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Tag No.: A0385
Due to the manner and degree of the findings, this Condition of Participation (42 CFR 482.23 Nursing Services) was found out of compliance.
Based on observation, interview, medical record review, and policy review, the provider failed to ensure:
*Documentation was in place to support:
-The administration of a mind altering and sedating medication (med) to one of one sampled patient (2) prior to his discharge from the facility by one of one registered nurse (RN) C.
-One of one sampled patient (2) had been assessed and monitored for the effectiveness of an as needed (prn) antipsychotic med which had been administered to him for verbal and physical aggression by one of one RN C.
*The approved policy and procedure for:
-Administering medications with a dose range was followed by one of one RN C.
-Documentation by the licensed staff to support individualized care and status update had occurred for one of one sampled patient (2) while under the care and oversight of one of one RN E.
*Staff were knowledgeable of recent education provided to them on the required documentation for medication administration via email and daily morning huddles.
Findings include:
1. Interview and review with accreditation manager A on 5/11/21 at 2:30 p.m. of patient 2's medical record revealed:
*He had been admitted on 4/25/21 and discharged on 4/28/21.
*He had multiple complex medical problems including:
-A current right frontal subdural hematoma from an unwitnessed fall at the long term care facility (LTC) he was admitted from.
-Atrial fibrillation which required the use of an anticoagulant (blood thinner) med twice a day. He had been anticoagulated at the time of his fall with abnormal lab results.
-Parkinson's disease.
-Anxiety, agitation, and depression.
-Confusion with a diagnosis of dementia without behavioral disturbances. He was alert and oriented to self only.
-Failure to thrive.
-Blindness in the right eye and hard of hearing.
*After the fall he had loss consciousness of an unspecified amount of time upon initial encounter and assessment by the LTC facility.
*He had a long standing history of:
-Verbal and physical aggression towards others and required the use of an antidepressant and an antianxiety med to help with his mood.
-Refusing to eat, drink, take his prescribed meds, and accept assistance with personal care.
-Falls related to his confusion and poor safety awareness.
*A computed tomography scan of the brain was done on 4/25/21 and supported a small right frontal subdural hematoma which was in stable condition.
*Upon admission to the emergency department he was alert to self, confused, and withdrawn.
*His discharge goal was to return to his prior living arrangement once his condition returned to baseline.
Continued interview and review with accreditation manager A on 5/11/21 at 4:00 p.m. of patient 2's nursing notes and assessments from 4/25/21 through 4/28/21 revealed:
*He continued to be confused, easily agitated, verbally and physically aggressive with staff during assessments, personal care, and processes that would have required close contact with him.
*He could have Haldol (antipsychotic) 1 to 2 milligrams (mg) per intravenous (IV) prn every four hours for increased agitation and behaviors.
-From 4/25/21 through 4/28/21 he was administered IV Haldol for increased behaviors seven times.
*On 4/26/21:
-Certified nurse practitioner (CNP) K ordered Zyprexa (antipsychotic) 5 mg to 10 mg per intramuscular (IM) every hour prn for agitation and resistance with cares.
-He received two doses of prn Haldol during the night shift for increased behaviors at 6:32 p.m. and 2:04 a.m.
-There was no documentation to support he had required a dose of Zyprexa.
*On 4/27/21 from 7:00 a.m. through 7:00 p.m.:
-RN E had not completed a care plan note to support the patient's status and condition for that shift.
-There was no documentation that he required any additional medications for increased behaviors during that timeframe.
*On 4/28/21:
-He was to be discharged from the facility that morning via wheelchair express and return to the LTC setting he resided at prior to his admission.
-At at 8:58 a.m. RN C documented on the patient's flowsheet note that he was agitated, restless, confused, and verbally aggressive.
-At 10:06 a.m. RN C documented on the patient's care plan note that he was alert, cooperative, had clear speech, followed commands, vital signs were stable, and he took all of his meds.
-At 10:50 a.m. he was given 10 mg of Zyprexa by IM injection.
*On 4/28/21 there were no nursing assessment or documentation to support:
-The purpose and reason for the administration of Zyprexa at the highest dose possible ordered for him at approximately forty-four minutes later.
-He had been monitored and assessed for possible side effects after the administration of a med he had not taken before.
-Follow-up assessments for the effectiveness of that med without adverse effects.
-A safety concern for him to be discharged to a facility that was over an hour away.
-He had received Zyprexa ten minutes prior to his discharge from the hospital.
*RN C completed a phone handoff report on 4/28/21 at 11:22 a.m. to the receiving facility.
-He was discharged from the hospital as planned at approximately 11:00 a.m.
-He was transported to the LTC facility he was admitted from via wheelchair express.
-The distance from the hospital to that facility was seventy-eight miles away and over an hour long drive.
Review of the complaint call and narrative the South Dakota Department of Health (SD DOH) received on 4/28/21 at 2:01 p.m. regarding patient 2 revealed:
*He had been administered a dose of Zyprexa minutes prior to his discharge.
*He arrived at approximately 1:00 p.m. via wheelchair express to his receiving facility.
*The van driver had restrained him with a bedsheet because he was falling forward in the wheelchair and was unresponsive.
-He was worried the patient would fall out of the wheelchair.
*He was immediately assessed by the accepting facility and his blood pressure (b/p) was critically low at 70/40 millimeters of mercury.
*The primary care provider and family was notified of his current condition upon admission with orders given to monitor closely, complete neurology checks, and administer oxygen at 2 liters per minutes.
2. Interview on 5/11/21 at 12:20 p.m. with RN G revealed she:
*Confirmed the nursing staff were able to administer meds that had range doses. The policy was for them to start low and go slow.
*Stated:
--"It would be rare to give the high dose unless you could support the reason for it."
--"I don't remember ever giving an antipsychotic med prior to a patient discharging. To me, their condition wouldn't be stable and I probably wouldn't discharge them then."
--"We can request them to stay longer if we don't think they are stable enough to leave."
--"Yes, we should assess a patient before and after giving a prn med. We are to chart that information too."
--"To my knowledge we haven't had any education on med administration and documentation recently. I know that is something we do with our yearly training."
Interview on 5/11/21 at 12:22 p.m. with RN L revealed she confirmed:
*A patient should have been monitored for 30 minutes or longer when they were administered a new med.
-That would have allowed time to determine how well the patient had tolerated the new med.
*There had been several items to consider when administering a med with a dose range. Some of those items had been:
-The history of the patient should have been reviewed and compared to his current condition.
-Critical thinking should have been involved in determining the dose to start with.
-To follow the policy of start low and go slow.
-Documentation should have been in place to support actions taken when administering a med with a dose range.
*She stated:
-"I'm not sure why a high-risk med would be given before discharge."
-"If it was, then maybe more education was needed."
-"Can always reach out to the director [nurse manager] as a resource if there are questions."
Interview on 5/11/21 at 12:45 p.m. with case managers H, I, and J revealed:
*They had been responsible for discharge planning from the time a patient was admitted through their discharge date.
*The discharge plan and date was flexible and could have been adjusted as needed.
*They would have tentatively put in a discharge date, but the physician's discharge order and assessment would have been a guide to determine if the patient was safe for discharge.
*Should there had been a change in the patient's condition the day of discharge, it would have been the floor nurse's responsibility to work with the physician and determine if the discharge should be placed on hold.
Interview on 5/12/21 at 9:31 a.m. with RN C regarding patient 2 revealed:
*She had remembered the patient and the day she had taken care of him.
*He was scheduled to be discharged from the hospital on that day.
*She stated:
-"He was cooperative in the morning with breakfast and his pills, but then he started getting physical and verbally abusive when getting him ready for discharge."
-"He pulled out an IV and I then pulled out the other one."
-"I gave him some Zyprexa and put in a Foley. He was still physically and verbally abusive at that time."
*She had:
-Given the Zyprexa between 10:30 a.m. and 11:00 a.m.
-Discharged him to the receiving LTC facility between 11:30 a.m. and 12:00 noon.
*His behaviors had been minimal to no change prior to his discharge from the facility.
*She stated:
-"The van driver was asking about his behaviors and if he was going to be okay and not get out of the chair."
-"I told him, I gave him something 45 minutes ago."
*She had done a handoff report with the receiving facility.
-The report included the insertion of the Foley catheter and administration of the Zyprexa for his behaviors.
*She stated:
-"I didn't really know how far he had to travel."
-"Sometimes we give people Ativan or something to keep them calm and comfortable for the ride."
-"Case management had asked me to give him something for the ride. Sometimes they do that so I didn't think anything of it."
-"I didn't have IV access anymore and so I discussed with case management that my only option was to give him Zyprexa."
-"He had Zyprexa 5 mg to 10 mg ordered."
-"With range orders it's the nurse's discretion on what dose to give."
*For pain medication staff should start low and go slow.
*She had given him the highest dose of the Zyprexa order due to:
-He had required the use of prn Haldol during the night for increased behaviors.
-The distance he had to travel and there had been multiple things to complete for him prior to his discharge.
*She stated:
-"We were having trouble getting him out the door."
-"I thought once we stopped bothering him, he would mellow out."
*She had been comfortable with his discharge to the LTC facility because he had a history of aggressive and verbal behaviors at the nursing home.
*She stated: "He was at his baseline and I don't know what I could have done differently."
*She confirmed:
-The minimum requirements for shift documentation was one care plan note and a daily assessment in the flowsheet notes.
-The expectation was to have documentation prior to giving a med such as Zyprexa.
*She stated:
-"No, I don't believe you have to chart anything after you give it."
-"Just an assessment before hand."
-"You should find a note by me before I gave it."
*To her knowledge there was no discussion or education related to medication administration recently.
*She had:
-Received a recommendation that she should have documented in more detail regarding his discharge process.
-Stated: "In our daily huddle meeting there was a review done to make sure we do post assessment vitals after giving an antipsychotic. Nothing further."
Interview on 5/12/21 at 10:20 a.m. with RN F revealed:
*She was the nursing director on unit 4000.
*Each unit was treated individually and that included determining what additional education was needed for the staff.
*Annually all staff completed Sanford learn modules on medication administration and medications ordered in ranges.
*The medication administration policy indicates to "start low and go slow" with med range orders.
*She confirmed the minimum documentation requirements per shift had been:
-A care plan note at the end of each shift to summarize about their routine during the day.
-A flow sheet assessment and any other note the staff deem appropriate.
*The staff were to have completed a Discharge Navigator at the time of discharge to discuss:
-Who you handed the report off to?
-Any special requirements completed.
-Where they were discharged to.
*There are times when a patient might require meds to be given prior to their discharge.
-The patient should stay longer if that med is new to them.
-There should be documentation to support how the patient tolerated the med and if they returned to their baseline.
*Several LTC facilities would refuse to take a patient if they were on Zyprexa or Ativan and it was new to them.
-Most nursing homes would require those patients to be weaned off of those meds prior to taking them back.
Interview on 5/12/21 at 1:23 p.m. with RN E regarding patient 2 revealed:
*RN E had admitted him to the floor and then a couple days later transferred him to another floor.
*He had:
-Been verbally and physically aggressive upon admission from the emergency department (ED).
-Required a constant observer and was administered IV Haldol for those behaviors in the ED.
*He:
-Refused cares and was aggressive towards RN E when he attempted to draw blood for lab work.
-Was much calmer on the second day and was transferred to another unit that evening.
*RN E was not aware on 4/27/21 he had not completed the minimum required shift documentation on the patient.
*RN E stated:
-"We are supposed to document at least three times a day."
-"I rarely miss my charting so if it's not all there, yes, it should have been done."
*RN E confirmed:
-All prn meds required a follow-up assessment and documentation to support the purpose for administering it.
-There should have been a follow-up note 15 to 30 minutes post administration.
-Meds that had a range order should have been administered with the lowest dose initially and slowly increase the dose as tolerated.
*He could not recall the last time med administration education had been completed.
-Training on medications that were ordered in a dose range would have been covered during initial orientation.
-There was required yearly training on med administration.
3. Review of the 5/3/21 Action Items/Plan provided to the SD DOH complaint department revealed:
*"Nursing director will provide remedial education regarding required documentation with the involved nurse during the next scheduled shift."
*"Starting 5/3/21, the nursing director will provide education to all nursing staff via email and daily huddles regarding required documentation."
*"Starting 5/10/21, the nursing director or designee will complete 20 audits a month for three months to monitor assessments and reassessments of PRN medication documentation."
*"Compliance will be reported to Quality Council at the end of three months. At that time, Quality Council will determine the need for ongoing compliance monitoring."
Review of unit 5000 huddles notes and email to all staff from director M dated 5/7/21 revealed:
*On 5/7/21 at 11:12 a.m. she had sent an email to all staff that worked on unit 5000.
-That email reviewed the huddle notes from 5/3/21.
*The 5/3/21 huddle notes had reviewed "PRN medications, per SMC [facility name] policy."
-Sections of medication administration processes were copied from that policy.
*There was no documentation to support:
-How long after 5/3/21 those huddle notes were reviewed by all the staff.
-What staff were present for the policy review.
-Those staff who were not present on 5/3/21 had read the email containing medication administration education prior to their scheduled shift.
*Director M was not available for comment and interview.
Review and interview on 5/12/21 from 2:40 p.m. through 3:10 p.m. with education director E and RN clinical education manager O regarding RN C's training and education revealed:
*RN C had:
-Been hired on 7/6/20.
-Reviewed the Medication Administration Standard Operating Policy on 7/6/20. That policy included training on medications ordered in ranges.
-Viewed a live course on medication presentation by the safety officer that had discussed orders, documentation, and medication errors.
-Completed training on management of aggressive behaviors on 7/15/20.
*On 8/6/20 the preceptor for RN C verified she had successfully completed her range dose training for prn orders.
-She had exceeded her training expectations including critical thinking and reasoning skills for that task.
*There was no documentation in her training file to support medication administration and documentation:
-Had occurred on 5/3/21 or after the incident and discharge of patient 2 on 4/28/21.
-Had been provided via email or daily huddle starting on 5/3/21.
Interview on 5/11/21 at the time of the medical record review for patient 2 and again on 5/12/21 at 2:10 p.m. with accreditation manager A confirmed:
*The minimum a professional nurse staff should have documented was one flowsheet assessment and one care plan note.
-The nursing staff worked 12 hours shifts from 7:00 a.m. through 7:00 p.m.
-There were daily huddle meetings at 7:00 a.m. to ensure both the day and night shift were present for review of the patients and any changes occurring within the department.
*On 4/27/21 RN E had not followed the documentation policy to support the status and well-being of the patient for the entire shift that day.
*On 4/28/21 RN C should have assessed and documented on the patient's condition to support the administration of Zyprexa at the highest dose ordered for him.
*RN C should have had documentation to support the patient was monitored and assessed after the administration of Zyprexa 10 mg to support the effectiveness of that med without adverse side effects.
*The patient should not have been discharged from the facility until it was determined his condition was stable for transport.
*The floor nurses do have the capability of determining if patients were stable to discharge as planned or if their condition had changed and supported further assessment and care.
-The physician should have been involved with the decision to place a planned discharge on hold or if their condition was stable enough to preceded with the discharge.
*The Action plan/items that had been submitted to the SD DOH on 5/3/21 on staff education.
*The review of the huddle note from 5/3/21 and the educational email that was sent to all staff on 5/7/21.
*There was no documentation to support:
-What staff had been present at the huddle meeting on 5/3/21 and received the initial education on medication administration and documentation. He agreed there should have been.
-Ongoing education had occurred in the daily huddle meetings after 5/3/21 and their should have been.
-When and if the staff reviewed the email sent to them on 5/7/21 prior to their next scheduled shift.
-Audits had been started on 5/10/21 per their action plan.
*He and the management staff were informed and aware of how patient 2 had been discharged from the hospital by RN C and his condition/status upon arriving at the receiving LTC facility.
*He agreed the following policies had not been followed to support patient safety was maintained:
-Medication administration of meds with dosing ranges.
-Shift documentation and assessment protocols for the patient.
-Assessment and documentation to support the administration of a high risk med prior to d/c was appropriate.
-Assessment and follow-up documentation to support the effectiveness of a high risk med without adverse side effects had occurred.
Review of the provider's 8/26/20 Medication-Prescribing and Administration policy revealed:
*Purpose: "To describe the uniform system for the safe prescribing and administration of medication."
*Policy:
-2.1.5 " Range orders are acceptable, and will be allowed for a medication to be prescribed with a dose range, provided the administration of the medication follows the procedure outlined in section 3.8."
-2.7 "All activities related to medication administration and patient's response (when appropriate) will be recorded in the patient's electronic medical record."
*Procedure: "3.8 Range orders are to be followed using the lowest dosage at the shortest dosing interval to achieve the desired effect. The initial dose will be followed using the lowest dosage unless specific parameters are provided, such as sliding scale order, or if the patient's clinical assessment indicates lowest dosage would not be appropriate to manage the patient's condition."
Review of the provider's 9/14/20 Documentation System policy revealed:
*Purpose: "To reflect the individualized care that is provided to all patients."
*Policy: "Documentation will reflect the care prescribed and provided and the patient's response to that care."
*No process for the staff to follow on the minimum required shift documentation on each patient.
Review of the provider's 9/14/20 Plan of Care policy revealed: Patient progress "Document the patient's progression toward the goal on each shift the goal was addressed."
Review of the provider's following policies revealed no documentation to support a process was in place for the staff to follow and determine if a patient's discharged status and condition changed and/or should be placed on hold until a stabilized condition had been reached:
*Discharge Planning policy dated 2/7/20.
*Discharge Care of Patient policy dated 8/5/19.
*Continuum of Care policy dated 7/5/18.