The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

NOVANT PRINCE WILLIAM MEDICAL CENTER 8700 SUDLEY RD MANASSAS, VA 20110 Feb. 1, 2013
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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 January 29, 2013 at 2:55 p.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 [DIAGNOSES REDACTED] a life threatening condition associated with the use of Succinylcholine. [According to www.drugs.com "Possibly fatal [DIAGNOSES REDACTED]; manifested by a rapid, profound elevation in body temperature and sometimes extreme muscular rigidity. Risk increases with concomitant administration of inhalation anesthetics. If [DIAGNOSES REDACTED] 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, [DIAGNOSES REDACTED], stroke, or injury to the spine. This medicine can also help prevent and treat a condition called [DIAGNOSES REDACTED], 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 January 25, 2013.
? Interviews conducted by the two Medical Facilities Inspectors, on January 29, 2013 at approximately 2:55 p.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 [DIAGNOSES REDACTED]. The free standing off campus ED nursing staff did not acknowledge the need for the immediate access to Dantrolene in the case of [DIAGNOSES REDACTED].
? Interviews were conducted by the two Medical Facilities Inspectors, on January 29, 2013 at approximately 3:18 p.m., with staff from the main campus ED and Operating Rooms. The interviews revealed a lack of knowledge/training regarding the facility's policies/procedures/protocols for the potentially fatal adverse side effects associated with the use of Succinylcholine and [DIAGNOSES REDACTED].
VIOLATION: PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION Tag No: A0123
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, record review and interview the facility failed to provide written notification related to the results of the grievance process for two of four. (Patient #12 and # 23)

The findings included:

1. Review of facility's grievance documents revealed a complainant filed a grievance related to Patient #12. The written notification document did not contain the required elements that described the complaint decision, the investigative steps, the results of the investigation or the date of completion.

An interview conducted on January 31, 2013 at 10:46 a.m., Staff #44 examined the facility's grievance process. Staff #44 explained a face-to-face discussion had been conducted with the complainant regarding Patient #12's care. Staff #44 stated, "I arranged through the hospitalist coordinator, for a hospitalist to review [Patient #12's name]'s chart. Doctor [name of Staff #56] reviewed the chart and had a face-to-face discussion with [name of complainant] regarding care provided to [name of Patient #12]. I met with [name of complainant] on November 5, 2012 and November 14, 2012 regarding [his/her] concerns. The last meeting I had, was November 16, (2012) and [he/she/] confirmed all of [his/her] questions and concerns had been answered." The surveyor requested that Staff #44 read the letter sent to the complainant; Staff #44 stated, "I had already discussed the issues I sent more of a consolation letter related to [name of Patient #12]'s death. The grievance had been resolved by then." Staff #44 reported no other letter had been sent. Staff #44 acknowledged the letter sent to the complainant dated November 29, 2012, did not contain the required elements needed in a written notification.




2. On 1/29/13 during the tour of the Obstetric Units with Employees #33 and #12 the information given to a new patient on how to file a complaint with the State Agency was provided and reviewed. The information with the State Agency's address was incorrect. On 1/30/13 Employee #3 was asked to provide the information given to Emergency Department patients on filing a complaint. The information provided to emergency patients was also had an incorrect address. A tour of the Emergency Department with Employee #12. It was pointed out that there was no signage posted on how patients were to obtain the information of filing a compliant. Employee # 12 stated, "We give all our patients the folder with the complaint information in it. We understand it needs to be corrected which we will do immediately."

The medical record of Patient #25 was reviewed on 1/30 and 31/13. Patient #25 was admitted on [DATE] with the diagnoses of Hyponatremia and Gluteus Abscess. Patient #25 did not want to be discharged which occurred on 2/29/11 and filed a grievance with the hospital staff. The hospital staff documented in a grievance investigation they could not send a letter to Patient #25 to share the results of their investigation due to Patient #25 being homeless. Patient #25's medical record listed a local address as Patient #25's home. There was no evidence of a certified letter being sent to document an attempt to reach Patient #25 had been made.

Employee #25 and #3 reviewed the complaint/grievance file for Patient #25 and could not locate either an attempt to contact or a returned certified letter. Employee #25 review the medical record and stated, "Yes an address is listed, but it may be from a previous admission. We should have updated our information."


A tour of the hospital Emergency Department and Obstetric Department was conducted on 1/29/13. A request for the information related to what is provided to each patient regarding the patient's rights was provided. The "What are your rights" information provided to each patient on admission was reviewed on 1/29 and 30/13. The information provided to patients had an incorrect address listed. Employee #12 stated, "We will get that corrected immediately."
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
Based on record review and interview the facility failed to maintain an accurate and complete medical record for two (2) of 31 patients in the survey sample. (Patient #12 and #31)

1. Inaccurate assessment information related to Patient #12's fall during hospitalization .

2. Staff failed to ensure verbal orders were authenticated within 48 hours, that physician orders were accurately discontinued and that physician orders were noted by the licensed nurse when written for Patient #31.

The findings include:

1. Review of Patient #12's medical record (electronic and paper) was conducted on January 29, 2013 from 1:29 p.m. to 2:49 p.m., with Staff #35. During the review, documentation detailed Patient #12 had fallen on October 20, 2012. Review of the shift assessments for October 22 and 23, 2012 and the discharge assessment for October 24, 2012 revealed documentation that Patient #12 had not fallen in the last three months.

An interview was conducted on January 29, 2013 at 2:44 p.m., Staff #35. Staff #35 stated, "The staff charted incorrect assessments of the patient's fall." Staff #35 reviewed with the surveyor and acknowledged Patient #12's medical record had inaccurate fall assessments documented by three different staff. Staff #35 reported the staff should have been aware of Patient #12's fall. Staff #35 stated, "There are at least three ways staff are informed of falls, we have a huddle each morning that discuss falls, during the bedside shift report between on-coming and outgoing staff and during the safety call; a roll call of units that identifies which patients have fallen."




2. On 2/1/13 the medical record of Patient #31 was reviewed with employee #4 present. The verbal orders written on 12/31/12 at 2145 and on 1/1/13 at 0300 were not authenticated by the physician who gave the orders.

The physician's order written on 12/31/12 had a line drawn through the 8th (as numbered) order written with a note below the order to cancel it. The order was written by one physician and canceled by another without an order to do so.

Employee #4 stated, "The physicians are supposed to authenticate their orders within 48 hours. The nurses are supposed to note the order and carry it out or call the physician and let them know of needed changes."
VIOLATION: INTEGRATION OF EMERGENCY SERVICES Tag No: A1103
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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 1/29/2013 at 2:55 p.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 (Pyxis system) was observed. The medication "succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter)", eight vials-were available for use. The ED's pharmaceutical inventory list did not evidence the presence of dantrolene, a medication used in the event of an adverse reaction to the succinylcholine-[DIAGNOSES REDACTED] (MH). The policy for the use and administration of succinylcholine was requested. The ED Nurse Manager was interviewed at the point of discovery and he/she stated it was approximately fifteen 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 (Staff # 22) stated the ED personnel were aware of the risk of [DIAGNOSES REDACTED] associated with the use of succinylcholine, yet did not have a MH ([DIAGNOSES REDACTED] cart) in place, did not have dantrolene on site and all employees did not have the required training. Staff # 22 stated the facility was waiting for all employees to be trained before implementing the policy regarding the use of triggering agents in the off-site ED. Staff # 22 stated the succinylcholine was available for current use. Review of hospital documentation revealed that a patient had received succinylcholine on 1/25/2013. The medication was currently available for use, and was used without the rescue agent Dantrolene, adequate staff training or equipment. The cart identified by the Nurse Manager (Staff # 22) was observed and did not contain any supplies. Staff # 22 stated the facility staff became aware of the issue and risk of having succinylcholine without a MH cart or protocol "in December." Staff # 22 stated it was the hospital's plan to train everyone before the implementation of the policy/protocol. No reason was provided for the continued use and availability of succinylcholine without proper training, equipment and supply availability. The RN stated alternate medications were available for use, including non-triggering agents. (The offsite ED did not utilize or have available other triggering agents.)

The hospital policy "[DIAGNOSES REDACTED]" was presented. The policy was dated as having been reviewed on 11/2012. The policy was approved by the Director of Surgical Services and the Chief Nurse Executive (Staff # 37) but did not evidence approval by the Director of Emergency Services (Staff # 20 (off-site ED director), the Emergency Department Medical Director (Employee # 27), or the ED Nurse Manager (Employee # 22), the Director of Patient Care Management at the offsite ED (Staff # 21) or the onsite ED Director (Staff # 16). 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's. The policy included procedures to implement if a patient experienced a [DIAGNOSES REDACTED] crisis after the use of a triggering agent post surgery or anesthesia only. The policy stated: "...1. The anesthesiologist is in charge of crisis intervention." The policy directed a registered nurse to obtain the MH cart and to assist with the administration of Dantrolene should a patient exhibit signs of MH. The policy stated the dantrolene was located in the Operating room hyperthermia cart. The policy also directed the notification of the Operating room "front desk" to request additional assistance. The offsite ED did not have an operating room, and did not provide procedures specific to that area. The policy stated that all new employees would receive training related to [DIAGNOSES REDACTED] and would receive annual reviews. The facility staff did not conduct an initial or annual training related MH. No evidence
was presented that the training was conducted as directed by facility policy.

Hospital documentation and observation revealed that the medication was available, and was recently used- without the availability of the rescue drug dantrolene, refrigerated saline, or appropriate staff training. The succinylcholine was most recently accessed from the ED medication supply and administered to Patient #10 on 1/25/2013.

The Director of Pharmaceutical Services (Staff # 58) was interviewed on 1/31/2013 at 09:50 a.m. Staff # 58 stated he/she was aware the RIS kits provided to the outpatient ED by Pharmaceutical Services included the triggering agent succinylcholine. Staff # 58 stated the use of succinylcholine and all medications, was electronically documented. Staff # 58 stated that he/she became aware of the noted concern "weeks ago", as he/she was informed by a colleague by e-mail, of a similar concern at a competitor's free standing ED in December. Staff # 58 stated the concern was taken to the MUSIC (Medication Use Safety Improvement Committee) and the need for a MH cart at the off-site ED was determined.
Staff # 58 stated it was the decision of the "emergency room physicians" to continue the use of the triggering agency-succinylcholine, without the rescue drugs, policies or training. Staff # 58 stated it was determined to be "More risk for changing (to a non-triggering agent) than switching back"; "we hadn't thought of that, we associated that (MH crisis) with the inhalation agents, not injectable medications." Inhalation gases and other triggering agents were not on the off-site ED formulary. Staff # 58 stated he/she was a member of the Pharmaceutical and Therapy Committee (P&T), direction and coordination of drug dispersement and advisement of the medical staff related to medication information. Staff # 58 stated he/she had not informed the P&T Committee of the informal decision by the MUSIC.

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 to ensure patient safety.








Interviews conducted on January 29, 2013 from 3:18 p.m. to 3:40 p.m., with Staff #16, and Staff #34 reviewed the main campus Emergency Department (ED)'s [DIAGNOSES REDACTED] (MH) protocols and processes. Staff #16 reported the ED did utilize Succinylcholine as part of their rapid sequence intubation. Staff #16 reported the main campus ED utilized the MH cart, which belonged to the operating suites (OR). Staff #16 reported if an incident of MH was determined, the ED staff would notify the Nursing supervisor and he/she would obtain the MH cart from the OR. Staff #16 determined the distance from the OR to the ED was approximately "100 to 200 feet."

Observations and interviews conducted within the OR (hallway) on January 29, 2013 at 3:30 p.m. with Staff #16, Staff #34, Staff #54 and Staff #59 reviewed the contents of the OR's MH cart. Staff #59 opened the MH cart; the cart in part contained 36 vials of Dantrolene, four- 60 ml (milliliter) syringes, three- 20 ml syringes and four- 10 ml syringes, 20 needles and two- 1000 L (liter) bags of sterile water. Staff #59 reported the 60 ml of sterile water needed to reconstitute each of the 36 Dantrolene vials would be drawn from the two bags of sterile water. Staff #59 and Staff #16 with the surveyors calculated the 2000 L of sterile water would only reconstitute approximately 33 vials of Dantrolene. The diagram available for the use of the bags of sterile water outlined for the bags to be spiked with an intravenous line and the sterile water obtained from a port along the line. Staff #54 stated, "That diagram is outdated." Staff #54 and Staff #59 confirmed their MH book contained no other diagrams for utilizing the bags of sterile water. According to the supplies on hand within the MH cart, the cart did not contain enough sterile water to reconstitute the 36 vials of Dantrolene, there were only eleven syringes of which only four were 60 ml syringes nor enough needles to reconstitute 36 vials of Dantrolene. Staffs #16, #34, #54, #59 acknowledged the supplies on hand within the OR's MH cart were not sufficient to reconstitute even 33 vials of Dantrolene without re-using syringes and needles.
VIOLATION: VERBAL ORDERS AUTHENTICATED BASED ON LAW Tag No: A0457
Based on document review and interviews the facility failed to ensure verbal orders were authenticated within 48 hours for 1 of 31 patients, Patient #31.

The findings include:

On 2/1/13 the medical record of Patient #31 was reviewed with employee #4 present. The verbal orders written on 12/31/12 at 2145 and on 1/1/13 at 0300 were not authenticated by the physician who gave the orders.

Employee #4 stated, "The physicians are supposed to authenticate their orders within 48 hours."
VIOLATION: PHARMACIST RESPONSIBILITIES Tag No: A0492
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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 1/29/2013 at 2:55 p.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 (Pyxis system) was observed. The medication "succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter)", eight vials-were available for use. The ED's pharmaceutical inventory list did not evidence the presence of dantrolene, a medication used in the event of an adverse reaction to the succinylcholine-[DIAGNOSES REDACTED] (MH). The policy for the use and administration of succinylcholine was requested. The ED Nurse Manager was interviewed at the point of discovery and he/she stated it was approximately fifteen 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 (Staff # 22) stated the ED personnel were aware of the risk of [DIAGNOSES REDACTED] associated with the use of succinylcholine, yet did not have a MH ([DIAGNOSES REDACTED] cart) in place, did not have dantrolene on site and all employees did not have the required training. Staff # 22 stated the facility was waiting for all employees to be trained before implementing the policy regarding the use of triggering agents in the off-site ED. Staff # 22 stated the succinylcholine was available for current use. Review of hospital documentation revealed that a patient had received succinylcholine on 1/25/2013. The medication was currently available for use, and was used without the rescue agent Dantrolene, adequate staff training or equipment. The cart identified by the Nurse Manager (Staff # 22) was observed and did not contain any supplies. Staff # 22 stated the facility staff became aware of the issue and risk of having succinylcholine without a MH cart or protocol "in December." Staff # 22 stated it was the hospital's plan to train everyone before the implementation of the policy/protocol. No reason was provided for the continued use and availability of succinylcholine without proper training, equipment and supply availability. The RN stated alternate medications were available for use, including non-triggering agents. (The offsite ED did not utilize or have available other triggering agents.

The hospital policy "[DIAGNOSES REDACTED]" was presented. The policy was dated as having been reviewed on 11/2012. The policy was approved by the Director of Surgical Services and the Chief Nurse Executive (Staff # 37) but did not evidence approval by the Director of Emergency Services (Staff # 20 (off-site ED director), the Emergency Department Medical Director (Employee # 27), or the ED Nurse Manager (Employee # 22), the Director of Patient Care Management at the offsite ED (Staff # 21) or the onsite ED Director (Staff # 16). 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's. The policy included procedures to implement if a patient experienced a [DIAGNOSES REDACTED] crisis after the use of a triggering agent post surgery or anesthesia only. The policy stated: "...1. The anesthesiologist is in charge of crisis intervention." The policy directed a registered nurse to obtain the MH cart and to assist with the administration of Dantrolene should a patient exhibit signs of MH. The policy stated the dantrolene was located in the Operating room hyperthermia cart. The policy also directed the notification of the Operating room "front desk" to request additional assistance. The offsite ED did not have an operating room, and did not provide procedures specific to that area. The policy stated that all new employees would receive training related to [DIAGNOSES REDACTED] and would receive annual reviews. The facility staff did not conduct an initial or annual training related MH. No evidence
was presented that the training was conducted as directed by facility policy.

Hospital documentation and observation revealed that the medication was available, and was recently used- without the availability of the rescue drug dantrolene, refrigerated saline, or appropriate staff training. The succinylcholine was most recently accessed from the ED medication supply and administered to Patient #10 on 1/25/2013.

The Director of Pharmaceutical Services (Staff # 58) was interviewed on 1/31/2013 at 09:50 a.m. Staff # 58 stated he/she was aware the RIS kits provided to the outpatient ED by Pharmaceutical Services included the triggering agent succinylcholine. Staff # 58 stated the use of succinylcholine and all medications, was electronically documented. Staff # 58 stated that he/she became aware of the noted concern "weeks ago", as he/she was informed by a colleague by e-mail, of a similar concern at a competitor's free standing ED in December. Staff # 58 stated the concern was taken to the MUSIC (Medication Use Safety Improvement Committee) and the need for a MH cart at the off-site ED was determined. The MUSIC committee consisted of Staff # 58 (Director of Pharmaceutical Services) and the Medication Safety Officer. Staff # 58 stated that this meeting was informal and there was no documentation of the meeting or the discussion of a MH cart/succinylcholine use at the off-site ED. Staff # 58 stated the MUSIC "immediately realized we needed to document and educate and get the equipment (including a refrigerator and chilled fluids.). Staff # 58 stated the identified interventions started approximately four days after the MUSIC informal decision. Staff # 58 stated it was the decision of the "emergency room physicians" to continue the use of the triggering agency-succinylcholine, without the rescue drugs, policies or training. Staff # 58 stated it was determined to be "More risk for changing (to a non-triggering agent) than switching back"; "we hadn't thought of that, we associated that (MH crisis) with the inhalation agents, not injectable medications." Inhalation gases and other triggering agents were not on the off-site ED formulary. Staff # 58 stated he/she was a member of the Pharmaceutical and Therapy Committee (P&T), direction and coordination of drug dispersement and advisement of the medical staff related to medication information. Staff # 58 stated he/she had not informed the P&T Committee of the informal decision by the MUSIC.

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 P&T committee or medical staff executive aware of the presence of a potential medication adverse outcome.
VIOLATION: PATIENT RIGHTS: GRIEVANCES Tag No: A0118
A tour of the hospital Emergency Department and Obstetric Department was conducted on 1/29/13. A request for the information related to what is provided to each patient regarding the patient's rights was provided. The "What are your rights" information provided to each patient on admission was reviewed on 1/29 and 30/13. The information provided to patients had an incorrect address listed. Employee #12 stated, "We will get that corrected immediately."
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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 a medication readily available for administration-succinylcholine. This finding resulted in an Immediate Jeopardy finding by the State Agency on 01/29/2013 at 2:55 p.m. The immediacy of the situation was removed on 1/29/2013 at 6:18 p.m. as evidenced by a plan of action presented by the facility staff.

Findings:

On 1/29/2013 at 2:55 p.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 (Pyxis system) was observed. The medication "succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter)", eight vials-were available for use. The ED's pharmaceutical inventory list did not evidence the presence of dantrolene, a medication used in the event of an adverse reaction to the succinylcholine-[DIAGNOSES REDACTED] (MH). The policy for the use and administration of succinylcholine was requested. The ED Nurse Manager was interviewed at the point of discovery and he/she stated it was approximately fifteen 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 (Staff # 22) stated the ED personnel were aware of the risk of [DIAGNOSES REDACTED] associated with the use of succinylcholine, yet did not have a MH ([DIAGNOSES REDACTED] cart) in place, did not have dantrolene on site and all employees did not have the required training. Staff # 22 stated the facility was waiting for all employees to be trained before implementing the policy regarding the use of triggering agents in the off-site ED. Staff # 22 stated the succinylcholine was available for current use. Review of hospital documentation revealed that a patient had received succinylcholine on 1/25/2013. The medication was currently available for use, and was used without the rescue agent Dantrolene, adequate staff training or equipment. The cart identified by the Nurse Manager (Staff # 22) was observed and did not contain any supplies. Staff # 22 stated the facility staff became aware of the issue and risk of having succinylcholine without a MH cart or protocol "in December." Staff # 22 stated it was the hospital's plan to train everyone before the implementation of the policy/protocol. No reason was provided for the continued use and availability of succinylcholine without proper training, equipment and supply availability. The RN stated alternate medications were available for use, including non-triggering agents. (The offsite ED did not utilize or have available other triggering agents.

The hospital policy "[DIAGNOSES REDACTED]" was presented. The policy was dated as having been reviewed on 11/2012. The policy was approved by the Director of Surgical Services and the Chief Nurse Executive (Staff # 37) but did not evidence approval by the Director of Emergency Services (Staff # 20 (off-site ED director), the Emergency Department Medical Director (Employee # 27), or the ED Nurse Manager (Employee # 22), the Director of Patient Care Management at the offsite ED (Staff # 21) or the onsite ED Director (Staff # 16). 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's. The policy included procedures to implement if a patient experienced a [DIAGNOSES REDACTED] crisis after the use of a triggering agent post surgery or anesthesia only. The policy stated: "...1. The anesthesiologist is in charge of crisis intervention." The policy directed a registered nurse to obtain the MH cart and to assist with the administration of Dantrolene should a patient exhibit signs of MH. The policy stated the dantrolene was located in the Operating room hyperthermia cart. The policy also directed the notification of the Operating room "front desk" to request additional assistance. The offsite ED did not have an operating room, and did not provide procedures specific to that area. The policy stated that all new employees would receive training related to [DIAGNOSES REDACTED] and would receive annual reviews. The facility staff did not conduct an initial or annual training related MH. No evidence
was presented that the training was conducted as directed by facility policy.

Hospital documentation and observation revealed that the medication was available, and was recently used- without the availability of the rescue drug dantrolene, refrigerated saline, or appropriate staff training. The succinylcholine was most recently accessed from the ED medication supply and administered to Patient # 10 on 1/25/2013.

The Director of Pharmaceutical Services (Staff # 58) was interviewed on 1/31/2013 at 09:50 a.m. Staff # 58 stated he/she was aware the RIS kits provided to the outpatient ED by Pharmaceutical Services included the triggering agent succinylcholine. Staff # 58 stated the use of succinylcholine and all medications, was electronically documented. Staff # 58 stated that he/she became aware of the noted concern "weeks ago", as he/she was informed by a colleague by e-mail, of a similar concern at a competitor's free standing ED in December. Staff # 58 stated the concern was taken to the MUSIC (Medication Use Safety Improvement Committee) and the need for a MH cart at the off-site ED was determined. The MUSIC committee consisted of Staff # 58 (Director of Pharmaceutical Services) and the Medication Safety Officer. Staff # 58 stated that this meeting was informal and there was no documentation of the meeting or the discussion of a MH cart/succinylcholine use at the off-site ED. Staff # 58 stated the MUSIC "immediately realized we needed to document and educate and get the equipment (including a refrigerator and chilled fluids.). Staff # 58 stated the identified interventions started approximately four days after the MUSIC informal decision. Staff # 58 stated it was the decision of the "emergency room physicians" to continue the use of the triggering agency-succinylcholine, without the rescue drugs, policies or training. Staff # 58 stated it was determined to be "More risk for changing (to a non-triggering agent) than switching back"; "we hadn't thought of that, we associated that (MH crisis) with the inhalation agents, not injectable medications." Inhalation gases and other triggering agents were not on the off-site ED formulary. Staff # 58 stated he/she was a member of the Pharmaceutical and Therapy Committee (P&T), direction and coordination of drug dispersement and advisement of the medical staff related to medication information. Staff # 58 stated he/she had not informed the P&T Committee of the informal decision by the MUSIC.

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 P&T committee or medical staff executive aware of the presence of a potential medication adverse outcome.
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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, which was available for administration and had been recently utilized. The medication was not dispensed in a manner consistent with the standards of practice set forth by the [DIAGNOSES REDACTED] 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 1/29/2013 at 2:55 p.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 (Pyxis system) was observed. The medication "succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter)", eight vials-were available for use. The ED's pharmaceutical inventory list did not evidence the presence of dantrolene, a medication used in the event of an adverse reaction to the succinylcholine-[DIAGNOSES REDACTED] (MH). The policy for the use and administration of succinylcholine was requested. The ED Nurse Manager was interviewed at the point of discovery and he/she stated it was approximately fifteen 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 (Staff # 22) stated the ED personnel were aware of the risk of [DIAGNOSES REDACTED] associated with the use of succinylcholine, yet did not have a MH ([DIAGNOSES REDACTED] cart) in place, did not have dantrolene on site and all employees did not have the required training. Staff # 22 stated the facility was waiting for all employees to be trained before implementing the policy regarding the use of triggering agents in the off-site ED. Staff # 22 stated the succinylcholine was available for current use. Review of hospital documentation revealed that a patient had received succinylcholine on 1/25/2013. The medication was currently available for use, and was used without the rescue agent Dantrolene, adequate staff training or equipment. The cart identified by the Nurse Manager (Staff # 22) was observed and did not contain any supplies. Staff # 22 stated the facility staff became aware of the issue and risk of having succinylcholine without a MH cart or protocol "in December." Staff # 22 stated it was the hospital's plan to train everyone before the implementation of the policy/protocol. No reason was provided for the continued use and availability of succinylcholine without proper training, equipment and supply availability. The RN stated alternate medications were available for use, including non-triggering agents. (The offsite ED did not utilize or have available other triggering agents.

The hospital policy "[DIAGNOSES REDACTED]" was presented. The policy was dated as having been reviewed on 11/2012. The policy was approved by the Director of Surgical Services and the Chief Nurse Executive (Staff # 37) but did not evidence approval by the Director of Emergency Services (Staff # 20 (off-site ED director), the Emergency Department Medical Director (Employee # 27), or the ED Nurse Manager (Employee # 22), the Director of Patient Care Management at the offsite ED (Staff # 21) or the onsite ED Director (Staff # 16). 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's. The policy included procedures to implement if a patient experienced a [DIAGNOSES REDACTED] crisis after the use of a triggering agent post surgery or anesthesia only. The policy stated: "...1. The anesthesiologist is in charge of crisis intervention." The policy directed a registered nurse to obtain the MH cart and to assist with the administration of Dantrolene should a patient exhibit signs of MH. The policy stated the dantrolene was located in the Operating room hyperthermia cart. The policy also directed the notification of the Operating room "front desk" to request additional assistance. The offsite ED did not have an operating room, and did not provide procedures specific to that area. The policy stated that all new employees would receive training related to [DIAGNOSES REDACTED] and would receive annual reviews. The facility staff did not conduct an initial or annual training related MH. No evidence
was presented that the training was conducted as directed by facility policy.

Hospital documentation and observation revealed that the medication was available, and was recently used- without the availability of the rescue drug dantrolene, refrigerated saline, or appropriate staff training. The succinylcholine was most recently accessed from the ED medication supply and administered to Patient #10 on 1/25/2013.

The Director of Pharmaceutical Services (Staff # 58) was interviewed on 1/31/2013 at 09:50 a.m. Staff # 58 stated he/she was aware the RIS kits provided to the outpatient ED by Pharmaceutical Services included the triggering agent succinylcholine. Staff # 58 stated the use of succinylcholine and all medications, was electronically documented. Staff # 58 stated that he/she became aware of the noted concern "weeks ago", as he/she was informed by a colleague by e-mail, of a similar concern at a competitor's free standing ED in December. Staff # 58 stated the concern was taken to the MUSIC (Medication Use Safety Improvement Committee) and the need for a MH cart at the off-site ED was determined. The MUSIC committee consisted of Staff # 58 (Director of Pharmaceutical Services) and the Medication Safety Officer. Staff # 58 stated that this meeting was informal and there was no documentation of the meeting or the discussion of a MH cart/succinylcholine use at the off-site ED. Staff # 58 stated the MUSIC "immediately realized we needed to document and educate and get the equipment (including a refrigerator and chilled fluids.). Staff # 58 stated the identified interventions started approximately four days after the MUSIC informal decision. Staff # 58 stated it was the decision of the "emergency room physicians" to continue the use of the triggering agency-succinylcholine, without the rescue drugs, policies or training. Staff # 58 stated it was determined to be "More risk for changing (to a non-triggering agent) than switching back"; "we hadn't thought of that, we associated that (MH crisis) with the inhalation agents, not injectable medications." Inhalation gases and other triggering agents were not on the off-site ED formulary. Staff # 58 stated he/she was a member of the Pharmaceutical and Therapy Committee (P&T), direction and coordination of drug dispersement and advisement of the medical staff related to medication information. Staff # 58 stated he/she had not informed the P&T Committee of the informal decision by the MUSIC.

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 P&T committee or medical staff executive aware of the presence of a potential medication adverse outcome.

According to an article by MHAUS ([DIAGNOSES REDACTED] Association of the United States) drugs, which trigger [DIAGNOSES REDACTED] (MH) include "...volatile gaseous inhalation anesthetics..." and "succinylcholine" a "depolarizing muscle relaxant." MHAUS directs that "... MHC ([DIAGNOSES REDACTED] 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]"
VIOLATION: EMERGENCY SERVICES POLICIES Tag No: A1104
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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 1/29/2013 at 2:55 p.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 (Pyxis system) was observed. The medication "succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter)", eight vials-were available for use. The ED's pharmaceutical inventory list did not evidence the presence of dantrolene, a medication used in the event of an adverse reaction to the succinylcholine-[DIAGNOSES REDACTED] (MH). The policy for the use and administration of succinylcholine was requested. The ED Nurse Manager was interviewed at the point of discovery and he/she stated it was approximately fifteen 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 (Staff # 22) stated the ED personnel were aware of the risk of [DIAGNOSES REDACTED] associated with the use of succinylcholine, yet did not have a MH ([DIAGNOSES REDACTED] cart) in place, did not have dantrolene on site and all employees did not have the required training. Staff # 22 stated the facility was waiting for all employees to be trained before implementing the policy regarding the use of triggering agents in the off-site ED. Staff # 22 stated the succinylcholine was available for current use. Review of hospital documentation revealed that a patient had received succinylcholine on 1/25/2013. The medication was currently available for use, and was used without the rescue agent Dantrolene, adequate staff training or equipment. The cart identified by the Nurse Manager (Staff # 22) was observed and did not contain any supplies. Staff # 22 stated the facility staff became aware of the issue and risk of having succinylcholine without a MH cart or protocol "in December." Staff # 22 stated it was the hospital's plan to train everyone before the implementation of the policy/protocol. No reason was provided for the continued use and availability of succinylcholine without proper training, equipment and supply availability. The RN stated alternate medications were available for use, including non-triggering agents. (The offsite ED did not utilize or have available other triggering agents.

The hospital policy "[DIAGNOSES REDACTED]" was presented. The policy was dated as having been reviewed on 11/2012. The policy was approved by the Director of Surgical Services and the Chief Nurse Executive (Staff # 37) but did not evidence approval by the Director of Emergency Services (Staff # 20 (off-site ED director), the Emergency Department Medical Director (Employee # 27), or the ED Nurse Manager (Employee # 22), the Director of Patient Care Management at the offsite ED (Staff # 21) or the onsite ED Director (Staff # 16). 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's. The policy included procedures to implement if a patient experienced a [DIAGNOSES REDACTED] crisis after the use of a triggering agent post surgery or anesthesia only. The policy stated: "...1. The anesthesiologist is in charge of crisis intervention." The policy directed a registered nurse to obtain the MH cart and to assist with the administration of Dantrolene should a patient exhibit signs of MH. The policy stated the dantrolene was located in the Operating room hyperthermia cart. The policy also directed the notification of the Operating room "front desk" to request additional assistance. The offsite ED did not have an operating room, and did not provide procedures specific to that area. The policy stated that all new employees would receive training related to [DIAGNOSES REDACTED] and would receive annual reviews. The facility staff did not conduct an initial or annual training related MH. No evidence
was presented that the training was conducted as directed by facility policy.

Hospital documentation and observation revealed that the medication was available, and was recently used- without the availability of the rescue drug dantrolene, refrigerated saline, or appropriate staff training. The succinylcholine was most recently accessed from the ED medication supply and administered to Patient #10 on 1/25/2013.

The Director of Pharmaceutical Services (Staff # 58) was interviewed on 1/31/2013 at 09:50 a.m. Staff # 58 stated he/she was aware the RIS kits provided to the outpatient ED by Pharmaceutical Services included the triggering agent succinylcholine. Staff # 58 stated the use of succinylcholine and all medications, was electronically documented. Staff # 58 stated that he/she became aware of the noted concern "weeks ago", as he/she was informed by a colleague by e-mail, of a similar concern at a competitor's free standing ED in December. Staff # 58 stated the concern was taken to the MUSIC (Medication Use Safety Improvement Committee) and the need for a MH cart at the off-site ED was determined. Staff # 58 stated it was the decision of the "emergency room physicians" to continue the use of the triggering agency-succinylcholine, without the rescue drugs, policies or training. Staff # 58 stated it was determined to be "More risk for changing (to a non-triggering agent) than switching back"; "we hadn't thought of that, we associated that (MH crisis) with the inhalation agents, not injectable medications." Inhalation gases and other triggering agents were not on the off-site ED formulary.

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.