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This Condition of Participation is not met based on record review, staff interview, and review of hospital policies and procedures for restraints and incident reporting, the facility failed to ensure 1 (Patient #3) of 5 sampled patients who were ordered restraints were free from inappropriate restraint use and failed to ensure the restraints were discontinued at the earliest possible time. Nursing staff failed to attempt to implement any other interventions to avoid the use of restraints to Patient #3; failed to investigate bruising of unknown origin to the patient's left foot and hip and failed to implement measures to ensure the least effective restraint possible was utilized.

Review of hospital policies and procedures for restraints, the facility failed to ensure 1 (Patient #3) of 5 sampled patients who was ordered restraints was free from the inappropriate use of chemical restraints. Nursing staff failed to assess the cause of the patient's behavioral episodes and failed to attempt implementation of any other interventions to manage the patient's behavior prior to the administration of chemical restraints.

These failures present a substantial probability to adversely affect all patients' physical health, safety and well-being.

Please refer to A-0154 and A-0160 for additional information.

Based on record review, staff interview, and review of hospital policies and procedures for restraints and incident reporting, the facility failed to ensure 1 (Patient #3) of 5 sampled patients who were ordered restraints were free from inappropriate restraint use and failed to ensure the restraints were discontinued at the earliest possible time. Nursing staff failed to attempt to implement all interventions to avoid the use of restraints to Patient #3; failed to investigate bruising of unknown origin to the patient's left foot and hip and failed to implement measures to ensure the least effective restraint possible was utilized.

The findings include:

1. Record review on 10/27/10 for Patient #3 revealed the patient was found by neighbors outside his home on 5/15/10 in his yard naked and doing yard work. EMS (Emergency Medical Services) was called. EMS transported the patient to the emergency room and according to the ED (Emergency Department) physician addendum dated 5/15/10, indicated ground up oxycodone pills were found in the patient's mouth. The physician documented the patient was Baker Acted because he was refusing to stay, was refusing help and was not alert enough to appropriately make that decision himself. The physician documented the patient was at harm to himself and had apparently overdosed on pain medication.

The patient was admitted to 3N (north) and the Baker Act was placed on hold pending medical clearance.

Nurses notes dated 5/15/10 at 2055 (8:55 p.m.) revealed the patient was lying in bed with no complaints and a sitter was at the bedside.

Review of the "ADULT ASSESSMENT" by the nurse dated 5/16/10 at 0010 (12:10 a.m.) revealed the patient was calm but refused to participate in the assessment. The nurse documented the patient had no pain and was alert and oriented x 3. All other systems were assessed and were within normal limits.

Review of the Security Incident report dated 5/16/10 at 6:30 a.m. revealed Security Control received a phone call from 3 N indicating that a Baker Act patient was attempting to leave. Officers were dispatched to the area to intercept the situation. Upon arrival, the patient was sitting on his bed indicating that he was going to go downstairs. The patient was informed that due to the status as a Baker Act, that he could not leave his room and that he needed to lie back in the bed. The patient "gave some verbal resistance and minimal physical resistance and was placed in 2 point soft restraints along with a Posey vest...no injuries to staff or the patient were indicated."

At 0635 (6:35 a.m.) on 5/16/10, nursing notes reflect the patient started getting agitated and insisted on leaving. The nurse explained the reasons for the patient to stay; however, the patient was trying to leave the room. The charge nurse was notified and "manpower" was called. At 0645 (6:45 a.m.), the nurse medicated the patient with Ativan 1 mg. and applied bilateral soft wrist restraints and a vest restraint. (Ativan is a sedative, hypnotic; antianxiety medication)

Documentation failed to identify if the nurse determined whether the Ativan would decrease the patient's agitation before applying the wrist and vest restraints.

Review of the "ADULT ASSESSMENT" dated 5/16/10 at 0800 (8:00 a.m.) revealed the patient was calm and refused to participate in care at times and was confused at times. The nurse documents the patient is alert and oriented x 3. Nursing documentation reveals the patient is incontinent, and has scrapes and scabs to bilateral feet and knees and scrapes to the left hip. The nurse documented the patient was oriented to staff, room and call light and the "sitter" was at the bedside.

At 1255 (12:55 p.m.), nursing documents the patient had gotten aggressive and agitated and was found with the intravenous (IV) site out of (his) arm. There was no indication how the IV site was found out of the patient's arm while having a "sitter" at the bedside. An ice pack was placed on the hematoma felt at the (IV) site by the nurse in order to bring down the swelling.

At 1328 (1:28 p.m.), nursing documents "the patient is still trying to get out of bed...frequent monitoring." The notes do not specify what frequent monitoring was being conducted at this time. There was no assessment documented to determine the patient's needs or why the patient was trying to get out of bed. At 1400 (2:00 p.m.), nursing notes revealed bilateral feet restraints were placed on the patient in addition to bilateral upper limb restraints and a Posey vest.

Review of the restraint orders dated 5/16/10 at 1400 (2:00 p.m.) confirmed right upper and right lower as well as left upper and left lower limb restraints were applied to the patient's extremities in addition to a vest restraint and side rails x 4. The order also indicated a physician evaluation must be completed within 24 hours of the order.

Review of the physician's progress notes for 5/16/10 and 5/17/10 failed to document the time the physician evaluated the patient after the initiation of the restraints on 5/16/10. Physician notes did not reflect the patient was seen within the 24 hour time period as stipulated by the restraint order.

Review of the restraint flow sheet for 5/16/10 at 1400 (2:00 p.m.) revealed documentation by the nurse for "restraint alternatives" being "sitter" and "verbal intervention", which were the same interventions used while the patient had the upper extremity and vest restraint applied at 0635 (6:35 a.m.).

There was no documentation to support the nurse attempted to use other alternative interventions than the same alternative used at 0635 (6:35 a.m.) before placing lower limb restraints on the patient's extremities and raising 4 side rails.

Fifteen minutes after placing the lower limb restraints on the patient and raising the 4 side rails, nursing notes document the patient was very agitated and the sitter "blew whistle." The patient's left arm was out of the restraint, the vest was untied and sitting on the side of the bed. The patient attempted to untie the right arm. The notes indicate the nurse was unable to reason or orient the patient to "situation." The patient was combative as staff attempted to get the patient back to bed and attempted to kick staff. The patient was assisted back to bed and ankle restraints were added. Geodon 10 mg. was given IM in the right thigh. (Geoden is an Antipsychotic/neuroleptic and doses of 10mg IM may be given every 2 hours as indicated)

Review of the physician's orders dated 5/15/10 at 1645 (4:45 p.m.) included Ativan 0.5-1 mg. IV/PO (by mouth) every 4 hours prn (as needed) for anxiety and Geodon 10 mg. IM (intramuscular) q (every) 12 hours; there was no indication on the order for use of the Geodon. Review of the Therapeutic Substitution Orders dated 5/15/10 at 2100 (9:00 p.m.) revealed the pharmacist changed the routine order of the Geodon to a "prn" (as needed) order without documentation to support why or whether the physician approved. In addition, there continued to lack an indication for the use of the medication.

Nursing continued to administer the Geodon to the patient without specific indications for its use.

The same alternatives to restraints by the nurses are documented for 1600 (4:00 p.m.). These interventions were "sitter" and "verbal instruction." At 1825, (6:25 p.m.) nursing documents the patient was agitated, trying to get out of the restraints, stating (he) "wants to go." The nurse administered 1 mg. of Ativan. The nurse did not document whether any other intervention were attempted on behalf of the patient prior to medicating the patient with Ativan.

Nurses notes for 5/16/10 at 2000 (8:00 p.m.) through 5/17/10 at 1400 (2:00 p.m.) continued to document the same alternative to restraint use. There was no indication any other alternatives were attempted by the nursing staff. Record review reveals the restraint orders were renewed on 5/17/10 at 1400 (2:00 p.m.) without any other alternatives attempted toward restraint reduction. Review of the nursing notes during this time period failed to reflect any increase in the patient's behaviors which would warrant all 4 limbs and chest to be restrained with 4 side rails up.

Nursing notes for 5/17/10 related to the patient's skin assessment revealed the patient remained with scrapes and scabs to bilateral feet and knees as well as left hip, however, ecchymosis was also assessed to the left hip and no indication for the cause of the left hip ecchymosis was documented/investigated.

Review of the neurological consultation dated 5/17/10 revealed a physical examination of the patient as a "healthy appearing (patient) in four point restraints...the patient is well developed, well nourished, provides a coherent history and is in no acute distress... (he) is alert, oriented to person, place and time...speech is clear and fluent...and seems to confabulate at times when asked questions about ...personal history...has some basic knowledge and recall of current events..."

Review of the restraint orders on 5/18/10 at 1000 (10:00 a.m.) revealed the limb restraints were discontinued and the Posey vest remained on the patient. Physician orders for 5/18/10 at 5:05 p.m. medically cleared the patient for a psych transfer and at 1900 (7:00 p.m.), nursing documents there was no need for the patient to wear the Posey vest and it was removed.

Review of the "ADULT ASSESSMENT" for 5/20/10 at 1830 (6:30 p.m.) revealed the patient was medicated for pain related to aching pain to the left foot. The nurse documented the top of the patient's left foot was edematous and bruised looking, however, did not document there was an investigation into the cause of the bruising or whether the physician was notified.

Nursing notes from 5/18/10 at 1900 (7:00 p.m.) through 5/20/10 at 2331 (11:31 p.m.) revealed the patient to be calm and cooperative. At 0730 (7:30 a.m.) on 5/21/10, the patient became combative when the nurse attempted to obtain vital signs. The nurse documented at 0740 (7:40 a.m.) the patient was an immediate threat to safety and "manpower" was called.

Review of the security report dated 5/21/10 at 7:43 a.m. revealed four "heavy duty restraints" were applied to the patient based on orders of the house supervisor. The report indicated the patient gave a "fair amount of resistance."

Restraint orders dated 5/21/10 at 0800 (8:00 a.m.) revealed 4 point leather restraints were applied to the patient's upper and lower extremities. The time limited to the restraint use was left blank as was the expiration time and date of the restraint and at 0805 (8:05 a.m.) on 5/21/10, nursing documents the patient was confused, combative and hallucinating and the patient's left hip and left foot remained ecchymotic.

Review of the restraint flowsheet dated 5/21/10 revealed assessment checks of the leather restraints by nursing every 15 minutes. The checks began at 0815 (8:15 a.m.) and continued through 0900 (9:00 a.m.) where nursing documents the psychiatric ARNP (Advanced Registered Nurse Practitioner) was notified of the patient's aggression and agitation.

Review of the verbal orders by the ARNP for 5/21/10 at 0900 (9:00 a.m.) revealed the patient was ordered Haldol 4 mg. IV three times a day (hold for sedation) and Haldol 4 mg. IV every 4 hours as needed (prn) for agitation. In addition, Ativan 1 mg. was ordered twice a day (indication for use not specified).

Review of the MAR (Medication Administration Record) for 5/21/10 at 9:25 a.m. revealed the nurse hand wrote, "Haldol 2 mg. IV now" and then administered the 2 mg. dose of Haldol.

There was no physician's order for "Haldol 2 mg. IV now." (Haldol is an antipsychotic, neuroleptic.)

Further review of the MAR revealed the nurse administered an additional 2 mg. of Haldol at 0935 (9:35 a.m.) when the order indicated 4 mg. of Haldol to be given for agitation. The nurse split the 4 mg. dose without a physician's order.

The nurse failed to assess the efficacy of the Haldol 2mg. on the patient's agitation before administering another 2 mg. dose of the medication to the patient 10 minutes after the initial dose.

Nursing notes at 0950 (9:50 a.m.) revealed an assessment of the patient's agitation as "Agitated" and additionally medicated the patient with Ativan 2 mg. IV. Post intervention assessment of the patient at 1025 (10:25 a.m.) revealed the patient as "drowsy."

Nursing administered sedative medications to the patient which chemically restrain his behavior without documenting any other alternative interventions other than the ones already in place (sitter, reality orientation and verbal instruction). The nurse failed to assess the effects of the medication on the patient's behavior after administering the 2nd dose of Haldol to determine whether the medication lessened the severity of agitation.

The patient remained in 4 point leather restraints and on 5/21/10 (no time of order), was ordered to be transferred to the ICU (Intensive Care Unit) for multisubstance abuse and psychotic episode.

Review of the "Reassessment" of the patient on 5/21/10 at 1045 (10:45 a.m.) revealed the patient remained agitated and brief episodes of drowsiness. The nurse documents the patient is disoriented to place and time and re-oriented the patient to place/room and unit. At 11:31 a.m., the nurse documents the patient as confused and anxious, but exhibits no signs/symptoms of alcohol withdrawal. Fifteen minute checks of the leather restraints were documented from 0800 (8:00 a.m.) through 1200 (12:00 p.m.) without any changes to the restraint alternatives and without attempting any other alternatives, the 4 point leather restraints were re-ordered. In addition, the order indicated a physician evaluation must be completed within one hour of initiation of the 4 point leather restraints and there was no documented evidence the physician evaluated the patient within that timeframe. The renewed order indicated the patient with immediate and serious danger to patient safety and others as well as sever aggressiveness, combative and/or destructive behavior; however, there was no indication in the clinical record the patient exhibited these symptoms.

Nursing notes document the patient became restless at 1333 (1:33 p.m.) and administered Haldol 4 mg. IV. There was no indication the patient was agitated which would warrant the administration of the Haldol according to physician's orders. At 1430 (2:30 p.m.), the nurse documents the patient was "a little calmer, remains with word salad" and removed the right lower leg restraint. At 1600 (4:00 p.m.), despite the patient being "calm", the nurse documents the physician was notified and the behavior restraint was re-ordered and the patient remained with 4 point restraints. The clinical record did not show evidence of the re-renewed order nor did nursing implement alternative interventions for a lesser restraint before renewing the order for leather restraints.

During an interview on 10/28/10 at 11:45 a.m. with the RN responsible for assessing the need for 4 point leather restraints while in ICU, she could not confirm the patient was aggressive or combative. She stated she "was going by the report of the patient's behavior from the nurse who took care of the patient while (he) was on the 3rd floor." The nurse then stated she couldn't remember the patient.

Review of the hospital policy and procedure for restraints revealed the purpose of the policy was "to minimize the use of restraints to situations where all alternatives/least restrictive measures have been determined to be inadequate, for the purpose of promoting a safer environment for the patient." The policy indicates on page 4 of 20, limiting use of restraints only to emergencies where there is a risk of the patient harming himself/herself or others, using the "least restrictive method possible"...and, "re-assess and encourage release of restraints as soon as possible." Under "Key Procedural Points: "...a restraint is to be limited to emergencies. Unless there is an immediate and overriding concern for safety, the restraint utilized only after 'all' alternative and 'less restrictive treatment interventions' have been tried without success...Implementing time-limited orders does not indicate that the intervention must be applied for the entire length of time for which the order is written...physician's orders must specify...duration."

During an interview with the Risk Manager on 10/28/10 at 1:00 p.m., she was asked whether staff should complete an incident report related to the unexplained ecchymotic areas to the patient's left hip and top of left foot. She stated "the nurses should have completed an assessment and investigation as to the cause of the ecchymosis, not complete an incident report." The RM stated she "wouldn't have an incident report for that."

Review of the hospital's policy and procedure for reporting incidents and adverse events, Section "C", page 4 of 7 reveals, "Whenever injury or harm occurs to a patient/visitor, it must be reported via "Softmed", or utilizing the paper form when "Softmed" is not available. If utilizing the paper form, the report must be forwarded to Risk Management within 3 working days."

*Medication descriptions based on Mosby's Nursing Drug Reference, 23rd Edition, 2010.

Based on record review, staff interview and review of hospital policies and procedures for restraints, the facility failed to ensure 1 (Patient #3) of 5 sampled patients who was ordered restraints was free from the inappropriate use of chemical restraints. Nursing staff failed to assess the cause of the patient's behavioral episodes and attempt to implement all interventions to manage the patient's behavior prior to the administration of chemical restraints.

The findings include:

1. Record review on 10/27/10 for Patient #3 revealed the patient was found naked outside by neighbors on 5/15/10 in his yard doing yard work and EMS (Emergency Medical Services) was called. EMS transported the patient to the emergency room and according to the ED (Emergency Department) physician addendum, dated 5/15/10, indicated ground up oxycodone pills were found in the patient's mouth. The physician documented the patient was Baker Acted because he was refusing to stay and was refusing help, but, was not oriented to appropriately make that decision and documented the patient was at harm to her/himself and had apparently overdosed on pain medication.

Patient #3 was admitted to 3N (north) for medical clearance. Baker Act was placed on hold.

Nurses notes dated 5/15/10 at 2055 (8:55) revealed the patient was lying in bed with no complaints and a sitter was at the bedside.

Review of the "ADULT ASSESSMENT" by the nurse dated 5/16/10 at 0010 (12:10 a.m.) revealed the patient was calm but refused to participate in the assessment. The nurse documented the patient had no pain and was alert and oriented x 3. All other systems were assessed and were within normal limits.

At 0635 (6:35 a.m.) on 5/16/10, nursing notes reflect the patient started getting agitated and insisted on leaving. The nurse explained the reason for the patient to stay, however, the patient was trying to leave the room. The charge nurse was notified and "manpower" was called. At 0645 (6:45 a.m.), the nurse medicated the patient with Ativan 1 mg. and applied bilateral soft wrist restraints and a vest restraint.

The nurse failed to determine whether the Ativan would decrease the patient's agitation before applying the wrist and vest restraints.

Review of the "ADULT ASSESSMENT" dated 5/16/10 at 0800 (8:00 a.m.) revealed the patient was calm and refused to participate at times and was confused at times. The nurse documents the patient is alert and oriented x 3, and the patient is confused at times as well. The nurse documents the patient is incontinent, and has scrapes and scabs to bilateral feet and knees and scrapes to the left hip. The nurse documented the patient was oriented to staff, room and call light and the "sitter" was at the bedside.

At 12:55 p.m., nursing documents the patient had gotten aggressive and agitated and was found with the intravenous (IV) site out of (his/her) arm.

At 1328 (1:28 p.m.), nursing documents "the patient is still trying to get out of bed...frequent monitoring." The notes do not specify what frequent monitoring was being conducted at this time. There was no assessment documented to determine the patient's needs or why the patient was trying to get out of bed. At 1400 (2:00 p.m.), nursing notes revealed bilateral feet restraints were placed on the resident in addition to bilateral upper limb restraints and a Posey vest.

Fifteen minutes after placing the lower limb restraints on the patient and raising the 4 side rails, nursing notes document the patient was very agitated and the sitter "blew whistle." The patient's left arm was out of the restraint, the vest was untied and sitting on the side of the bed. The patient attempted to untie the right arm. The notes indicate the nurse was unable to reason or orient the patient to "situation." The patient was combative as staff attempted to get the patient back to bed and attempted to kick staff. The patient was assisted back to bed and ankle restraints were added. Geodon 10 mg. was given IM in the right thigh.

Review of the physician's orders dated 5/15/10 at 16:45 included Ativan 0.5-1 mg. IV/PO (by mouth) every 4 hours prn (as needed) for anxiety and Geodon 10 mg. IM (intramuscular) q (every) 12 hours; there was no indication for use of the Geodon. Review of the Therapeutic Substitution Orders dated 5/15/10 at 2100 (9:00 p.m.) revealed the pharmacist changed the routine order of the Geodon to a "prn" (as needed) order without documentation to support why or whether the physician approved. In addition, there was no indication for the use of the medication.

The nurse administered the Geodon to the patient without specific indications for its use.

According to the manufacturer's specifications, adverse side effects of Geodon include, but are not limited to, hostility, confusion, amnesia, delirium, withdrawal syndrome, mania/hypomania.

Review of the restraint flow sheet dated 5/16/10 1400 revealed the same alternatives to restraints by the nurses at 1400(2:00 p.m.) and 1600 (4:00 p.m.). These interventions were "sitter" and "verbal instruction." At 1825 (6:25 p.m.), nursing documents the patient was agitated, trying to get out of the restraints, stating (he) "wants to go." The nurse administered 1 mg. of Ativan. The nurse did not document whether any other intervention as attempted on behalf of the patient instead of medicating the patient with Ativan.

Review of the neurological consultation dated 5/17/10 revealed a physical examination of the patient as a "healthy appearing (patient) in four point restraints...the patient is well developed, well nourished, provides a coherent history and is in no acute distress...(he) is alert, oriented to person, place and time...speech is clear and fluent...and seems to confabulate at times when asked questions about ...personal history...has some basic knowledge and recall of current events..."

According to the manufacturer's indications and usage for Geodon, Geodon "is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients."

The clinical record failed to reveal the patient presented with a definitive diagnosis of bipolar disorder or schizophrenia.

Review of the restraint orders on 5/18/10 at 1000 (10:00 a.m.) revealed the limb restraints were discontinued and the Posey vest remained on the patient. Physician orders for 5/18/10 at 5:05 p.m. medically cleared the patient for a psych transfer and at 1900 (7:00 p.m.), nursing documents there was no need for the patient to wear the Posey vest and it was removed.

Nursing notes from 5/18/10 at 1900 (7:00 p.m.) through 5/20/10 at 2331 (11:31 p.m.) revealed the patient to be calm and cooperative. At 0730 (7:30 a.m.) on 5/21/10, the patient became combative when the nurse attempted to obtain vital signs. The nurse documented at 0740 the patient was an immediate threat to safety and "manpower" was called. The nurse medicated the patient with 1 mg. of Ativan intravenously.

Documentation failed to reveal any other alternatives to the patient's behavior prior to administering the Ativan.

Review of the security report dated 5/21/10 at 7:43 a.m. revealed four "heavy duty restraints" were applied to the patient based on orders of the house supervisor. The report indicated the patient gave a "fair amount of resistance."

At 0805 (8:05 a.m.) on 5/21/10, nursing documents the patient was confused, combative and hallucinating and restraint orders dated 5/21/10 at 0800 (8:00 a.m.) reveal 4 point leather restraints were applied to the patient's upper and lower extremities. The time limited to the restraint use was left blank as was the expiration time and date of the restraint.

Review of the restraint flowsheet dated 5/21/10 revealed assessment checks of the leather restraints by nursing every 15 minutes. The checks began at 0815 (8:15 a.m.) and continued through 0900 (9:00 a.m.) where nursing documents the psychiatric ARNP (Advanced Registered Nurse Practitioner) was notified of the patient's aggression and agitation.

Review of the verbal orders by the ARNP for 5/21/10 at 0900 (9:00 a.m.) revealed the patient was ordered Haldol 4 mg. IV three times a day (hold for sedation) and Haldol 4 mg. IV every 4 hours as needed for agitation. In addition, Ativan 1 mg. was ordered twice a day (indication for use not specified).

Review of the MAR (Medication Administration Record) for 5/21/10 at 9:25 a.m. revealed the nurse hand wrote, "Haldol 2 mg. IV now" and proceeded to administer the 2 mg. dose of Haldol.

There was no physician's order for "Haldol 2 mg. IV now."

Further review of the MAR revealed the nurse administered an additional 2 mg. of Haldol at 0935 (9:35 a.m.) when the order indicated 4 mg. of Haldol to be given for agitation. The nurse split the 4 mg. dose without a physician's order.

The nurse failed to assess the efficacy of the Haldol 2 mg. on the patient's agitation before administering another 2 mg. dose of the medication to the patient 10 minutes after the initial dose for which there was no order.

Nursing notes at 0950 (9:50 a.m.) revealed an assessment of the patient's agitation as "Agitated" and additionally medicated the patient with Ativan 2 mg. IV.

Post intervention assessment of the patient at 1025 (10:25 a.m.) revealed the patient as "drowsy."

According to the U.S. National Library of Medicine, National Institutes of Health, revised 11/2008, side effects of Haldol may include, but are not limited to, nervousness, mood changes, restlessness, agitation and drowsiness.

Nursing administered sedative medications to the patient to chemically restrain the patient's behavior without documenting any other alternative interventions than the ones already in place (sitter, reality orientation, and verbal instruction). The nurse failed to assess the effects of the medication on the patient's behavior after administering the 2nd dose of Haldol to determine whether the medication lessened the severity of agitation.

The patient remained in 4 point leather restraints and on 5/21/10 (no time of order), was ordered to be transferred to the ICU (Intensive Care Unit) for multisubstance abuse and psychotic episode.

Review of the reassessment of the patient on 5/21/10 at 1045 (10:45 a.m.) revealed the patient remained agitated by brief episodes of drowsiness. The nurse documents the patient is disoriented to place and time and re-oriented the patient to place/room and unit. At 11:31 a.m., the nurse documents the patient as confused and anxious, but exhibits no signs/symptoms of alcohol withdrawal. Fifteen minute checks of the leather restraints were documented from 0800 (8:00 a.m.) through 1200 (12:00 p.m.) without any changes to the restraint alternatives and without attempting any other alternatives, the 4 point leather restraints were re-ordered. In addition, the order indicated a physician evaluation must be completed within one hour of initiation of the 4 point leather restraints and there was no documented evidence the physician evaluated the patient within that timeframe. The renewed order indicated the patient with immediate and serious danger to patient safety and others as well as severe aggressiveness, combative and/or destructive behavior; however, there was no indication in the clinical record the patient exhibited these symptoms.

Nursing notes document the patient became restless at 1333 (1:33 p.m.) and administered Haldol 4 mg. IV. There was no indication the patient was agitated which would warrant the administration of the Haldol according to physician's orders. At 1430 (2:30 p.m.), the nurse documents the patient was "a little calmer, remains with word salad" and removed the right lower leg restraint. At 1600 (4:00 p.m.), despite the patient being "calm", the nurse documents the physician was notified and the behavior restraint was re-ordered and the patient remained with 4 point restraints. The clinical record did not show evidence of the re-newed order nor did nursing implement alternative interventions for a lesser restraint before renewing the order for leather restraints.

During an interview on 5/28/10 at 11:45 a.m. with the RN responsible for assessing the need for 4 point leather restraints of the patient while in ICU, she could not confirm the patient was aggressive or combative. She stated she "was going by the report of the patient's behavior from the nurse who took care of the patient while (he) was on the 3rd floor." The nurse then stated she couldn't remember the patient.

Staff failed to demonstrate documented evidence that all interventions, per hospital policy, were attempted prior to chemically restraining the patient's behavioral episodes with Ativan, Geodon, and Haldol.

See A-0154 for additional information.

This Condition of Participation is not met based on record review, interview, and review of hospital policies and procedures, the registered nurse failed to adequately assess the nursing care as it relates to physical and chemical restraints, incontinence, pressure sores and injury of unknown origin for 1 (Patient #3) of 5 sampled patients.

These failures present a substantial probability to adversely affect all patients' physical health, safety and well-being.

Refer to A-0115 and A-0395 for additional information.

Based on record review, interview, and review of hospital policies and procedures, the registered nurse failed to adequately assess the nursing care as it relates to physical and chemical restraints, incontinence, pressure sores, and injury of unknown origin for 1 (Patient #3) of 5 sampled patients.

The findings include:

1. Record review on 10/27/10 for Patient #3 revealed the patient was found naked and outside on 5/15/10 in his yard doing yard work and EMS (Emergency Medical Services) was called. EMS transported the patient to the emergency room and according to the ED (Emergency Department) physician addendum, dated 5/15/10, indicated ground up oxycodone pills were found in the patient's mouth. The physician documented the patient was Baker Acted because she/he was refusing to stay and was refusing help, but, was not oriented to appropriately make that decision and documented the patient was at harm to her/himself and had apparently overdosed on pain medication.

The Baker Act was placed on hold, the patient admitted to 3 North pending medical clearance.

Review of the "ADULT ASSESSMENT" conducted on 5/16/10 at 2050 (8:50 p.m.) revealed the patient remained incontinent with a new development of a Stage II pressure area to the coccyx. The wound was not measured.

Review of the "ADULT ASSESSMENT" conducted on 5/17/10 at 0930 (9:30 a.m.) revealed the patient remained incontinent and measured the Stage II pressure area on the coccyx as 2 cm (length) x 1 cm (width). The depth of the pressure ulcer was not identified.

Review of the hospital's policy and procedure for wound assessment, page 2 of 9, revealed assessment includes the "depth and size" as well as tunneling of a wound.

Physician's orders, dated 5/17/10 at 1:00 p.m., included an order for a Foley catheter to be inserted; however, there was no indication why the patient required a Foley catheter.

Staff failed to assess the cause of the patient's incontinence and failed to demonstrate evidence as to why the Foley catheter was inserted. The patient remained with a catheter in place until 5/18/10 at 1741 (5:41 p.m.) when it was removed.

Review of the "ADULT ASSESSMENT" for 5/20/10 at 1830 (6:30 p.m.) revealed the patient was medicated for pain related to aching pain to the left foot. The nurse documented the top of the patient's left foot was edematous and bruised looking, however, did not assess the cause of the bruising or notify the physician.

Review of the verbal orders by the ARNP for 5/21/10 at 0900 (9:00 a.m.) revealed the patient was ordered Haldol 4 mg. IV three times a day (hold for sedation) and Haldol 4 mg. IV every 4 hours as needed for agitation. In addition, Ativan 1 mg. was ordered twice a day (indication for use not specified).

Review of the MAR (Medication Administration Record) for 5/21/10 9:25 a.m. revealed the nurse hand wrote, "Haldol 2 mg. IV now" and proceeded to administered the 2 mg. dose of Haldol.

There was no physician's order for "Haldol 2 mg. IV now."

Further review of the MAR revealed the nurse administered an additional 2 mg. of Haldol at 0935 (9:35 a.m.) when the order indicated 4 mg. of Haldol to be given for agitation. The nurse split the 4 mg. dose without a physician's order.

The nurse failed to assess the efficacy of the Haldol 2 mg. on the patient's agitation before administering another 2 mg. dose of the medication to the patient 10 minutes after the initial dose for which there was no order.

Nursing notes at 0950 (9:50 a.m.) revealed an assessment of the patient's agitation as "Agitated" and additionally medicated the patient with Ativan 2 mg. IV.

Post intervention assessment of the patient at 1025 (10:25 a.m.) revealed the patient as "drowsy."

According to the U.S. National Library of Medicine, National Institutes of Health, revised 11/2008, side effects of Haldol may include, but are not limited to, nervousness, mood changes, restlessness, agitation, and drowsiness.

Nursing administered sedative medications to the patient to chemically restrain the patient's behavior without assessing for or changing alternative interventions than the ones already in place (sitter, reality orientation and verbal instruction) on behalf of the patient. The nurse failed to assess the effects of the medication on the patient's behavior after administering the 2nd dose of Haldol to determine whether the medication lessened the severity of agitation.

Review of the reassessment of the patient on 5/21/10 at 1045 (10:45 a.m.) revealed the patient remained agitated by brief episodes of drowsiness. The nurse documents the patient is disoriented to place and time and re-oriented the patient to place/room and unit. At 11:31 a.m., the nurse documents the patient as confused and anxious, but exhibits no signs/symptoms of alcohol withdrawal. This third nurse documents the ecchymosis to the patient's left hip and ecchymosis and edema to the top of the patient's left foot and failed to assess the cause of the ecchymosis or notify the physician of the areas.

On 5/21/10, nursing notes document the patient became restless at 1333 (1:33 a.m.) and administered Haldol 4 mg. IV. There was no assessment of the patient being agitated which would warrant the administration of the Haldol.

Staff failed to demonstrate documented evidence that all interventions, per hospital policy, were attempted prior to chemically restraining the patient's behavioral episodes with Ativan, Geodon, and Haldol. Nursing failed to assess the indications for use of Geodon. Nursing failed to re-assess the efficacy of the medication Haldol on the patient's behavior prior to redosing the patient with the medication and adding a 2nd sedating medication, Ativan, 15 minutes after dosing the patient with Haldol.

Nursing failed to determine the cause of the change of the patient's continency or assess whether the use of the restraints contributed to the incontinency. Nursing failed to determine why the Foley catheter was ordered for a patient with previous history urinary continence.

Nursing failed to assess the cause of the onset of ecchymosis to the patient's left hip and left foot and failed to notify the physician of same.

Based on record review and interview, the pharmacy failed to ensure 1 (Patient #3) of 5 sampled patients' medication orders were reviewed for appropriateness and frequency of a medication and documented a rationale for variation from organization criteria for its use. The pharmacist changed the frequency of the medication, Geodon, and failed to clarify the appropriateness of its use after it was ordered by the physician.

The findings include:

1. Record review on 10/27/10 for Patient #3 revealed the patient was found naked and outside by neighbors on 5/15/10 in his yard doing yard work and EMS (Emergency Medical Services) was called. EMS transported the patient to the emergency room and according to the ED (Emergency Department) physician addendum, dated 5/15/10, indicated ground up oxycodone pills were found in the patient's mouth. The physician documented the patient was Baker Acted because she/he was refusing to stay and was refusing help, but, was not oriented to appropriately make that decision and documented the patient was at harm to her/himself and had apparently overdosed on pain medication.

Review of the physician's orders, dated 5/15/10 at 16:45 (4:45 p.m.) included, Geodon 10 mg. IM (intramuscularly) q (every) 12 hours. There was no indication of the use of the medication.

Review of the Pharmacist's Therapeutic Substitution Orders dated, 5/15/10 at 2100 (9:00 p.m.), revealed the pharmacist changed the Geodon from being administered "routinely" every 12 hours to being administered "prn" (as needed).

Review of the clinical record failed to reveal why the pharmacist changed the physician's orders from "routine" to "prn." In addition, the pharmacist failed to consult the physician to the medication change and for the indication of the use of the medication.

Interview with the Risk Manager on 10/27/10 at 3:30 p.m. revealed she spoke with the director of the pharmacy who could not confirm why the pharmacist changed the physician's orders. She stated the pharmacist who changed the orders "was not available for an interview and because the order was so old, the Director of the Pharmacy stated there was no way of going back into the computer to determine if notes were made related to the change."