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Based on observation, record review and interview, the Medical Staff failed to ensure the Medical Staff by-laws were enforced. A medication (succinylcholine) which was not approved by the Medical Staff, and not included in the hospital formulary, was utilized and was available for use.

Findings:

The Medical Staff by-laws were reviewed on 10/09/12. The by-laws stated that the medical staff were to approve and were responsible for the medications to be utilized by the hospital, and were to be listed on the hospital Formulary.

The emergency/crash cart on Unit 2 East was observed to include an "intubation box", which included a document which stated the box contained "Succinylcholine-200 mg/10 ml, 3 vials."

On 10/10/12 at 9:30 a.m. the hospital's printed Formulary, with the hospital's name and address was presented by the Director of Pharmacy (Employee # 7). The Formulary did not include the drug Succinylcholine. Employee # 7 was interviewed and a policy for the use of succinylcholine was requested. Employee # 7 stated the hospital did not have a policy "per se" for the use of succinylcholine, as it was requested by a specific pulmonologist. The Director of Pharmacy was informed the drug was not included on the hospital formulary she presented, and she stated she was unaware the drug was not on the formulary. The Pharmacy Director also stated the hospital "Never had IV (intravenous) Dantrolene-the rescue agent used in the event of an adverse reaction which may occur with the use of a triggering agent-(succinylcholine). The event-malignant hyperthermia-has a significant rate of death if not treated immediately upon recognition of the crisis. The Malignant Hyperthermia Association of the United States (MHAUS) defines malignant hyperthermia: "The MH crisis is a biochemical chain reaction response, "triggered" by commonly used general anesthetics and the paralyzing agent succinylcholine, within the skeletal muscles of susceptible individuals. The general signs of the MH crisis include tachycardia, a greatly increased body metabolism, muscle rigidity and/or fever that may exceed 110 degrees F. Severe complications include: cardiac arrest, brain damage, internal bleeding or failure of other body systems. Thus, death, primarily due to a secondary cardiovascular collapse, can result." (Accessed at http://www.mhaus.org/mhaus-faqs-healthcare-professionals/what-is-malignant-hyperthermia/#.UH1TXm9IhAU 10/10/12 at 11:02 a.m.). MHAUS also states: "Treatment is predicated upon preparation for a rare event. Every anesthetic must be associated with a plan for treatment of unanticipated MH. With the plan in place, treatment can be prompt and lifesaving. Prompt recognition of the signs of MH is essential to an optimal outcome. Preparedness is essential to prevent death from MH." "MH can occur if trigger anesthetics and/or succinylcholine are used in any location, such as emergency rooms, dental surgeries, surgeon's offices or intensive care units."

On 10/10/12 at approximately 12:25 p.m. a Pharmacist (Employee # 12) was interviewed and the PYXIS (medication storage system) on Unit 2 West was reviewed. The refrigerator contained three vials of succinylcholine. No evidence of Dantrolene was presented. Employee # 12 stated the facility did not stock intravenous dantrolene, but did stock oral dantrolene. Employee # 12 did not respond when a policy for the use of oral dantrolene during a malignant hyperthermic (MH) crisis was requested.

Employee # 7 (Director of Pharmacy) also stated the hospital did not stock intravenous Dantrolene, the rescue agent in the event of a MH crisis. MHAUS's position on rescue agents states: "To treat an MH episode, an initial dose of dantrolene at 2.5 mg/kg is recommended, with a suggested upper limit of 10 mg/kg. If a patient of average weight (approximately 70 kg) were to require dantrolene at the upper dosing limit, then at least 700 mg of dantrolene would be needed. In addition, a review of cases has shown that in a "worse case" scenario of a very large person (i.e., about 100-110 kg or 220 - 250 pounds) having an acute MH incident, as much as 8-10 mg/kg will be needed for treatment; higher doses may be required on rare occasions. Thirty-six (36) vials of dantrolene will allow for initial stabilization and treatment while more vials are being acquired to continue treatment, as needed." The hospital did not have a policy to identify, treat or transport a patient exhibiting signs of MH. The formulary did include Dantrolene: "20 mg IV" and 25 mg oral capsules. The Director of Pharmacy stated the hospital did not stock IV Dantrolene, "never did."

The hospital did not have a policy or procedure for the administration of the triggering agent-succinylcholine (Anectine), or a policy to direct treatment of the event of a crisis.
The medical staff did not approve the medication which was available for use. The Director of Pharmacy stated it was at least five minutes by ambulance transport to the closest Emergency Department. This hospital did not provide emergency or operating services.

The Medical Executive Committee meeting minutes and the Pharmacy/Nutrition & Therapeutics meeting minutes were reviewed on 10/10/12. The Pharmacy, Nutrition & Therapeutics Subcommittee meeting minutes for April 17 and May 22, 20012 were reviewed. The meeting minutes revealed the emergency medications present in the PYXIS system were reviewed. A review of succinylcholine presence and availability for use without procedures or rescue medications available, was not documented. In April 2012 the Medication Formulary was approved by the committee, although a medication available for use (succinylcholine) was not included. The drug Dantrolene, was listed on the Formulary as available orally and intravenous. The intravenous medication was not present in the facility.

The Medical Executive Committee meeting minutes revealed the Formulary was approved on 5/03/2012.

The Director of Risk Management was informed of this concern on 10/10/12 at 2:45 p.m. and she stated the medication was removed from the facility at that time and was not available for administration until further investigation.

On 10/10/12 at 4:10 p.m. the Director of Pharmacy was interviewed and she presented evidence the succinylcholine was utilized and administered to a patient 11/22/2011 without a written protocol, policies for the administration, a rescue plan or medications or a plan for transferring the patient in the event of a crisis. The Director of Pharmacy stated: "We can account for all but one vial..." (Of succinylcholine).

No further information was presented to evidence the Medical Staff enforced the requirement set forth in the bylaws regarding the approval of the Formulary to include all drugs utilized at the facility, to include criteria for use and risks of succinylcholine.

Based on a complaint investigation, interviews, and document review, the hospital staff failed to ensure sufficient nursing staff to answer all patient's call lights, or to complete patient care as needed for six of 13 patients reviewed-Patient #'s 1, 5, 6, 7, 9 and 10.

Findings:

The hospital staff failed to ensure sufficient nursing staff were employed to complete patient care as needed. Call lights were not answered timely, patient assessment and care was not completed as needed. Patient care was not completed as ordered by the physicians.

A complaint investigation was conducted on 10/09/2012 through 10/10/2012. Current patients and families (Patient #'s 1, 2, 7, 8 and 9) were interviewed on 10/09/12 and 10/10/12 and each stated the nursing staff do not answer call lights timely. Patient #'s 5, 6, 9 and 10 were not turned every two hours according to physician's orders. Patient # 1 did not receive an appropriate assessment or oversight of care by a registered nurse, pressure ulcer prevention, assessment or treatment, daily hygiene and was not out of bed as ordered by the physician.

1. Patient # 5 was not turned and repositioned as ordered by the physician. The patient was admitted on 9/6/12 and physician's orders included: "turn and reposition Q 2 h" (every two hours.) The clinical record did not evidence this was completed as ordered. The nursing care flow sheets revealed in part the following times the patient was not turned as ordered: 10/5/12-between 9:47 am and 2:00 p.m.; 10/6/12 between 1:30 p.m. and 4:00 p.m.; 10/07/12 between 4:54 a.m. and 10:23 a.m.; 10/7/12 between 10:23 a.m. and 2:19 p.m.; 10/09 and 10/10/12 between 8:12 p.m. until 12:27 a.m.; 10/10/12 between 12:27 a.m. and 5:05 a.m., 5:05 a.m. and 8:02 a.m. and 8:02 a.m. until 11:21 a.m. The documentation did not evidence the patient was repositioned as ordered. The patient was not alert or oriented and was unable to confirm or deny this information, and could not reposition himself.

2. Patient # 7 was interviewed on 10/10/2012 at 09:40 a.m. Patient # 7 stated she had to call her daughter in the early morning of 10/10/12, as no one responded to her call light for greater than twenty-five minutes. After waiting twenty-five minutes, Patient # 7 stated "someone" responded to her call remotely and stated "someone" would be there shortly. The patient stated still no one responded in person to assist her. The patient stated that she waited again, and finally called her daughter at home. The patient's daughter called the nurse's station for assistance. This patient was unable to transfer to the bathroom independently.

3. Patient # 8 was interviewed on 10/10/12 at 10:20 a.m. Patient # 8 stated she had to wait an extraordinary amount of time for someone to respond to her requests for assistance.

4. Patient # 9 was interviewed on 10/09/12 at 3:00 p.m. Patient # 9 stated he had to telephone his wife, who had to call the nurse's station to get a response to his call light. Patient # 9 stated this was a typical requirement, as the nursing staff did not respond to his call light. This patient was paralyzed in his lower extremities and had limited upper extremity use. The patient also stated he had only been out of bed one time since his admission on 9/26/2012. The patient's spouse was interviewed by telephone on 10/09/12 at 4:00 p.m. and she stated the patient had not been out of bed as needed for his "physical and mental health." The patient's wife also stated she arrived several times to find the patient soiled with dried feces on his buttocks. The patient was observed om 10/10/12 at 8:40 a.m. and again at 10:45 a.m., each time the patient was noted to be on his back.

The clinical record included a physician's order: "Turn/reposition Q 2" (every two hours). A review of the nursing flow sheets, on which the physician's ordered treatment (turning) should have been documented, revealed the patient was not repositioned as ordered. Examples of this non-compliance with this physician's order: 10/4/12-no documentation of repositioning the patient between 6:08 a.m. and 1:22 p.m.; 10/05/12-2:00 p.m. and 7:24 p.m.; 10/06/12-10:26 a.m. and 1:42 p.m.; 10/7/12- 5:44 a.m. and 9:47 a.m.; 10/8/12- 4:00 a.m. and 7:22 a.m.; 10/9/12- 11:56 a.m. and 3:58 p.m.; 10/9/12- 9:55 p.m. and (10/10) 12:28 a.m.; 10/10/12-12:28 a.m. and 10:53 a.m.

The clinical record also evidenced the patient was confined to his bed except on three occasions: 9/28/12 (PT eval), 10/1/12 and 10/5/12. The patient was paraplegic and could not complete any activity of daily living or transfer himself.

5. Patient # 10 was not turned and repositioned according to physician's orders. Patient # 10 was observed on his back in bed on 10/9/12 at 2:50 p.m. The patient was non-interviewable or able to reposition himself. The clinical record included a physician's order: "turn and reposition Q 2 hrs." A review of the nursing flow sheets revealed the patient was not repositioned as ordered: On 10/1/12 the patient was turned at 11:05 a.m. and not again until 2:06 p.m., and then not until 6:50 p.m.; 10/2/12-between 12:28 p.m. and 4:05 p.m.; 10/3/12-12:00 p.m. and 3:57 p.m. and not again until 8:00 p.m.; 10/4/12-11:17 a.m. until 4:04 p.m.; 10/5/12-5:26 p.m. to 9:30 p.m.; 10/6/12-4:39 p.m. to 8:10 p.m. 10/9/12-3:43 p.m. until 8:00 p.m.

On 10/09/12 at 3:31 p.m. the Director of Nursing (Employee # 6) was interviewed. Employee # 6 stated: "we have been understaffed with CNA's (certified nursing assistants)." She stated this was an issue for "a couple months." Employee # 6 stated that the goal was to have a nursing supervisor on each shift, but this did not always occur as the scheduled supervisor was required to cover for patient care at times. Employee # 6 was interviewed regarding the complaint log review. The complaint log revealed multiple complaints regarding staff not answering call lights and not answering the outside phone. Employee # 6 stated the hospital was aware of the patient and family concerns. She stated that sometimes the issue was the staff were "Not physically able to get there." Employee # 6 stated the hospital's response to these multiple complaints was to "beef up staff" and to educate the nursing staff regarding their verbal response to call lights.

On 10/09/12 at 3:48 p.m., the Director of Nursing was observed to answer a call light from the desk. She asked the patient if she could help, by intercom/call system from the desk. The Director of Nursing then stated to the Unit Secretary: "(Room # 209) wants pain meds, she's waiting for (nurse's name)." This patient (Patient # 13) received her pain medication at 4:21 p.m.

On 10/09/12 at 4:00 p.m. the Administrator and the Director of Clinical Services were interviewed regarding the patient observations, complaints and interviews with the employees. The Administrator stated that part of the issue related to call bells was communication and "clarifying reasonable expectations."

The certified nursing assistant (CNA) (Employee # 10) responsible for Patient #'s 5 and 9 on 10/10/12 was interviewed on 10/10/12 at 12:40 p.m. Employee # 10 stated that she was responsible for seven patients that required total assistance for daily care and one patient that required moderate amounts of assistance. Employed # 10 stated the case load was difficult and when completing total care for seven patients, answering call lights was difficult. Employee # 10 stated that care was documented at each patient's bedside immediately after completion.

Employee # 11, a CNA, was interviewed on 10/10/12 at 12:50 p.m. Employee # 11 stated her usual case load was three to four patients with mixed care requirements. The assignment sheet for 10/10/12 revealed her case load was seven patients. Employee # 11 stated the patient acuity (needing total care by nursing for activities of daily living) was currently high. In regards to answering the outside telephone, the CNA stated that if everyone were out completing patient care, no one was present after 7:00 p.m. to answer the phone. A unit secretary was not assigned to any floor after 7:00 p.m.

The nursing assignment sheets were reviewed for the months of March through October 2012. At times nursing assistants were responsible for up to thirteen patients each. The 10/8/12 schedule revealed each nursing assistant was responsible for 10 patients on the 7:00 p.m. to 7:00 a.m. shift. On 10/9/12 for the 7:00 a.m. to the 7:00 p.m. shift, each nursing assistant was responsible for ten patients. For 10/09/12 7:00 p.m. to 7:00 a.m. each nursing assistant was assigned twelve and thirteen patients.

On 10/10/12 at 1:10 p.m. the nursing supervisor on duty (Employee # 8) was interviewed. Employee # 8 stated the hospital currently had enough nursing assistants employed- "...we have enough, but not when they don't come in..."

On 10/10/12 at 1:25 the Director of Nursing (Employee # 6) was interviewed regarding the documentation which evidence patients were not turned and repositioned according to physician's orders. Employee # 6 stated: "We may have identified a definite problem for two, there are staff in there constantly." Employee # 6 stated that after each episode of care or treatment, the nurse or nursing assistant is required to document at the bedside computer, the care provided. No explanation for the lack of documentation to evidence care was provided as ordered.

On 10/10/12 at 1:40 p.m. the Director of Nursing (Employee # 6) and the Director of Clinical Services (Employee # 4) were interviewed. Employee # 6 stated: "The acuity tracking shows we need additional CNA's"; "told us per numbers we need more." Employee # 6 stated there were issues with recruiting, the recruiter was based out of Texas and no applications were received. Employee # 6 stated the recruiter was now located in Virginia and multiple applications had been received.



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6. Patient #1 did not receive (a) proper pressure sore assessment and treatment, (b) daily hygiene/bathing, (c) pain medications, and (d) was not assisted out of bed per physician's orders.
(a) Patient #1 was admitted to the facility on 3/2/12 with multiple pressure ulcers. The pressure ulcers were documented by the physician in the "History and Physical" dated 3/2/12 as follows: sacrum- stage II pressure ulcer, medial aspect right knee- open area with yellow slough, medial aspect of the right fifth toe- ulceration, and bilateral stage II ulcers on the heels.

The nursing admission assessment dated 3/2/12 did not contain any documentation regarding the wounds. The section under "integumentary system" was blank. There were no treatment orders, nor care plan relating to the pressure ulcers.

On 3/3/12, a nursing assessment was completed at 10:07 a.m.. This assessment documented an "Integumentary assessment" which included, "...wound noted to L (left) and R (right) heel, R (right) inner thigh and R groin, mid abd (abdomen)..." There was no documentation of a sacral decubitus. A treatment order was documented for the right groin area. There was no evidence of any physician ordered treatment for any of the other documented wounds. On 3/3/12 the "Hospitalist Progress Note" documented, "...bilateral heel stage II pressure ulcers and right fifth toe medial aspect ulceration. Continue wound care. Continue bunny boots. Podiatry consult placed...Stage II sacral decubitus ulcer. Continue wound care. Turn every 2 hours..." A physician's order for a podiatry consult was evidenced on 3/3/12, however there were no orders for any wound treatment or bunny boots. A "Daily Wound Assessment" also dated 3/3/12 documented an assessment of the right groin wound with a treatment of Santyl (a debriding agent) and Mepele (a specialized dressing). The right heel was also assessed and treated with saline and "meeled" (sic) dressing. There were no physician's orders found for any of these treatments. There was no documentation regarding the sacral decubitus. There was no revision of the care plan to include any skin/decubitus ulcer prevention or any treatment.

Again, on 3/4/12, the "Hospitalist Progress Note" evidenced Patient #1 with, "...bilateral heel stage II pressure ulcers, right fifth toe medical aspect ulceration...stage II sacral decubitus ulcer..."

On 3/5/12, the Patient Care Plan" evidenced the inclusion of impaired skin integrity, however there were no interventions listed in the care plan area.
There was documented an additional "History and Physical" dated 3/5/12 which evidenced the physician's "plan" for treatment to the groin and left heel, with the addition of multi-podus boots and to keep both heels elevated. The attending physician documented in a "Progress Note" the presence of the stage II sacral decubitus.

The first documentation in the clinical record of an assessment of the "coccyx" wound was documented on 3/5/12 at 1826 (6:26 p.m.). The "wound care" nurse documented the following: "...pressure ulcer coccyx...community acquired...length 3 cm, width 1 cm, depth 0.5 cm, stage III...full thickness (skin loss involving damage or necrosis of subcutaneous tissue; may extend down to but not through underlying fascia...), ...loosely adherent yellow slough...purulent exudate...90% slough, 10% pink..."

This documentation evidenced the progression of the sacral/coccyx decubitus from a stage II to a stage III ulcer. There was no evidence of any assessment or treatment ordered for this decubitus ulcer on admission. There was no care plan developed any of the skin impairment, or potential for skin impairment on admission.

The facility policy "Standards of Patient Care" documented, in part: ASPECT OF CARE- Maintenance of Skin Integrity/Wound Management: Standard of Care: Each patient can expect that skin/wound integrity will be assessed at the time of admission and necessary measures/interventions taken to prevent breakdown or worsening of existing skin/wound condition. 1. Skin/wound assessment completed by an RN at the time of admission....

On 10/10/12 at 1:30 p.m., the surveyor discussed the concerns regarding the lack of assessment of the sacral decubitus on admission, the lack of care planning for impairment in skin integrity both actual and potential, lack of physician orders for treatment, and delay in treatment of the sacral decubitus resulting in the progression of the wound from a stage II to a stage III with Employee #'s 4, and 6, and further information was requested.

On 10/10/12 at 3:00 p.m., Employee #4 stated he/she was unable to locate any evidence of assessment, care planning or treatment for the sacral wound on admission. He/she stated the wound was not documented to have been assessed until 3/5/12, which was 3 days after admission, and acknowledged the deterioration in the condition of the wound.

(b) Patient #1 did not receive daily hygiene/bathing.

Further review of the clinical record for Patient #1 for the readmission date 3/13/12, evidenced no documentation that the patient received bathing/hygiene care on 3/19 through 3/21/12 and 3/24 and 3/25/12. On 10/10/12 at 2:00 p.m., the surveyor requested information pertaining to bathing/hygiene documentation for Patient #1 for the dates listed. Employee #4 stated, "If the information was there, it would be documented in the record. I cannot find any other documentation that he/she received care..."

(C) Patient #1 did not receive physician ordered pain medications when he/she experienced pain and there was no evidence pain medications were offered/administered when wound care was performed.

On 3/8/12 at 0939 (9:39 a.m.) an occupational therapist (OT) documented, "...Pt (patient) seen by OT with focus on bed mobility. Upon entering room, pt. alert and willing to work with OT. As this OT pulled back pt covers, it was noticed that pt. was sitting in a pool of blood. Nurse (name) immediately informed of pt's condition... Pt with open wound on bottom...Pt with gestures of pain as this OT wiped pt's bottom..."

There was no documentation in the clinical record that Patient #1 was offered pain medication when the patient "gestured" evidence of pain. The clinical record evidences pain medication administered on 3/8/12 at 0030 (12:30 a.m.), however, there was no evidence the patient was offered or administered pain medications when wound care was done.


(d) The facility staff did not follow physician's orders to get Patient #1 out of bed "as tolerated".

A physician's order dated 3/2/12 evidenced: "Out of bed to chair as tolerated'.

Review of the closed clinical record for Patient #1 evidenced no documentation Patient #1 was gotten out of bed during the admission 3/2 through 3/9/12.

On 3/13/12, Patient #1 was readmitted to the facility. There was a physician's order as follows: "Out of bed to chair as tolerated." Review of the closed clinical record documented Patient #1 was assisted out of bed only by the Physical or Occupational Therapist on the following dates:

3/15/12- OT evaluation
3/15/12- PT evaluation
3/16/12 - PT visit- Out of bed for therapy...tolerated sitting on EOB (edge of bed) x (times) 15 min (minutes).
3/19/12- OT visit- Moved supine to sit EOB with mod assist...complete 2 (two) ex. (exercises) then requested to lie back down...
3/19/12- PT visit- EOB sitting 15 minutes
3/20/12- PT visit- tolerated sitting in wheelchair x5 minutes
3/20/12- OT visit- returned pt to room...transferred back to bed per (family) request...seated in chair to participate in exercises...
3/21/12- PT visit - stand/pivot transfer
3/21/12- OT visit- Moved supine to sit EOB with MIN assist, sit to stand with MOD assist,...trial gel foam cushion to w/c (wheelchair)...
3/23/12- PT visit- sit to stand...EOB maintained approx. 5 minutes...
3/26/12- PT visit- EOB x 5 min, sit to stand...sitting exercises...
3/26/12- OT visit- ...PT exiting, patient sitting in manual wheelchair...encouraged to remain seated upright...
(Nurses notes on 3/26/12 document patient sitting up in wheelchair, however the time documented was 10:00 a.m., and coincided with the time therapy was providing treatment to the patient.)
3/27/12- PT visit- ...spoke with Dr. (doctor) regarding discharge plans...returned to bed...

There was no documentation/evidence of the nursing staff assisting Patient #1 out of the bed per physician's orders. As evidenced above, the only documentation of Patient #1 being out of bed was during therapy treatments.

On 10/10/12 at 2:30 p.m., the surveyor requested evidence the staff assisted Patient #1 out of bed as ordered by the physician. No information was provided by the end of the survey.

Based on complaint investigation, clinical record review, facility document review and staff interview, the facility staff failed to ensure one of 13 patient's of the survey sample, Patient #1, was thoroughly assessed upon admission.

Patient #1 was admitted to the facility with a surgical wound and pressure ulcers documented by the physician. There was no assessment of the skin condition of Patient #1 upon admission. When the sacral wound was finally assessed by the wound nurse, it had progressed from a stage II to a stage III ulcer.

The findings included:

Patient #1 was admitted to the facility on 3/2/12 with multiple pressure ulcers. The pressure ulcers were documented by the physician in the "History and Physical" dated 3/2/12 as follows: sacrum- stage II pressure ulcer, medial aspect right knee- open area with yellow slough, medial aspect of the right fifth toe- ulceration, and bilateral stage II ulcers on the heels.

The nursing admission assessment dated 3/2/12 did not contain any documentation regarding the wounds. The section under "integumentary system" was blank. There were no treatment orders, nor care plan relating to the pressure ulcers.

On 3/3/12, a nursing assessment was completed at 10:07 a.m.. This assessment documented an "Integumentary assessment" which included, "...wound noted to L (left) and R (right) heel, R (right) inner thigh and R groin, mid abd (abdomen)..." There was no documentation of a sacral decubitus. On 3/3/12 the "Hospitalist Progress Note" documented, "...bilateral heel stage II pressure ulcers and right fifth toe medial aspect ulceration. Continue wound care... Stage II sacral decubitus ulcer... Continue wound care... Turn every 2 hours..."

Again, on 3/4/12, the "Hospitalist Progress Note" evidenced Patient #1 with, "...bilateral heel stage II pressure ulcers, right fifth toe medical aspect ulceration...stage II sacral decubitus ulcer..."

The first documentation in the clinical record of an assessment of the "coccyx" wound was documented on 3/5/12 at 18:26 p.m. (6:26 p.m.). The "wound care" nurse documented the following: "...pressure ulcer coccyx...community acquired...length 3 cm, width 1 cm, depth 0.5 cm, stage III...full thickness (skin loss involving damage or necrosis of subcutaneous tissue; may extend down to but not through underlying fascia...), ...loosely adherent yellow slough...purulent exudate...90% slough, 10% pink..."

This documentation evidenced the progression of the sacral/coccyx decubitus from a stage II to a stage III ulcer. There was no evidence of any assessment or treatment ordered for this decubitus ulcer on admission. There was no care plan developed regarding any of the skin impairment,or potential for skin impairment on admission.

On 10/10/12 at 1:30 p.m., the surveyor discussed the concerns regarding the lack of assessment of the sacral decubitus on admission, the lack of care planning for impairment in skin integrity both actual and potential, lack of physician orders for treatment, and delay in treatment of the sacral decubitus resulting in the progression of the wound from a stage II to a stage III with Employee #'s 4, and 6, and further information was requested.

On 10/10/12 at 3:00 p.m., Employee #4 stated he/she was unable to locate any evidence of assessment, care planning or treatment for the sacral wound on admission. He/she stated the wound was not documented to have been assessed until 3/5/12, which was 3 days after admission, and acknowledged the deterioration in the condition of the wound.

The facility policy "Standards of Patient Care" documented, in part: ASPECT OF CARE- Maintenance of Skin Integrity/Wound Management: Standard of Care: Each patient can expect that skin/wound integrity will be assessed at the time of admission and necessary measures/interventions taken to prevent breakdown or worsening of existing skin/wound condition. 1. Skin/wound assessment completed by an RN at the time of admission....

Based on clinical record review, staff interview, facility document review, and during the course of a complaint investigation, the facility staff failed to ensure a care plan was developed and reviewed/revised to include significant aspects of care for one (1) of 13 patient's of the survey sample, Patient #1.

Patient #1 was admitted to the facility on 3/2/12. There was no care plan developed which addressed potential/actual impairment of skin integrity within 24 (twenty-four) hours of admission.

The findings included:

Patient #1 was originally admitted to the facility on 3/ 2/12 with diagnoses of, but not limited to: respiratory failure with tracheostomy, stroke, femoropopliteal bypass, peripheral vascular disease, coronary artery disease, placement of percutaneous gastrostomy tube (feeding tube), diabetes, and pressure ulcers.

According to the "History and Physical" dated 3/2/12, the attending physician documented Patient #1 had a "vertical surgical scar midline...On the sacrum, the patient has a stage II (two) decubitus ulcer...right groin area...a 1 (one) cm (centimeter) open wound with yellow slough...medial aspect of the right knee, the patient has a 2- to 3- cm open wound with yellow slough...on the right medial aspect of his right fifth toe there is an ulceration...the patient has bilateral stage II heel ulcers..."

The initial "Care Plan" for Patient #1, dated 3/2/12, did not contain goals or interventions for any wounds or actual/potential compromise of skin integrity.

On 3/3/12, a nursing assessment was completed at 10:07 a.m.. This assessment documented an "Integumentary assessment" which included, "...wound noted to L (left) and R (right) heel, R (right) inner thigh and R groin, mid abd (abdomen)..." A "Daily Wound Assessment" also dated 3/3/12 documented an assessment of the right groin wound with a treatment of Santyl (a debriding agent) and Mepele (a specialized dressing). The right heel was also assessed and treated with saline and meeled (sic) dressing. There were no physician's orders found for any of these treatments. There was no documentation regarding the sacral decubitus. There was no revision of the care plan to include any skin/decubitus ulcer prevention or any treatment.

Again, on 3/4/12, the "Hospitalist Progress Note" evidenced Patient #1 with, "...bilateral heel stage II pressure ulcers, right fifth toe medical aspect ulceration...stage II sacral decubitus ulcer..."

On 3/5/12, the Patient Care Plan" evidenced the inclusion of impaired skin integrity, however there were no interventions listed in the care plan area.

Documentation on 3/5/12 from the "wound care nurse" evidenced the progression of the sacral/coccyx decubitus from a stage II to a stage III ulcer. There was no evidence of any assessment or treatment ordered for this decubitus ulcer on admission. There was no care plan developed any of the skin impairment, or potential for skin impairment on admission.

The facility policy "Multidisciplinary Care Planning" evidenced: "1. All patients will have a Plan of Care developed by the Nursing department in conjunction with other appropriate healthcare team members within 24 (twenty-four) hours of admission- a multidisciplinary care plan. 2. Nursing Care Plans will be reviewed daily..."

On 10/10/12 at 1:30 p.m., the surveyor discussed the concerns regarding the lack of care planning for impairment in skin integrity both actual and potential, and the progression of the wound from a stage II to a stage III with Employee #'s 4, and 6, and further information was requested.

On 10/10/12 at 3:00 p.m., Employee #4 stated he/she was unable to locate any evidence of assessment, care planning or treatment for the sacral wound on admission. He/she stated the wound was not documented to have been assessed until 3/5/12, which was 3 days after admission, and acknowledged the deterioration in the condition of the wound and lack of care plan.

Based on observation, document review, and interview, the Director of Pharmacy failed to develop and supervise medication use and protocols, and failed to ensure each medication in use was approved by the Medical Staff by-laws. The medication succinylcholine was used, and continued to be available for use, without being included on the Formulary, and without a written protocol for use or a rescue plan.

Findings:


The emergency/crash cart on Unit 2 East was observed to include an "intubation box", which included a document which stated the box contained "Succinylcholine-200 mg/10 ml, 3 vials." The intubation box was assessed, and did not include succinylcholine. On 10/10/12 at approximately 12:25 p.m. a Pharmacist (Employee # 12) was interviewed and the PYXIS (medication storage system) on Unit 2 West was reviewed. The refrigerator contained three vials of succinylcholine. Dantrolene-a rescue medication- was not present. Employee # 12 stated the facility did not stock intravenous dantrolene, but did stock oral dantrolene. Employee # 12 did not respond when a policy for the use of oral dantrolene during a malignant hyperthermic (MH) crisis was requested.

The Medical Staff by-laws stated that the medical staff were to approve and were responsible for the medications to be utilized by the hospital, and were to be listed on the hospital Formulary.

On 10/10/12 at 9:30 a.m. the printed Formulary, with the hospital's name and address was presented by the Director of Pharmacy (Employee # 7). The Formulary did not include the drug Succinylcholine. Employee # 7 was interviewed and a policy for the use of succinylcholine was requested. Employee # 7 stated the hospital did not have a policy "per say" for the use of succinylcholine, as it was requested by a specific pulmonologist. The Director of Pharmacy was informed the drug was not included on the hospital formulary she presented, and she stated she was unaware the drug was not on the formulary. The Pharmacy Director also stated the hospital "Never had IV (intravenous) Dantrolene-the rescue agent used in the event of an adverse reaction which may occur with the use of a triggering agent-(succinylcholine). The potential life threatening event-malignant hyperthermia-has a significant rate of death if not treated immediately upon recognition of the crisis. The Malignant Hyperthermia Association of the United States (MHAUS) defines malignant hyperthermia: "The MH crisis is a biochemical chain reaction response, " triggered " by commonly used general anesthetics and the paralyzing agent succinylcholine, within the skeletal muscles of susceptible individuals. The general signs of the MH crisis include tachycardia, a greatly increased body metabolism, muscle rigidity and/or fever that may exceed 110 degrees F. Severe complications include: cardiac arrest, brain damage, internal bleeding or failure of other body systems. Thus, death, primarily due to a secondary cardiovascular collapse, can result." (Accessed at http://www.mhaus.org/mhaus-faqs-healthcare-professionals/what-is-malignant-hyperthermia/#.UH1TXm9IhAU 10/10/12 at 11:02 a.m.). MHAUS also states: "Treatment is predicated upon preparation for a rare event. Every anesthetic must be associated with a plan for treatment of unanticipated MH. With the plan in place, treatment can be prompt and lifesaving. Prompt recognition of the signs of MH is essential to an optimal outcome. Preparedness is essential to prevent death from MH." "MH can occur if trigger anesthetics and/or succinylcholine are used in any location, such as emergency rooms, dental surgeries, surgeon's offices or intensive care units."

Employee # 7 (Director of Pharmacy) also stated the hospital did not stock intravenous Dantrolene, the rescue agent in the event of a MH crisis. MHAUS's position on rescue agents states: "To treat an MH episode, an initial dose of dantrolene at 2.5 mg/kg is recommended, with a suggested upper limit of 10 mg/kg. If a patient of average weight (approximately 70 kg) were to require dantrolene at the upper dosing limit, then at least 700 mg of dantrolene would be needed. In addition, a review of cases has shown that in a "worse case" scenario of a very large person (i.e., about 100-110 kg or 220 - 250 pounds) having an acute MH incident, as much as 8-10 mg/kg will be needed for treatment; higher doses may be required on rare occasions. Thirty-six (36) vials of dantrolene will allow for initial stabilization and treatment while more vials are being acquired to continue treatment, as needed. (MHAUS. org)." The hospital did not have a policy to identify, treat or transport a patient exhibiting signs of MH. The formulary did include Dantrolene: "20 mg IV" and "25 mg oral" capsules. The Director of Pharmacy stated the hospital did not stock IV Dantrolene, "never did."

The hospital did not have a policy or procedure for the administration of the triggering agent-succinylcholine (Anectine), or a policy to direct treatment in the event of a crisis.
The medical staff did not approve the medication which was available for use. The Director of Pharmacy stated it was at least five minutes by ambulance transport to the closest Emergency Department. This hospital did not provide emergency or operating services.

The Medical Executive Committee meeting minutes and the Pharmacy/Nutrition & Therapeutics meeting minutes were reviewed on 10/10/12. The Pharmacy, Nutrition & Therapeutics Subcommittee meeting minutes for April 17 and May 22, 20012 were reviewed. The Director of Pharmacy was a member and attended this meeting. The meeting minutes revealed the emergency medications present in the PYXIS system were reviewed. The inclusion of succinylcholine presence and availability for use without procedures or rescue medications available, was not documented. In April 2012 the Medication Formulary was approved by the committee, although a medication available for use (succinylcholine) was not included. The drug Dantrolene, was listed on the Formulary as available orally and intravenous. The intravenous medication was not present in the facility.

The Medical Executive Committee meeting minutes revealed the Formulary was approved on 5/03/2012.

The Director of Risk Management was informed of this concern on 10/10/12 at 2:45 p.m. and she stated the medication was removed from the facility at that time and was not available for administration until further investigation.

No further information was presented during the survey to evidence the Director of Pharmacy developed and supervised all aspects of pharmacy services to include all medications used and available for use.

Based on observation, record review and interview, the hospital staff failed to ensure a formulary system was established to ensure all medications were included on the formulary and included written criteria for use, risks and treatment of adverse events. A medication (succinylcholine) which was not approved by the Medical Staff, was not included in the hospital formulary, and did not have written protocols for use and treatment of adverse events, was utilized and was available for use.

Findings:

The Medical Staff by-laws were reviewed on 10/09/12. The by-laws stated that the medical staff were to approve and were responsible for the medications to be utilized by the hospital, and were to be listed on the hospital Formulary.

The emergency/crash cart on Unit 2 East was observed to include an "intubation box", which included a document which stated the box contained "Succinylcholine-200 mg/10 ml, 3 vials." The intubation box was assessed, and did not include succinylcholine. On 10/10/12 at approximately 12:25 p.m. a Pharmacist (Employee # 12) was interviewed and the PYXIS (medication storage system) on Unit 2 West was reviewed. The refrigerator contained three vials of succinylcholine. Dantrolene-the rescue drug in the event of an adverse event (malignant hyperthermia) was not available. Employee # 12 stated the facility did not stock intravenous dantrolene, but did stock oral dantrolene. Employee # 12 did not have a response when a policy for the use of oral dantrolene during a malignant hyperthermic (MH) crisis was requested.

On 10/10/12 at 9:30 a.m. the printed Formulary, with the hospital's name and address was presented by the Director of Pharmacy (Employee # 7). The Formulary did not include the drug Succinylcholine. Employee # 7 was interviewed and a policy for the use of succinylcholine was requested. Employee # 7 stated the hospital did not have a policy "per say" for the use of succinylcholine, as it was requested by a specific pulmonologist. The Director of Pharmacy was informed the drug was not included on the hospital formulary she presented, and she stated she was unaware the drug was not on the formulary. The Pharmacy Director also stated the hospital "Never had IV (intravenous) Dantrolene-the rescue agent used in the event of an adverse reaction which may occur with the use of a triggering agent-(succinylcholine). The event-malignant hyperthermia-has a significant rate of death if not treated immediately upon recognition of the crisis. The Malignant Hyperthermia Association of the United States (MHAUS) defines malignant hyperthermia: "The MH crisis is a biochemical chain reaction response, "triggered" by commonly used general anesthetics and the paralyzing agent succinylcholine, within the skeletal muscles of susceptible individuals. The general signs of the MH crisis include tachycardia, a greatly increased body metabolism, muscle rigidity and/or fever that may exceed 110 degrees F. Severe complications include: cardiac arrest, brain damage, internal bleeding or failure of other body systems. Thus, death, primarily due to a secondary cardiovascular collapse, can result." (Accessed at http://www.mhaus.org/mhaus-faqs-healthcare-professionals/what-is-malignant-hyperthermia/#.UH1TXm9IhAU 10/10/12 at 11:02 a.m.). MHAUS also states: "Treatment is predicated upon preparation for a rare event. Every anesthetic must be associated with a plan for treatment of unanticipated MH. With the plan in place, treatment can be prompt and lifesaving. Prompt recognition of the signs of MH is essential to an optimal outcome. Preparedness is essential to prevent death from MH." "MH can occur if trigger anesthetics and/or succinylcholine are used in any location, such as emergency rooms, dental surgeries, surgeon's offices or intensive care units."

Employee # 7 (Director of Pharmacy) also stated the hospital did not stock intravenous Dantrolene, the rescue agent in the event of a MH crisis. MHAUS's position on rescue agents states: "To treat an MH episode, an initial dose of dantrolene at 2.5 mg/kg is recommended, with a suggested upper limit of 10 mg/kg. If a patient of average weight (approximately 70 kg) were to require dantrolene at the upper dosing limit, then at least 700 mg of dantrolene would be needed. In addition, a review of cases has shown that in a " worse case " scenario of a very large person (i.e., about 100-110 kg or 220 - 250 pounds) having an acute MH incident, as much as 8-10 mg/kg will be needed for treatment; higher doses may be required on rare occasions. Thirty-six (36) vials of dantrolene will allow for initial stabilization and treatment while more vials are being acquired to continue treatment, as needed." The hospital did not have a policy to identify, treat or transport a patient exhibiting signs of MH. The formulary did include Dantrolene: "20 mg IV" and 25 mg oral capsules. The Director of Pharmacy stated the hospital did not stock IV Dantrolene, "never did." The drug Dantrolene, was listed on the Formulary as available orally and intravenous. The intravenous medication was not present in the facility. No reason was provided as to why the drug included on the formulary was not available.

The hospital did not have a policy or procedure for the administration of the triggering agent-succinylcholine (Anectine), or a policy to direct treatment of the event of a crisis.
The medical staff did not approve the medication which was available for use. The Director of Pharmacy stated it was at least five minutes by ambulance transport to the closest Emergency Department. This hospital did not provide emergency or operating services.

The Medical Executive Committee meeting minutes and the Pharmacy/Nutrition & Therapeutics meeting minutes were reviewed on 10/10/12. The Pharmacy, Nutrition & Therapeutics Subcommittee meeting minutes for April 17 and May 22, 20012 were reviewed. The meeting minutes revealed the emergency medications present in the PYXIS system were reviewed. The review of succinylcholine presence and availability for use without procedures or rescue medications available was not documented. In April 2012 the Medication Formulary was approved by the committee, although a medication available for use (succinylcholine) was not included.

The Medical Executive Committee meeting minutes revealed the Formulary was approved on 5/03/2012.

The Director of Risk Management was informed of this concern on 10/10/12 at 2:45 p.m. and she stated the medication was removed from the facility at that time and was not available for administration until further investigation.

Based on a review of medical records and staff interview, restorative therapy plans were not established and care was not implemented for three of 3 patients reviewed with restorative orders, Patients # 6, # 9, and # 10.

Findings:

Three of three patients with restorative therapy orders did not receive the therapy as ordered and a specific care plan to include goals, interventions or timeframe for completion, was not developed.

1. Patient # 6's clinical record revealed orders: "Restorative care 3-5 X week-BUE + BLE" (three to five times weekly, bilateral upper and lower extremities). This care is to be completed by a Restorative Therapy Aid. The clinical record did not include goals or specific interventions and time frames for this service. The clinical record did not evidence this patient received restorative therapy services as ordered. The patient was treated by the Restorative Aid three days (3) from 10/1/12, 10/5/12 and 10/10/12), not 3-5 times weekly as ordered.

2. Patient # 9 was evaluated by an Occupational Therapist on 9/27/2012 and by a Physical Therapist on 9/28/12. Each therapist stated the patient was not appropriate for active therapy at this time and recommended "Restorative 3-5 X Weekly-ADLS BUE/BLE strength + OOB as tol." (Three to five times weekly for activities of daily living, bilateral upper and lower extremity strengthening and out of bed as tolerated.) The patient was interviewed on 10/09/12 at 3:00 p.m. This patient was paralyzed in his lower extremities and had limited upper extremity use. The patient stated he had only been out of bed one time since his admission on 9/26/2012. The patient's spouse was interviewed by telephone on 10/09/12 at 4:00 p.m. and she stated the patient had not been out of bed as needed for his "physical and mental health." The patient's spouse stated that the patient had been transferred to this hospital for OT and PT, yet was not receiving these services and had not been consistently up out of bed for two weeks. The clinical record evidenced the patient was confined to his bed except on four occasions: 9/28/12 (PT eval), 10/1/12 and 10/5/12 and 10/9/12 (documented refusal to transfer this date.) The patient was paraplegic and could not complete any activity of daily living or transfer himself. The clinical record revealed a pre-admission Clinical evaluation which stated: "needs ongoing OT/PT d/t (due to) paraplegia. Restorative therapy documentation revealed the patient received Restorative care only three dates-10/1, 10/5 and 10/09/12.

3. Patient # 10 was evaluated by an Occupational Therapist on 9/28/12 and a Physical Therapist on 10/1/12. Both therapists stated that active Occupational and Physical Therapy was not indicated at this time, and recommended "restorative care." The clinical record revealed this patient received Restorative therapy services on 10/5/12 and 10/09/12.

The Restorative Therapy Aid (Employee # 13) was interviewed on 10/10/12 at 3:10 p.m. regarding the implementation of Restorative Therapy. Employee # 13 stated her current case load was nineteen patients for restorative and four patients for "foot care." Employee # 13 stated that "sometimes" she did not get to complete the frequency for all patients and when she was out sick or off, no one other staff assumed her restorative duties. In reference to the week of 10/1/12 frequencies not being completed as ordered, Employee # 13 stated she did not work three days that week. No reason was provided as to why the patients did not receive restorative services as ordered.

On 10/10/12 at 3:40 p.m. the Director of Nursing was interviewed and informed of the above concerns.

No further information or evidence that the patient's received the Restorative care as ordered, was provided during the inspection.