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The Condition of Participation for Patient Rights has not been met.
Based on medical record review, review of hospital policies and interviews for one of three patients who had a responsible party (P #1), the hospital failed to ensure that the appropriate legal consent from the responsible party was obtained for P #1's hospital care, surgical procedure and anesthesia administration prior to the procedure, and based on medical record review, review of hospital policies and interviews for one of three patients (P #5 newborn) who were dependent for all activities of daily living, the hospital failed to assess P #5 for fall risk and failed to devise, and/or revise a plan of care to ensure that P #5's safety was maintained to prevent a fall with injury.


Please see A131 and A144

Based on medical record review, review of hospital policies and interviews for one of three patients who had a responsible party (P #1), the hospital failed to ensure that the appropriate legal consent from the responsible party was obtained for P #1's hospital care, surgical procedure and anesthesia administration prior to the procedure. The finding includes:

P #1 resided in a congregate setting and was admitted to the hospital on 6/22/20 with a history of cognitive impairment and chronic kidney disease. MD #1's H&P (history and physical) dated 6/22/20 identified that P #1 had a bladder tumor and understood the need for surgical intervention and planned anesthesia. The H&P further indicated that on the day of surgery the actual decision to proceed with surgery would be a shared decision between the patient, surgeon and anesthesiologist.

P #1's patient information sheet in the clinical record dated 6/22/20 identified that Person #1 was P #1's Conservator of Person (in part, makes all medical decisions/legal representative). A scanned document identified that Person #1 was appointed P #1's conservator by the Probate court on 11/17/2011.

The hospital consent for treatment dated 6/22/20 identified that P #1 signed the consent form as the patient/legal authorized representative. The surgical consent dated 6/22/20 identified that P #1 signed the consent for the transurethral resection of the bladder tumor with right ureteral stent placement. The anesthesia consent documentation noted that P #1 signed the consent for general anesthesia with Anesthesiologist #1.

The operative report dated 6/22/20 identified P #1 underwent a transurethral resection of a 4 cm bladder tumor with right ureteral stent placement.

Interview with Person #1 on 2/23/21 at 2:01 PM indicated that he/she was not contacted for consent for P #1's surgical procedure that was performed on 6/22/20. Person #1 indicated that had he/she been contacted, he/she would have given consent for the surgery.

Interview with MD #1 on 2/23/21 at 1:08 PM indicated that he did have access to P #1's electronic patient information data on 6/22/20, but was not aware that P #1 had a conservator. MD #1 indicated that he had never had to contact a conservator for other procedures that were performed in his office and consented to by P #1.

Interview with Anesthesiologist #1 on 2/24/21 at 9:40 AM indicated that staff associated with preadmission testing would inform the anesthesia department if a patient was conserved and this was not done. He further indicated that the surgeon or nursing staff would also inform the anesthesia provider if a patient was conserved. Anesthesiologist #1 identified that if conservatorship was known, a call would be placed to the conservator and the procedure would not be performed until the consent was obtained, unless the procedure was an emergency.

Interview with the Regional Director of Quality on 2/23/21 at 11:50 AM indicated that a conservator was the person legally able to consent to treatment and procedures.

The hospital failed to ensure that the appropriate legal consent was obtained for P #1's 6/22/20 hospital care, surgical procedure and anesthesia administration.

The hospital policy entitled patient rights and responsibilities identified a right to make informed decisions. The hospital policy entitled informed consents identified that patients or legally authorized representatives giving informed consent have the capacity to appreciate the consequences of their decision. The policy further identified that if a conservator is appointed by the Probate court, the conservator is the legally authorized representative who will grant consent.

Based on medical record review, review of hospital policies and interviews for one of three patients (P #5 newborn) who were dependent for all activities of daily living, the hospital failed to assess P #5 for fall risk and failed to devise, and/or revise a plan of care to ensure that P #5's safety was maintained to prevent a fall with injury. The finding includes:

1. P #4 was admitted to the hospital on 1/19/21 for labor induction, had a history of substance abuse and a urine toxicology was negative at the time of admission. P #4's medications included daily Buprenex (agent for opioid withdrawal) and a toxicology report dated 1/5/21 identified P #4 was positive for Fentanyl (opioid).

Nursing narratives dated 1/21/21 indicated that a "removal" meeting was scheduled for 1/26/21 with DCF (Department of Children and Family) regarding alternate placement of P #4's newborn (P #5).

P #5 was born on 1/20/21 at 38 weeks gestation. P #5's urine toxicology screen dated 1/20/21 identified positive for Fentanyl and Buprenorphine (Buprenex). P #5's H&P (history and physical) dated 1/20/21 identified that P #5 would be monitored for NAS (neonatal abstinence syndrome- drug withdrawal) for 5-7 days.

P #4 signed a pledge form for infant fall prevention on 1/20/21 and was discharged to "boarder status" (provided a room as a visitor not a patient) on 1/22/21. P #4's discharge medications included the continuation of daily Buprenex.

P #5's medical record identified that safety education was provided to the patient/family for fall prevention on 1/21/21. The medical record failed to identify that P #5 was assessed for fall risk and a plan of care for falls was not developed.

Interview with Manager #1 on 2/24/21 at 10:30 AM indicated that the hospital did not have an assessment tool (process/protocol) specific to newborn falls and was currently working on one.

The hospital policy entitled fall prevention and management identified that a fall assessment will be performed upon admission, daily, change in patient condition, post fall and at nurse's discretion. The hospital policy entitled clinical assessment, documentation and care planning identified that completion of risk assessments upon admission can be used to individualize the plan of care. The policy further identified that the care plan must be individualized by adding specific preferences, goals and interventions.



2. In addition, nursing narratives for P #5 dated 1/24/21 at 3:00 AM indicated that P #4 (now a boarder parent) was found sleeping while holding P #5 and safe sleep was reinforced. P #5's plan of care was not updated to address an increased risk for falls due to P #4's unsafe behavior.

Interview with Manager #1 on 2/24/21 at 11:47 AM and on 2/26/21 at 1:09 PM noted that the current electronic medical record would not trigger a plan of care for fall prevention for newborns and would only do so if the newborn had a fall, and that the RN could free- text interventions when documenting the plan of care review.

The hospital policy entitled clinical assessment, documentation and care planning identified, in part, that the patient care overview was completed at the end of every shift and was a review of the overall progress and outcome summary that becomes the plan of care note communicated to the team.




3. In addition, P #5's nursing narratives dated 1/26/21 at 12:50 AM indicated that while holding P #5, P #4 (boarder parent) stated that he/she fell to the knees because his/her feet were swollen, and stated that P #5's head may have touched the ground a little. P #5 was immediately assessed by APRN #1 following the fall and no injury or change was identified. Although no injury was noted, P #5 was brought to the nursery for a two hour monitoring period.

RN #1's narratives for P #5 dated 1/26/21 at 2:49 AM identified that after P #5's two hour monitoring period, P #5 was escorted back to P #4. On entering the room, P #4 was found slumped in the chair and difficult to arouse following 10 seconds of vigorous shoulder shaking. The narrative further indicated that P #4's speech was very slurred. P #4 was returned to the nursery for the night.

On 1/26/21 at 9:45 AM, P #5 was identified with left posterior head swelling, transferred to Hospital #2 and diagnosed with a left parietal skull fracture.

P #4's ED record dated 1/26/21 at 12:46 PM noted negative urine toxicology screens, and two plus significant pitting edema (swelling) to both lower extremities.

Interview with the Regional Director of Quality on 1/23/21 at 1:45 PM identified that "boarders" are considered visitors. She further identified that a nurse is assigned to the baby and would check on the baby to perform assessments and answer questions but the boarder is the main care giver. The Regional Director of Quality indicated that the Hospital did not have a policy for boarder status visitors that would guide staff on measures to ensure newborn safety.

The hospital failed to develop a safe plan of care for P #5 to prevent a fall with injury following P #4's discharge and change to boarder status, and after observing an unsafe behavior when P #4 was found sleeping while holding P #5.

Subsequent to the event, the hospital submitted an immediate action plan for staff education regarding safe sleep reminders. The hospital also submitted a corrective action plan dated 2/25/20 to include an interim education document for newborn fall prevention to include "boardered care givers" with staff education and the future development of a neonatal fall risk assessment and fall prevention/ post fall assessment policy. The hospital was found to be compliant with the plans as submitted on 3/2/21.