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Based on a review of the restraint log on November 20, 2013, 18 patients were identified who were listed between January 2013 and November 17, 2013 as having died in physical and chemical restraints. The medical records of these 18 patients were reviewed. Since all 18 were intensive care unit (ICU) patients, a further two open ICU patient records were reviewed. Based on the record review and staff interviews, it was determined that the 18 patients listed as having died under physical and chemical restraint were not under chemical restraint when they died and were listed, and reported, erroneously.


The restraint death log contained all of the required elements for patients who died while in soft two-point wrist restraints. However, in the comments section, several patients were noted to have died with soft wrist restraints, siderails, and sedation and/or pain medication. These common interventions were listed as chemical restraints and reported as such to CMS. A review of the corresponding medical records revealed that the medications were administered within the standard of care for end-of-life ICU patients. For example:


Patient 2 was admitted to a medical-surgical (M/S) unit in January 2013 with many chronic medical conditions including diabetes, alcoholism, cirrhosis of the liver, and ascites (an abnormal collection of fluid in the abdomen). Patient no. 2 started seizing and suffered a cardiac arrest on the M/S unit. He was moved to the ICU and continued to deteriorate. He was placed on Fentanyl, a narcotic pain reliever. He suffered another cardiac arrest and was given paralytics and an anti-anxiety medication while he was being intubated and placed on a ventilator. He could not be resuscitated despite aggressive measures. The medical record indicates that this patient had wrist restraints on for three minutes. Even though this patient's care, including the use of narcotics and sedation, was within the standard of care, he was listed on the log as having died in physical and chemical restraints.


Patient 11 was admitted to the ICU in August after arriving at the emergency department in a full cardiac arrest. Approximately one month prior to this, he had suffered a heart attack and had stents placed at another hospital. On the day of admission, he became unresponsive after complaining of chest pain at home. Patient 11 was only inpatient for three hours before his family decided he should have comfort care but no further resuscitation efforts. He died very shortly after this decision was made. He had been placed on a Morphine drip shortly before his death. Even though the use of pain medication at the end of life is compassionate and consistent with the standard of care, he was listed on the log as having died under chemical restraint, and his death was reported as such to CMS.


Patient 13 was found unconscious in the community in September 2013. He was determined to have suffered a narcotic overdose. He was intubated in the emergency department and admitted to the ICU with a very low body temperature, shock, and organ failure brought on rhabdomyolisis, a condition in which muscle tissue breaks down and circulates throughout the blood stream. He suffered several cardiac arrests and was on maximum doses of life-supporting medications. His family agreed to a " Do Not Resuscitate" order on day four and patient no. 13 died. Again, consistent with the standard of care, patient no. 13 was on pain medication and anti-anxiety medication when he died but was listed as having died with wrist and chemical restraints.


These findings were verified in interviews conducted on November 20, 2013 with the RN responsible for compiling the restraint death log and reporting to CMS, and with the Director of the QA department who provides oversight of the listing and reporting process.

Based on review of the hospital's restraint log, it was determined that the hospital failed to use the data collected to monitor the safety of services and quality of care. The log contained a list of the 50 patients that died at the hospital from January 6, 2013 to November 17, 2013. Eighteen of these patients were erroneously noted to be under chemical restraint when they died. According to medical record review of these 18 closed records plus two open ICU patient records, the medications used for these patients were consistent with the standard of care for ICU patients at the end of life.

The erroneous reporting continued for more then 11 months. The lack of oversight of the record abstraction process and the CMS reporting process meant that, had this log represented actual practice, it is unlikely the QAPI department would have identified a possible serious patient care and safety problem and address it through the QA process.

During an interview on November 20, 2013, these findings were verified by the RN responsible for compiling the log and reporting to CMS. In a separate interview on that same date, the Director of the QAPI department also verified the findings and indicated that she had reviewed the log and reporting process as part of her QA oversight.