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.

BEHAVIORAL HEALTHCARE CENTER AT HUNTSVILLE, INC 5315 MILLENIUM DRIVE, NW HUNTSVILLE, AL July 15, 2013
VIOLATION: GOVERNING BODY Tag No: A0043
Based on review of medical records and interview it was determined the Hospital Administration failed to:

1. Ensure the Pharmaceutical services of the hospital provided uninterrupted medications to patients 24/7.

2. Ensure patients were provided care in a safe environment, free from unnecessary restraint.

3. Ensure the Director of Nursing met the education and training requirements.

This had the potential to affect all patients served.

Findings include:

Refer to A 159 and A 492, A 493, A505 and A 511.

Refer to B 147.
VIOLATION: PATIENT RIGHTS Tag No: A0115
This condition was not met based on observation, review of medical records and interview it was determined the patients were being:

1. Left in Geri-chairs with their feet elevated for extended periods of time.

2. Prevented form being able to get out of the chairs and move independently.

3. Placed in Geri-chairs and chemically sedated instead of being engaged in an active treatment program to address their behaviors.

The facility failed to recognize the emotional and physical safety of the patient and provided a potentially unsafe environment. This had the potential to affect all patients served.

Findings Include:

Refer to A 144 and A 159.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, review of policy and procedure, review of medical records and interview it was determined the patients were being left in Gerichairs with their feet elevated for extended periods of time. This prevented the patients form being able to get out of the chairs and move independently. The facility failed to recognize the emotional and physical safety of the patient and provided a potentially unsafe environment. This had the potential to affect all patients served by the facility.

Findings include:

Policy and Procedure:
Occurrence Reporting of Critical Incidents/ Sentinel Events

Policy: To assure immediate documentation and reporting to proper supervisors when an overwhelming abnormal incident occurs.

Critical Incidents that should be reported immediately to the DON (Director of Nursing) and administrator may include but are not limited to:

Medication errors that resulted in harm.
Use of behavioral restraint...

1. The hospital will maintain a system for reporting and follow-up of incidents. The nurse event note/incident report serves to:
a. Prevent critical incidents from occurring.
b. Detect problems early.
c. Provide a mechanism to prevent future problems...

2. When the critical incident occurrence occurs, the individual discovering the incident will:
a. Notify the supervising RN (Registered Nurse) immediately.
b. The RN will assess the situation and direct other staff to provide appropriate care for the incident.
c. The physician will be notified of all occurrences. The RN will document who was notified, with date and time completed.

3. e. An appropriate intervention must be implemented by the charge nurse immediately to prevent reoccurrence.
f. Observe the patient for the next 72 hours, even if no injury found. Document observations each shift emphasizing pertinent problems that might occur from the occurrence.

Medical Record findings:

1. MR # 1 a current patient (pt) of the facility was admitted [DATE] with diagnosis of Dementia with Behavioral Disturbances.

The patient was admitted [DATE] at 3:00 PM from a long term care facility.

The patient care notes documented 7/8/13 at 9:30 PM, " Pt continues to be difficult to direct and easily agitated. MD (medical doctor) notified. Orders received prn (as needed) Seroquel 12.5 mg (milligrams) given by mouth for agitation.

The patient care notes documented 7/9/13 at 2:00 AM, " Pt observed sitting in floor at the foot of her bed. Pressure alarm had sounded, MHT (mental health technician) entered pt room. This RN (Registered Nurse) was called to pt room and observed... to have a large contusion to the middle of the forehead. Pt was assessed and no other visible injuries was noted...MD and responsible party notified." 7/9/13 at 2:30 AM, " Pt continues to be combative with staff...3:30 AM, MD returned call. Orders received, pt to be sent to Crestwood for head CT (Computerized Tomography Scan).

The patient care notes documented 7/9/13 at 7:00 AM, " Pt returned to unit from Crestwood ER (emergency room )...no behavior noted,no complaint of pain..."

The patient care notes documented 7/9/13 at 9:00 AM, " Pt is calm and cooperative... she has bruising across her forehead, swelling over right eye, bruising noted to bilateral hands..."

The surveyor observed MR # 1 reclined in a Geri-chair 7/9/13 at 10:15 AM in the Group Room asleep.

The patient care notes documented 7/9/13 at 1:00 PM, " Pt resting quietly in Geri-chair, continue to have bruising and swelling...ice pack applied."

The surveyor observed MR # 1 reclined in a Geri-chair 7/9/13 at 12:15 PM in the Dining Room asleep.

The surveyor observed MR # 1 reclined in a Geri-chair 7/9/13 at 2:15 PM and 4:15 PM in the Group Room asleep.

The physician wrote an order 7/9/13 at 11:40 AM, Discontinue Seroquel, Haldol 0.5 mg by mouth every 4 hours prn agitation. Label chart allergic to Seroquel and Aricept.

The patient care notes documented 7/9/13 at 8:00 PM, " Pt resting quietly in reclined Geri-chair in DR (dining room)."

The patient care notes documented 7/9/13 at 9:00 PM, " Awake and alert in DR...Pt assisted to her room without incident."

2. MR # 2 was admitted to the facility on [DATE] with a diagnosis of Dementia with Behavioral Disturbances.

On 6/22/13 a Nurse's Event Note at 10:00 AM, documented a medication error in the activities room. Description of incident, " Failed to check armband, meds (medications) given to wrong patient. Pt (patient) wrong meds given: Nexium, Bystolic, Allopurinol, Vitamin D, ASA (aspirin) baby and Losartan. Physician notified 6/22/13 at 10:05 AM. Orders received to monitor B/P (blood pressure) every 4 hours. Responsible party notified."

A review of the physician orders 6/22/13 failed to reveal any orders for B/P checks every 4 hours. A review of the medical physician and psychiatric physician progress notes for 6/22/13 failed to reveal any follow up by either physician related to the medication error.

The patient care notes documented 6/22/13 by the nurse failed to mention anything related to the medication error or the monitoring of the blood pressure.

The census on 6/22/13 was 17 patients. The LPN (Licensed Practical Nurses) passing medications was in orientation with the regularly scheduled LPN supervising the medication pass.

A note was attached by the two LPNs to the DON, " We inserviced ourselves and put a copy on the MAR (Medication Administration Record) and in the communication book!" Attachment was Principles in Administering Medications, 6 rights of drug administration.

The policy was not followed to observe the patient for the next 72 hours, even if no injury found. There was no documentation of observations each shift emphasizing pertinent problems that might occur from the occurrence.



Refer to A 159.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0159
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of medical records, definition of restraint by CMS (The Centers for Medicare and Medicaid) and interview it was determined that patients were being left in Gerichairs with their feet elevated for extended periods of time. This prevented the patients form being able to get out of the chairs and move independently. The facility failed to recognize the emotional and physical safety of the patient and provided a potentially unsafe environment. This had the potential to affect all patients served by the facility and did affect Medical Record (MR) # 6, # 10 and # 11.


Findings include:

Definition of restraint:

This restraint definition applies to all uses of restraint in all hospital care settings. Under this definition, commonly used hospital devices and other practices could meet the definition of a restraint, such as:

Geri chairs or recliners, only if the patient cannot easily remove the restraint appliance and get out of the chair on his or her own.

Note: Generally, if a patient can easily remove a device, the device would not be considered a restraint. In this context, "easily remove" means that the manual method, device, material, or equipment can be removed intentionally by the patient in the same manner as it was applied by the staff (e.g.), side rails are put down, not climbed over; buckles are intentionally unbuckled; ties or knots are intentionally untied; etc.) considering the patient's physical condition and ability to accomplish objective (e.g., transfer to a chair, get to the bathroom in time).


Medical Record findings:


1. MR # 10 was admitted to the facility 6/6/13 with diagnosis of Dementia with Behavioral Disturbances.

The patient care notes dated 6/6/13 at 12:00 PM documented, " Attempted to raise out of chair... transferred to a reclining Geri-chair with feet elevated to reduce edema."

On the Special Precautions- Special Monitoring form documented 15 minute checks by the MHT (mental health technicians) documented the patient was in a gerichair 100 % of the day in the dining room or the group room on the following days, 6/10/13, 6/11/13, 6/13/13, 6/14/13, 6/15/13, 6/16/13, 6/17/13, 6/18/13, 6/19/13, 6/20/13, 6/21/13, 6/22/13, 6/23/13, 6/24/13, 6/25/13, 6/26/13 included 2 hours and 15 minutes spent in the hallway, 6/27/13 and 6/28/13.

The patient care notes dated 6/7/13 documented the following information at the times listed:

8:00 AM-In Geri-chair in DR (Dining Room)
9:15 AM- In activity room in Geri-chair
8:00 PM- Client up in Geri-chair.

The patient care notes dated 6/8/13 documented the following information at the times listed:

12 midnight- pt assisted up to Geri-chair
9:00 PM- pt transferred back to Geri-chair and to DR.

The patient care notes dated 6/9/13 documented the following information at the times listed:

12 midnight- client in ger-chair in DR
8:00 AM- in DR in Geri-chair taken to activity room for group
8:00 PM- client resting quietly in Geri-chair in DR
9:30 PM- got pt up into Geri-chair shortly post laying pt down

The patient care notes dated 6/10/13 documented the following information at the times listed:

12 midnight- client in ger-chair in DR
4:00 AM-up in Geri-chair in DR
8:00 AM-pt was sitting quietly in Geri-chair in DR
4:05 PM-pt was in activity room
8:00 PM-sitting in DR

The patient care notes dated 6/11/13 documented the following information at the times listed:

8:00 AM-pt was in DR in Geri-chair
12:10 PM-pt is in DR
3:00 PM-pt is in activity room in Geri-chair

The patient care notes dated 6/12/13 documented the following information at the times listed:

8:00 AM-pt was in Geri-chair
8:00 PM-in reclining Geri-chair in DR


The patient care notes dated 6/13/13 documented the following information at the times listed:

12 midnight-client resting quietly in Geri-chair in DR
8:00 AM-pt is in DR in Geri-chair
12:15 PM- pt is in DR. She received Haldol 1 mg IM prn for agitation at 10:05 AM
4:15 PM- pt is in activity room
8:00 PM-client up in Geri-chair in DR

The patient care notes dated 6/14/13 documented the following information at the times listed:

12 midnight-client resting quietly in Geri-chair in DR
8:00 AM-in reclined ger-chair in DR
8:00 PM-pt is in Geri-chair in DR

The patient care notes dated 6/15/13 documented the following information at the times listed:

12 midnight- resting quietly in reclined chair
4:00 AM-resting quietly in reclined chair
7:40 AM-awake in Geri-chair in DR
4:00 PM-in activity room
8:00 PM-sitting in reclined chair in DR

The patient care notes dated 6/16/13 documented the following information at the times listed:

12 midnight-client resting quietly in Geri-chair in DR
4:00 AM-pt awake in DR
8:25 AM-in reclined Geri-chair in DR
2:00 PM-she is screaming and cursing trying to get out of Geri-chair, Haldol 1 mg IM given
8:00 PM-sitting in reclined chair in DR

The patient care notes dated 6/17/13 documented the following information at the times listed:

8:00 AM-pt is in DR in Geri-chair
12:00 PM- pt is in DR in Geri-chair
8:00 PM-client up in comfort lounger

The patient care notes dated 6/18/13 documented the following information at the times listed:

12 midnight-client in comfort lounger in DR
8:00 AM-pt is in DR in Geri-chair
12:00 PM- pt is in DR
4:15 PM- pt is in activity room in Geri-chair
7:20 PM- pt is in recliner in DR

The patient care notes dated 6/19/13 documented the following information at the times listed:

12:05 AM- pt is resting in comfort lounger in DR
4:00 AM- pt is in comfort lounger talking to another patient
7:25 AM- in reclining Geri-chair in DR
8:00 PM-sitting in reclined chair in DR
11:30 PM-pt is sitting in reclined chair in DR

The patient care notes dated 6/20/13 documented the following information at the times listed:

12 midnight-resting quietly in reclined chair
4:00 AM-continues to rest quietly in reclined chair
7:30 AM-in Geri-chair in DR
11:30 AM-sitting up in Geri-chair
8:00 PM- sitting in reclined chair in DR

The patient care notes dated 6/21/13 documented the following information at the times listed:

12 midnight-resting quietly in Geri-chair
4:00 AM- resting quietly in Geri-chair
8:00 AM-pt is in DR she is in Geri-chair
12:05 PM-pt is in DR
4:00 PM- pt is in activity room

The patient care notes dated 6/22/13 documented the following information at the times listed:

12 midnight-client resting quietly in Geri-chair in DR
8:00 AM-pt is in Geri-chair in DR
12:15 PM- pt is in DR
4:05 PM- pt is in activity room
8:00 PM-up in Geri-chair

The patient care notes dated 6/23/13 documented the following information at the times listed:

12 midnight-client resting quietly in Geri-chair in DR
4:00 AM-client resting in Geri-chair
8:00 AM- in DR with peers

The patient care notes dated 6/24/13 documented the following information at the times listed:

12 midnight-client resting in Geri-chair
4:00 AM-pt resting up in Geri-chair in DR
8:00 AM-in reclined Geri-chair in DR
8:00 PM-pt is sitting quietly in reclined chair in DR

The patient care notes dated 6/25/13 documented the following information at the times listed:

12 midnight-resting quietly in reclined chair
4:00 AM-pt awake and sitting quietly in DR
8:00 AM-up in DR in reclined Geri-chair for comfort
8:30 PM-pt sitting in reclined Geri-chair in DR
9:30 PM-pt resting quietly in reclined Geri-chair

The patient care notes dated 6/26/13 documented the following information at the times listed:

2:00 AM-pt awake in DR
8:30 AM-up in reclined Geri-chair for comfort
12:10 PM-pt is in DR
2:30 PM-pt is in hallway to reduce external stimuli
4:05 PM-pt is in DR
8:00 PM- client is up in Geri-chair

The patient care notes dated 6/27/13 documented the following information at the times listed:

12 midnight-client resting quietly in Geri-chair in DR
8:00 AM-in DR with peers
12:00 PM anxious/shouting at staff, trying to get up from chair breaks(?) reclining Geri-chair in which she is sitting... prn meds given

The patient care notes dated 6/28/13 documented the following information at the times listed:

12 midnight-client up in Geri-chair in DR
10:00 AM- in Geri-chair in hallway to decrease stimuli as she is agitated, yelling
10:35 AM- in Geri-chair in hallway
8:00 PM-sitting up in DR

The patient care notes dated 6/29/13 documented the following information at the times listed:

12 midnight- resting quietly in reclined Geri-chair
1:45 AM- Pt shouting from DR. Pt observed laying on floor on her left side, complaint of left hip and left wrist pain...MD notified awaiting orders, pt assisted x 2 to chair...
4:30 AM-orders received Lortab 5/325 mg by mouth given x 1 dose for pain stat x-ray ordered. Pt has been awake in DR since incident occurred. Pull alarm in place.
5:55 AM-pt transferred via HEMSI to Crestwood ER (emergency room ) for x-ray to left hip and left wrist per doctor orders.
9:30 AM-admitted ... with fractured left hip.


From 6:15 AM until 7:00 AM on 6/29/13 it was documented the pt was in the hallway, although the patient was transferred to the hospital at 5:55 AM according to the patient care notes completed by the nurse.


The patient attempted to get out of the Geri-chair on 6/6/13, 6/16/13 and 6/27/13 prior to the fall resulting in the fracture on 6/29/13.

This patient had remained in the Geri-chair according to documentation for the majority of her 23 day stay and the incident occurred after midnight with the patient in the DR. The facility failed to provide safe treatment in a safe environment for this patient and failed to meet the needs of this patient who at times was combative and agitated.

There was no documentation of any type of alternative care provided to address the patient's behaviors.

In an interview with Employee Identifier (EI) # 3, RN Director of Quality 7/11/13 at 11:30 AM, the above information was confirmed.


2. MR # 6 was admitted to the facility 5/30/13 with a diagnosis of Alzheimer's Dementia with Behavioral Disturbance and Intermittent Explosive Disorder.

The medical record contained a treatment plan as followed:

Four of the Problems:

1. Risk for violence directed at others
2. ADL(activities of daily living) precautions
3. Altered thought content with delusions
4. Anxiety with agitation.

The goal for # 4, agitation was to attend group without agitation x 4 days. This goal was not met.

Problems number 1 through 4 were documented as being resolved 6/3/13, although the patient continued to require prn (as needed) medication for agitation 6/1/13, 6/2/13, 6/3/13, 6/4/13 and 6/5/13.

The patient was admitted [DATE] at 4:00 PM, the patient care notes documented, " Pt (patient) combative when assistance is provided to him, cursing at times...pt is presently in activity room with staff in ger-chair reclined."

The patient care notes documented at 6:07 PM on 5/30/13, " Pt presently in reclined gerichair in dining room..."

The patient care notes documented at 8:00 PM on 5/30/13, "Client up in gerichair, restless, confused, non-cooperative, unable to voice needs, prn ( as needed) Seroquel administered..."

On admission 5/30/13 the Special Precautions- Special Monitoring form documented 15 minute checks by the MHT (mental health technicians) documented the patient in the Group Room (GR) from 4:00 PM until 5:45 PM, then in the Dining Room (DR) from 6:00 PM until 9:00 PM.

On 5/31/13 the patient received prn medications for anger, agitation and restlessness at 1:00 PM, Haldol 1 mg (milligrams) IM (intramuscular) and at 3:00 PM for anger and verbally abusive behavior received Zyprexa 5 mg IM.

On 6/2/13 the patient received the following prn medications: Haldol 1 mg IM at 3:00 PM for agitation, tore buttons off his shirt and Haldol 1 mg by mouth at 10:30 PM for agitation.

On 6/3/13 the patient received the following prn medication: Geodon 10 mg IM at 12:45 PM for agitation and Geodon 10 mg IM at 10:00 PM for agitation, ripped IV (intravenous) out.

On 6/4/13 the patient received the following prn medications: Geodon 10 mg IM at 5:00 AM for agitation, pulled IV out and Geodon 10 mg IM at 11:15 AM for agitation.

The patient continued to receive prn medications as follows 6/5/13: Geodon 10 mg IM at 1:30 AM for agitation, kicking staff and Seroquel 25 mg IM at 4:00 PM for agitation.

There was no documentation of a least restrictive care to re-direct the patient's behaviors or an alternative care provided prior to medicating the patient to control behaviors.

The patient care notes documented 6/5/13 at 12:00 midnight, " Client up in dining room in Geri-chair..."

The patient care notes documented 6/5/13 at 8:05 AM, " Sitting in Geri-chair in dining room..."

The patient care notes documented 6/5/13 at 11:55 AM, " In DR waiting for lunch sitting in Geri-chair..."

On 6/6/13 the Special Precautions- Special Monitoring form documented 15 minute checks by the MHT (mental health technicians) documented the patient was in a reclined gerichair:
DR from 12:00 PM until 8:45 AM
GR from 9:00 AM until 11:30 AM
DR from 11:30 AM until 12:45 PM
GR from 1:00 PM until 3:15 PM
DR from 3;30 PM until 8:45 PM and then returned to his room.

The patient remained in the Geri-chair from 12:00 Midnight until 8:45 PM.

There was no documentation in the medical record to show MR # 6 was toileted or released from the Geri-chair.

The patient care notes documented 6/6/13 at 4:30 AM, " Pt resting quietly in reclined chair with eyes closed..."

The patient care notes documented 6/6/13 at 8:00 AM, " Restless in reclined Geri-chair, continued attempting to get up out of chair..."

The patient care notes documented 6/6/13 at 10:00 PM, " Resting quietly reclined chair with eyes closed. "

The patient care notes documented 6/7/13 at 3:30 AM, " Resting quietly in reclined chair with eyes closed. "

The patient care notes documented 6/7/13 at 8:30 AM, "In reclining chair in dining room asleep. "

The patient care notes documented 6/7/13 at 2:00 PM, " He is awake in soft recliner in dining room."

On 6/7/13 the Special Precautions- Special Monitoring form documented 15 minute checks by the MHT (mental health technicians) documented the patient was in a reclined gerichair:
DR from 12:30 AM until 6:00 AM
Nurses Station (NS) from 6:15 AM until 7:30 AM
DR from 7:30 AM until 9:00 AM
GR from 9:00 AM until 11:15 AM
DR from 11:30 AM until 12:45 PM and then returned to his room.

The patient remained in the chair from 12:30 AM until 12:45 PM on 6/7/13. There was no documentation in the medical record to show MR # 6 was toileted or released from the Geri-chair.

The patient was discharged to home hospice care on 6/7/13 at 2:30 PM.

In an interview 7/11/13 at 9:40 AM, Employee Identifier (EI) # 3, RN (Registered Nurse) Director of Quality, confirmed the patient was in the Geri-chair, but EI # 3 stated it was not a restraint it was for the comfort of a home environment.

There was no documentation in the medical record that the patient was able to remove self from the Geri-chair without staff assistance.

3. MR #11 was readmitted [DATE] with a diagnosis of Dementia with Behavioral Disturbances.

On the first admission a Nurses Event Note dated 6/8/13 at 1:30 PM was from her first admission. The event note documented, " Observed in the activities room, restraint- reclined in gerichair with a blanket tied around her waste area and chair. Restraint removed. Staff present stated they did not know how blanket got tied in place."

The occurrence investigation documented, " Only 1 MHT (mental health technician) here, 2 had called in, additional staff called in to assist..."

In an interview with Employee Identifier (EI) # 2, Risk Manager/Interim Director of Nursing, the above information was confirmed.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
This condition of participation for Pharmaceutical Services is out of compliance based on review of the pharmacy contract with AmPharm, observation, review of Medication Administration records.

The facility failed to:

1. Coordinate with the consulting pharmacist.

2. Provide ordered medications to patients timely.

3. Notify physician of medications unavailable for the patients.

4. Destroy unusable drugs in the facility.

This had the potential to affect all patient served by the facility.


Refer to A 492, A 493, A505 and A 511.
VIOLATION: PHARMACIST RESPONSIBILITIES Tag No: A0492
Based on review of pharmacy services agreement and interviews, it was determined the facility failed to have a consulting pharmacist comply with the agreement by coordinating all activities of the pharmacy and being actively involved in the facility's programs and committees on a monthly basis.

Findings include:

Pharmacy Services Agreement

This agreement entered into...between Ampharm, Inc (incorporated)...this 1st day May, 2012 as follows:
Recitals:
...PHARMACY to provide its unique pharmacy consulting, dispensing, and delivery services to HOSPITAL and its patients and to implement Pharmacy's systems and procedures...

...A. Pharmacy Services- Consulting
1. The PHARMACY shall be responsible for the general supervision of the HOSPITAL'S pharmaceutical services. More specifically, these services shall include:

a. General supervision of the HOSPITAL'S procedures for the control and accountability for all drugs and biologicals throughout HOSPITAL and that such drugs and biologicals shall be approved and dispensed in compliance with Federal and State laws.
b. Supervision of the records and disposition of all controlled drugs and the maintenance of such records...so as to allow an accurate reconciliation...
d. Supervision of the labeling of all drugs...to insure that such labeling is based on accepted professional pharmacy principles and includes...cautionary instructions as well as the expiration date...
f. Written reports quarterly to the HOSPITAL on the status of the HOSPITAL's pharmaceutical services and staff performance.
G. Being an active member of the HOSPITAL's pharmacy and therapeutics and infections control committees.
...i. The provision of a report to the Administrator of the HOSPITAL after each pharmacy consultant visit which will include suggestions of improving pharmacy services and/or correcting any pharmacy related problems.

...2. PHARMACY agrees...during the term of this agreement as follows: one (1) routine and regular visit by a pharmacy consultant to the HOSPITAL per month and as reasonably necessary...

The surveyor requested documentation of the monthly pharmacist visits from the Nursing Coordinator, LPN, (Licensed Practical Nurse) Employee Identifier (EI) # 1 on 7/9/13 at 11:00 AM, during a tour of the pharmacy. EI # 1 stated that he only knew of one time the pharmacist had come to the facility and he thought that was in March 2013 to destroy narcotics.

A representative pharmacist from Ampharm, Inc came to the facility 7/11/13 at 11:30 AM and met with the surveyors. The pharmacist stated that this visit was only the second time anyone from Ampharm had physically been to the facility but they were always available electronically.

The hospital failed to assure it's contracted pharmacy services agreement was followed and fully implemented. There was no supervision of the pharmacy services onsite at the hospital at least monthly or more often.
VIOLATION: PHARMACY PERSONNEL Tag No: A0493
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, review of Medication Administration Records (MAR), review of the Pharmacy Services Agreement, review of medical records and interviews, it was determined the facility failed to provide accurate and timely delivery of ordered medications and notify the physician when medications were not available or refused by the patient. The pharmacy contract does not provide 24 hour/day, 7 days a week coverage for medication supply and delivery. This had the potential to affect all patients served by the facility.

A review of memos from the communication book for the staff revealed a memo from Administration to Nursing staff dated February 4, 2013, " If we have medication that needs to be picked up during regular business hours please let one of us (4 names listed) know so we can save the carrier fee...After hours and weekends the carrier needs to be called."

A second memo from Administration to Nursing staff dated February 5, 2013, " Only use back up pharmacy for stat and now orders. If a patient is admitted at 2:00 PM and the MD (medical doctor) orders medications, please call AmPharm to notify them and fax the order...has asked us to notify her of all admits and discharges. Communication with AmPharm with this will save us quite a bit of money, time and frustration."


Pharmacy Services Agreement dated May 1, 2012

B. PHARMACY SERVICES-DRUG DISPENSING AND DELIVERY

1. PHARMACY, being duly registered and licensed in the State of Tennessee agrees to provide, furnish and supply pharmaceuticals and drugs to HOSPITAL and/or to the residents therein...{The agreement given to the survey team for this Alabama hospital listed the state of Tennessee in the agreement not Alabama}
2. PHARMACY agrees to provide a drug delivery system that complies with all applicable state and federal laws and regulations...
3. PHARMACY agrees to routinely and regularly deliver to HOSPITAL all prescriptions and supplies within reasonable times without reasonable delay, except for circumstances and conditions beyond PHARMACY's control...PHARMACY's nightly delivery and courier services shall be provided in consideration of the compensation...
...4. To the full extent practicable, all medications provided by PHARMACY will be dispensed and delivered "unit dose". HOSPITAL shall be allowed to return all unused, unopened unit dose medications to PHARMACY...
5. Pharmacy agrees to make non-routine or emergency deliveries to and as requested by Hospital for which Hospital will pay Pharmacy a minimum fee of... per such non-routine or emergency delivery if such delivery is occasioned by Hospital's oversight or delay.


Findings include:

A review of medical records and MARs during the survey process 7/9/13 through 7/11/13 revealed a number of medications not available to the patients from AmPharm the consulting pharmacy.

In an interview with Employee Identifier (EI) # 1, Nursing Coordinator, LPN, (Licensed Practical Nurse) on 7/9/13 at 11:30 AM stated that if a patient is admitted and medications are ordered before 4:00 PM the same day, the medications will come on the 11:30 PM courier. If the patient needs any medications not available in the stock box then the medications are delivered from a local pharmacy and delivered to the hospital by a courier service in town.

Accurate and timely medication delivery was not available to patients in this hospital.

Medical Record findings:

1. Medical Record (MR) # 5 was admitted to the hospital 5/20/13 with diagnoses of Depression with Suicidal Ideations, Hypertension and Gastric Reflux.

The patient arrived at the facility at 5:35 PM.

The patient is under the care of a pain specialist for chronic back and generalized pain.

The admission medication form included an order for Oxycodone Hcl
(hydrochloride) 15 mg (milligrams) by mouth every 4 hours prn (as needed) for pain.

The patient was admitted [DATE] and the physician wrote an order for Lortab 7.5/325 mg by mouth now times one dose at 7:00 PM.
The patient received the dose of Lortab as ordered on [DATE].

The patient continued to complain of pain through out the night. The nurse documented 5/21/13 at Midnight, " Client resting quietly in bed, awake, up often complaint of discomfort in back and all over, agitated, states that he wishes he never came here, states that he only came here to get his pain under control. Talked with client about how depression can worsen pain, client replied that his pain is what causes his depression."

The next entry at 4:00 AM, 5/21/13 documented, " Client resting in bed, continues to get up often and complain of consistent pain in his back..."

The patient did not receive the medication ordered by the physician every 4 hours as needed and the nurses made no effort to contact the physician to receive an order for an alternate medication that was available in stock. There was no documentation a local pharmacy was contacted to get the drug ordered.

The patient went 16 hours without pain medication recieving the ordered medication on 5/21/13 at 11:00 AM when it arrived from the local pharmacy.

The Social Worker documented 5/21/13 at 2:20 PM, " He wrote a sentence ' I wish I lived in a tent'- he said he finally got his pain meds (medication) but I just hurt all over. Staff report this AM he was irritable due to his pain, calmed down post meds given."

The patient received Oxycodone 15 mg a total of 32 times from 5/21/13 until discharge 6/29/13.

The surveyor requested a list of medications that had been ordered in June for patients from the local pharmacy. A total of thirty prescriptions had to be delivered to the hospital for patients and this did not cover all of the needed medications as some patients missed doses.

Refer to the following for specific doses of medications missed.






Findings include:

On 7/10/13 at 7:00 AM, a medication (med) pass was observed by survey staff with Employee Identifier (EI) # 5, Licensed Practical Nurse. EI # 5 administered medications to 14 patients. EI # 5 was unable to administer 3 medications to 3 different patients during the 7/10/13 AM scheduled med pass due to medications being unavailable. Medications not available were Multi Vitamin with Iron, Low dose Enteric Coated Aspirin and Amitiza.

An interview was conducted with EI # 5 on 7/10/13 at 1:50 PM who reported the night shift's responsibility was to reconcile pharmacy orders with each patient's prescribed medications found in the patient's med cart drawer. If meds were not available, Ampharm (contracted pharmacy) was notified that morning.The medication was ordered and would be delivered via courier by 11:00 PM that evening. Medications needed immediately could be ordered from the local backup pharmacy and would be be delivered to the facility by courier.

Review of a medication administration record for unsampled medical record # 1 admitted to the facility on [DATE] at 4:00 PM revealed documentation that 4 medications, Lisinopril, Magnesium, Tylenol Arthritis and Calcium were ordered twice daily. The medication administration record documentation failed to reveal the patient received the evening dose of the ordered medications.

Review of a medication administration record unsampled medical record # 2 with the medical diagnosis of Chronic Obstructive Pulmonary disease had Albuterol nebulizer treatments prescribed twice daily. Documentation revealed 16 treatments had been refused with no reason documented as why the treatment was refused by the patient. There was no documentation the physician was notified of the continued nebulizer treatment refusals.

Review of a medication administration record for MR # 11 revealed the patient had Amitiza 24 micrograms prescribed twice daily. Documentation review revealed 9 times the patient did not receive the Amitiza and/or unable to swallow the medication. There was no documentation the physician was notified the patient had not received the medication as ordered or that an alternate form of drug should be given.

During a 7/11/13 9:30 AM review of the 15 current patient medication administration records, documentation revealed 4 of 15 active patients failed to receive 10 ordered medications from 7/1/13 to 7/10/13 due to medication unavailable.

An interview was conducted on 7/11/13 at 11:50 AM with EI # 1, Nursing Coordinator and EI # 3, Director of Quality, who verified the above findings.

There was no documentation the consulting pharmacist made any recommendation, was consulted for alternatives or that the contracted pharmacy provided medications 24/7 to all patients.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on observation, review of facility policy and procedure, communication book memos from Nursing Administration, review of the pharmacy services agreement and interview it was determined the facility failed to return patient's medications and destroy unused drugs which included controlled drugs. This had the potential to affect all patients served by this facility.

Findings include:

Policy and Procedure: Disposal of Medication

Policy: It is the policy of Behavioral Healthcare of Huntsville to dispose of all medications properly and in accordance with all state and federal guidelines.

Procedure:

2. Documentation of drugs destroyed will be logged in a medication destruction book with the date, patients name, type of medication and the log book is maintained in the Nurse managers office.

Patient's Own Medication Administration

Policy: It is the policy of Behavioral Healthcare of Huntsville that no medication will be administered by the patient.

Procedure:

1. Medication brought into the hospital by the patient or his/her family will be collected and sent home with the family.

Nursing Administration Memo dated 3/1/2013:

Remember to fax the discharge order to AmPharm so that they do not send more medication. We can refuse medication but cannot return it. The courier can wait while you check promptly. Otherwise, Alabama law requires we destroy the unused medication. This memo was initialed by 9 staff members as having been read.






Pharmacy Services Agreement

This agreement entered into...between Ampharm, Inc (incorporated)...this 1st day May, 2012 as follows:
Recitals:
...PHARMACY to provide its unique pharmacy consulting, dispensing, and delivery services to HOSPITAL and its patients and to implement Pharmacy's systems and procedures...

...A. Pharmacy Services- Consulting
1. The PHARMACY shall be responsible for the general supervision of the HOSPITAL'S pharmaceutical services. More specifically, these services shall include:

a. General supervision of the HOSPITAL'S procedures for the control and accountability for all drugs and biologicals throughout HOSPITAL and that such drugs and biologicals shall be approved and dispensed in compliance with Federal and State laws.
b. Supervision of the records and disposition of all controlled drugs and the maintenance of such records...so as to allow an accurate reconciliation...
d. Supervision of the labeling of all drugs...to insure that such labeling is based on accepted professional pharmacy principles and includes...cautionary instructions as well as the expiration date...
f. Written reports quarterly to the HOSPITAL on the status of the HOSPITAL's pharmaceutical services and staff performance.
G. Being an active member of the HOSPITAL's pharmacy and therapeutics and infections control committees.
...i. The provision of a report to the Administrator of the HOSPITAL after each pharmacy consultant visit which will include suggestions of improving pharmacy services and/or correcting any pharmacy related problems.

...2. PHARMACY agrees...during the term of this agreement as follows: one (1) routine and regular visit by a pharmacy consultant to the HOSPITAL per month and as reasonably necessary...

B. PHARMACY SERVICES-DRUG DISPENSING AND DELIVERY

1. PHARMACY, being duly registered and licensed in the State of Tennessee agrees to provide, furnish and supply pharmaceuticals and drugs to HOSPITAL and/or to the residents therein...{The agreement given to the survey team for this Alabama hospital listed the state of Tennessee in the agreement, not Alabama}
2. PHARMACY agrees to provide a drug delivery system that complies with all applicable state and federal laws and regulations...
3. PHARMACY agrees to routinely and regularly deliver to HOSPITAL all prescriptions and supplies within reasonable times without reasonable delay, except for circumstances and conditions beyond PHARMACY's control...PHARMACY's nightly delivery and courier services shall be provided in consideration of the compensation...
...4. To the full extent practicable, all medications provided by PHARMACY will be dispensed and delivered "unit dose". HOSPITAL shall be allowed to return all unused, unopened unit dose medications to PHARMACY...

During an observation of the medication room on 7/9/13 at 11:15 AM, the surveyors observed multiple medications boxed and bagged on the counter, in the cabinets and in the refrigerator. The surveyor asked if the medications were for patients currently in the facility. EI # 1 (Employee Identifier), Nursing Coordinator, verified each of the patients identified below had been discharged from the facility.

Refrigerated medications included the following:
Influenza vaccine 0.5 ml (milliliter) qty (quantity) 2 expired 6/2013, unnamed patient
Novolin R (regular) insulin 10 ml belonging to unnamed patient.
Pneumococcal Vaccine Polyvalent 0.5 ml qty 2 expired 5/2/2013, unnamed patient
Levemir Flex insulin pen 100 unit (u)/ml 20 units sq (subcutaneous) at bedtime, dated 2/5/13 and labeled "expires 28 days after removing from refrigerator", belonging to unsampled medical (MR) # 3.

The following medications, observed in the medication room, laying on the counter and in cabinets in boxes and plastic bags, were prescribed for patients no longer in the facility:
Digoxin tab 250 mcg (microgram) qty 1, belonging to unsampled MR # 4.
Metformin HCL (hydrochloride) 500 mg (milligram) tab qty 1, belonging to unsampled MR # 5.
"Eliquis 5 mg 1/2 tab", qty 1, belonging to unsampled MR # 6.
Deep Sea Premium Nasal Spray qty 1, belonging to unsampled MR # 7
Sulfameth/Trimethoprim 800/160 mg qty 1, belonging to unsampled MR # 8
Lisinopril-HCTZ (Hydrochlorothiazide) 20/25 mg qty 1, belonging to unsampled MR # 9
Cyanocobalamin 1,000 mcg/ml (milliliter) 1 ml qty 1, Metoprolol Succinate ER (extended release) 500 mg qty 1, Amitiza 24 mcg qty 1, Risperdone 0.5 mg, qty 1, Risperidone 1 mg qty 1, Simvastin 20 mg qty 1, Trazodone 50 mg qty 1, belonging to MR # 11
Budesonide 0.5 mg/2 ml inhalation suspension 2 mls, qty 1, belonging to unsampled MR # 10
Mupirocin Ointment 2 % (percent) tube qty 1, belonging to unsampled MR # 11
Saline Mist 0.65% spray bottle, qty 1, belonging to unsampled MR # 12
Brimonidine Tar (tartrate) 0.2 % Ophthalmic solution, qty 1, belonging to unsampled MR # 13
Lumigan 0.01 % ophthalmic solution, qty 1, belonging to unsampled MR # 14
Cyanocobalamin 1,000 mcg/ml 1 ml qty 1, belonging to unsampled MR # 15
Cephalexin 500 mg qty 1, belonging to unsampled MR # 16
Cymbalta 60 mg qty 1, Furosemide 20 mg qty 1, Potassium Chloride 20 meq (milliequivalent) qty 1, belonging to unsampled MR # 17
Oxcarbazepine 300 mg qty 14, expired 6/29/13; Paxil 40 mg qty 10, expired 6/29/13, Zyprexa 10 mg qty 6, expired 7/1/13, Zydus qty # 11, belonging to unsampled MR # 18
Budesonide ampule 6 packs, belonging to unsampled MR # 19
Spivira tab qty 9, belonging to unsampled MR # 20
Turenne Assisted Living 6 pouches with multiple medications, belonging to unsampled MR # 21
HCTZ 12.5 mg qty 3, Sertraline 100 mg qty 9, belonging to unsampled MR # 22
Metoprolol 25 mg qty 1, belonging to unsampled MR # 23
Trazadone 150 mg qty 30, belonging to unsampled MR # 24
Fluorometholone 0.1% 10 ml qty 2, Latanoprost-(not labeled to dispense) 2 boxes, Advair 250-50 Diskus with no fill date, Fluticasone 50 mcg qty 1, belonging to unsampled MR # 25
Refresh eye ointment 0.25 ounces qty 1, Azelastine HCL 0.05 % opthalamic drops qty 1, belonging to unsampled MR # 26
Latanoprost 0.005 % opthalamic drops qty 1, belonging to unsampled MR # 27
Patanol 0.1 % opthalmic solution qty 1, belonging to unsampled MR # 28
Metformin HCL 850 mg tabs qty 5, Lorstatan-HCTZ qty 1, belonging to unsampled MR # 29
Neupro 4 mg/24 hr (hour) patch ty 1, belonging to unsampled MR # 30
Ofloxacin 0.3 % opthalmic solution qty 1, belonging to unsampled MR # 31
Nystatin 100,000 u/ml qty 2 bottles, Chloraseptic qty 1 bottle, belonging to MR # 3
Sumatriptan 50 mg qty, belonging to unsampled MR # 32

The below medications had no patient names attached and included the following:
Ramipril tablet (tab)10 mg qty 2
Omeprazole capsule (cap) 20 mg qty 1
Digoxin 125 mcg qty 1
Quetiapine 100 mg qty 1
Ferocon cap qty 1
Quetiapine 25 mg qty 4
Gabapentin cap 100 mg qty 2
Risperidone 0.5 mg qty 6
Carvedilol 3.125 mg qty 1
Levothyroxine 3.125 mg qty 1
Fenofibrate 145 mg qty 1
Risperidone 0.25 mg qty 1
Propranolol ER (extended release) cap 60 mg qty 1
Bystolic 10 mg qty 1
Invega 1.5 mg qty 1
Fluconazole 150 mg tab qty 3
Ondansetron 8 mg qty 1
Restasis 0.05 % eye drops qty 3 bottles
Ipratropuim Bromide 0.5 mg/Albuterol Sulfate 3 mg/3 ml inhalation aerosol
qty 2
Cymbalta qty 4

Verification of the narcotic count was conducted 7/9/13 at 1:10 PM with EI # 1, Nursing Coordinator. The locked narcotic cabinet in the medication room was found to contain the below medications for patients no longer in the facility:
Fentanyl 75 mcg patches qty 3, dated 5/20/13, belonging to unsampled MR # 10

Morphine Sulfate IR (intermediate release) 15 qty 30, dated 3/21/13, belonging to unsampled MR # 33

Clonizapine 100 mg qty 30, dated 5/15/13, belonging to unsampled MR # 34

Ativan 0.5 mg qty 17 in blister pack. Controlled Drug Receipt /Record/Disposition Form documentation revealed disposition of remaining doses quantity destroyed 17 dated 3/29/13, belonging to unsampled MR # 35

Oxycodone HCL 15 mg qty 26, belonging to unsampled MR # 36

Tramadol 37.5/325 qty # 27, dated 3/13/13, belonging to unsampled MR # 37

The medications had not been destroyed as documented on the drug disposition form.

An interview was conducted with EI # 1, Nursing Coordinator on 7/9/13 at 1:15 PM, who confirmed pharmacy services had visited the facility once since opening August 2012 to destroy medications and that outdated and unusable drugs remain in the facility.
VIOLATION: FORMULARY SYSTEM Tag No: A0511
Based on observation and interview the facility failed to have a formulary available and approved by the medical staff. This had the potential to negatively affect all patient's served by this facility.

Findings include:

This psychiatric hospital was licensed on July 19, 2012 and begin operating August 21, 2012.

The medical staff in consultation with the pharmacy service was to establish a formulary system.

The surveyor asked the Nursing Coordinator, LPN, (Licensed Practical Nurse) Employee Identifier (EI) # 1 for a copy of the formulary 7/10/13 at 3:30 PM. EI # 1 stated he was not aware of a formulary onsite but he would ask management.

On 7/11/13 at 8:20 AM, EI # 3, Registered Nurse (RN) Director of Quality provided a single page medication formulary.

The formulary failed to have a date or any evidence of approval by the medical staff. The surveyor asked for documentation of approval.

EI # 3 provided a copy of the minutes from the Medical Staff Meeting July 12, 2012.
The document included the follow information:
" 3. DON (Director of Nursing) was finalizing the medication formulary for the initial drug order from AmPharm."

The facility provided no further information regarding the formulary.
VIOLATION: ORGANIZATION Tag No: A0619
Based on United States Health Public Food Code 2009 regulations, observations and interview, it was determined the hospital failed to ensure food was stored in a safe and sanitary manner. This had the potential to negatively affect all patients.

Findings include:

United States Health Public Food Code 2009

3-302.12 Food Storage Containers, Identified with
Common Name of Food.
Except for containers holding FOOD that can be readily and unmistakably recognized such as dry pasta, working containers holding FOOD or FOOD ingredients that are removed from their original packages for use in the FOOD ESTABLISHMENT, such as cooking oils, flour, herbs, potato flakes, salt, spices, and sugar shall be identified with the common name of the FOOD...

3-501.17 Ready-to-Eat, Potentially Hazardous Food
(Time/Temperature Control for Safety Food),
Date Marking.
...commercially processed food open and hold cold
(B) Except as specified in ?? (D) - (F) of this section, refrigerated, READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) prepared and PACKAGED by a FOOD PROCESSING PLANT shall be clearly marked, at the time the original container is opened in a FOOD ESTABLISHMENT and if the FOOD is held for more than 24 hours, to indicate the date or day by which the FOOD shall be consumed on the PREMISES, sold, or discarded, based on the temperature and time combinations specified in
? (A) of this section and: Pf (1) The day the original container is opened in the FOOD ESTABLISHMENT shall be counted as Day 1; Pf and (2) The day or date marked by the FOOD ESTABLISHMENT may not exceed a manufacturer's use-by date if the manufacturer determined the use-by date based on FOOD safety...
(C) A refrigerated, READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) ingredient or a portion of a refrigerated, READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) that is subsequently combined with additional ingredients or portions of FOOD shall retain the date marking of the earliest- repared or first prepared ingredient. Pf
(D) A date marking system that meets the criteria stated in ?? (A) and (B) of this section may include:...
(2) Marking the date or day of preparation, with a procedure to discard the FOOD on or before the last date or day by which the FOOD must be consumed on the premises, sold, or discarded as specified under ? (A) of this section;
(3) Marking the date or day the original container is opened in a FOOD ESTABLISHMENT, with a procedure to discard the FOOD on or before the last date or day by which the FOOD must be consumed on the premises, sold, or discarded as specified under ? (B) of this section...

Observations on 7/9/13 at 11:00 AM during a tour in the snack room revealed the following:

Dietary Refrigerator: 2 plastic containers with beige colored liquid undated and unlabeled; 1 plastic bag that contained 6 fruit cookies unlabelled and undated; 1/2 gallon orange juice open, undated and unlabeled; 1 pitcher of tea undated and unlabeled; 1/2 gallon Almond milk opened greater than 72 hours (expired).

During an interview conducted on 7/9/13 at 11:04 AM with Employee Identifier (EI) # 1, Nursing Coordinator, confirmed the items were not dated and labeled and the above items were discarded during the tour.