HospitalInspections.org

Based on observation, interviews and record review the governing body failed to ensure the provision of safe and quality patient care at the facility's off campus Emergency Department as evidence by an immediate jeopardy situation.

The findings included:

Two Medical Facilities Inspectors conducting observations at the facility's free standing off campus Emergency Department on December 4, 2012, at 9:20 a.m. discovered a medication, Succinylcholine, was accessible without the needed medications and supplies to treat its potentially fatal adverse side effect. The two Medical Facilities Inspectors observed the following findings:
? The free standing off campus Emergency Department had three vials of the medication Succinylcholine available for use. [According to www.drugs.com "Succinylcholine is a muscle relaxant that is used for surgeries. It is also used for bringing on anesthesia or for the insertion of tubes into windpipes. The medication is classified as being a depolarizing muscle relaxant, and prevents the muscles from contracting. The contraction of muscles can lead to paralysis of the facial muscles, including those that are vital for movement and breathing. There are possible side effects that are occasionally associated with Succinylcholine use."]
? The free standing off campus Emergency Department did not have immediate access to the necessary medication, Dantrolene, needed to treat Malignant Hyperthermia a life threatening condition associated with the use of Succinylcholine. [According to www.drugs.com "Possibly fatal Malignant Hyperthermia; manifested by a rapid, profound elevation in body temperature and sometimes extreme muscular rigidity. Risk increases with concomitant administration of inhalation anesthetics. If Malignant Hyperthermia occurs, discontinue all anesthetic agents and initiate IV Dantrolene therapy in conjunction with supportive measures (e.g., administering oxygen, treating metabolic acidosis, instituting cooling procedures); maintain urinary output and monitor serum electrolytes."] [According to www.askhealth.com "DANTROLENE (DAN troe leen) helps to relieve spasms and stiffness of muscles in conditions such as multiple sclerosis, cerebral palsy, stroke, or injury to the spine. This medicine can also help prevent and treat a condition called Malignant Hyperthermia, which may occur after surgery or anesthesia."]
? Review of the free standing off campus Emergency Department (ED) records documented Succinylcholine had not been administered since the opening of the free standing Emergency Department in March 2012.
Interviews conducted by the two Medical Facilities Inspectors, on November 27, 2012 at approximately 9:30 a.m., with the free standing off campus ED nursing staff did not provide evidence of knowledge/training or policies/procedures/protocols of the potentially fatal adverse side effects associated with the use of Succinylcholine and Malignant Hyperthermia. The free standing off campus ED nursing staff did not acknowledge the need for the immediate access to Dantrolene in the case of Malignant Hyperthermia.

Based on a complaint investigation, document review and interview, the hospital staff failed to ensure a physician acted on a critical lab value for one patient, Patient # 1. The patient was discharged after a critical lab value related to the administration of an anticoagulant medication was reported and recorded by the laboratory.

A complaint investigation was conducted 12/3/12 through 12/6/12. Thirty patient records were reviewed in conjunctions with personnel interviews and record review, observations of current patients and policy review.

Patient # 1 had a critical lab result which was not acted upon by the discharging physician. The patient was discharged with elevated INR (blood clotting time).

Findings:

Patient # 1 had "critical" laboratory results and the clinical record did not evidence the physician acted on the results. The clinical record did not evidence the physician reviewed the lab results, which were available prior to discharge of the patient.

On 11/14/11 at 12:35 p.m. a laboratory technician documented a "critical" laboratory result of the clotting time "INR" of 5.74 was called to the registered nurse responsible for Patient # 1 on that date. The clinical record did not evidence the physician reviewed or acted on this critical lab result. The patient was discharged at approximately 4:00 p.m. The physician's discharge orders included the continuation of coumadin (an anticoagulant medication). The physician's discharge summary did not evidence his acknowledgement of the critical lab value.

The hospital's Medical Director (Employee # 4) and the Chief Nurse Executive were interviewed on 12/06/12 at 10:00 a.m. The Medical Director stated the physician did not review the critical laboratory results prior to discharge, and had been reprimanded for his inaction. The Medical Director stated the expected action for a "critical" INR result should have resulted in the medication-Coumadin- being "held" or discontinued.

Based on a complaint investigation, record review and interview, the hospital staff failed to:
1. Ensure Patient # 1 received "An Important Message from Medicare (IM) within two days of admission.
2. Ensure all patients received a copy of rights and responsibilities upon admission to the facility for one (1) of thirty (30) patients in the survey sample.

Findings:

1. Based on a complaint investigation, record review and interview, the hospital staff failed to:
Ensure Patient # 1 received "An Important Message from Medicare (IM) within two days of admission.

Patient # 1's clinical record was reviewed during a complaint investigation on 12/3-6/2012. The clinical record did not include documentation to evidence the patient had received "An Important Message from Medicare" within two days of admission. The patient was admitted on 10/3/11. The IM message was not provided to the patient or her representatives until two hours prior to discharge on 11/14/2011, fourteen days after admission.

The Director of Patient Access (Employee # 13) was interviewed on 12/5/2012 at 1:55 p.m. and he stated the IM is completed upon admission to the emergency department registrar. Employee # 13 stated the IM is not present in Patient # 1's clinical record and did not appear to have been provided to the patient or her representatives within two days of admission.

No further information was provided to evidence Patient # 1 and/or her representatives were provided "An Important Message from Medicare" within two days of admission.


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2. Based on a review of the clinical record it was determined the agency failed to ensure all patients received a copy of rights and responsibilities upon admission to the facility for one (1) of thirty (30) patients in the survey sample.
The findings were:
A review of the clinical record revealed patient #26 had no consent for treatment on file. The consent for treatment contains the signature from the patient attesting to having received a copy of the rights of patient's handout given at admission.

Based on a review of the clinical record it was determined the facility staff failed to document , report and track an adverse event for one (1) of thirty (30) patients in the survey sample.
The findings were:
A review of the clinical record for patient # 19 revealed the patient had surgery on 12/3/12. The anesthesia record note states at 15:50 " when removing the bair hugger blanket a blister was noted on the left shoulder. This was under the warm air inlet hose attachment. The blister had already broken open. " The wound was dressed with bacitracin ointment. The clinical record indicates report regarding the blister was passed on to the staff in the PACU (post operative care). There is no further indication in the record of assessment or treatment of the wound as of 12/6/12.
An interview conducted with the Chief Executive Office of the facility on 12/6/12 at 10:20am revealed the facility has a contract with the anesthesiology group and they would file with their insurance, if the problem was bigger we would talk about shared responsibility " . " If it was a severe injury it would have come up right away, it would have risen to a STAR report " . The anesthesiology group filled out a report.
A copy of the report filed by the anesthesia group was obtained and included an email to the medical director of anesthesia from the CRNA (certified registered nurse anesthetist) who worked in the operating room the day of the surgery and the email outlined the details of the event as stated above. The form titled Clinical Anesthesia Report of Events Follow-Up Form also listed the events that occurred. The form said " confidential for QI and attorney work and had a number where it should be faxed.
The facility policy on adverse events titled Incident and Event Reporting states in part: Complete a STARS online incident report via the Wavenet. STARS is used for reporting patient safety, visitor and property related events at all (facility name) hospitals and off site facilities. The supplemental guidance section of the policy further states: these variances, events, etc., may or may not involve actual injury or loss, but should minimally include situations which represent the possibility of injury or loss.
The Vice President of Operations stated a STARS report had not been filled out for this occurrence.

Based on a complaint investigation, document review and interview, the hospital staff failed to ensure nursing services were provided in a manner to promote the appropriate delivery of services to 3 of 30 patients reviewed, Patient #'s 1, 28 and 29.

A complaint investigation was conducted 12/3/12 through 12/6/12. Thirty patient records were reviewed in conjunctions with personnel interviews and record review, observations of current patients and policy review.

Patient # 1's clinical record review revealed insufficient interventions and a failure to implement the hospital's policies resulted in skin breakdown (pressure ulcer development).

Three of 30 patient's clinical records revealed insufficient pain management, assessment and treatment was sufficient. Policies regarding the assessment and reassessment of pain was not implemented. (Patient #'s 1, 28, 29)

Patient # 1's critical lab results were not acted upon per hospital policy. Patient # 1 had "critical lab" results which were not reported to the physician and an Event Report was not completed per hospital policy. The patient was discharged with elevated INR (blood clotting time).

Findings:

1. A. Patient # 1 was admitted to the hospital on 10/31/2011 with the diagnosis of a ruptured bladder related to undiagnosed squamous cell carcinoma of the bladder, peritonitis, peritoneal carcinomatosis, small bowel obstruction, dehydration, cachexia and malnutrition. The patient was assessed daily as having a high risk for pressure ulcer development (daily Braden scale nursing assessments). On 11/06/11 at 4:55 a.m. a registered nurse documented the patient's sacral area was "red". The clinical record also included nurse's documentation on 11/7/11 at 8:00 a.m. and 8:00 p.m. the patient's sacrum was red. The hospital's policy which was in effect 11/11-"Pressure ulcer management and Prevention"- stated: "...V. Policy Statement: ...C. Upon assessment and identification of a pressure ulcer, the nurse will evaluate for the appropriate stage as listed in Clinical Practice Manual 'Pressure Ulcer Classification.' SWAT team (team to assess skin/wounds) will be ordered by physician..."; "...VIII...C. Care plans will be updated dependent on the progression/regression of the wound...E. Complete the Skin/wound care assessment sheet and place it on the chart..." The clinical record did not include evidence that the "Swat" team or the physician were alerted to the stage I pressure ulcer development, or that a "skin/wound care assessment sheet was completed per policy. (NOTE: An air mattress and barrier ointment was applied at this time and the patient was encouraged and assisted to change positions frequently.) On 11/14/2011 at 09:50 a.m. a registered nurse documented the patient had a "pressure ulcer" on the electronic health record. The record did not include an assessment of the pressure ulcer, evidence the SWAT team or physician was notified of the breakdown, or a skin/wound care assessment sheet was completed. The clinical record evidenced the patient was assessed by a by a "wound care nurse" on 11/14/2011 at 3:11 p.m. The wound care nurse (a nurse practitioner) documented an assessment of the patient's urostomy, but did not document a general skin assessment to include the patient's buttocks or sacrum. The patient was discharged to a skilled nursing facility on 11/14/11. The discharge documentation did not include the assessment or treatment of the wound. A review of the admission assessment conducted by the long term care skilled nursing facility revealed an assessment dated 11/14/11 at 6:22 p.m. : "...left buttock and sacrum with stage 2 ulcers..."; and four centimeters by 4 centimeters in size. The wound assessment describe the wound perimeter: "Peri-wound"-"Red" and "stage I."

The Chief Nurse Executive and the Director of Acute Care Services (Employee #'s 9 and 12) were interviewed on 12/06/12 at 9:35 a.m. and the clinical record was reviewed. Employee # 9 stated the physician should have been notified and acknowledged that the hospital's policy related to pressure ulcers was not completely implemented when Patient # 1 presented with reddened areas on her sacrum and the documented pressure ulcer on 11/6, 11/7 and 11/14/2011.

B. Patient # 1 experienced and exhibited pain signs and symptoms which were not sufficiently assessed or treated according to hospital policy.

Patient # 1 presented to the Emergency Department on 10/31/11 with complaints of abdominal pain. The patient was appropriately assessed and treated for pain until 11/09/2011. On this date the patient exhibited signs of pain, and described unrelieved pain. The facilities policy regarding the assessment and treatment of pain was not implemented. Post pain medication administration pain assessments were not complete per order, and when the assessments evidenced continued pain-the physician was not notified.

On 11/9/11 at 8:30 p.m. the medication administration record revealed a single dose of as needed morphine 10 milligrams was administered. A pain assessment was not completed at that time. At 2126 (9:26 p.m.) the same registered nurse documented a pain assessment. which revealed the patient's perception of pain, located in both leg and abdomen, at a level of "3" at rest and a level of "9" with activity. The description of pain included: "constant; aching; incisional; and throbbing." The nurse described the patient as "moaning" and "restless." The assessment revealed that the patient's description of an acceptable or tolerable pain level was "2." The nurse's documented interventions at this time to included: a "single medication administration", environment adjustment, relaxation and bedrest. The medication administration record did not evidence additional pain medications were administered at the time of this assessment (9:26 p.m.). The nurse documented the patient's response to these interventions: "No change in pain." No further assessment of pain, notification of the physician of the continued pain. The patient was administered an anxiolytic agent-Ativan at 3:26 a.m., for the patient's inability to rest. A pain assessment was not conducted to determine if pain was the reason for her restlessness. The next pain assessment was not conducted until 9:00 a.m. the next day-11/10/12.

The facility's policy in place during this event, regarding the assessment, treatment and reassessment of pain was reviewed. The policy "Pain Management" stated that an assessment of pain would be conducted prior to the administration of pain medication and when the patient reported an increase in pain. The policy also stated a reassessment for pain would be conducted within sixty minutes of any interventions.

On 12/6/12 at 9:45 a.m. the Chief Nurse Executive and the Director of Acute Care Services (Employee #'s 9 and 12) were interviewed and the clinical record was reviewed. No further documentation was presented during the survey to evidence the patient was appropriately assessed and treated for signs, symptoms and complaints of pain. Employee # 9 acknowledged the facility's policy regarding the assessment and reassessment of pain was not implemented.


C. Patient # 1 had "critical" laboratory results and the clinical record did not evidence the physician was notified.

On 11/14/11 at 12:35 p.m. a laboratory technician documented a "critical" laboratory result of the clotting time "INR" of 5.74 was called to the registered nurse responsible for Patient # 1 on that date. The clinical record did not evidence the physician was informed or acted on this critical lab result. The patient was discharged at approximately 4:00 p.m. The physician's discharge orders included the continuation of coumadin, (an anticoagulant blood thinner)

The facility's policy in effect November 2011 regarding "critical" laboratory results stated the nurse who received the critical lab results would notify the physician. The policy stated it was the nurse's decision to notify the physician immediately or "during rounds." The patient was scheduled for discharge and was not seen during rounds by a physician.

The hospital's Medical Director (Employee # 4) and the Chief Nurse Executive were interviewed on 12/06/12 at 10:00 a.m. The Medical Director stated the physician did not review the critical laboratory results prior to discharge, and had been reprimanded for his inaction. The Medical Director stated the expected action for a "critical" INR result should have resulted in the medication-Coumadin- being "held" or discontinued. No reason was provided related to the nurse's inaction or failure to document the physician was notified of the critical lab result. An Event report was not completed for this critical finding. The Chief Nurse Executive stated that an event report should have been completed, per the Event Report (STARS) policy.

This patient required an assessment and admission to another acute care hospital on 11/15/2011.

Based on observations, staff interview and policy review, the hospital's Pharmaceutical services failed to ensure necessary medications, equipment, training and policies were sufficient to meet the potential needs of patients. The hospital's off-site Emergency Department was not sufficiently equipped to respond to a potential adverse reaction to the medication readily available for administration-succinylcholine. This finding resulted in an Immediate Jeopardy finding by the State Agency on December 04, 2012, at 12:10 p.m. The immediacy of the situation was removed on December 04, 2012, at 3:37 p.m., as evidenced by the delivery of appropriate equipment and medications to the off-site Emergency Department, a revision of the hospital policies, and documented training of the appropriate employees on duty.

The findings included:

On 12/04/2012 at 9:23 a.m. the hospital's off-site Emergency Department (ED) was inspected by two Medical Facilities Inspectors from the Virginia Department of Health. The ED's medication storage unit (Acudose) was observed, and the content list ("Acudose-Rx Station Inventory") was reviewed. The medication "Succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter)", one vial each - were listed on the inventory of the three Rapid Sequence Intubation Boxes. Observation of the stock medications revealed the presence of Succinylcholine. The inventory list did not evidence the presence of Dantrolene, a medication used in the event of an adverse reaction to the Succinylcholine-malignant Hyperthermia (MH). A registered nurse present in the ED were interviewed at 9:30 a.m. (Employee # 6). RN #6 did not have knowledge of the potential adverse event related to the administration of a triggering agent-Succinylcholine. The policy for the use and administration of Succinylcholine was requested. The ED physician #9, stated the ED did not have a specific policy for the use of Succinylcholine or a policy related to malignant Hyperthermia. The Chief Executive Officer stated stated it was approximately ten minutes to transport patient's to the main campus ED-in the event a patient needed a higher level of care.

On 12/04/2012 at 09:50 a.m. Employee #11 (Vice President of Medical Affairs) was interviewed and a policy related to the use of triggering agents such as Succinylcholine in the ED was requested. A "general hospital policy"-"Malignant Hyperthermia" was faxed to the ED and was presented. The policy was dated as reviewed and revised on November 16, 2011. The policy was approved by the Director of Nursing Services but did not evidence approval by the Assistant Director of Emergency Services (Employee # 9), or the Assistant Director of Pharmaceutical Services Employee #12) (The Director of Pharmaceutical Services was not available for interview during the survey.) The policy did not include procedures to direct the use of a triggering agent or rescue measures to implement in the event of a MH (Malignant Hyperthermia) crisis in the ED. The policy included procedures to implement if a patient experienced a malignant hyperthermia crisis after the use of a triggering agent post surgery or anesthesia only. The policy referred to the location of a MH cart and supplies in the the "OR (Operating room)." The policy did not include the use, required rescue medications or personnel training for the use of a triggering agent in the on-campus ED or the off-campus ED. (The triggering agent succinylcholine was observed to be present in both ED's during the survey .) The policy only addressed the operating room and anesthesia personnel.

The policy stated: "Malignant Hyperthermia (MH) is a rare, life threatening complication that may be triggered by drugs, commonly used in anesthesia. Succinylcholine and volatile anesthesia agents (i.e., halothane, isoflurane) are the most frequently triggering agents.

Malignant hyperthermia can also be induced by trauma, strenuous exercise, or emotional stress.

Characteristics of the syndrome include generalized contracture of skeletal muscles, marked temperature elevations, tachycardia, metabolic acidosis, cardiac dysrhythmias, and hypoxia. These may occur during induction or maintenance of anesthesia, although, the syndrome can occurred postoperatively or even after repeated exposures to anesthesia.

Most frequently in children and adolescents.

Although malignant hyperthermia is a rare occurrence, time is critical when it occurs and OR nursing personnel must be familiar with the protocol for its management.

Standing Operating Procedure:

Duties of the Circulator:

1). Have the following supplies in the room available for every case where malignant hyperthermia emergency may occur:

a)Number 18 Fr salem sump (x2).
b) Toomey syringes 50 ml (x2)
c) Single basin
d) Isolation\Bowel bag from OR supply
e) Extra K-Thermia unit, and blanket on shelf.
f) Foley Catheter Kit.

2) Call Front Desk on Intercom to have the following notified:

a) Staff Anesthesiologist running the floor.
b) Operating Room Floor Nurse

3) Call Anesthesia Workroom to have the malignant hyperthermia crash box brought to room.

4) Remain in operating room! Runners will obtain other needed supplies. Assist anesthesia as directed.

5) Be ever mindful of patient safety-safety straps, proper padding, keeping patient dry, etc.
g) Duties of the Surgical Technician:

1) Maintain sterile field, assist surgeons as directed to finish procedure as quickly as possibly.
2) Move sterile back table a safe distance from the operating room table for placement of crushed ice externally and hypothermia blankets on the patient.

h. Duties of the Runners:

1) Obtain defibrillator machine from core if needed.
2) Carry two empty kick buckets with liners to SICU kitchen IMMEDIATELY upon notification of malignant hyperthermia emergency. Fill with ice and return to the OR.
3) Obtain cold IV solutions from refrigerator in B-core.
4) Set up K-thermia machine. This may be placed on top of the patient.
5) Place crushed ice in plastic bag for external placement on patient.
6) Stamp twenty (20) labels with patient's stamp plate (addressograph).
7) Stamp up needed laboratory slips.

a) Chem 1 (x3)
b) Chem (x1)
c) Miscellaneous (x4)
d) Hematology (x1)
e) Blood Gas slips (red or blue as needed depending on time of occurrence) x3.

8) Obtain the following supplies for lab tests:

a) one (1) 10ml red top tube
b) one (1) 7ml red top tube
c) One (1) 7ml purple top tube
d) two (2) 3ml blue top tubes
e) three (3) blood gas syringes/kits
f) one (1) clean catch cup (specimen cup)

9) Wait for lab tests to be drawn and deliver to labs 'A' or 'B' as appropriate.

i. Laboratory Tests:

1) Laboratory 'A':

a) Chemistry-Lytes: Chem I slip and 3ml red top tube.
b) Coagulation Test (PT and PTT): Miscellaneous slip and 3 ml blue top tube.
c) Hematology: Hematology slip and 3ml purple top tube (or with blue blood gas slip).
d). Arterial Blood Gas: Blue blood gas slip and blood gas syringe. **Red blood gas slip after duty hours (1600 hours) and to Respiratory Therapy**

2) Lab 'B'

a) Enzymes: Chem I slip and 10ml red top tube.
b) CA# and Bilirubin: Chem I slip and 3ml red top tube.
c) Lactate: Miscellaneous slip and 3ml red top tube.
d) Coagulation studies: Hematology, SF 549, or Miscellaneous slip and 3ml blue top tube.
e) T3,T4, Serum Thyroxine: Chem II and 7ml red top tube.
f) Myoglobin: Miscellaneous slip and clean catch specimen cup.

Exceptions: None

Monitoring:

All OR Personnel

Document Management- Director , Anesthesia Services and Director, Perioperative Services."

The Governing Body, the Director of Pharmaceutical Services, and the Emergency Director failed to adequately prepare for a critical outcome, if Malignant Hyperthermia occurred in the Free Standing Emergency Department.

The Vice President of Medical Affairs, Emergency Department Director (On 12/04/2012 at 09:50 a.m. Employee #11 (Vice President of Medical Affairs)was interviewed and a policy related to the use of triggering agents such as Succinylcholine in the ED off-site was requested.

The Alternate Director of Pharmaceutical Services (Employee #12) was interviewed on 12/04/2012, at 10:31 a.m. Employee # 12 stated all Malignant Hyperthermia kits should be standardized and the policy protocol was 100% responsible with Anesthesia. Employee #12 was unsure of how many vials of Dantolene should be in the Malignant Hyperthermia kits, but thought it should be ten to twelve vials. During this interview, Employee #12 stated that he did not believe that a high incidence of Malignant Hyperthermia, but he was sure that the potential was there for it to occur in the hospital.

The hospital's Pharmaceutical Services did not ensure sufficient oversight of medication dispensing, administration and policy development to minimize the potential risks of significant adverse events related to medications available to the offsite Emergency Department. The Director of Pharmaceutical Services did not provide sufficient medication related information to the hospital's health care professionals; did not collaborate with other departments of the hospital to ensure appropriate policies were developed to ensure optimal therapeutic outcomes and to minimize the potential for negative outcomes; and did not make the determination of the presence of a potential medication adverse outcome.

Based on observation, staff interview and policy review, the hospital's Director of Pharmaceutical services failed to ensure necessary medications, training and policies were sufficient to meet the potential needs of patients. The hospital's off-site Emergency Department was not sufficiently equipped and the employees were not trained to respond to a potential adverse reaction to the medication readily available for administration-Succinylcholine.

Findings:

On 12/04/2012 at 9:23 a.m. the hospital's off-site Emergency Department (ED) was inspected by two Medical Facilities Inspectors from the Virginia Department of Health. The ED's medication storage unit (Acudose) was observed, and the content list ("Acudose-Rx Station Inventory") was reviewed. The medication "Succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter)", one vial each - were listed on the inventory of the three Rapid Sequence Intubation Boxes. Observation of the stock medications revealed the presence of Succinylcholine. The inventory list did not evidence the presence of Dantrolene, a medication used in the event of an adverse reaction to the Succinylcholine-malignant Hyperthermia (MH). A registered nurse present in the ED were interviewed at 9:30 a.m. (Employee # 6). RN #6 did not have knowledge of the potential adverse event related to the administration of a triggering agent-Succinylcholine. The policy for the use and administration of Succinylcholine was requested. The ED physician #9, stated the ED did not have a specific policy for the use of Succinylcholine or a policy related to malignant Hyperthermia. The Chief Executive Officer stated stated it was approximately ten minutes to transport patient's to the main campus ED-in the event a patient needed a higher level of care.

On 12/04/2012 at 09:50 a.m. Employee #11 (Vice President of Medical Affairs) was interviewed and a policy related to the use of triggering agents such as Succinylcholine in the ED was requested. A "general hospital policy"-"Malignant Hyperthermia" was faxed to the ED and was presented. The policy was dated as reviewed and revised on November 16, 2011. The policy was approved by the Director of Nursing Services but did not evidence approval by the Assistant Director of Emergency Services (Employee # 9), or the Assistant Director of Pharmaceutical Services Employee #12) (The Director of Pharmaceutical Services was not available for interview during the survey.) The policy did not include procedures to direct the use of a triggering agent or rescue measures to implement in the event of a MH (Malignant Hyperthermia) crisis in the ED. The policy included procedures to implement if a patient experienced a malignant hyperthermia crisis after the use of a triggering agent post surgery or anesthesia only. The policy referred to the location of a MH cart and supplies in the the "OR (Operating room)." The policy did not include the use, required rescue medications or personnel training for the use of a triggering agent in the on-campus ED or the off-campus ED. (The triggering agent succinylcholine was observed to be present in both ED's during the survey .) The policy only addressed the operating room and anesthesia personnel.

The policy stated: "Malignant Hyperthermia (MH) is a rare, life threatening complication that may be triggered by drugs, commonly used in anesthesia. Succinylcholine and volatile anesthesia agents (i.e., halothane, isoflurane) are the most frequently triggering agents.

Malignant hyperthermia can also be induced by trauma, strenuous exercise, or emotional stress.

Characteristics of the syndrome include generalized contracture of skeletal muscles, marked temperature elevations, tachycardia, metabolic acidosis, cardiac dysrhythmias, and hypoxia. These may occur during induction or maintenance of anesthesia, although, the syndrome can occurred postoperatively or even after repeated exposures to anesthesia.

Most frequently in children and adolescents.

Although malignant hyperthermia is a rare occurrence, time is critical when it occurs and OR nursing personnel must be familiar with the protocol for its management.

Standing Operating Procedure:

Duties of the Circulator:

1). Have the following supplies in the room available for every case where malignant hyperthermia emergency may occur:

a)Number 18 Fr salem sump (x2).
b) Toomey syringes 50 ml (x2)
c) Single basin
d) Isolation\Bowel bag from OR supply
e) Extra K-Thermia unit, and blanket on shelf.
f) Foley Catheter Kit.

2) Call Front Desk on Intercom to have the following notified:

a) Staff Anesthesiologist running the floor.
b) Operating Room Floor Nurse

3) Call Anesthesia Workroom to have the malignant hyperthermia crash box brought to room.

4) Remain in operating room! Runners will obtain other needed supplies. Assist anesthesia as directed.

5) Be ever mindful of patient safety-safety straps, proper padding, keeping patient dry, etc.
g) Duties of the Surgical Technician:

1) Maintain sterile field, assist surgeons as directed to finish procedure as quickly as possibly.
2) Move sterile back table a safe distance from the operating room table for placement of crushed ice externally and hypothermia blankets on the patient.

h. Duties of the Runners:

1) Obtain defibrillator machine from core if needed.
2) Carry two empty kick buckets with liners to SICU kitchen IMMEDIATELY upon notification of malignant hyperthermia emergency. Fill with ice and return to the OR.
3) Obtain cold IV solutions from refrigerator in B-core.
4) Set up K-thermia machine. This may be placed on top of the patient.
5) Place crushed ice in plastic bag for external placement on patient.
6) Stamp twenty (20) labels with patient's stamp plate (addressograph).
7) Stamp up needed laboratory slips.

a) Chem 1 (x3)
b) Chem (x1)
c) Miscellaneous (x4)
d) Hematology (x1)
e) Blood Gas slips (red or blue as needed depending on time of occurrence) x3.

8) Obtain the following supplies for lab tests:

a) one (1) 10ml red top tube
b) one (1) 7ml red top tube
c) One (1) 7ml purple top tube
d) two (2) 3ml blue top tubes
e) three (3) blood gas syringes/kits
f) one (1) clean catch cup (specimen cup)

9) Wait for lab tests to be drawn and deliver to labs 'A' or 'B' as appropriate.

i. Laboratory Tests:

1) Laboratory 'A':

a) Chemistry-Lytes: Chem I slip and 3ml red top tube.
b) Coagulation Test (PT and PTT): Miscellaneous slip and 3 ml blue top tube.
c) Hematology: Hematology slip and 3ml purple top tube (or with blue blood gas slip).
d). Arterial Blood Gas: Blue blood gas slip and blood gas syringe. **Red blood gas slip after duty hours (1600 hours) and to Respiratory Therapy**

2) Lab 'B'

a) Enzymes: Chem I slip and 10ml red top tube.
b) CA# and Bilirubin: Chem I slip and 3ml red top tube.
c) Lactate: Miscellaneous slip and 3ml red top tube.
d) Coagulation studies: Hematology, SF 549, or Miscellaneous slip and 3ml blue top tube.
e) T3,T4, Serum Thyroxine: Chem II and 7ml red top tube.
f) Myoglobin: Miscellaneous slip and clean catch specimen cup.

Exceptions: None

Monitoring:

All OR Personnel

Document Management- Director , Anesthesia Services and Director, Perioperative Services."

The Governing Body, the Director of Pharmaceutical Services, and the Emergency Director failed to adequately prepare for a critical outcome, if Malignant Hyperthermia occurred in the Free Standing Emergency Department.

The Vice President of Medical Affairs, Emergency Department Director (On 12/04/2012 at 09:50 a.m. Employee #11 (Vice President of Medical Affairs)was interviewed and a policy related to the use of triggering agents such as Succinylcholine in the ED off-site was requested.

The Alternate Director of Pharmaceutical Services (Employee #12) was interviewed on 12/04/2012, at 10:31 a.m. Employee # 12 stated all Malignant Hyperthermia kits should be standardized and the policy protocol was 100% responsible with Anesthesia. Employee #12 was unsure of how many vials of Dantolene should be in the Malignant Hyperthermia kits, but thought it should be ten to twelve vials. During this interview, Employee #12 stated that he did not believe that a high incidence of Malignant Hyperthermia, but he was sure that the potential was there for it to occur in the hospital.

The hospital's Pharmaceutical Services did not ensure sufficient oversight of medication dispensing, administration and policy development to minimize the potential risks of significant adverse events related to medications available to the offsite Emergency Department. The Director of Pharmaceutical Services did not provide sufficient medication related information to the hospital's health care professionals; did not collaborate with other departments of the hospital to ensure appropriate policies were developed to ensure optimal therapeutic outcomes and to minimize the potential for negative outcomes; and did not make the determination of the presence of a potential medication adverse outcome.

Based on observation, staff interview and policy review, the hospital's Pharmaceutical Services failed to ensure high risk medications were safely dispensed, sufficient policies were developed and clinical staff were educated on the potential adverse outcomes related to the administration of a triggering agent-succinylcholine, available for administration. The medication was not dispensed in a manner consistent with the standards of practice set fourth by the Malignant Hyperthermia Association. The hospital's off-site Emergency Department was not sufficiently equipped to respond to a potential adverse reaction to the medication-rescue protocols and medications were not immediately available and the clinical nurse # was not provided education to recognize potential adverse events.

The findings included:

On 12/04/2012 at 9:23 a.m. the hospital's off-site Emergency Department (ED) was inspected by two Medical Facilities Inspectors from the Virginia Department of Health. The ED's medication storage unit (Acudose) was observed, and the content list ("Acudose-Rx Station Inventory") was reviewed. The medication "Succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter)", one vial each - were listed on the inventory of the three Rapid Sequence Intubation Boxes. Observation of the stock medications revealed the presence of Succinylcholine. The inventory list did not evidence the presence of Dantrolene, a medication used in the event of an adverse reaction to the Succinylcholine-malignant Hyperthermia (MH). A registered nurse present in the ED were interviewed at 9:30 a.m. (Employee # 6). RN #6 did not have knowledge of the potential adverse event related to the administration of a triggering agent-Succinylcholine. The policy for the use and administration of Succinylcholine was requested. The ED physician #9, stated the ED did not have a specific policy for the use of Succinylcholine or a policy related to malignant Hyperthermia. The Chief Executive Officer stated stated it was approximately ten minutes to transport patient's to the main campus ED-in the event a patient needed a higher level of care.

On 12/04/2012 at 09:50 a.m. Employee #11 (Vice President of Medical Affairs)was interviewed and a policy related to the use of triggering agents such as Succinylcholine in the ED was requested. A "general hospital policy"-"Malignant Hyperthermia" was was presented to the faxed to the ED and was presented. The policy was dated as reviewed and revised on November 16, 2011. The policy was approved by the Director of Nursing Services but did not evidence approval by the Assistant Director of Emergency Services (Employee # 9), or the Assistant Director of Pharmaceutical Services Employee #12) (The Director of Pharmaceutical Services was not available for interview during the survey.) The policy did not include procedures to direct the use of a triggering agent or rescue measures to implement in the event of a MH crisis in the ED. The policy included procedures to implement if a patient experienced a malignant hyperthermia crisis after the use of a triggering agent post surgery or anesthesia only. The policy referred to the location of a MH cart and supplies in the the "OR (Operating room)." The policy did not include the use, required rescue medications or personnel training for the use of a triggering agent in the on-campus ED or the off-campus ED. (The triggering agent succinylcholine was observed during the survey to be present in both ED's.) The policy only addressed the operating room and anesthesia personnel.

The policy stated: "Malignant Hyperthermia (MH) is a rare, life threatening complication that may be triggered by drugs, commonly used in anesthesia. Succinylcholine and volatile anesthesia agents (i.e., halothane, isoflurane) are the most frequently triggering agents.

Malignant hyperthermia can also be induced by trauma, strenuous exercise, or emotional stress.

Characteristics of the syndrome include generalized contracture of skeletal muscles, marked temperature elevations, tachycardia, metabolic acidosis, cardiac dysrhythmias, and hypoxia. These may occur during induction or maintenance of anesthesia, although, the syndrome can occurred postoperatively or even after repeated exposures to anesthesia.

Most frequently in children and adolescents.

Although malignant hyperthermia is a rare occurrence, time is critical when it occurs and OR nursing personnel must be familiar with the protocol for its management.

The hospital's Pharmaceutical Services did not ensure sufficient oversight of medication dispensing, administration and policy development to minimize the potential risks of significant adverse events related to medications available to the offsite Emergency Department. The Director of Pharmaceutical Services did not provide sufficient medication related information to the hospital's health care professionals; did not collaborate with other departments of the hospital to ensure appropriate policies were developed to ensure optimal therapeutic outcomes and to minimize the potential for negative outcomes; and did not make the determination of the presence of a potential medication adverse outcome.

According to an article by MHAUS (Malignant Hyperthermia Association of the United States) drugs, which trigger Malignant Hyperthermia (MH) include "...volatile gaseous inhalation anesthetics..." and "succinylcholine" a "depolarizing muscle relaxant." MHAUS directs that "... MHC (Malignant Hyperthermia Crisis) must be identified and treated early in its course in order for there to be a successful outcome. The treatment must be swift, focused and continued for many hour after the episode begins. Since 1979, the drug Dantrolene sodium for injection ... has been available for the treatment of an MHC and has contributed greatly to a dramatic decline in deaths and/or resultant disabilities associated with such occurrences. It is therefore vital that all hospitals, ambulatory centers, and offices where general anesthesia is administered have a full supply of Dantrolene immediately available. [sic]"

Based on observation, staff interview and policy review, the hospital's Emergency Services Department failed to ensure services were integrated with other departments of the hospital. The hospital's off-site Emergency Department was not sufficiently equipped to respond to a potential adverse reaction to the medication readily available for administration-succinylcholine. The ED policies and staff training were not developed in collaboration with Pharmaceutical Services to ensure integration and sufficient medications and training were provided to minimize the risk of negative patient events.

Findings:

On 12/04/2012 at 9:23 a.m. the hospital's off-site Emergency Department (ED) was inspected by two Medical Facilities Inspectors from the Virginia Department of Health. The ED's medication storage unit (Acudose) was observed, and the content list ("Acudose-Rx Station Inventory") was reviewed. The medication "Succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter)", one vial each - were listed on the inventory of the three Rapid Sequence Intubation Boxes. Observation of the stock medications revealed the presence of Succinylcholine. The inventory list did not evidence the presence of Dantrolene, a medication used in the event of an adverse reaction to the Succinylcholine-malignant Hyperthermia (MH). A registered nurse present in the ED were interviewed at 9:30 a.m. (Employee # 6). RN #6 did not have knowledge of the potential adverse event related to the administration of a triggering agent-Succinylcholine. The policy for the use and administration of Succinylcholine was requested. The ED physician #9, stated the ED did not have a specific policy for the use of Succinylcholine or a policy related to malignant Hyperthermia. The Chief Executive Officer stated stated it was approximately ten minutes to transport patient's to the main campus ED-in the event a patient needed a higher level of care.

On 12/04/2012 at 09:50 a.m. Employee #11 (Vice President of Medical Affairs) was interviewed and a policy related to the use of triggering agents such as Succinylcholine in the ED was requested. A "general hospital policy"-"Malignant Hyperthermia" was faxed to the ED and was presented. The policy was dated as reviewed and revised on November 16, 2011. The policy was approved by the Director of Nursing Services but did not evidence approval by the Assistant Director of Emergency Services (Employee # 9), or the Assistant Director of Pharmaceutical Services Employee #12) (The Director of Pharmaceutical Services was not available for interview during the survey.) The policy did not include procedures to direct the use of a triggering agent or rescue measures to implement in the event of a MH (Malignant Hyperthermia) crisis in the ED. The policy included procedures to implement if a patient experienced a malignant hyperthermia crisis after the use of a triggering agent post surgery or anesthesia only. The policy referred to the location of a MH cart and supplies in the the "OR (Operating room)." The policy did not include the use, required rescue medications or personnel training for the use of a triggering agent in the on-campus ED or the off-campus ED. (The triggering agent succinylcholine was observed to be present in both ED's during the survey .) The policy only addressed the operating room and anesthesia personnel.

The policy stated: "Malignant Hyperthermia (MH) is a rare, life threatening complication that may be triggered by drugs, commonly used in anesthesia. Succinylcholine and volatile anesthesia agents (i.e., halothane, isoflurane) are the most frequently triggering agents.

Malignant hyperthermia can also be induced by trauma, strenuous exercise, or emotional stress.

Characteristics of the syndrome include generalized contracture of skeletal muscles, marked temperature elevations, tachycardia, metabolic acidosis, cardiac dysrhythmias, and hypoxia. These may occur during induction or maintenance of anesthesia, although, the syndrome can occurred postoperatively or even after repeated exposures to anesthesia.

Most frequently in children and adolescents.

Although malignant hyperthermia is a rare occurrence, time is critical when it occurs and OR nursing personnel must be familiar with the protocol for its management.

Standing Operating Procedure:

Duties of the Circulator:

1). Have the following supplies in the room available for every case where malignant hyperthermia emergency may occur:

a)Number 18 Fr salem sump (x2).
b) Toomey syringes 50 ml (x2)
c) Single basin
d) Isolation\Bowel bag from OR supply
e) Extra K-Thermia unit, and blanket on shelf.
f) Foley Catheter Kit.

2) Call Front Desk on Intercom to have the following notified:

a) Staff Anesthesiologist running the floor.
b) Operating Room Floor Nurse

3) Call Anesthesia Workroom to have the malignant hyperthermia crash box brought to room.

4) Remain in operating room! Runners will obtain other needed supplies. Assist anesthesia as directed.

5) Be ever mindful of patient safety-safety straps, proper padding, keeping patient dry, etc.
g) Duties of the Surgical Technician:

1) Maintain sterile field, assist surgeons as directed to finish procedure as quickly as possibly.
2) Move sterile back table a safe distance from the operating room table for placement of crushed ice externally and hypothermia blankets on the patient.

h. Duties of the Runners:

1) Obtain defibrillator machine from core if needed.
2) Carry two empty kick buckets with liners to SICU kitchen IMMEDIATELY upon notification of malignant hyperthermia emergency. Fill with ice and return to the OR.
3) Obtain cold IV solutions from refrigerator in B-core.
4) Set up K-thermia machine. This may be placed on top of the patient.
5) Place crushed ice in plastic bag for external placement on patient.
6) Stamp twenty (20) labels with patient's stamp plate (addressograph).
7) Stamp up needed laboratory slips.

a) Chem 1 (x3)
b) Chem (x1)
c) Miscellaneous (x4)
d) Hematology (x1)
e) Blood Gas slips (red or blue as needed depending on time of occurrence) x3.

8) Obtain the following supplies for lab tests:

a) one (1) 10ml red top tube
b) one (1) 7ml red top tube
c) One (1) 7ml purple top tube
d) two (2) 3ml blue top tubes
e) three (3) blood gas syringes/kits
f) one (1) clean catch cup (specimen cup)

9) Wait for lab tests to be drawn and deliver to labs 'A' or 'B' as appropriate.

i. Laboratory Tests:

1) Laboratory 'A':

a) Chemistry-Lytes: Chem I slip and 3ml red top tube.
b) Coagulation Test (PT and PTT): Miscellaneous slip and 3 ml blue top tube.
c) Hematology: Hematology slip and 3ml purple top tube (or with blue blood gas slip).
d). Arterial Blood Gas: Blue blood gas slip and blood gas syringe. **Red blood gas slip after duty hours (1600 hours) and to Respiratory Therapy**

2) Lab 'B'

a) Enzymes: Chem I slip and 10ml red top tube.
b) CA# and Bilirubin: Chem I slip and 3ml red top tube.
c) Lactate: Miscellaneous slip and 3ml red top tube.
d) Coagulation studies: Hematology, SF 549, or Miscellaneous slip and 3ml blue top tube.
e) T3,T4, Serum Thyroxine: Chem II and 7ml red top tube.
f) Myoglobin: Miscellaneous slip and clean catch specimen cup.

Exceptions: None

Monitoring:

All OR Personnel

Document Management- Director , Anesthesia Services and Director, Perioperative Services."

The Governing Body, the Director of Pharmaceutical Services, and the Emergency Director failed to adequately prepare for a critical outcome, if Malignant Hyperthermia occurred in the Free Standing Emergency Department.

The Vice President of Medical Affairs, Emergency Department Director (On 12/04/2012 at 09:50 a.m. Employee #11 (Vice President of Medical Affairs)was interviewed and a policy related to the use of triggering agents such as Succinylcholine in the ED off-site was requested.

The Alternate Director of Pharmaceutical Services (Employee #12) was interviewed on 12/04/2012, at 10:31 a.m. Employee # 12 stated all Malignant Hyperthermia kits should be standardized and the policy protocol was 100% responsible with Anesthesia. Employee #12 was unsure of how many vials of Dantrolene should be in the Malignant Hyperthermia kits, but thought it should be ten to twelve vials. The hospital's Emergency Services Department did not ensure sufficient integration and collaboration with Pharmaceutical Services to develop policies and ensure sufficient medications and training was provided. is interview, Employee #12 stated that he did not believe that a high incidence of Malignant Hyperthermia, but he was sure that the potential was there for it to occur in the hospital.


The hospital's Emergency Services Department did not ensure sufficient integration and collaboration with Pharmaceutical Services to develop policies and ensure sufficient medications and training was provided.

Based on observation, staff interview and policy review, the hospital's Medical Staff failed to ensure policies were sufficient to meet the potential needs of patients. The hospital's off-site Emergency Department was not sufficiently equipped to respond to a potential adverse reaction to the medication readily available for administration-succinylcholine. This finding resulted in an Immediate Jeopardy finding by the State Agency.

Findings:

On 12/04/2012 at 9:23 a.m. the hospital's off-site Emergency Department (ED) was inspected by two Medical Facilities Inspectors from the Virginia Department of Health. The ED's medication storage unit (Acudose) was observed, and the content list ("Acudose-Rx Station Inventory") was reviewed. The medication "Succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter)", one vial each - were listed on the inventory of the three Rapid Sequence Intubation Boxes. Observation of the stock medications revealed the presence of Succinylcholine. The inventory list did not evidence the presence of Dantrolene, a medication used in the event of an adverse reaction to the Succinylcholine-malignant Hyperthermia (MH). A registered nurse present in the ED were interviewed at 9:30 a.m. (Employee # 6). RN #6 did not have knowledge of the potential adverse event related to the administration of a triggering agent-Succinylcholine. The policy for the use and administration of Succinylcholine was requested. The ED physician #9, stated the ED did not have a specific policy for the use of Succinylcholine or a policy related to malignant Hyperthermia. The Chief Executive Officer stated stated it was approximately ten minutes to transport patient's to the main campus ED-in the event a patient needed a higher level of care.

On 12/04/2012 at 09:50 a.m. Employee #11 (Vice President of Medical Affairs) was interviewed and a policy related to the use of triggering agents such as Succinylcholine in the ED was requested. A "general hospital policy"-"Malignant Hyperthermia" was faxed to the ED and was presented. The policy was dated as reviewed and revised on November 16, 2011. The policy was approved by the Director of Nursing Services but did not evidence approval by the Assistant Director of Emergency Services (Employee # 9), or the Assistant Director of Pharmaceutical Services Employee #12) (The Director of Pharmaceutical Services was not available for interview during the survey.) The policy did not include procedures to direct the use of a triggering agent or rescue measures to implement in the event of a MH (Malignant Hyperthermia) crisis in the ED. The policy included procedures to implement if a patient experienced a malignant hyperthermia crisis after the use of a triggering agent post surgery or anesthesia only. The policy referred to the location of a MH cart and supplies in the the "OR (Operating room)." The policy did not include the use, required rescue medications or personnel training for the use of a triggering agent in the on-campus ED or the off-campus ED. (The triggering agent succinylcholine was observed to be present in both ED's during the survey .) The policy only addressed the operating room and anesthesia personnel.

The policy stated: "Malignant Hyperthermia (MH) is a rare, life threatening complication that may be triggered by drugs, commonly used in anesthesia. Succinylcholine and volatile anesthesia agents (i.e., halothane, isoflurane) are the most frequently triggering agents.

Malignant hyperthermia can also be induced by trauma, strenuous exercise, or emotional stress.

Characteristics of the syndrome include generalized contracture of skeletal muscles, marked temperature elevations, tachycardia, metabolic acidosis, cardiac dysrhythmias, and hypoxia. These may occur during induction or maintenance of anesthesia, although, the syndrome can occurred postoperatively or even after repeated exposures to anesthesia.

Most frequently in children and adolescents.

Although malignant hyperthermia is a rare occurrence, time is critical when it occurs and OR nursing personnel must be familiar with the protocol for its management.

Standing Operating Procedure:

Duties of the Circulator:

1). Have the following supplies in the room available for every case where malignant hyperthermia emergency may occur:

a)Number 18 Fr salem sump (x2).
b) Toomey syringes 50 ml (x2)
c) Single basin
d) Isolation\Bowel bag from OR supply
e) Extra K-Thermia unit, and blanket on shelf.
f) Foley Catheter Kit.

2) Call Front Desk on Intercom to have the following notified:

a) Staff Anesthesiologist running the floor.
b) Operating Room Floor Nurse

3) Call Anesthesia Workroom to have the malignant hyperthermia crash box brought to room.

4) Remain in operating room! Runners will obtain other needed supplies. Assist anesthesia as directed.

5) Be ever mindful of patient safety-safety straps, proper padding, keeping patient dry, etc.
g) Duties of the Surgical Technician:

1) Maintain sterile field, assist surgeons as directed to finish procedure as quickly as possibly.
2) Move sterile back table a safe distance from the operating room table for placement of crushed ice externally and hypothermia blankets on the patient.

h. Duties of the Runners:

1) Obtain defibrillator machine from core if needed.
2) Carry two empty kick buckets with liners to SICU kitchen IMMEDIATELY upon notification of malignant hyperthermia emergency. Fill with ice and return to the OR.
3) Obtain cold IV solutions from refrigerator in B-core.
4) Set up K-thermia machine. This may be placed on top of the patient.
5) Place crushed ice in plastic bag for external placement on patient.
6) Stamp twenty (20) labels with patient's stamp plate (addressograph).
7) Stamp up needed laboratory slips.

a) Chem 1 (x3)
b) Chem (x1)
c) Miscellaneous (x4)
d) Hematology (x1)
e) Blood Gas slips (red or blue as needed depending on time of occurrence) x3.

8) Obtain the following supplies for lab tests:

a) one (1) 10ml red top tube
b) one (1) 7ml red top tube
c) One (1) 7ml purple top tube
d) two (2) 3ml blue top tubes
e) three (3) blood gas syringes/kits
f) one (1) clean catch cup (specimen cup)

9) Wait for lab tests to be drawn and deliver to labs 'A' or 'B' as appropriate.

i. Laboratory Tests:

1) Laboratory 'A':

a) Chemistry-Lytes: Chem I slip and 3ml red top tube.
b) Coagulation Test (PT and PTT): Miscellaneous slip and 3 ml blue top tube.
c) Hematology: Hematology slip and 3ml purple top tube (or with blue blood gas slip).
d). Arterial Blood Gas: Blue blood gas slip and blood gas syringe. **Red blood gas slip after duty hours (1600 hours) and to Respiratory Therapy**

2) Lab 'B'

a) Enzymes: Chem I slip and 10ml red top tube.
b) CA# and Bilirubin: Chem I slip and 3ml red top tube.
c) Lactate: Miscellaneous slip and 3ml red top tube.
d) Coagulation studies: Hematology, SF 549, or Miscellaneous slip and 3ml blue top tube.
e) T3,T4, Serum Thyroxine: Chem II and 7ml red top tube.
f) Myoglobin: Miscellaneous slip and clean catch specimen cup.

Exceptions: None

Monitoring:

All OR Personnel

Document Management- Director , Anesthesia Services and Director, Perioperative Services."

The Governing Body, the Director of Pharmaceutical Services, and the Emergency Director failed to adequately prepare for a critical outcome, if Malignant Hyperthermia occurred in the Free Standing Emergency Department.

The Vice President of Medical Affairs, Emergency Department Director (On 12/04/2012 at 09:50 a.m. Employee #11 (Vice President of Medical Affairs)was interviewed and a policy related to the use of triggering agents such as Succinylcholine in the ED off-site was requested.

The Alternate Director of Pharmaceutical Services (Employee #12) was interviewed on 12/04/2012, at 10:31 a.m. Employee # 12 stated all Malignant Hyperthermia kits should be standardized and the policy protocol was 100% responsible with Anesthesia. Employee #12 was unsure of how many vials of Dantrolene should be in the Malignant Hyperthermia kits, but thought it should be ten to twelve vials. The hospital's Emergency Services Department did not ensure sufficient integration and collaboration with Pharmaceutical Services to develop policies and ensure sufficient medications and training was provided. is interview, Employee #12 stated that he did not believe that a high incidence of Malignant Hyperthermia, but he was sure that the potential was there for it to occur in the hospital.