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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 November 27, 2012 at 9:35 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 nine 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 been administered to a patient on October 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 observation and staff interview, the hospital staff did not inform each patient of their patient rights in the outpatient radiology department located off campus of the hospital.

The findings included:

During the inspection of the offsite location on 11/27/12 at 9:00 a.m., there was no information posted or provided to patients regarding their rights in the outpatient radiology or laboratory department. The surveyor requested any information which was presented to patients at registration and was provided with a HIPPA notice of privacy only. Employee #'s 24. 29, and 46 were present at the time and aware of the findings.

On 11/27/12 at 4:00 p.m. the surveyor discussed the findings with the hospital administrative team including Employee #2, #29, #24, and #46.

Based on observation, staff interview and hospital document review, the hospital staff failed to ensure patients were informed to whom they could report a complaint or grievance and failed to ensure accurate information was provided.

The findings included:

During the inspection of the free-standing emergency department and outpatient location on 11/27/12 at 9:00 a.m., the surveyors observed the information listed on the posting and in the pamphlet provided to patients in the emergency department for lodging a complaint had incorrect information regarding the address/location of the State Agency. In the outpatient radiology department, there was no posting or pamphlets available for patients which informed them of their right to file a complaint/grievance and information of who to contact.

On 11/27/12 at 9:15 a.m. Employee # 46 stated the pamphlets did have incorrect information and there were "new ones" which would be made available for patients. Employee #46 also removed the sign from the waiting area which contained the incorrect information and stated a new poster would be ordered. He/She stated the information would also be posted and pamphlets made available for patients in the outpatient radiology department.

On 11/27/12 at 4:00 p.m. the observations were discussed with the administrative team of the hospital.

Based on observation, 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 11/27/2012 at 09:35 a.m. The immediacy of the situation was removed on 11/27/2012 at 3:24 p.m., as evidenced by the delivery of appropriate equipment and medications to the offsite ED, a revision of hospital policies, and documented training of the appropriate employees on duty.

Findings:

On 11/27/2012 at 9:30 a.m. the hospital's offsite 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)", four vials- was listed on the inventory. Observation of the stock medications revealed the presence of five vials of succinylcholine located in the refrigerated unit, and four vials located in prepared kits for the use in rapid sequence intubation (RSI) events. 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). All registered nurses present in the ED were interviewed at 9:35 a.m. (Employee # 24, 31, 33, 34, 46 and 51). The RN's did not have knowledge of the potential adverse event related to the administration of a triggering agent-succinylcholine-which was available for administration. The policy for the use and administration of succinylcholine was requested. The nurses stated it was approximately fourteen minutes to transport patient's to the main campus ED-in the event a patient needed a higher level of care. The ED Nurse Manager (Employee # 33) stated the ED did not have a specific policy for the use of succinylcholine or a policy related to malignant hyperthermia.

On 11/27/2012 Employee # 46 (Quality Department RN) 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 Crisis-Collaborative Practice Guidelines" was faxed to the ED and was presented. The policy was dated as reviewed and revised on 9/2012. The policy was approved by the Director of Surgical Services but did not evidence approval by the Director of Emergency Services (Employee # 47), the Emergency Department Medical Director (Employee # 48), or the ED Nurse Manager (Employee # 33). 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 "PACU (post anesthesia care unit)"and 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, the PACU and anesthesia personnel.

The policy stated: "Malignant Hyperthermia (MH) is a life threatening syndrome that occurs in individuals who have a skeletal muscle disorder which may be hereditary. In these people, a triggering agent (see page 3 and 11) may cause an acute hyper metabolic crisis which may occur during anesthesia induction (immediately upon exposure to a triggering agent) or anytime throughout the intraoperative or immediate post-operative phase. Therefore, OR (operating room), PACU (post anesthesia care unit), and Anesthesia personal need to be alert to the signs and symptoms of MH, a medical emergency that must be detected early and treated immediately and vigorously." The policy's "equipment needed" list included a MH cart, refrigerated normal saline for for intravenous and cavity irrigation. These items were not present in the off campus ED. The "needed equipment list did not include the medication Dantrolene, although the policy's "Interventions" directed the immediate administration of the medication: "7. Dantrolene sodium (Dantrium) should be administered with an initial dose of up to 2.5 mg/kg IV (intravenous) in a continuous push and repeated every five to ten minutes until a maximum cumulative dose of 10 mg/kg has been reached or until the episode has been controlled. The policy also included additional cooling method options: ...9. Any or all of the following cooling methods may be used to reduce the patient's temperature: a. Refrigerated IV fluids (normal saline)...b. Refrigerated saline irrigation of body cavities:...;" The off campus ED did not maintain a supply of refrigerated normal saline for IV administration or irrigation. The policy also suggested the administration of Pronestyl, which was also not listed as available for administration. This medication (succinylcholine) was available for administration in the outpatient ED since at least January 2012. The hospital staff could not determine the original date of availability.

Hospital documentation and observation revealed that the medication was available, and was recently used- without the availability of the rescue drug dantrolene, refrigerated saline, Pronestyl, or appropriate staff training. The succinylcholine was most recently accessed from the ED medication supply and administered to Patient # 17 on 10/08/2012. The patient received 100 milligrams of succinylcholine prior to being intubated due to the diagnosis of hypercarbia and acute respiratory failure. The facility policy "Rapid Sequence Induction" was reviewed and revised on 9/2012 by the ED Director (Employee # 47) and the ED Medical Director (Employee # 48). The policy purpose stated: "Purpose: To provide safe and efficient airway stabilization and prevent cerebral-cellular anoxia by rapid correction of tissue hypoxia and/or hypercarbia."; "Definition: Rapid sequence induction is a technique where a potent sedative or induction agent is administered virtually simultaneously with a paralyzing dose of neuromuscular blocking agent to facilitate rapid tracheal intubation." The policy included the use of a triggering agent-succinylcholine- available as the neuromuscular blocking agent. The policy did not include the potential threat of MH crisis with the use of the triggering agent or rescue procedures to be implemented. The policy did not refer to a MH cart in the ED, staff training, post procedural monitoring for MH or a reference to the MH policy.

The hospital's Chief Nurse Executive (CNE) was interviewed on 11/27/12 at 10:20 a.m. regarding the availability of a triggering agent-succinylcholine- in the off site ED. The CNE stated the hospital's medication system changed in the "Spring" on 2012 and dantrolene was inadvertently left out of the new system. The CNE stated that dantrolene was currently only available in the MH carts maintained in the OR-"The ED at Cornwall out patient ED does not have dantrolene or a MH cart."

On 11/27/12 at 12:11 p.m. the CNE was informed of the discovery and determination of Immediate Jeopardy situation. A plan of removal for the Immediate Jeopardy finding was accepted by the State Survey Team at 3:24 p.m. to include the observed placement of medications at the offsite ED (11:43 a.m.), evidence of current effected staff training, revision of the MH Crisis policy.

The Emergency Department Director (Employee # 47), the Emergency Department Medical Director and Employee # 1 (Senior Director) were interviewed on 11/28/2012 at 10:25 a.m. and the policies regarding MH and rapid intubation sequence were reviewed. Employee # 47 stated she could not recall if the Pharmacy Director was directly involved in the development, review and revision of the policies. The Medical Director stated that the ED's had switched to a different medication (Rocuronium) to be used for rapid intubation situations and the medication cart should have not have had the succinylcholine: (We) "should have switched substances." The Medical Director stated that Pharmaceutical Services was responsible for the provision of the MH cart in the OR. Employee # 1 stated the Pharmacy would be responsible for the protocol.

The Director of Pharmaceutical Services (Employee # 50) was interviewed on 11/28/2012 at 10:50 a.m. Employee # 50 stated she did not participate in the development or review of the "Rapid Intubation Sequence" policy. Employee # 50 stated she was aware the RIS kits provided to the outpatient ED by Pharmaceutical Services did include the triggering agent succinylcholine, and that additional succinylcholine vials were maintained in the medication refrigerator at the ED. Employee # 50 also stated it was the responsibility of the Pharmacy Services to maintain the par levels of medications, and the department would have received electronic alerts of the use of succinylcholine in October 2012, and replaced the medication to maintain the minimum levels available. Employee # 50 stated she was responsible for providing medication training and information to clinical staff and had disseminated information regarding MH and the use of triggering agents by way of a "news letter." Employee # 50 stated "(I) don't do as a formal (training)", when evidence of staff training related to MH or triggering agents was requested. Employee # 50 stated the MH cart and dantrolene were not dispensed to the off site ED, as the most common use of a triggering agent was in the OR, not the ED and that MH most commonly occurred, to her knowledge, with the concurrent use of an inhalation gases so the need for the rescue equipment and medications in the ED did not occur to her as pharmaceutical gases were not utilized at the offsite ED. The Director of Pharmaceutical Services's job description was reviewed and it included the responsibility of policy revision, a member of the Pharmaceutical and Therapy Committee, direction and coordination of drug dispersement and advisement of the medical staff related to medication information. The medical staff by-laws were reviewed and delegated authority and responsibility to the Pharmaceutical Services department for the development of policies and procedures. The job description did not include the responsibility of directing staff education of potential medication interactions, errors or adverse events.

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.




21876

Two Medical Facilities Inspectors conducting observations at the facility's free standing off campus Emergency Department on November 27, 2012 at 9:35 a.m. discovered a medication was accessible without the needed medications and supplies to treat its potentially fatal adverse side effect. A Medical Facilities Inspector contacted the Team Coordinator on November 27, 2012 at 10:15 a.m. and relayed findings. The findings included:
· The free standing off campus Emergency Department had nine 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 been administered to a patient on October 2012.
· Interviews conducted 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.
On November 27, 2012 at 10:18 a.m., the two Medical Facilities Inspectors were asked to stay on-site at the free standing off campus ED. The remaining four Medical Facilities Inspectors were called together to discuss the findings. Telephone communication was maintained with the two Medical Facilities Inspectors at the free standing off campus ED, during the investigative process. One Medical Facilities Inspector re-toured the ED within the main facility with the focus on the availability of Dantrolene and staff knowledge of Malignant Hyperthermia.
On November 27, 2012 at 10:28 a.m., the Medical Facilities Inspectors as a team reviewed the procedures within Appendix Q to determine Immediate Jeopardy. At 10:30 a.m., a call was placed to inform the State agency office of the preliminary findings and the team's decision to review and investigate those findings in accord with Appendix Q- Immediate Jeopardy protocol.
The investigative process and team discussion on November 27, 2012 from 10:32 a.m. to 11:55 a.m. revealed the following:
· Immediacy- Yes the off campus Emergency Department (ED) had access to nine vials of Succinylcholine, which could be administered to any patient arriving at the ED in need of intubation at any moment. The off campus Emergency Department (ED) did not have the necessary medications or supplies available to treat a Succinylcholine induced Malignant Hyperthermia. At the time of discovery the off campus Emergency Department (ED) nursing staff were not able to access the facility's policy for Malignant Hyperthermia protocols. The off campus Emergency Department nursing staff were unaware of the adverse side effects associated with Succinylcholine.
· Potential for Harm- Yes: The off campus Emergency Department (ED) had access to nine vials of Succinylcholine. In case of an adverse side effect to the Succinylcholine-the off campus ED did not have a Malignant Hyperthermia (MH) cart with needed supplies or access to medication (Dantrolene). On-line research, [www.drugs.com] provided information related to MH and death. The offsite ED was six miles from the main campus per interview on November 27, 2012 at 10:59 a.m., with Staff #2 and travel time was reported as "fifteen minutes or more depending on traffic and other conditions." The off campus ED staff had last used Succinylcholine in October of 2012 and the nursing staff lack of knowledge regarding potential adverse side effects of Succinylcholine, the procedure for Malignant Hyperthermia and the non-availability of necessary medication and supplies.
· Culpability: Yes- The requested facility's Malignant Hyperthermia (MH) policy indicated Succinylcholine could trigger the adverse and fatal Malignant Hyperthermia. The main facility's pharmacy was aware of the need for the availability of Dantrolene in connection with Succinylcholine administration. The main campus Emergency Department (ED) staff were aware of the potential adverse side effects from Succinylcholine administration and the immediate need of Dantrolene for treating MH.
On November 27, 2012 at 11:55 a.m., a call was placed to the State agency office with the above findings and the decision for IJ.
On November 27, 2012 at 11:58 a.m., Staff #2 was asked to meet with the Medical Facilities Inspectors located within the main campus. At 12:11 p.m. Staff #2 arrived at the conference room with Staff #1, Staff #25, Staff #50 and Staff #52. A State agency Supervisor and two Medical Facilities Inspectors were present by telephone, and three other Medical Facilities Inspectors, when the Medical Facilities Inspectors' team coordinator informed the facility's administrative staff of the findings and the determination of Immediate Jeopardy. Staff #2 verbalized understanding of the need for an immediate resolution with a written plan of immediate action.
On November 27, 2012 at 3:16 p.m., Staff #2 presented the following "Immediate Response Plan" read: "Issues: [Name of Facility] was notified at 12:10 p.m. on 11/27/2012 that we were in IJ (immediate jeopardy) for the lack of availability of the drug Dantrolene at [the name of the off campus ED] in the presence of Succinoylcholine (Succinylcholine). Immediate Response: A Malignant Hyperthermia cart was delivered to [the name of the off campus ED] at 11:30 a.m. A corrective action plan was developed for immediate response as follows: 1. Placement of the Malignant Hyperthermia cart at [initials for the off campus ED] (completed 11/27 at 11:30) 2. Update of the Management of Malignant Hyperthermia policy to match the cart (completed 11/27 at 2:30 p.m.) 3. All [initials for the off campus ED] staff will receive immediate in-service to review policy today 11/27/12. 4. All Emergency St Department staff will complete the Malignant Hyperthermia module in [name of the facility's online education system] by December 7, 2012. "
The document was signed by Staff #2 and Staff #55. Staff #2 presented the in-service power point material and a sign-in list of the off-campus ED staff that had received training as of 3:16 p.m. on November 27, 2012.
The placement of the Malignant Hyperthermia cart at the free standing off-campus ED was verified by the two Medical Facilities Inspectors.
The facility was informed the IJ was removed at 3:24 p.m. on November 27, 2012 and that deficient practice would be cited.

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 11/27/2012 at 9:30 a.m. the hospital's offsite 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)", four vials- was listed on the inventory. 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). All registered nurses present in the ED were interviewed at 9:35 a.m. (Employee # 24, 31, 33, 34, 46 and 51). The RN's 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 Nurse Manager (Employee # 33) stated the ED did not have a specific policy for the use of succinylcholine or a policy related to malignant hyperthermia. The nurses stated it was approximately fourteen minutes to transport patient's to the main campus ED-in the event a patient needed a higher level of care.

On 11/27/2012 at 09:50 a.m. Employee # 46 (Quality Department RN) 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 Crisis-Collaborative Practice Guidelines" was faxed to the ED and was presented. The policy was dated as reviewed and revised on 9/2012. The policy was approved by the Director of Surgical Services but did not evidence approval by the Director of Emergency Services (Employee # 47), the Emergency Department Medical Director (Employee # 48), the ED Nurse Manager (Employee # 33) or the Director of Pharmaceutical Services. 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 "PACU (post anesthesia care unit)"and 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, the PACU and anesthesia personnel.

The policy stated: "Malignant Hyperthermia (MH) is a life threatening syndrome that occurs in individuals who have a skeletal muscle disorder which may be hereditary. In these people, a triggering agent (see page 3 and 11) may cause an acute hyper metabolic crisis which may occur during anesthesia induction (immediately upon exposure to a triggering agent) or anytime throughout the intraoperative or immediate post-operative phase. Therefore, OR (operating room), PACU (post anesthesia care unit), and Anesthesia personal need to be alert to the signs and symptoms of MH, a medical emergency that must be detected early and treated immediately and vigorously." The policy's "equipment needed" list included a MH cart, refrigerated normal saline for for intravenous and cavity irrigation. These items were not present in the off campus ED. The "needed equipment list did not include the medication Dantrolene, although the policy's "Interventions" directed the immediate administration of the medication: "7. Dantrolene sodium (Dantrium) should be administered with an initial dose of up to 2.5 mg/kg IV (intravenous) in a continuous push and repeated every five to ten minutes until a maximum cumulative dose of 10 mg/kg has been reached or until the episode has been controlled. The policy also suggested the administration of Pronestyl, which was also not listed as available for administration. This medication (succinylcholine) was available for administration in the outpatient ED since at least January 2012. The hospital staff could not determine the original date of availability.

Hospital documentation and observation revealed that the medication was available, and was recently used- without the availability of the rescue drug dantrolene, Pronestyl, or appropriate staff training. The succinylcholine was most recently accessed from the ED medication supply and administered to Patient # 17 on 10/08/2012. The patient received 100 milligrams of succinylcholine prior to being intubated due to the diagnosis of hypercarbia and acute respiratory failure. The facility policy "Rapid Sequence Induction" was reviewed and revised on 9/2012 by the ED Director (Employee # 47) and the ED Medical Director (Employee # 48). The policy purpose stated: "Purpose: To provide safe and efficient airway stabilization and prevent cerebral-cellular anoxia by rapid correction of tissue hypoxia and/or hypercarbia."; "Definition: Rapid sequence induction is a technique where a potent sedative or induction agent is administered virtually simultaneously with a paralyzing dose of neuromuscular blocking agent to facilitate rapid tracheal intubation." The policy included the use of a triggering agent-succinylcholine- available as the neuromuscular blocking agent. The policy did not include the potential threat of MH crisis with the use of the triggering agent or rescue procedures to be implemented. The policy did not refer to a MH cart in the ED, staff training, post procedural monitoring for MH or a reference to the MH policy.

The hospital's Chief Nurse Executive (CNE) was interviewed on 11/27/12 at 10:20 a.m. regarding the availability of a triggering agent-succinylcholine- in the off site ED. The CNE stated the hospital's medication system changed in the "Spring" on 2012 and dantrolene was inadvertently left out of the new system. The CNE stated that dantrolene was currently only available in the MH carts maintained in the OR-"The ED at Cornwall out patient ED does not have dantrolene or a MH cart."

The Emergency Department Director (Employee # 47), the Emergency Department Medical Director and Employee # 1 (Senior Director) were interviewed on 11/28/2012 at 10:25 a.m. and the policies regarding MH and rapid intubation sequence were reviewed. Employee # 47 stated she could not recall if the Pharmacy Director was directly involved in the development, review and revision of the policies. The Medical Director stated that the ED's had switched to a different medication (Rocuronium) to be used for rapid intubation situations and the medication cart should have not have had the succinylcholine: (We) "should have switched substances." The Medical Director stated that Pharmaceutical Services was responsible for the provision of the MH cart in the OR. Employee # 1 stated the Pharmacy would be responsible for the protocol.

The Director of Pharmaceutical Services (Employee # 50) was interviewed on 11/28/2012 at 10:50 a.m. Employee # 50 stated she did not participate in the development or review of the "Rapid Intubation Sequence" policy. Employee # 50 stated she was aware the RIS kits provided to the outpatient ED by Pharmaceutical Services did include the triggering agent succinylcholine, and that additional succinylcholine vials were maintained in the medication refrigerator at the ED. Employee # 50 also stated it was the responsibility of the Pharmacy Services to maintain the par levels of medications, and the department would have received electronic alerts of the use of succinylcholine in October 2012, and replaced the medication to maintain the minimum levels available. Employee # 50 stated she was responsible for providing medication training and information to clinical staff and had disseminated information regarding MH and the use of triggering agents by way of a "news letter." Employee # 50 stated "(I) don't do as a formal (training)", when evidence of staff training related to MH or triggering agents was requested. Employee # 50 stated the MH cart and dantrolene were not dispensed to the off site ED, as the most common use of a triggering agent was in the OR, not the ED and that MH most commonly occurred, to her knowledge, with the concurrent use of an inhalation gases so the need for the rescue equipment and medications in the ED did not occur to her as pharmaceutical gases were not utilized at the offsite ED. The Director of Pharmaceutical Services's job description was reviewed and it included the responsibility of policy revision, a member of the Pharmaceutical and Therapy Committee, direction and coordination of drug disbursement and advisement of the medical staff related to medication information. The medical staff by-laws were reviewed and delegated authority and responsibility to the Pharmaceutical Services department for the development of policies and procedures. The job description did not include the responsibility of directing staff education of potential medication interactions, errors or adverse events.

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 nurses were not provided education to recognize potential adverse events.

The findings included:

On 11/27/2012 at 9:30 a.m. the hospital's offsite 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)", four vials- was listed on the inventory. Observation of the stock medications revealed the presence of five vials of succinylcholine located in the refrigerated unit, and four vials located in prepared kits for the use in rapid sequence intubation (RSI) events. 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). All registered nurses present in the ED were interviewed at 9:35 a.m. (Employee # 24, 31, 33, 34, 46 and 51). The RN's did not have knowledge of the potential adverse event related to the administration of a triggering agent-succinylcholine-which was available for administration. The policy for the use and administration of succinylcholine was requested. The nurses stated it was approximately fourteen minutes to transport patient's to the main campus ED-in the event a patient needed a higher level of care. The ED Nurse Manager (Employee # 33) stated the ED did not have a specific policy for the use of succinylcholine or a policy related to malignant hyperthermia.

On 11/27/2012 Employee # 46 (Quality Department RN) 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 Crisis-Collaborative Practice Guidelines" was faxed to the ED and was presented. The policy was dated as reviewed and revised on 9/2012. The policy was approved by the Director of Surgical Services but did not evidence approval by the Director of Emergency Services (Employee # 47), the Emergency Department Medical Director (Employee # 48), or the ED Nurse Manager (Employee # 33). 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 MH cart was only present at the OR and PACU of the main hospital campus. 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, the PACU and anesthesia personnel.

The policy stated: "Malignant Hyperthermia (MH) is a life threatening syndrome that occurs in individuals who have a skeletal muscle disorder which may be hereditary. In these people, a triggering agent (see page 3 and 11) may cause an acute hyper metabolic crisis which may occur during anesthesia induction (immediately upon exposure to a triggering agent) or anytime throughout the intraoperative or immediate post-operative phase. Therefore, OR (operating room), PACU (post anesthesia care unit), and Anesthesia personal need to be alert to the signs and symptoms of MH, a medical emergency that must be detected early and treated immediately and vigorously." The policy's "equipment needed" list included a MH cart, refrigerated normal saline for for intravenous and cavity irrigation. These items were not present in the off campus ED. The "needed equipment list did not include the medication Dantrolene, although the policy's "Interventions" directed the immediate administration of the medication: "7. Dantrolene sodium (Dantrium) should be administered with an initial dose of up to 2.5 mg/kg IV (intravenous) in a continuous push and repeated every five to ten minutes until a maximum cumulative dose of 10 mg/kg has been reached or until the episode has been controlled. The policy also included additional cooling method options: ...9. Any or all of the following cooling methods may be used to reduce the patient's temperature: a. Refrigerated IV fluids (normal saline)...b. Refrigerated saline irrigation of body cavities:...;" The off campus ED did not maintain a supply of refrigerated normal saline for IV administration or irrigation. The policy also suggested the administration of Pronestyl, which was also not listed as available for administration. This medication (succinylcholine) was available for administration in the outpatient ED since at least January 2012. The hospital staff could not determine the original date of availability. Hospital documentation and observation revealed that the medication was available, and was recently used- without the availability of the rescue drug dantrolene, refrigerated saline, Pronestyl, or appropriate staff training. The succinylcholine was most recently accessed from the ED medication supply and administered to Patient # 17 on 10/08/2012. The patient received 100 milligrams of succinylcholine prior to being intubated due to the diagnosis of hypercarbia and acute respiratory failure.

The facility policy "Rapid Sequence Induction" was reviewed and revised on 9/2012 by the ED Director (Employee # 47) and the ED Medical Director (Employee # 48). The policy purpose stated: "Purpose: To provide safe and efficient airway stabilization and prevent cerebral-cellular anoxia by rapid correction of tissue hypoxia and/or hypercarbia."; "Definition: Rapid sequence induction is a technique where a potent sedative or induction agent is administered virtually simultaneously wit ha paralyzing dose of neuromuscular blocking agent to facilitate rapid tracheal intubation." The policy included the use of a triggering agent-succinylcholine- available as the neuromuscular blocking agent. The policy did not include the potential threat of MH crisis with the use of the triggering agent or rescue procedures to be implemented. The policy did not refer to a MH cart in the ED, staff training, post procedural monitoring for MH or a reference to the MH policy.

The hospital's Chief Nurse Executive (CNE) was interviewed on 11/27/12 at 10:20 a.m. regarding the availability of a triggering agent-succinylcholine- in the off site ED. The CNE stated the hospital's medication system changed in the "Spring" on 2012 and dantrolene was inadvertently left out of the new system. The CNE stated that dantrolene was currently only available in the MH carts maintained in the OR-"The ED at Cornwall out patient ED does not have dantrolene or a MH cart."

The Emergency Department Director (Employee # 47), the Emergency Department Medical Director and Employee # 1 (Senior Director) were interviewed on 11/28/2012 at 10:25 a.m. and the policies regarding MH and rapid intubation sequence were reviewed. Employee # 47 stated she could not recall if the Pharmacy Director was directly involved in the development, review and revision of the policies. The Medical Director stated that the ED's had switched to a different medication (Rocuronium) to be used for rapid intubation situations and the medication cart should have not have had the succinylcholine: (We) "should have switched substances." The Medical Director stated that Pharmaceutical Services was responsible for the provision of the MH cart in the OR. Employee # 1 stated the Pharmacy would be responsible for the protocol.

The Director of Pharmaceutical Services (Employee # 50) was interviewed on 11/28/2012 at 10:50 a.m. Employee # 50 stated she did not participate in the development or review of the "Rapid Intubation Sequence" policy. Employee # 50 stated she was aware the RIS kits provided to the outpatient ED by Pharmaceutical Services did include the triggering agent succinylcholine, and that additional succinylcholine vials were maintained in the medication refrigerator at the ED. Employee # 50 also stated it was the responsibility of the Pharmacy Services to maintain the par levels of medications, and the department would have received electronic alerts of the use of succinylcholine in October 2012, and replaced the medication to maintain the minimum levels available. Employee # 50 stated she was responsible for providing medication training and information to clinical staff and had disseminated information regarding MH and the use of triggering agents by way of a "news letter." Employee # 50 stated "(I) don't do as a formal (training)", when evidence of staff training related to MH or triggering agents was requested. Employee # 50 stated the MH cart and dantrolene were not dispensed to the off site ED, as the most common use of a triggering agent was in the OR, not the ED and that MH most commonly occurred, to her knowledge, with the concurrent use of an inhalation gases so the need for the rescue equipment and medications in the ED did not occur to her as pharmaceutical gases were not utilized at the offsite ED. The Director of Pharmaceutical Services's job description was reviewed and it included the responsibility of policy revision, a member of the Pharmaceutical and Therapy Committee, direction and coordination of drug disbursement and advisement of the medical staff related to medication information. The medical staff by-laws were reviewed and delegated authority and responsibility to the Pharmaceutical Services department for the development of policies and procedures. The job description did not include the responsibility of directing staff education of potential medication interactions, errors or adverse events.

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 review of the Life Safety Code survey report of the Life Safety survey which ended December 13, 2012, it was determined the hospital was not in compliance with 42 CFR Part 482: Conditions of Participation for Hospitals (Rev. October 11/2008) for Physical Environment.

Findings:

Please refer to the Life Safety Code report of December 13, 2012.

4. Observations and interviews conducted on November 26, 2012 at 2:25 p.m., with Staff #8, Staff #10, and Staff #11 revealed one of one sink in the sandwich prep area had items stored on and beneath the sink. The sandwich prep sink had a posted sign, which read, "Food Prep only sink. NOT for washing hands." A partially consumed cup of soft drink had been placed/stored at the back of the sink between the faucets and the backwash. Staff #8 reported all kitchen staff was aware not to eat and drink in the food prep areas. Staff #8 reviewed the contents stored under the sink in the sandwich prep area and verified the two chemicals (stainless steel cleaner) and the two outerwear jackets should not have been under the sink. Staff #8 stated, "We have a storage area for chemical near the dish room." Staff #8 reported staff had an area in their lounge to store their personal clothing. Staff #8 reported awareness that no items were to be stored under the sinks.

Observations and interviews conducted on November 26, 2012 at 2:25 p.m., with Staff #8, Staff #10, and Staff #11 revealed one of one sink with a cabinet in the retail food area had the following items stored under the sink:
· Five empty sanitation buckets, and
· Two commercial coffee servers
Staff #8 reported the sanitation bucket should have been stored in the kitchen. Staff #8 reiterated no items were to be stored under the sink.












25746

Based on observations and interviews the facility staff failed to ensure the surgical tables and stools in the operating suite (4 of 8 rooms observed) and the Birthing Inn (1 of 2 rooms observed) were intact to promote cleaning, failed to ensure expired supplies were not available for use, surgical instruments were cleaned with the enzymatic cleaner per the manufactures directions and items (chemicals, staff outerwear, personal partially consumed food items) where not stored on or beneath sinks in the food prep and service areas in the kitchen.

The findings include:

1. During the initial tour of the facility on 11/26/12 at approximately 13:59, with the Interim Director of the Operating Department (OD) and several other staff member the following was observed.
Operating Room #3: Operating table had tears and tape residue, stool had tears and 2 disposable staple removers were expired; one 12/2011 and the other 02/2012.
Cysto Room: Operating table and stool had tears and one vacutainer expired 10/2012.
Operating Room #5: Operating table had tears and tape residue
Operating Room #4: Operating table had tears
The remaining 4 rooms were not observed due to procedures were occurring at the time of the observations.

2. An observation was also made of the sterile processing department in conjunction with the observations of the Operating Suite. Upon entering the dirty side of the sterile processing department a SPD (Sterile Process Department) tech was observed washing surgical instruments in a compartment sink. The sink had a mark indicating were to fill the water level. The mark was visible and the water level was approximately half way from the mark. The SPD tech was asked how much water was in the sink and he stated, "I don't know." The SPD tech explained when he would push a button on an automatic enzymatic cleaning dispenser when the sink was full and push another button when it was half full. The dispenser was automatically dispense the appropriate amount of cleaner.
The SPD Lead Tech was also present and was asked how many gallons of water was in the sink. She stated, "I don't know."

There were no additional measuring devices present to measure the water to determine how much enzymatic cleaner needed to be dispensed when the sink was only half full of water.

The label on the enzymatic cleaner stated to add 1/8 to 1/2 fl. oz. of cleaner per gallon of water depending on the soil load.

The SPD tech's personal file was reviewed for training on infection control. Training for the 2011 and to date training for 2012 could not be located. The Human Resource Director stated, "He should have completed his training online and when he did not an alert would have gone to his supervisor to inform them the training had not been completed."

3. The Birthing Inn was observed on 11/27/12 at approximately 11:30 A.M. One of two surgical tables was observed and found to have tears. The Birthing Inn Manager was present and acknowledged the tears in the surgical table mattress.

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 11/27/2012 at 9:30 a.m. the hospital's offsite 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)", four vials- was listed on the inventory. Observation of the stock medications revealed the presence of five vials of succinylcholine located in the refrigerated unit, and four vials located in prepared kits for the use in rapid sequence intubation (RSI) events. 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). All registered nurses present in the ED were interviewed at 9:35 a.m. (Employee # 24, 31, 33, 34, 46 and 51). The RN's did not have knowledge of the potential adverse event related to the administration of a triggering agent-succinylcholine-which was available for administration. The policy for the use and administration of succinylcholine was requested. The nurses stated it was approximately fourteen minutes to transport patient's to the main campus ED-in the event a patient needed a higher level of care. The ED Nurse Manager (Employee # 33) stated the ED did not have a specific policy for the use of succinylcholine or a policy related to malignant hyperthermia.

On 11/27/2012 Employee # 46 (Quality Department RN) 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 Crisis-Collaborative Practice Guidelines" was faxed to the ED and was presented. The policy was dated as reviewed and revised on 9/2012. The policy was approved by the Director of Surgical Services but did not evidence approval by the Director of Emergency Services (Employee # 47), the Emergency Department Medical Director (Employee # 48), or the ED Nurse Manager (Employee # 33). 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 "PACU (post anesthesia care unit)"and 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, the PACU and anesthesia personnel.

The policy stated: "Malignant Hyperthermia (MH) is a life threatening syndrome that occurs in individuals who have a skeletal muscle disorder which may be hereditary. In these people, a triggering agent (see page 3 and 11) may cause an acute hyper metabolic crisis which may occur during anesthesia induction (immediately upon exposure to a triggering agent) or anytime throughout the intraoperative or immediate post-operative phase. Therefore, OR (operating room), PACU (post anesthesia care unit), and Anesthesia personal need to be alert to the signs and symptoms of MH, a medical emergency that must be detected early and treated immediately and vigorously." The policy's "equipment needed" list included a MH cart, refrigerated normal saline for for intravenous and cavity irrigation. These items were not present in the off campus ED. The "needed equipment list did not include the medication Dantrolene, although the policy's "Interventions" directed the immediate administration of the medication: "7. Dantrolene sodium (Dantrium) should be administered with an initial dose of up to 2.5 mg/kg IV (intravenous) in a continuous push and repeated every five to ten minutes until a maximum cumulative dose of 10 mg/kg has been reached or until the episode has been controlled. The policy also included additional cooling method options: ...9. Any or all of the following cooling methods may be used to reduce the patient's temperature: a. Refrigerated IV fluids (normal saline)...b. Refrigerated saline irrigation of body cavities:...;" The off campus ED did not maintain a supply of refrigerated normal saline for IV administration or irrigation. The policy also suggested the administration of Pronestyl, which was also not listed as available for administration. This medication (succinylcholine) was available for administration in the outpatient ED since at least January 2012. The hospital staff could not determine the original date of availability.

Hospital documentation and observation revealed that the medication was available, and was recently used- without the availability of the rescue drug dantrolene, refrigerated saline, Pronestyl, or appropriate staff training. The succinylcholine was most recently accessed from the ED medication supply and administered to Patient # 17 on 10/08/2012. The patient received 100 milligrams of succinylcholine prior to being intubated due to the diagnosis of hypercarbia and acute respiratory failure. The facility policy "Rapid Sequence Induction" was reviewed and revised on 9/2012 by the ED Director (Employee # 47) and the ED Medical Director (Employee # 48). The policy purpose stated: "Purpose: To provide safe and efficient airway stabilization and prevent cerebral-cellular anoxia by rapid correction of tissue hypoxia and/or hypercarbia."; "Definition: Rapid sequence induction is a technique where a potent sedative or induction agent is administered virtually simultaneously wit ha paralyzing dose of neuromuscular blocking agent to facilitate rapid tracheal intubation." The policy included the use of a triggering agent-succinylcholine- available as the neuromuscular blocking agent. The policy did not include the potential threat of MH crisis with the use of the triggering agent or rescue procedures to be implemented. The policy did not refer to a MH cart in the ED, staff training, post procedural monitoring for MH or a reference to the MH policy.

The hospital's Chief Nurse Executive (CNE) was interviewed on 11/27/12 at 10:20 a.m. regarding the availability of a triggering agent-succinylcholine- in the off site ED. The CNE stated the hospital's medication system changed in the "Spring" on 2012 and dantrolene was inadvertently left out of the new system. The CNE stated that dantrolene was currently only available in the MH carts maintained in the OR-"The ED at Cornwall out patient ED does not have dantrolene or a MH cart."

The Emergency Department Director (Employee # 47), the Emergency Department Medical Director and Employee # 1 (Senior Director) were interviewed on 11/28/2012 at 10:25 a.m. and the policies regarding MH and rapid intubation sequence were reviewed. Employee # 47 stated she could not recall if the Pharmacy Director was directly involved in the development, review and revision of the policies. The Medical Director stated that the ED's had switched to a different medication (Rocuronium) to be used for rapid intubation situations and the medication cart should have not have had the succinylcholine: (We) "should have switched substances." The Medical Director stated that Pharmaceutical Services was responsible for the provision of the MH cart in the OR. Employee # 1 stated the Pharmacy would be responsible for the protocol.

The Director of Pharmaceutical Services (Employee # 50) was interviewed on 11/28/2012 at 10:50 a.m. Employee # 50 stated she did not participate in the development or review of the "Rapid Intubation Sequence" policy. Employee # 50 stated she was aware the RIS kits provided to the outpatient ED by Pharmaceutical Services did include the triggering agent succinylcholine, and that additional succinylcholine vials were maintained in the medication refrigerator at the ED. Employee # 50 also stated it was the responsibility of the Pharmacy Services to maintain the par levels of medications, and the department would have received electronic alerts of the use of succinylcholine in October 2012, and replaced the medication to maintain the minimum levels available. Employee # 50 stated she was responsible for providing medication training and information to clinical staff and had disseminated information regarding MH and the use of triggering agents by way of a "news letter." Employee # 50 stated "(I) don't do as a formal (training)", when evidence of staff training related to MH or triggering agents was requested. Employee # 50 stated the MH cart and dantrolene were not dispensed to the off site ED, as the most common use of a triggering agent was in the OR, not the ED and that MH most commonly occurred, to her knowledge, with the concurrent use of an inhalation gases so the need for the rescue equipment and medications in the ED did not occur to her as pharmaceutical gases were not utilized at the offsite ED. The Director of Pharmaceutical Services's job description was reviewed and it included the responsibility of policy revision, a member of the Pharmaceutical and Therapy Committee, direction and coordination of drug disbursement and advisement of the medical staff related to medication information. The medical staff by-laws were reviewed and delegated authority and responsibility to the Pharmaceutical Services department for the development of policies and procedures. The job description did not include the responsibility of directing staff education of potential medication interactions, errors or adverse events.

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 11/27/2012 at 9:30 a.m. the hospital's offsite Emergency Department (ED) was inspected by two Medical Facilities Inspectors from the Virginia Department of Health. The medication "succinylcholine" a triggering agent was available for use rapid sequence intubation (RSI) events. The ED did not evidence the presence of dantrolene, a medication used in the event of an potential, immediate adverse reaction to the succinylcholine-malignant hyperthermia (MH). All registered nurses present in the ED were interviewed at 9:35 a.m. (Employee # 24, 31, 33, 34, 46 and 51). The RN's did not have knowledge of the potential adverse event related to the administration of a triggering agent-succinylcholine-which was available for administration. The policy for the use and administration of succinylcholine was requested. The nurses stated it was approximately fourteen minutes to transport patient's to the main campus ED-in the event a patient needed a higher level of care. The ED Nurse Manager (Employee # 33) stated the ED did not have a specific policy for the use of succinylcholine or a policy related to malignant hyperthermia.

On 11/27/2012 Employee # 46 (Quality Department RN) 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 Crisis-Collaborative Practice Guidelines" was faxed to the ED and was presented. The policy was dated as reviewed and revised on 9/2012. The policy was approved by the Director of Surgical Services but did not evidence approval by the the Emergency Department Medical Director (Employee # 48). 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 "PACU (post anesthesia care unit)"and 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, the PACU and anesthesia personnel.

The policy stated: "Malignant Hyperthermia (MH) is a life threatening syndrome that occurs in individuals who have a skeletal muscle disorder which may be hereditary. In these people, a triggering agent (see page 3 and 11) may cause an acute hyper metabolic crisis which may occur during anesthesia induction (immediately upon exposure to a triggering agent) or anytime throughout the intraoperative or immediate post-operative phase. Therefore, OR (operating room), PACU (post anesthesia care unit), and Anesthesia personal need to be alert to the signs and symptoms of MH, a medical emergency that must be detected early and treated immediately and vigorously." The policy's "equipment needed" list included a MH cart, refrigerated normal saline for for intravenous and cavity irrigation. These items were not present in the off campus ED. The "needed equipment list did not include the medication Dantrolene, although the policy's "Interventions" directed the immediate administration of the medication: "7. Dantrolene sodium (Dantrium) should be administered with an initial dose of up to 2.5 mg/kg IV (intravenous) in a continuous push and repeated every five to ten minutes until a maximum cumulative dose of 10 mg/kg has been reached or until the episode has been controlled. The policy also included additional cooling method options: ...9. Any or all of the following cooling methods may be used to reduce the patient's temperature: a. Refrigerated IV fluids (normal saline)...b. Refrigerated saline irrigation of body cavities:...;" The off campus ED did not maintain a supply of refrigerated normal saline for IV administration or irrigation. The policy also suggested the administration of Pronestyl, which was also not listed as available for administration. This medication (succinylcholine) was available for administration in the outpatient ED since at least January 2012. The hospital staff could not determine the original date of availability.

Hospital documentation and observation revealed that the medication was available, and was recently used- without the availability of the rescue drug dantrolene, refrigerated saline, Pronestyl, or appropriate staff training. The succinylcholine was most recently accessed from the ED medication supply and administered to Patient # 17 on 10/08/2012. The patient received 100 milligrams of succinylcholine prior to being intubated due to the diagnosis of hypercarbia and acute respiratory failure.

he facility policy "Rapid Sequence Induction" was reviewed and revised on 9/2012 by the ED Director (Employee # 47) and the ED Medical Director (Employee # 48). The policy purpose stated: "Purpose: To provide safe and efficient airway stabilization and prevent cerebral-cellular anoxia by rapid correction of tissue hypoxia and/or hypercarbia."; "Definition: Rapid sequence induction is a technique where a potent sedative or induction agent is administered virtually simultaneously wit ha paralyzing dose of neuromuscular blocking agent to facilitate rapid tracheal intubation." The policy included the use of a triggering agent-succinylcholine- available as the neuromuscular blocking agent. The policy did not include the potential threat of MH crisis with the use of the triggering agent or rescue procedures to be implemented. The policy did not refer to a MH cart in the ED, staff training, post procedural monitoring for MH or a reference to the MH policy.

The Emergency Department Director (Employee # 47), the Emergency Department Medical Director and Employee # 1 (Senior Director) were interviewed on 11/28/2012 at 10:25 a.m. and the policies regarding MH and rapid intubation sequence were reviewed. Employee # 47 stated she could not recall if the Pharmacy Director was directly involved in the development, review and revision of the policies. The Medical Director stated that the ED's had switched to a different medication (Rocuronium) to be used for rapid intubation situations and the medication cart should have not have had the succinylcholine: (We) "should have switched substances." The Medical Director stated that Pharmaceutical Services was responsible for the provision of the MH cart in the OR. Employee # 1 stated the Pharmacy would be responsible for the protocol.

The hospital's Medical Staff did not ensure policies and procedures governing care in the ED provided sufficient information and direction in the event of an adverse reaction related to the administration of a triggering agent. The current policies directing the use of succinylcholine and the training and preparedness of ED staff were insufficient to ensure patient safety.