The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ASCENSION GENESYS HOSPITAL ONE GENESYS PARKWAY GRAND BLANC, MI 48439 May 31, 2018
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0167
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on document review and interview, the facility failed to ensure that an order for a physical restraint was written by a provider with privileges to order restraints for one (#1) of one post hip replacement surgery patients reviewed for physical restraints out of seven patients reviewed for physical restraints, out of a total sample of 23, resulting in the potential for less than optimal patient outcomes. Findings include:

On 5/31/18 at approximately 0830, review of a facility adverse event report for an "orthopedic event" dated 4/12/18 for Patient #1 revealed that an order for four point (both wrists and both ankles) was written by a Nurse Practitioner (NP), Staff Y, for Patient #1 two days after hip replacement surgery. The patient was diagnosed with an "iatrogenic" (healthcare acquired) dislocated hip and returned to surgery for a repair of the hip replacement. The Adverse Event Report noted, "patient developed hip dislocation while in restraints S/P (after) hip revision surgery."

On 5/31/18 at approximately 0930, Patient #1's clinical record was reviewed with Staff O, the facility Service Line Director, and Staff D, the Director of Critical Care. The following information was revealed:

Patient #1 was a [AGE] year old female who was admitted to the facility on [DATE] and had surgery on 3/6/18 to repair her left hip joint replacement, (revision). Diagnoses included Dementia, Bilateral Lower Extremity Contractures, Hip Pain, and Parkinson's Disease.

Patient #1 went to the Intensive Care Unit (ICU) on 3/6/18 after surgery, and was transferred to a Medical Surgical Unit on 3/8/18 at 1100.

On 3/8/18 at 2355, Nurse Practitioner (NP) Staff Y wrote an order for "Soft restraints, both wrists; both ankles (24 hour/calendar day renewal)" . "Co-signed" (signed by a physician) was documented as "not applicable".

Review of an Physician's Operative Summary Note, dated 3/12/18 at 2016 for Patient #1's surgery to repair her dislocated left hip revealed the surgeon documented the following, "Indications for the surgery that a Nurse Practitioner took a distant oriented patient after a hip revision and decided to restrain her without talking to the Orthopedic Attending. All four limbs were tied to the bed which should never happen after a revision surgery. I do not understand how a Nurse Practitioner can write this order. Require the patient to go back to surgery. I will make jump distance harder to dislocate, maybe unknowledgeable nursing staff will not be able to cause it to happen again."

On 5/31/18 at approximately 1400, the facility Regulatory Coordinator, Staff B was interviewed. Staff O and Staff D were also interviewed at this time. Staff B reported that Nurse Practitioner privileges in the facility did not allow them to write orders for restraints per facility policy. Staff B provided documentation that Staff Y was entered into the facility's disciplinary action program, but did not provide documentation of education or counseling provided when requested. When queried, Staff B, Staff O and Staff D stated that no training or education on facility policy for restraint orders was provided to other facility Nurse Practitioner. When queried, Staff B, Staff O and Staff D all said that no inservices or counseling were done after this event to educate all the facility Nursing staff on which providers were allowed to write orders for physical restraints.

Review of the facility policy entitled, "Restraint Usage", dated 11/2016 revealed the following statement, "Only licensed independent practitioners and Physician Assistants can authorize restraint orders. This EXCLUDES Residents, Nurse Practitioners,Nurse Anesthetist and Clinical Nurse Specialists."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0170
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on document review and interview, the facility failed to ensure that the Attending Physician/Surgeon was consulted prior to applying four point (all limb) physical restraints to a patient after hip replacement surgery for one (#1) of one patients reviewed for restraint use after hip surgery out of a total of 7 patients reviewed for restraint use, out of a total sample of 23, resulting in the potential for less than optimal patient outcomes. Findings include:

On 5/31/18 at approximately 0830, review of a facility adverse event report for an "orthopedic event" dated 4/12/18 for Patient #1 revealed that an order for four point (both wrists and both ankles) was written by a Nurse Practitioner (NP), Staff Y, for Patient #1 two days after hip replacement surgery. The patient was diagnosed with an "Iatrogenic" (health care acquired) dislocated hip and returned to surgery for a repair of the hip joint replacement. The Adverse Event Report noted, "patient developed hip dislocation while in restraints S/P (after) hip revision surgery."

On 5/31/18 at approximately 0930, Patient #1's clinical record was reviewed with Staff O, the facility Service Line Director, and Staff D, the Director of Critical Care. The following information was revealed:

Patient #1 was a [AGE] year old female who was admitted to the facility on [DATE] and had surgery on 3/6/18 to repair her left hip joint replacement, (revision). Diagnoses included Dementia, Bilateral Lower Extremity Contractures, Hip Pain, and Parkinson's Disease.

Patient #1 went to the Intensive Care Unit (ICU) after surgery, and was transferred to a Medical Surgical Unit on 3/8/18 at 1100.

On 3/8/18 at 2355, Nurse Practitioner (NP) Staff Y wrote an order for "Soft restraints, both wrists; both ankles (24 hour/calendar day renewal)" .

There was no documentation to indicate that the Attending Physician/Surgeon Staff W, or the Orthopedic Surgery fell ow, Staff V were consulted before putting Patient #1 into four point restraints. There was no documentation to indicate that the Attending Physician Staff W or Staff V were ever notified that Patient #1 was in four point restraints. There was no documentation to indicate that Staff W or Staff V were aware that Patient #1 was in four point restraints until after the patient's left (surgical) hip was discovered to be dislocated on 3/10/18.

A Physical Therapy (PT) note dated 3/9/18 at 1029 noted that Patient #1 was unable to participate in therapy due to severe pain and her left lower extremity (left leg) was internally rotating into the pillow (a sign of dislocation). The Physical Therapist documented that four point restraints were reapplied before she left the room. There was no documentation to indicate that a physician was notified of the increased pain or left leg internal rotation. There was no documentation to indicate that nursing noticed this during their assessment of the patient each shift.

Patient #1's four point (both wrists and both ankles) restraints were discontinued on 3/09/18 at 2100 (11 1/2 hours after the PT assessment).

A Physician's Progress Note by Staff X dated 3/10/18 at 0800 documented, "There is some internal rotation and shortening of the left leg. Will obtain X-ray Pelvis to assess." An X-ray dated 3/10/18 noted that the patient's left hip was dislocated.

Review of an Physician's Operative Summary Note, dated 3/12/18 at 2016 for Patient #1's surgery to repair her dislocated left hip revealed the surgeon documented the following statements, "Indications for the surgery that a Nurse Practitioner took a distant oriented patient after a hip revision and decided to restrain her without talking to the Orthopedic Attending. All four limbs were tied to the bed which should never happen after a revision surgery on a hip, should never happen without talking to the orthopedic department. "

On 5/31/18 at approximately 1400, the facility Regulatory Coordinator, Staff B was interviewed. Staff O and Staff D were also interviewed at this time. Staff B was asked to provide documentation that the orthopedic department was notified or consulted regarding Patient #1's restraint, but was unable to provide any additional information. Review of Physician's progress notes from 3/8/18 through 3/10/18 revealed no documentation to indicate that the surgeon or orthopedics department were aware that Patient #1 was placed in four point physical restraints.

On 3/8/18 at approximately 1420, when asked to provide documentation of the facility's corrective measures for the incident, Staff B provided documentation that Staff Y was entered into the facility's disciplinary action program, but did not provide documentation of education or counseling provided. When queried, Staff B, Staff O and Staff D stated that no training or education on facility policy for restraint orders was provided to other facility Nurse Practitioner. When queried, Staff B, Staff O and Staff D were unable to provide documentation that inservices or counseling were done after this event to educate the facility Nursing staff on the need to consult the Orthopedic Surgeon or orthopedic department before applying physical restraints to a post surgical patient.

The Adverse Event Summary for Patient #1's hip dislocation documented the following:

1. "Was there a deviation from Generally Accepted Performance Standards? No."
2. "Were there any preventable known complications? No."
3. "Was the event preventable? No."
4. "Was this a safety event? No."
5. "Closure Reason: No further follow up needed."

On 5/31/18 at approximately 1500, the Medical Director of Orthopedics Staff X was interviewed regarding Patient #1 and said that either the Orthopedic Surgeon or a covering Orthopedic Physician should always be consulted about restraining a postoperative Orthopedic patient. Dr X stated, "We clearly could have done a better job with this patient."

Review of the facility policy entitled, "Restraint Usage", dated 11/2016 revealed the following statement, "The attending physician must be consulted as soon as possible, if the attending physician did not order the restraint or seclusion."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0171
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on document review and interview, the facility failed to ensure that a physical restraint was discontinued at the earliest possible time for one (#1) of seven patients reviewed for physical restraints out of a total sample of 23, resulting in the potential for emotional distress and injury due to unnecessary restraint for the patient concerned. Findings include:

On 5/31/18 at approximately 0930, Patient #1's clinical record was reviewed with Staff O, the facility Service Line Director, and Staff D, the Director of Critical Care. The following information was revealed:

Patient #1 was a [AGE] year old female who was admitted to the facility on [DATE] and had surgery on 3/6/18 to repair her left hip joint replacement, (revision). The Patient developed an "Iatrogenic hip dislocation" (health care acquired) during her admission and underwent an additional hip joint replacement surgery on 3/12/18 . Diagnoses included Dementia, Bilateral Lower Extremity Contractures, Hip Pain, Anemia of Chronic Disease, and Parkinson's Disease.

Patient #1 went to the Intensive Care Unit (ICU) after surgery on 3/6/18, and was transferred to a Medical Surgical Unit on 3/8/18 at 1100.

On 3/8/18 at 2355 (after transfer to the medical Surgical unit), Nurse Practitioner (NP) Staff Y wrote an order for "Soft restraints, both wrists; both ankles (24 hour/calendar day renewal)". There were no nursing notes which documented that Patient #1 exhibited behaviors that required her to be restrained for her own protection..

The Restraint Documentation Flowsheet dated 3/8/18 documented that four point soft restraints (both wrists and both ankles were secured to the bed) were applied at 3/9/18 at 0000.

A Nursing Shift Assessment and Evaluation Flowsheet dated 3/8/18 at 1730 documented that Patient #1 was calm and cooperative and asked questions appropriately, and was alert and oriented to self and place. The assessment documented that Patient #1's ability to self position (change positions in bed) was "limited", and that she was a high fall risk, but was unable to rise without assistance. The Flowsheet documented that Patient #1 was an extremely high safety risk and needed to be monitored every 30 minutes. This 30 minute monitoring for safety was not documented as done from 3/8/18 at 2300 through 3/9/18 at 0800.

There were no nursing notes describing Patient #1 behaviors which required four point restraints. Physician Progress notes from 3/6/18 through 3/19/19 documented that Patient #1 had Contractures (frozen joints) in both legs, and weakness and Contractures of 30 degrees at the left hip and knee. Physician's orders and Nursing Flow Sheets documented that Patient #1 had a hip adductor pillow (a triangular wedge pillow placed between the patient's legs and attached to each leg with straps) and a foot pump on each foot (pneumatic compression boot to prevent blood clots).

A Physical Therapy Progress Note dated 3/8/18 at 1120 documented that Patient #1 was mildly agitated but was reassured by occasional touching, hugging or being talked to. The note documented that Patient #1 cooperated with therapy, but was unable to change position or sit up without staff assistance.

The Restraint Flowsheet dated 3/8/18 documented that the reason for Patient #1's 4 point restraints were, "Danger to self. Attempting to remove lines/tubes. Confusion/disorientation. Lack of judgement. Removing medical device. Unable to follow directions." It was unclear how a patient with bilateral leg contractions, left leg weakness, a hip adductor pillow and foot pumps could remove devices tubes and lines with her feet, requiring ankle restraints. The restraint flow sheet documented that the restraints and evaluation of continued need for restraints needed to be done every two hours.

The 3/8/18 Restraint Flowsheet for Patient #1 documented the patient was assessed again on 3/9/18 at 0200. The current behavior was documented as, "Harm to self, Confused, Crying, Depressed, Restless." There was no documentation of any attempt to see if the patient could be consoled or redirected, or whether the behaviors documented posed a risk for self injury that could not be redirected or prevented by less restrictive methods. There was no documentation of restraint monitoring, or assessment that Patient #1 could have the restraints safely removed from all her limbs or reduced to wrist restraints between 0200 and 0800 (six hours) on 3/9/18.

A Nursing Assessment and Evaluation Flowsheet for night shift dated 3/9/18 at 0350 documented that Patient #1 was "calm and Cooperative" with "passive acceptance" of treatment. There was no documentation to indicate that the need for continued restraints on all for limbs was necessary. It was unclear why Patient #1 remained restrained to the bed by both ankles and both wrists if she was calm and cooperative. There were no additional nursing documentation until 0800 (four hours later). Patient #1 remained in four point restraints.

The 3/8/18 Restraint Flowsheet documented a restraint assessment for Patient #1 was done at 0800. The "current behavior", was documented as "harm to self, Confused, Crying, Restless." The Patient remained in 4 point restraints.

A Physical Therapy note dated 3/9/18 at 1029 documented that Patient #1 was reassured by occasional touching, hugging or being talked to, and was distractible (easily redirected). The therapy note documented that Patient #1 was in too much pain with movement to work with therapy and that her left leg was internally rotated (a symptom of hip joint dislocation). The Therapist documented that she replaced the four point restraints at the end of therapy.

A Geriatrics Physician Progress note dated 3/9/18 at 0942 noted that Patient #1 was in four point soft restraints, was unresponsive and had minimal response to noxious stimuli. It was unclear why Patient #1 required all four limbs to be restrained if she was lethargic and minimally responsive.

There was no physician Face to Face Assessment documented for Patient #1's restraints from 3/8/18 through 3/10/18. There was no documentation to indicate that Nursing staff noted the left leg internal rotation (symptoms of hip joint dislocation) observed by the physical therapist on 3/9/18 and by the Orthopedic physician on 3/10.18, and confirmed by X-ray on 3/10/18 as a dislocated left hip joint.

Patient #1's four point (both wrists and both ankles) restraints were discontinued on 3/09/18 at 2100.

On 5/31/18 at approximately 1400, the facility Regulatory Coordinator, Staff B and Staff T, the Unit Manager where Patient #1 was located from 3/7/18 through discharge on 3/20/18 were both interviewed. Staff B reported that an investigation was conducted regarding Patient #1's physical restraints from 3/9/10 at 0000 to 3/09/18 at 2100 because the patient developed a dislocated left hip joint (hip replacement) and required an additional surgery to repair it, and the attending surgeon had blamed the dislocation on the physical restraints.

Review of the provided Adverse Event" report dated 4/12/18 with Staff B and Staff T at this time revealed the Nurse Practioner who ordered the restraint, Staff Y reported that Patient #1's nurse had requested the restraints on 3/8/18 at 2300 because Patient #1 was, "thrashing in bed and trying to kick us in the head." Staff T was asked how a postoperative hip replacement patient who had bilateral leg contractures at knee and hip, left leg weakness, was anemic from blood loss, could not move herself in bed, was wearing soft, air filled, balloon-like pneumatic boots on both feet, and had a hip adductor cushion strapped between her legs could manage to kick nursing staff in the head. Staff T said, "You'd be surprised at what patients can do when they're delirious." The Nurses involved in the event were unavailable for interview at the time of survey.

At this time, Staff T reported that Patient #1 was assigned a "float" Nurse (assigned to fill in where needed), Staff BB for 4 hours during night shift on the morning of 3/9/18. When queried, Staff B and Staff T were unable to provide any additional documentation to support the need for all four of Patient #1's limbs to be restrained from 3/9/18 at 0000 through 3/09/18 at 2100. Staff T and Staff B were unable to explain why there was no documentation of any restraint assessment for six hours between 0200 and 0800 on 3/9/18, and why restraints on all four of Patient #1's limbs were necessary when nursing and physical therapy documented the patient was either calm and cooperative or else slightly agitated but easily consolable and cooperative. When asked whether staffing issues played a role in the decision to restrain Patient #1 by all four limbs, Staff B and Staff T declined to answer. Staff T reported that she had talked to the nursing staff on her unit during "morning huddle"about avoiding restraints if alternatives were successful. No agenda or sign in sheets were provided when requested. Staff B stated that no other Nursing Staff were educated or counseled on restraint evaluation after this incident. Nursing Staffing levels were requested but not provided.

Review of the facility policy entitled, "Restraint Usage", dated 11/2016 revealed the following statement, "A clinical assessment should be conducted for the purpose of ruling out physiological causes of agitation or maladaptive behavior. The assessment should be completed within the physician's Face to Face minimally every calendar day. Patients restrained for any reason should have the following care a minimum of every 2 hours unless a patient's behavior/condition warrants more frequently: fluids/nourishment, opportunity to toilet, range of motion, physical emotional and mental status assessed, skin care, and evaluation to determine if criteria are met for release. The RN (Registered Nurse) continually assesses the patient to determine if criteria for release are met. Any trained RN may remove the restraint when the criteria for removal are met."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on document review and interview, the facility failed to ensure that a Face to Face physician restraint assessment was conducted and Nursing monitoring and evaluation were done every two hours per facility policy for one (#1) of seven patients reviewed for restraints, out of a total sample of 23, resulting in the potential for unnecessary restraint use and the potential for physical/emotional injury for the patient concerned. Findings include:

On 5/31/18 at approximately 0930, Patient #1's clinical record was reviewed with Staff O, the facility Service Line Director, and Staff D, the Director of Critical Care. The following information was revealed:

Patient #1 was a [AGE] year old female who was admitted to the facility on [DATE] and had surgery on 3/6/18 to repair her left hip joint replacement, (revision). The Patient developed an "Iatrogenic hip dislocation" (health care acquired) during her admission and underwent an additional hip joint replacement surgery on 3/12/18 . Diagnoses included Dementia, Bilateral Lower Extremity Contractures, Hip Pain, Anemia of Chronic Disease, and Parkinson's Disease.

On 3/8/18 at 2355, Nurse Practitioner (NP) Staff Y wrote an order for "Soft restraints, both wrists; both ankles (24 hour/calendar day renewal)".

The Restraint Documentation Flowsheet dated 3/8/18 documented that four point soft restraints (both wrists and both ankles were secured to the bed) were applied at 3/9/18 at 0000. The Restraint Flowsheet dated 3/8/18. The Restraint FlowSheet documented that the restraints and evaluation of continued need for restraints needed to be done every two hours.

Nursing documented restraint assessments for Patient #1 on the Restraint Documentation Flowsheet at the following times between 3/9/18 at 0000 and 3/9/18 at 0800:

3/9/18 at 0000
3/9/18 at 0200
3/9/18 at 0800

A Nursing Assessment and Evaluation Flowsheet for night shift dated 3/9/18 at 0350 documented that Patient #1 was "calm and Cooperative" with "passive acceptance" of treatment. There was no documentation to indicate that the need for continued restraints on all for limbs was necessary. There were no additional nursing documentation until 0800 (four hours later). Patient #1 remained in four point restraints.

There was no physician Face to Face Assessment documented for Patient #1's restraints from 3/8/18 through 3/10/18.

There was no documentation to indicate that Nursing staff noted the left leg internal rotation (symptoms of hip joint dislocation) observed by the physical therapist on 3/9/18 and by the Orthopedic physician on 3/10.18, and confirmed by X-ray on 3/10/18 as a dislocated left hip joint.

Patient #1's four point (both wrists and both ankles) restraints were discontinued on 3/09/18 at 2100.

On 5/31/18 at approximately 1400, the facility Regulatory Coordinator, Staff B and Staff T, the Unit Manager where Patient #1 was located from 3/7/18 through discharge on 3/20/18 were both interviewed. Staff T and Staff B were unable to explain why there was no documentation of any restraint assessment for six hours between 0200 and 0800 on 3/9/18, and why there was no Physician Face to Face restraint Assessment documented. Staff T reported that she had talked to the nursing staff on her unit during "morning huddle"about avoiding restraints if alternatives were successful." No agenda or sign in sheets were provided when requested. Staff B stated that no other Nursing Staff were educated or counseled on restraint monitoring or evaluation after this incident, or the need for the physician to be notified that a restraint assessment was needed.

Review of the facility policy entitled, "Restraint Usage", dated 11/2016 revealed the following statement, "A clinical assessment should be conducted t for the purpose of ruling out physiological causes of agitation or maladaptive behavior. The assessment should be completed within the physician's Face to Face minimally every calendar day. Patients restrained for any reason should have the following care a minimum of every 2 hours unless a patient's behavior/condition warrants more frequently: fluids/nourishment, opportunity to toilet, range of motion, physical emotional and mental status assessed, skin care, and evaluation to determine if criteria are met for release."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and documentreview, the facility failed to 1) In addition, based on observation, interview and record review, the facility failed to ensure that nurses followed facility policy for storage of medications for 3 of 5 patient's observed for medication storage (#3, #4, and #7), and one discharged patient (#1) out of a total sample of 23, resulting in the potential for missed doses due to misplaced medications, and the potential for adverse events and treatment failure related to inappropriate storage and handling of medications of the patients involved. 2) ensure that medications to treat Parkinson's Disease were consistently administered per physician's orders for one (#1) of three patients reviewed for home medication administration, out of a total sample of 23, resulting in possible/potential complications from exacerbation of Parkinson's Disease symptoms for the patient concerned. Findings include:

1) On 5/30/18 between approximately 1200 to 1250, during the initial tour of the facility with Staff H, three of five patients observed for medications stored in the room drawer were noted to have medications stored in the room drawer against facility policy. The following was noted:

On 5/30/18 at approximately 1205, observation of Patient #4's room revealed two opened, partially used multi dose 5 milliliter (ml) vials of injectable labetalol hydrochloride 100 milligrams (mg) per 20 ml (a blood pressure medication) were in the drawer in the patient room. The vials were not labeled with the date opened, or the name of the patient they were prescribed for. Staff Nurse K was interviewed regarding this and stated, "They're PRNs (prescribed to be given as needed)." Staff K was unable to state how old the medications were. Staff H stated that medications were supposed to be stored in the dispensing machine (Pyxis) and not in the rooms. Staff H stated that all medications should be labeled with the patient name and the date opened. Review of Patient #4's clinical record at this time revealed Patient #4 was a [AGE] year old female who was admitted on [DATE] with diagnoses which included Hemorrhagic Stroke. The patient had a Physician's Order for intravenous administration (IV push) labetalol PRN for hypertension, dated 5/13/18. the last documented dose given was on 5/25/18 at 0012.

On 5/30/18 at approximately 1215, observation of Patient #7's room revealed an opened, unlabeled, undated 5 ml vial of partially used labetalol hydrochloride in the drawer in the room. Staff Nurse L was interviewed and was unable to say when it was opened or when it was last given. Staff L stated, "It's a PRN for hypertension, we keep it in the room in case of emergencies." Review of Patient #7's clinical record at this time with Staff H revealed the following information: Patient #7 was a [AGE] year old female who was admitted on [DATE] with diagnoses which included Sepsis. Review of Physician's Orders for Patient #7 revealed that Patient #7 did not have a physician's order (prescription) for labetalol.

On 5/30/18 at approximately 1230, Patient #3's room was observed and revealed a 1000 liter bag of intravenous multivitamins in glucose solution for intravenous administration was in the drawer in the room. The Unit Manager. Staff I, who was present at that time stated, "I didn't expect to see that." Review of Patient #3's clinical record at this time revealed the following: Patient #3 was a [AGE] year old male who was admitted on [DATE] with diagnoses which included Multiple Rib Fractures due to a Motor Vehicle Accident.

On 5/31/18 at approximately 0930, Patient #1's clinical record was reviewed with Staff O, the facility Service Line Director, and Staff D, the Director of Critical Care. The following information was revealed:

Patient #1 was a [AGE] year old female who was admitted to the facility on [DATE] and had surgery on 3/6/18 to repair her left hip replacement, (revision). Diagnoses included Dementia, Bilateral Lower Extremity Contractures, Hip Pain, and Parkinson's Disease.

Admission medication orders included the following orders for anti- Parkinson's Disease medications that were not available on the Hospital Pharmacy's formulary list (medicines stocked in the facility pharmacy):

1. "Azilect 0.5 milligram tablet, give 1 milligram (mg) by mouth (PO) every day at 0800. Non formulary Medication. Instructions: requested by physician. Azilect 0.5 mg tab- patient own medication. Patients medication from home - Azilect 0.5 mg oral tablet. Reason: not on formulary."

2. "Rytary 48.75/195 capsule, 3 capsules (caps) PO three times a day (0800, 1300 and 1800). Non formulary Medication. Instructions: requested by physician. Azilect 0.5 mg tab- patient own medication. Patients medication from home - Rytary 48.75/195 mg oral capsules. Reason: not on formulary."

Review of Patient #1's Medication Administration Record (EMAR) revealed Patient #1's home anti-Parkinson's disease medications were not given (omissions) on the following occasions for the noted reasons:

3/9/18 at 0800 - "medication not available" (Rytary and Azilect)
3/9/18 at 1300 - "medication not available" (Rytary)
3/9/18 at 1800 - "medication not available" (Rytary)

On 5/31/18 at approximately 1400, the facility Regulatory Coordinator, Staff B and Staff T, the Unit Manager where Patient #1 was located from 3/7/18 through discharge on 3/20/18 were both interviewed, and A facility Adverse Event Report for Patient #1, dated 4/12/18 was reviewed with Staff B and Staff T. The Report noted that Staff Nurse BB reported that Patient #1's medications from home, Rytary and Azilect were in the drawer in the patient room on 3/9/18 during midnight shift but reported that she was unsure if she passed that information on to the next shift. Staff CC, Patient #1's day shift nurse, Staff CC was documented as saying that she was unaware that the two home medications were in the drawer in the patient's room. The report noted that the two medications were found in the room drawer on 3/9/18 at 2033, and a dose of Rytary was given at 2033.

At this time, Staff T reported that per facility policy, no medications are supposed to be stored in patient rooms, and that all medications should be stored in the unit medication dispensing machine (Pyxis). Staff T stated as a corrective measure for this event, the Nursing staff on her unit were re-educated on facility policy for medication storage, but was unable to provide any agenda or staff sign in (attendance) sheets to document this. When asked at this time, Staff B stated that no training of other Nursing staff in the hospital was done. Staff B and Staff T were advised at this time of medications that were found on 5/30/18 for three out of five patients observed on a different unit. Staff B stated that the corrective re-education of nursing staff house wide was not done because "It's hospital policy that medications have to be stored in the pyxis, so we expect staff to follow it."

Interviews with staff BB and Staff CC were unavailable for interview.

Review of the facility policy entitled, "Medication Storage and Control", dated 11/16 revealed the following statements:

"Medications removed from stock shall be kept under the direct supervision of the healthcare provider until administered to a patient, returned to stock or pharmacy, or destroyed according to hospital policy. Healthcare providers shall return all medications that were not administered and not distroyed to stock or pharmacy no later than the end of the individual's shift or sooner if indicated by a department specific procedure. Medications that are expired shall be removed and returned to pharmacy."
VIOLATION: SELF-ADMINISTRATION - DRUGS FROM HOME Tag No: A0413
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure that it's policy for administering medications brought from a patient's home was followed for one (#1) of three patients reviewed for home medication use out of a total sample of 23. Findings include:

On 5/30/18 at approximately 1205, the 4th floor pharmacist, Staff M was interviewed regarding the process for storage and handling of a patient's own medicines brought in to the facility from home for use in the facility. Staff M stated that if the Physician wanted to keep the patient on a medication that was not available in the hospital formulary, the patient could bring in their medicine from home to use in the hospital. Staff M stated that the physician needed to write an order for the medication and include in the order that that the medication was not available in formulary, and that the medication would be brought in to the hospital from home. Staff M stated that Pharmacy would note the order for home medication use as they would any other medication order, and it would be included on the electronic Medication Administration Record (e-MAR). Staff M stated that the apothecary office ( nursing unit Pharmacy) was staffed with a pharmacist from 0700 to 2230. Staff M stated that when the home medication was brought to the hospital, Nursing was supposed to send it to the Pharmacist assigned to the floor. The Pharmacist then verified the medication (made sure it was what it was supposed to be) and then printed a green (non home medications had white labels) facility label in the apothecary office and put it in the patient's specific box in the bottom compartment of the medication dispensing machine (pyxis). Staff M stated that if the medication was brought in after 2230, Nursing was supposed to send the home medication down to the main pharmacy for verification and labeling, as it was staffed 24 hours a day, seven days a week. Staff M stated, "Sometimes it takes a couple of days for the family to bring the medication in. We (pharmacy) don't have any way of tracking that unless the nurse calls us. There needs to be a better follow up on when the patient actually gets it."

On 5/30/18 at approximately 1540, the Manager of Pharmacy Services, Staff CC was interviewed and demonstrated the process for verifying a home medication. The actual medications were matched with an online database to ensure that the medicine was what it was supposed to be. The medication was checked with the Physician's Order, and then labeled with a green label containing the medication name, dosage, patient name and a bar code for scanning and matching to the patient's name band. When asked, Staff CC was able to print a report of patients with physician's orders for administration of medications brought in from home. when asked, Staff CC was not able to provide a list of patients whose home medications were received by the facility. When asked, Staff CC stated that he expected Nursing to contact the pharmacy or the physician if the home medication was not brought in by the second missed dose. Staff CC stated that the Pharmacy would discuss alternatives with the Physician, including using a generic substitute until the patient's home medication was brought in, or obtaining the medication from an outside pharmacy.

On 5/31/18 at approximately 0930, Patient #1's clinical record was reviewed with Staff O, the facility Service Line Director, and Staff D, the Director of Critical Care. The following information was revealed:

Patient #1 was a [AGE] year old female who was admitted to the facility on [DATE] and had surgery on 3/6/18 to repair her left hip replacement, (revision). Diagnoses included Dementia, Bilateral Lower Extremity Contractures, Hip Pain, and Parkinson's Disease.

Admission medication orders included the following orders for anti- Parkinson's Disease medications that were not available on the Hospital Pharmacy's formulary list (medicines stocked in the facility pharmacy):

1. "Azilect 0.5 milligram tablet, give 1 milligram (mg) by mouth (PO) every day at 0800. Non formulary Medication. Instructions: requested by physician. Azilect 0.5 mg tab- patient own medication. Patients medication from home - Azilect 0.5 mg oral tablet. Reason: not on formulary."

2. "Rytary 48.75/195 capsule, 3 capsules (caps) PO three times a day (0800, 1300 and 1800). Non formulary Medication. Instructions: requested by physician. Azilect 0.5 mg tab- patient own medication. Patients medication from home - Rytary 48.75/195 mg oral capsules. Reason: not on formulary."

Review of Patient #1's Medication Administration Record (EMAR) revealed Patient #1's home anti-Parkinson's disease medications were not given (omissions) on the following occasions for the noted reasons:

3/9/18 at 0800 - "medication not available" (Rytary and Azilect)
3/9/18 at 1300 - "medication not available" (Rytary)
3/9/18 at 1800 - "medication not available" (Rytary)

On 5/31/18 at approximately 1400, the facility Regulatory Coordinator, Staff B and Staff T, the Unit Manager where Patient #1 was located from 3/7/18 through discharge on 3/20/18 were both interviewed, and A facility Adverse Event Report for Patient #1, dated 4/12/18 was reviewed with Staff B and Staff T. The Report noted that Staff Nurse BB reported that Patient #1's medications from home, Rytary and Azilect were in the drawer in the patient room) on 3/9/18 during midnight shift, but reported that she was unsure if she passed that information on to the next shift. Staff CC, Patient #1's day shift nurse, Staff CC was documented as saying that she was unaware that the two home medications were in the drawer in the patient's room. The report noted that the two medications were found in the room drawer on 3/9/18 at 2033, and a dose of Rytary was given at 2033.

At this time, Staff T reported that per facility policy, no medications are supposed to be stored in patient rooms, and that all medications should be stored in the unit medication dispensing machine (Pyxis). Staff T was unable to explain why there was no documentation to indicate when the home medications were brought in to the hospital. Staff T was unable to explain why Nursing did not follow policy and send the home medications to pharmacy to be verified and labeled when they were brought in by the family. Staff T stated, "The medications came in pill cards that were too large to fit in the patient's box in the pyxis." The two nurses identified in the adverse event report were unavailable for interview.

Review of the facility policy entitled, "Medications brought from Home", dated 5/17 revealed the following statements:

"The nurse caring for the patient shall obtain the prescribed home medication and forward the medication to a pharmacist. A Pharmacist will identify the drug(s) using available resources to confirm the identity and integrity of the drug(s) in each container. The Patient's own supply of medication will be securely stored in the patient specific bins of the Pyxis tower."