abuse and misuse would be completed on 11/14/18.

Review of the H&P for patient #16 showed:
- She was a 30 year old female admitted on 11/24/18 at 1:54 AM, with a chief complaint of an abscess (a collection of thick fluid caused from infection) on the lateral aspect of her right thigh.
- She had a past history of Hepatitis C (an infection caused by a virus that attacks the liver, can be caused by IV drug use) that had not been treated.
- She reported she had used IV drugs about a week ago. She missed the vein and injected Methamphetamine into the tissue of her right thigh.
- She confessed to self-destructive behavior and reported whenever she could not find a vein to inject she would randomly stab her arms or legs.

Review of Patient #16's Surgery Consultation Notes showed:
- She was homeless.
- She reported IV Methamphetamine use for some time and she would inject it into her right thigh.
- She had several areas on her arm where she had injected the drug.
- She had mild phlebitis (inflammation of a vein) in her left antecubital fossa (the triangular area in front of the elbow).

Review of Patient #16's Physician's Progress note dated 11/26/18, showed staff notified him that Patient #16 had made suicidal comments. She reportedly told staff she was tired of the hospital and just wanted to go to sleep and never wake up. The patient had a significant psychiatric and substance abuse history.

Review of Patient #16's Nursing Care Plan dated 11/24/18 showed that it addressed the patient's anxiety, falls, impaired skin integrity with open wounds, pain and smoking. Interventions were based on these specific problems, and did not address drug abuse.

Review of Patient #16 Nursing Documentation showed:
- The admission assessment was completed on 11/24/18 at 3:54 AM and the patient told the nurse she smoked and she abused IV Methamphetamines.
- Nursing made no further documented references of IV drug abuse in the medical record.
- On 11/26/18 the patient told staff she wanted to sleep forever and she no longer wanted to be in the hospital.
- On 11/27/18 the patient was discharged. She received education on wound care, smoking cessation, and polysubstance (multiple drugs) abuse.

During an interview on 11/27/18 at 10:00 AM, Staff Z, RN, stated that:
- Patient #16 was admitted due to an abscess on her thigh that was caused when she injected methamphetamines and missed the vein.
- She knew about the patient's self-destructive behavior and drug abuse but did not report this to the physician.
- She received this information in report from the nurse who took care of the patient on the night shift.
- She received the education on drug abuse and IVs.
- The patient's IV ports did not have a sticker on them.
- She had not implemented the interventions and she had not made any changes or updates to the care plan.

During an interview on 11/27/18 at 1:58 PM, Staff K, DO, stated that he had not received education on new or revised policies and procedures related to inpatient drug abuse and IVs, after the death of Patient #8 on 10/26/18.

During an interview on 11/27/18 at 1:40 PM, Staff J, Housekeeper, stated that she had not received education on new of revised policies and procedures related to inpatient drug abuse and IVs, after the death of Patient #8 on 10/26/18.

During an interview on 11/27/18 at 3:10 PM, Staff I, Vice President of Nursing Services, stated that not all of the facility providers had been educated on newly implemented and changed policies and procedures since the death of Patient #8 on 10/26/18.









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