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.

BON SECOURS MARYVIEW MEDICAL CENTER 3636 HIGH STREET PORTSMOUTH, VA 23707 Feb. 22, 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 February 19, 2013 at 3:45 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 2 vials of the medication succinylcholine and 1 vial each in 2 RSI (rapid sequence intubation) kits 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."
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on document review and interview the facility failed to ensure the patient's and/or the patient representative's rights regarding informed consent for treatments and transfer were upheld for three of twelve transferred patients included in the survey sample. (Patients #20, Patient #13, and Patient #14)

The findings included:

1. Patient #20 the facility failed to obtain and document appropriate consent for treatment. The facility failed to obtain informed consent from Patient #20's representative prior to transferring the patient to another facility. Patient #20 was admitted to the facility on [DATE] for altered mental status. The facility staff presented a consent for emergency treatment signed by the patient without a date or time. Patient #20's electronic medical record (EMR) included a transfer form with a handwritten notation "Pt (patient) unable to sign."

Patient #20's EMR revealed a nursing entry dated 01/28/2013 at 2:26 p.m., which read in part, "...speech incomprehensible--does not follow commands. [Son/daughter] at bedside and states '[he/she] wasn't really responding yesterday but today is worse'." A physician notation at 5:00 p.m., read in part "... [Son/daughter] reports ... Patient is normally confused due to a history of dementia and lives with [sons/daughters] ... Today the patient's decrease in responsiveness has worsened ..." The physician noted during the patient's neurological exam the patient was "not cooperating."

A physician's entry for "Critical Care" read in part "progressive altered loc (level of consciousness) with history of dementia. sah (subarachnoid hemorrhage) with [DIAGNOSES REDACTED] on ct scan [sic] ... discussed with family and with their concurrence elected to intubate for airway protection ... Verbal consent ...given by power of attorney..."

An interview was conducted during the review of Patient #20's EMR on 02/20/2013 at 12:05 p.m., with Staff #1. Staff #1 reported verbal consent did not need the documentation of a witness related to the patient's consent for treatment signed on admission to the emergency department. Staff #1
acknowledged Patient #20's "Authorization for Treatment" was not part of the patient's EMR as of 02/20/2013.

During the interview on 02/20/2013 at 12:05 p.m., Staff #1 reviewed Patient #20's "Transfer Certificate" dated "1/28/13". Staff #1 acknowledged the section, which read: "I understand the risks and benefits of my transfer. I hereby CONSENT to transfer [sic]: Patient signature or signature of responsible person on behalf of patient" had not been signed. Staff #1 stated, "If the family was present, the nurse should have had ensured [Patient #20's name] family members were aware of the risks and benefits of transfer and signed the form and not just wrote in the patient was unable to sign."

On 02/21/2013 at approximately 1:44 p.m., Staff #1 presented a copy of Patient #20's "Authorization for Treatment." Staff #1 acknowledged the form indicated Patient #20 had signed the form. Staff #1 reported the "Authorization for Treatment" did not provide evidence it had been signed by the patient's representative. Staff #1 reported someone with altered mental status should not sign "Authorization for Treatment." Staff #1 acknowledged the facility staff failed to ensure there was documented proof Patient #20's family was aware of the risks and benefits in order to make an informed consent for transfer.

2. Patient #13 was transferred from the facility's freestanding emergency department (ED) to the main hospital campus for treatment. Patient #13's EMR did not contain documentation regarding the risks and benefits of transfer/transport to the main campus. Patient #13's EMR did not have documentation the facility staff had discussed the transfer/transport with the patient.

An interview was conducted on 02/20/2013 at 11:43 a.m., with Staff #4 during the review of Patient #13's EMR. Staff #4 reported the facility did not consider transporting a patient from the freestanding ED to the main campus as a transfer. Staff #4 reported Patient #13's EMR did not contain evidence the staff had discussed and documented the risks or benefits of "transporting" the patient to the hospital's main campus. Staff #4 verbally agreed the potential risks for the worsening of condition or motor vehicle crash were similar to a transfer of a patient to another facility. Patient #13's EMR did not contain documentation that the patient understood the reasons, risks and benefits related to his/her "transport" to the main hospital campus.

3. Patient #14 was transferred from the facility's freestanding emergency department (ED) to the main hospital campus for treatment. Patient #14's EMR did not contain documentation regarding the risks and benefits of transfer/transport to the main campus. Patient #14's EMR did not have documentation the facility staff had discussed the transfer/transport with the patient.

An interview was conducted on 02/20/2013 at 1:31 p.m., with Staff #4 during the review of Patient #14's EMR. Staff #4 reported Patient #14's EMR did not contain evidence the staff had discussed and documented the risks or benefits of "transporting" the patient to the hospital's main campus. Staff #4 stated, "I'm sure the discussion occurs, but there is no documentation." Staff #4 verbally agreed without documentation that the patient understood the discussion surrounding the risk, benefits and reasons, informed consent for transfer/transport.

Review of the facility's policy "Informed Consent/Informed Refusal" read in part "... Purpose: To assure that patients and their surrogate decision-makers are fully informed as to the expected benefits, risks, consequences, and any alternative treatment or procedures that are medically-indicated and available for treatment of their condition ... IV. Informed Written Consent: Patient rights include, but are not limited to, the opportunity to be informed and to receive from and discuss with their physician the following: ... H. Acknowledgement of the patient or surrogate decision-maker's understanding of the explanation of the proposed treatment and the opportunity to ask questions and have their questions answered in a manner that they understand ..."
VIOLATION: PATIENT RIGHTS: PRIVACY AND SAFETY Tag No: A0142
Based on observations, interviews and document reviews the facility staff failed to protect 1 of 26 patients (Patient #1) privacy and safety. A page of labels with Patient #1's name, date of birth, sex, social security number and date of service was found under a gurney mattress in the Emergency Department (ED).

The findings include:

On 2/19/13 an initial tour of the ED was conducted at approximately 10:40 A.M. with the Director of Nursing (DON) and ED charge nurse. During the inspection of the gurney mattress in Bay 8 for tears and cleanliness a page of labels that was approximately 3/4 full was found. The labels contained Patient #1's name, date of birth, sex, social security number and date of service. Patient #1 had last been in the ED on 2/9/13 (10 days prior to the inspection). The labels were picked up by the ED charge nurse and immediately placed in the locked cabinet of papers to be shredded. The ED charge nurse acknowledged which patient the labels identified. Also under the mattress gurney was a blood pressure cuff. The ED charge nurse stated, "Those things shouldn't be there."

A copy of the facilitiy's policy "Uses and Disclosure of Protected Health Information" was provided by the facility staff. The policy defines Protected Health Information (PHI) as individually identifialble health information...

Employee #18 was interviewed regarding the cleaning of mattresses on the gurneys. Employee #18 stated, "It is everyone's responsibility to ensure the gurneys and mattresses are cleaned between each patient. The environmental department then takes each gurney and mattress and clean them from top to bottom every 7 days."
VIOLATION: PATIENT RIGHTS: PERSONAL PRIVACY Tag No: A0143
Based on observations, interviews and document reviews the facility staff failed to protect 1 of 26 patients (Patient #1) personal privacy. A page of labels with Patient #1's name, date of birth, sex, social security number and date of service was found under a gurney mattress in the Emergency Department (ED).

The findings include:

On 2/19/13 an initial tour of the ED was conducted at approximately 10:40 A.M. with the Director of Nursing (DON) and ED charge nurse. During the inspection of the gurney mattress in Bay 8 for tears and cleanliness a page of labels that was approximately 3/4 full was found. The labels contained Patient #1's name, date of birth, sex, social security number and date of service. Patient #1 had last been in the ED on 2/9/13 (10 days prior to the inspection). The labels were picked up by the ED charge nurse and immediately placed in the locked cabinet of papers to be shredded. The ED charge nurse acknowledged which patient the labels identified. Also under the mattress gurney was a blood pressure cuff. The ED charge nurse stated, "Those things shouldn't be there."

A copy of the facilitiy's policy "Uses and Disclosure of Protected Health Information" was provided by the facility staff. The policy defines Protected Health Information (PHI) as individually identifialble health information...

Employee #18 was interviewed regarding the cleaning of mattresses on the gurneys. Employee #18 stated, "It is everyone's responsibility to ensure the gurneys and mattresses are cleaned between each patient. The environmental department then takes each gurney and mattress and clean them from top to bottom every 7 days."
VIOLATION: FORM AND RETENTION OF RECORDS Tag No: A0438
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

2. The facility failed to ensure the "Transfer Certificates" for three of ten patients transferred to an outside facility. (Patients #16, #19 and #20)

a. Patient #16 was admitted to the facility's Emergency department (ED) on 01/31/2013 related to nasal septal hematoma. Patient #16's electronic medical record (EMR) indicated the patient was transferred related to "Services and equipment not available." The physician documented Patient #16 had been accepted at another local hospital.

Review of Patient #16's "Transfer Certificate" documented under accepting hospital "None" and under accepting representative "none."

An interview conducted on 02/20/2013 at 12:18 p.m., with Staff #1 and Staff #4. Staff #4 reviewed Patient #16's EMR and "Transfer Certificate" with the surveyor. Staff #4 reported the staff failed to accurately complete the "Transfer Certificate."


b. Patient #19 was admitted to the facility's Emergency department (ED) on 01/31/2013 related to a bleeding dialysis fistula. Patient #19's EMR revealed the ED physician consulted with vascular surgery. Patient #19's vascular surgeon requested the patient be transferred to another local hospital. Review of Patient #19's "Transfer Certificate" under the section related to the "Benefit" of transfer listed "Service unavailable."

An interview was conducted on 02/20/2013 at 1:16 p.m., Staff #4 during the review of Patient #19's EMR. Staff #4 stated, "That's not true, we did have services available. It was [Name of Patient #19]'s surgeon that requested the transfer." Staff #4 verbally acknowledged Patient #19's "Transfer Certificate" was incorrect.


c. Patient #20 admitted to the facility's ED on 01/28/2013 for altered mental status changes. Patient #20's EMR included a CT (computer tomography) scan, which indicated the patient had a "subarachnoid hemorrhage with [DIAGNOSES REDACTED]."

A physician's entry for "Critical Care" read in part "progressive altered loc (level of consciousness) with history of dementia. sah (subarachnoid hemorrhage) with [DIAGNOSES REDACTED] on ct scan [sic] ... discussed with family and with their concurrence elected to intubate for airway protection ... Verbal consent ...given by power of attorney..."

Patient #20 was transferred to a local hospital, which could provide a higher level of care. Review of the Transfer Certificate's revealed a section, which read: "I understand the risks and benefits of my transfer. I hereby CONSENT to transfer [sic]: Patient signature or signature of responsible person on behalf of patient." Patient #20's "Transfer Certificate" had a handwritten notation "Pt (patient) unable to sign." The facility staff failed to ensure Patient #20's "Transfer Certificate" had been acknowledged and signed by the patient's family member, who was present and making decisions for the patient's care/treatment.

An interview conducted on 02/20/2013 at 12:05 p.m., Staff #1 reviewed Patient #20's "Transfer Certificate" dated "1/28/13". Staff #1 acknowledged staff should have had Patient #20's family member sign the "Transfer Consent." Staff #1 reported although the patient was unable to sign, the patient's family member was actively making care and treatment decisions.








Based on observations, document review and interviews the facility staff failed to ensure the medical records for 5 of 26 patients (Patients # 10, #11, #16, #19 and #20) were complete. Two Patient's (#10 and #11) medical records were missing the EMS (Emergency Medical System) run sheets. The run sheets are documentation of what medical interventions were provided by the emergency medical staff in the field prior to the patient arriving at the hospital. The facility staff also failed to ensure the "Transfer Certificates" for three of ten patients transferred to an outside facility (Patients #16, #19 and #20).



The findings include:

1. A review of Patient #10 medical record was conducted on 2/20/13 and revealed the following information:
Patient #10 was an [AGE] year old who was treated on 2/11/13 after being found at home on the floor. The medical record section titled "Tx Prior to Arrival" Date and Time: 2/11/13 and 0819; Treatment given by: EMS (see ambulance sheet): Interventions: IV. The ambulance or EMS run sheet was not found in the medical record.

Patient #11's medical record was reviewed on 2/20/13 and revealed the following information:
Patient #11 was a [AGE] year old treated on 2/15/13 for convulsions. The medical record did not contain an EMS run sheet for 2/15/13 when Patient #11 was transported to the hospital.

Employee #8 was interviewed on 2/20/13 at approximately 9:45 A.M. and stated, "We sometimes have difficulty getting the run sheets from the ambulance crews. They are supposed to leave either an abbreviated report on the actual run sheet."

Employee #3 provided a copy of the regulations (12VAC-31-1140) the EMS staff are to follow which states the EMS personnel and EMS agencies shall provide the receiving medical facility or transporting EMS agency with a copy of the prehospital patient care report for each patient treated at the time of patient transfer. Should EMS personnel be unable to provide the full prehospital patient care report at the time of patient transfer, EMS personnel shall provide an abbreviated documented report with the critical EMS findings and actions at the time of patient transfer and full prehospital patient care report shall be provided to the accepting facility within 12 hours.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interviews and document 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 2/19/13 at 4:55 P.M. The immediacy of the situation was removed on 2/19/13 at 6:00 P.M. as evidenced by the removal of medications in the offsite ED.

The findings include:

On 2/19/13 at 3:45 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 (an automated medication dispensing system supporting decentralized medication management)) was observed. The Pyxis contained 2 RSI (rapid sequence intubation) kits which contained one vial of succinylcholine chloride 200 mg/10 ml (milligrams per milliliter). The medication refrigerator also contained 2 vials of succinylcholine chloride. The 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).

On 2/19/13 at approximately 4:10 P.M. Employee #4 was asked how they would treat a case of MH. Employee #4 stated, "I would go to our manual." Employee #4 proceed to a section of the nurses' station that housed several notebooks with various types of information. Employee #4 stated, "It is not here so I would use our Lippincott reference book." Employee #4 proceed to an office down the hallway from the nurses' station and returned stating, "The book is gone. I would then look it up on the computer." In total 3.5 minutes had past once Employee #4 began the computer search. Employee #4 then stated I would call (Name of hospital facility) and ask them. If we need dantrolene I would have them bring it to us."

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."

Per MapQuest. com the hospital is 13 minutes away from the offsite ED.

Employee #4 then stated, "We are going to remove the succinylcholine from our offsite ED."

On 2/21/13 Employee #3 provided a printout from Lippincott Williams & Wilkins "[DIAGNOSES REDACTED] Patient Care, PACU; October 6, 2012"

The printout stated "[DIAGNOSES REDACTED] (MH) is serious genetic, and potentially life threatening condition. It's characterized by a hypermetabolic state and rigidity of the skeletal muscles, and is triggered by several common inhaled anesthetic agents and some muscle relaxants. Unsafe drugs for MH-susceptible (MHS) patients are succinylcholine (Quelicin), sevoflurane (Ultane), desflurane (Suprane), isoflurane (Forane), and enflurane (Ethrane). Safe drugs for use in MHS patients include local and regional anesthesia, and IV drugs such as propofol, barbiturates, benzodiazepines, ketamine, droperidol, and edomidate. Nitrous oxide also is safe.

MH can occur during induction of anesthesia, during maintenance, or postoperatively in the patient who's susceptible. The tine it takes for symptoms of [DIAGNOSES REDACTED]"

This medication (succinylcholine) was available for administration in the outpatient ED since at least August 31, 2012. The hospital staff could not determine the original date of availability.

On 2/19/13 at 4:55 P.M. Employee #4 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 6:00 P.M. to include the observed removal of medications at the offsite ED by the pharmacist.

Employee #15 was interviewed on 2/21/13 at approximately 10:43 A.M. He stated, "I am the PIC (Pharmacist in Charge) for (Name of hospital and Name of offsite ED). I knew the succinylcholine was in the RSI kits. It is standard in all our RSI kits. Anesthesia assisted us in putting the kits together and we standardized the contents of the RSI kits. I did not know there were 2 loose vials in the Pyxis refrigerator. Those would be virtual kits (all the same medications found in the kit but in the Pyxis individually). Therefore we had 4 RSI kits available for use. Originally we did not have the RSI kits at (Name of offsite ED). Someone had to request it (the kit).

If the succinylcholine is not refrigerated it has a short shelf life. Anesthesia likes it (succinylcholine) because it has a short half life.

I was not aware dantrolene was not available. MH was not a disease in the top of my mind. I have been employed here 10 years. Originally the (offsite) ED was a part of the Ambulatory Surgical Center (ASC). Dantrolene is available in the ASC. The ASC spun off and no one connected the dots. We don't have access to the dantrolene now."

The Pyxis report dated 2/19/13 showed a discrepancy on 2/18/13 of the amount of succinylcholine available for use. The report noted one available and 2 were in the Pyxis refrigerator. Employee #15 stated, "I don't know why there is a discrepancy."

Employee #15 provided a copy of the High Alert Medications (HAM) last revised on 3/13/12. The policy states, "A list of High Alert Medications (HAMs) will be reviewed annually by the P&T (pharmacy and therapeutic) Committee based on national literature and the potential for causing harm. These medications will be stored separately from other medications and clearly labeled as HAMs....PROCEDURE: I. The following list of High Alert Medications may be easily identifiable by the acronym of GOPPINNCCHMS:
G General Anesthetics
O Oral hypoglycemics
P Potassium infusions
P Pitocin infusions and injections
I Insulin infusions and injections
N Narcotic infusions
N Neuromuscular Blocking Agents (Employee #15 stated, "This is succinylcholine.")....

II. The pharmacy will clearly distinguish the above medications through labeling, and trend data associated with their use....
VIOLATION: PHARMACIST RESPONSIBILITIES Tag No: A0492
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interviews and document review, the hospital's Pharmaceutical services failed to ensure the development, supervision and coordination of 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 2/19/13 at 4:55 P.M. The immediacy of the situation was removed on 2/19/13 at 6:00 P.M. as evidenced by the removal of medications in the offsite ED.

The findings include:

On 2/19/13 at 3:45 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 (an automated medication dispensing system supporting decentralized medication management)) was observed. The Pyxis contained 2 RSI (rapid sequence intubation) kits which contained one vial of succinylcholine chloride 200 mg/10 ml (milligrams per milliliter). The medication refrigerator also contained 2 vials of succinylcholine chloride. The 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).

On 2/19/13 at approximately 4:10 P.M. Employee #4 was asked how they would treat a case of MH. Employee #4 stated, "I would go to our manual." Employee #4 proceed to a section of the nurses' station that housed several notebooks with various types of information. Employee #4 stated, "It is not here so I would use our Lippincott reference book." Employee #4 proceed to an office down the hallway from the nurses' station and returned stating, "The book is gone. I would then look it up on the computer." In total 3.5 minutes had past once Employee #4 began the computer search. Employee #4 then stated I would call (Name of hospital facility) and ask them. If we need dantrolene I would have them bring it to us."

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."

Per MapQuest. com the hospital is 13 minutes away from the offsite ED.

Employee #4 then stated, "We are going to remove the succinylcholine from our offsite ED."

On 2/21/13 Employee #3 provided a printout from Lippincott Williams & Wilkins "[DIAGNOSES REDACTED] Patient Care, PACU; October 6, 2012"

The printout stated "[DIAGNOSES REDACTED] (MH) is serious genetic, and potentially life threatening condition. It's characterized by a hypermetabolic state and rigidity of the skeletal muscles, and is triggered by several common inhaled anesthetic agents and some muscle relaxants. Unsafe drugs for MH-susceptible (MHS) patients are succinylcholine (Quelicin), sevoflurane (Ultane), desflurane (Suprane), isoflurane (Forane), and enflurane (Ethrane). Safe drugs for use in MHS patients include local and regional anesthesia, and IV drugs such as propofol, barbiturates, benzodiazepines, ketamine, droperidol, and edomidate. Nitrous oxide also is safe.

MH can occur during induction of anesthesia, during maintenance, or postoperatively in the patient who's susceptible. The tine it takes for symptoms of [DIAGNOSES REDACTED]"

This medication (succinylcholine) was available for administration in the outpatient ED since at least August 31, 2012. The hospital staff could not determine the original date of availability.

On 2/19/13 at 4:55 P.M. Employee #4 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 6:00 P.M. to include the observed removal of medications at the offsite ED by the pharmacist.

Employee #15 was interviewed on 2/21/13 at approximately 10:43 A.M. He stated, "I am the PIC (Pharmacist in Charge) for (Name of hospital and Name of offsite ED). I knew the succinylcholine was in the RSI kits. It is standard in all our RSI kits. Anesthesia assisted us in putting the kits together and we standardized the contents of the RSI kits. I did not know there were 2 loose vials in the Pyxis refrigerator. Those would be virtual kits (all the same medications found in the kit but in the Pyxis individually). Therefore we had 4 RSI kits available for use. Originally we did not have the RSI kits at (Name of offsite ED). Someone had to request it (the kit).

If the succinylcholine is not refrigerated it has a short shelf life. Anesthesia likes it (succinylcholine) because it has a short half life.

I was not aware dantrolene was not available. MH was not a disease in the top of my mind. I have been employed here 10 years. Originally the (offsite) ED was a part of the Ambulatory Surgical Center (ASC). Dantrolene is available in the ASC. The ASC spun off and no one connected the dots. We don't have access to the dantrolene now."

The Pyxis report dated 2/19/13 showed a discrepancy on 2/18/13 of the amount of succinylcholine available for use. The report noted one available and 2 were in the Pyxis refrigerator. Employee #15 stated, "I don't know why there is a discrepancy."

Employee #15 provided a copy of the High Alert Medications (HAM) last revised on 3/13/12. The policy states, "A list of High Alert Medications (HAMs) will be reviewed annually by the P&T (pharmacy and therapeutic) Committee based on national literature and the potential for causing harm. These medications will be stored separately from other medications and clearly labeled as HAMs....PROCEDURE: I. The following list of High Alert Medications may be easily identifiable by the acronym of GOPPINNCCHMS:
G General Anesthetics
O Oral hypoglycemics
P Potassium infusions
P Pitocin infusions and injections
I Insulin infusions and injections
N Narcotic infusions
N Neuromuscular Blocking Agents (Employee #15 stated, "This is succinylcholine.")....

II. The pharmacy will clearly distinguish the above medications through labeling, and trend data associated with their use....
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interviews and document review, the hospital's Pharmaceutical services failed to ensure medications dispensed that could potentially harm patients also had the medication to counteract the reaction(s) were also dispensed sufficiently 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 2/19/13 at 4:55 P.M. The immediacy of the situation was removed on 2/19/13 at 6:00 P.M. as evidenced by the removal of medications in the offsite ED.

The findings include:

On 2/19/13 at 3:45 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 (an automated medication dispensing system supporting decentralized medication management)) was observed. The Pyxis contained 2 RSI (rapid sequence intubation) kits which contained one vial of succinylcholine chloride 200 mg/10 ml (milligrams per milliliter). The medication refrigerator also contained 2 vials of succinylcholine chloride. The 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).

On 2/19/13 at approximately 4:10 P.M. Employee #4 was asked how they would treat a case of MH. Employee #4 stated, "I would go to our manual." Employee #4 proceed to a section of the nurses' station that housed several notebooks with various types of information. Employee #4 stated, "It is not here so I would use our Lippincott reference book." Employee #4 proceed to an office down the hallway from the nurses' station and returned stating, "The book is gone. I would then look it up on the computer." In total 3.5 minutes had past once Employee #4 began the computer search. Employee #4 then stated I would call (Name of hospital facility) and ask them. If we need dantrolene I would have them bring it to us."

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."

Per MapQuest. com the hospital is 13 minutes away from the offsite ED.

Employee #4 then stated, "We are going to remove the succinylcholine from our offsite ED."

On 2/21/13 Employee #3 provided a printout from Lippincott Williams & Wilkins "[DIAGNOSES REDACTED] Patient Care, PACU; October 6, 2012"

The printout stated "[DIAGNOSES REDACTED] (MH) is serious genetic, and potentially life threatening condition. It's characterized by a hypermetabolic state and rigidity of the skeletal muscles, and is triggered by several common inhaled anesthetic agents and some muscle relaxants. Unsafe drugs for MH-susceptible (MHS) patients are succinylcholine (Quelicin), sevoflurane (Ultane), desflurane (Suprane), isoflurane (Forane), and enflurane (Ethrane). Safe drugs for use in MHS patients include local and regional anesthesia, and IV drugs such as propofol, barbiturates, benzodiazepines, ketamine, droperidol, and edomidate. Nitrous oxide also is safe.

MH can occur during induction of anesthesia, during maintenance, or postoperatively in the patient who's susceptible. The tine it takes for symptoms of [DIAGNOSES REDACTED]"

This medication (succinylcholine) was available for administration in the outpatient ED since at least August 31, 2012. The hospital staff could not determine the original date of availability.

On 2/19/13 at 4:55 P.M. Employee #4 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 6:00 P.M. to include the observed removal of medications at the offsite ED by the pharmacist.

Employee #15 was interviewed on 2/21/13 at approximately 10:43 A.M. He stated, "I am the PIC (Pharmacist in Charge) for (Name of hospital and Name of offsite ED). I knew the succinylcholine was in the RSI kits. It is standard in all our RSI kits. Anesthesia assisted us in putting the kits together and we standardized the contents of the RSI kits. I did not know there were 2 loose vials in the Pyxis refrigerator. Those would be virtual kits (all the same medications found in the kit but in the Pyxis individually). Therefore we had 4 RSI kits available for use. Originally we did not have the RSI kits at (Name of offsite ED). Someone had to request it (the kit).

If the succinylcholine is not refrigerated it has a short shelf life. Anesthesia likes it (succinylcholine) because it has a short half life.

I was not aware dantrolene was not available. MH was not a disease in the top of my mind. I have been employed here 10 years. Originally the (offsite) ED was a part of the Ambulatory Surgical Center (ASC). Dantrolene is available in the ASC. The ASC spun off and no one connected the dots. We don't have access to the dantrolene now."

The Pyxis report dated 2/19/13 showed a discrepancy on 2/18/13 of the amount of succinylcholine available for use. The report noted one available and 2 were in the Pyxis refrigerator. Employee #15 stated, "I don't know why there is a discrepancy."

Employee #15 provided a copy of the High Alert Medications (HAM) last revised on 3/13/12. The policy states, "A list of High Alert Medications (HAMs) will be reviewed annually by the P&T (pharmacy and therapeutic) Committee based on national literature and the potential for causing harm. These medications will be stored separately from other medications and clearly labeled as HAMs....PROCEDURE: I. The following list of High Alert Medications may be easily identifiable by the acronym of GOPPINNCCHMS:
G General Anesthetics
O Oral hypoglycemics
P Potassium infusions
P Pitocin infusions and injections
I Insulin infusions and injections
N Narcotic infusions
N Neuromuscular Blocking Agents (Employee #15 stated, "This is succinylcholine.")....

II. The pharmacy will clearly distinguish the above medications through labeling, and trend data associated with their use....
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observations, interviews and document reviews the facility staff failed to
ensure medical equipment and supplies were maintained by checking the crash carts, defibrillators, intubation boxes and emergency transport boxes on a daily basis per their policy.

The findings include:

On 2/19/13 at approximately 11:20 A. M during the initial tour of the Emergency Department (ED) with Employee #1 and #9 the crash cart and defibrillator "Hall By 21" was inspected. The test strip from the defibrillator noted the date of 2/15/13 indicating the last date it was checked. The equipment log book was asked for and reviewed by the surveyor with Employee #9.

The log book indicated the crash cart and defibrillator labeled "Hall By 21" was checked on 2/2/13, 2/3/13, 2/7/13 and 2/15/13. Fourteen (14) days had no documentation that the crash cart and defibrillator had been checked.

The ED had 2 additional emergency equipment carts one labeled Bed 1&2 and another labeled Bed 3&4. The log book for these defibrillators was reviewed and the following was noted. The defibrillator for Bed 1&2 had checks performed on 2/2,3,6,7,11,15/13. There were 12 days with no documentation that the defibrillator had been checked. The defibrillator for Bed 3&4 had checks performed on 2/2,3,6,7,11,15/13. There were 12 days with no documentation that the defibrillator had been checked.

The log books for the Pneumothorax Kit Checklist, External Pacemaker Checklist, Adult Internal Defibrillator Checklist, Pediatric Internal Defibrillator Checklist, Pediatric Broselow Cart Checklist and the Airway Cart Checklist logs were also reviewed and revealed the following:
Pneumothorax Kit Checklist: Checked on 2/2, 3, 6, 7, 11, 15/13; 12 with no documentation the cart had been checked.
External Pacemaker Checklist: Checked on 2/2, 3, 6, 7, 11, 15/13; 12 with no documentation the cart had been checked.
Adult Internal Defibrillator Checklist: Checked on 2/2, 3, 6, 7, 11, 15/13; 12 with no documentation the cart had been checked.
Pediatric Internal Defibrillator Checklist: Checked on 2/2, 3, 6, 7, 15/13; 13 with no documentation the cart had been checked.
Pediatric Broselow Cart Checklist: Checked on 2/2, 3, 7, 10, 12/13; 13 with no documentation the cart had been checked.
Airway Cart Checklist: Checked on 2/2, 3, 7, 11, 12/13; 13 with no documentation the cart had been checked.

The policy provided by Employee #3 titled Cardiopulmonary Resuscitation, Procedures for Number: 0950-06 Page 6 Section C #2 states, "Crash Carts/Defibrillators/Emergency Transport Boxes/Intubation Boxes will be checked every 24 hours and documented on the Emergency Equipment Check and Log..."
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations, document review, a complaint investigation and interviews the facility's infection control officer failed to maintain a system, which identified opportunities for infection prevention/control as evidenced by:
1. a. 2 - oxygen tanks on the floor
b. Portable registration cart moved from being in patient occupied room without being cleaned
c. Linen cart in hallway with linen and pillows lying on top uncovered
d. Linen closet in x-ray area with open door and linen uncovered
e. Torn positioning wedge in x-ray
f. Expired supplies
g. Items found under a gurney mattress that had potentially been there for 10 days
h. Tape residue on mattresses, torn mattresses
i. Uncleaned gurneys and bed with soiled linen stored in hallway outside of ED. The hallway is used for transportation and thoroughfare
j. Clean privacy curtain stored in soiled utility room.
k. EKG cart with coffee stains of the top of the cover, tape residue on carts.

The findings include:

On 2/19/13 at approximately 10:40 A.M. a tour of the Emergency Department (ED) with Employee #1, #9 and #13. During the tour the following items were noted:
a. 2 - oxygen tanks on the floor - An unsecured oxygen tank was found lying on the floor in the second triage room. A second unsecured oxygen tank was found lying on the floor in the linen closet of the x-ray area.

b. Portable registration cart moved from being in patient occupied room without being cleaned - At approximately 10:55 A.M. Employee #11 was observed leaving a room in the fast track area with a registration cart. Employee #11 left the room, traveled down a hallway passing 3 people on the way, entered a door that led to the registration area where 2 additional staff members were present.

Employee #11 was asked why the patient was being treated in the ED. Employee #11 stated, "I don't know but I can look to see what the triage nurse put in to the system." Employee #11 looked up the reason for Patient #3 being in the ED and stated, "She is here for fever and flu symptoms."

Employee #11 was not observed performing any type of hand hygiene and was not observed cleaning the machine used in the room with Patient #3. Employee #11 was asked when she would clean the cart used in the room. Employee #11 stated, "When I think about it."

Employee #3 provided a policy (Handling, Storage and Cleaning of Equipment and Supplies, last revised on 7/13/12) which stated, "...Portable and Stationary Computer Station...E. Outpatient Areas and other Settings: Keyboards will be cleaned after each patient in outpatient settings adn othe settings where patietn turnover is frequesnt such as in the emergency room , Operationg Room, PACU, Heat Center, etc.

c. Linen cart in hallway with linen and pillows lying on top uncovered - At approximately 11:10 A.M. a linen cart was observed in the hallway of the ED. The cart had linens stored inside with a cover over them but also had linens (3-4 sheets and 3-4 pillow cases) and hospital gowns (2 -3 gowns) stored on top of the cart with 2 pillows lying on top of the linens and gowns. Employee #9 stated, "Those should not be up there" and removed the items. Employee #9 was asked how a staff would know if the pillows were cleaned between patient use and Employee #9 stated, "I don't know."

d. Linen closet in x-ray area with open door and linen uncovered - During the observations of the x-ray area in the ED the linen closet was noted to have the door propped open with an over bed table. There were linens stored on the shelves in the closet. Employee #12 stated, "I will make sure the door gets closed."

e. Torn positioning wedge in x-ray - Also in the x-ray area of the ED a black positioning wedge was observed to have several tears in the outer covering layer leaving exposed porous foam.

f. Expired supplies - In room #1 an empty evacuated container 1000 ml (milliliters) used for admixing compatible medications under an aseptic technique was found with an expiration date of 9/1/12, 3 expired vaccutainers used for Protime studies. Employee #13 stated, "I don't know why the bottle for admixing is even in here."

g. Items found under a gurney mattress that had potentially been there for 10 days - At approximately 12:05 P.M. the gurney in bay #8 was observed. The gurney mattress had tape and tape residue on the mattress. When the underside of the mattress was observed a blood pressure cuff and a page of labels with a patient name, social security number, date of birth, sex and date of service was observed. The date of service was 2/9/13 (10 days prior to the ED tour on 2/19/13). Employee #9 and #18 was asked who cleans the gurneys and what to they clean. Employee #9 stated, "Anyone who has the time." Employee #18 stated, "The techs, nurses, and housekeeping clean the mattresses. They just clean the tops of the mattresses. The whole mattress and gurney are cleaned once a week. We must have missed this one."

h. Tape residue on mattresses, torn mattresses - Tape and tape residue observed on mattress in Bay #8, tape residue on gurney #25 and gurney mattresses on gurney #97 and gurney identified as 4 both had torn mattresses. Employee #18 stated, "We will get those cleaned and replaced immediately."

i. Four uncleaned gurneys and 3 uncleaned beds one with soiled linen still on the bed were observed stored in hallway outside of ED. The hallway is used for transportation and thoroughfare leaving passerbys exposed to what might be on the gurneys and beds.

j. Clean privacy curtain stored in soiled utility room. Employee #18 stated, "That should not be in there. It is clean."

k. EKG cart with coffee stains of the top of the cover, tape residue on carts. Carts were observed with coffee stains on the keyboard covers, dust on the bottom legs and tape residue on the handle and sides. Employee #9 stated, "We will get those cleaned."
VIOLATION: INTEGRATION OF EMERGENCY SERVICES Tag No: A1103
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interviews and document review, the hospital's Pharmaceutical services failed to ensure the necessary integration of medications, equipment, training and policies 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. This finding resulted in an Immediate Jeopardy finding by the State Agency on 2/19/13 at 4:55 P.M. The immediacy of the situation was removed on 2/19/13 at 6:00 P.M. as evidenced by the removal of medications in the offsite ED.

The findings include:

On 2/19/13 at 3:45 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 (an automated medication dispensing system supporting decentralized medication management)) was observed. The Pyxis contained 2 RSI (rapid sequence intubation) kits which contained one vial of succinylcholine chloride 200 mg/10 ml (milligrams per milliliter). The medication refrigerator also contained 2 vials of succinylcholine chloride. The 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).

On 2/19/13 at approximately 4:10 P.M. Employee #4 was asked how they would treat a case of MH. Employee #4 stated, "I would go to our manual." Employee #4 proceed to a section of the nurses' station that housed several notebooks with various types of information. Employee #4 stated, "It is not here so I would use our Lippincott reference book." Employee #4 proceed to an office down the hallway from the nurses' station and returned stating, "The book is gone. I would then look it up on the computer." In total 3.5 minutes had past once Employee #4 began the computer search. Employee #4 then stated I would call (Name of hospital facility) and ask them. If we need dantrolene I would have them bring it to us."

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."

Per MapQuest. com the hospital is 13 minutes away from the offsite ED.

Employee #4 then stated, "We are going to remove the succinylcholine from our offsite ED."

On 2/21/13 Employee #3 provided a printout from Lippincott Williams & Wilkins "[DIAGNOSES REDACTED] Patient Care, PACU; October 6, 2012"

The printout stated "[DIAGNOSES REDACTED] (MH) is serious genetic, and potentially life threatening condition. It's characterized by a hypermetabolic state and rigidity of the skeletal muscles, and is triggered by several common inhaled anesthetic agents and some muscle relaxants. Unsafe drugs for MH-susceptible (MHS) patients are succinylcholine (Quelicin), sevoflurane (Ultane), desflurane (Suprane), isoflurane (Forane), and enflurane (Ethrane). Safe drugs for use in MHS patients include local and regional anesthesia, and IV drugs such as propofol, barbiturates, benzodiazepines, ketamine, droperidol, and edomidate. Nitrous oxide also is safe.

MH can occur during induction of anesthesia, during maintenance, or postoperatively in the patient who's susceptible. The tine it takes for symptoms of [DIAGNOSES REDACTED]"

This medication (succinylcholine) was available for administration in the outpatient ED since at least August 31, 2012. The hospital staff could not determine the original date of availability.

On 2/19/13 at 4:55 P.M. Employee #4 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 6:00 P.M. to include the observed removal of medications at the offsite ED by the pharmacist.

Employee #15 was interviewed on 2/21/13 at approximately 10:43 A.M. He stated, "I am the PIC (Pharmacist in Charge) for (Name of hospital and Name of offsite ED). I knew the succinylcholine was in the RSI kits. It is standard in all our RSI kits. Anesthesia assisted us in putting the kits together and we standardized the contents of the RSI kits. I did not know there were 2 loose vials in the Pyxis refrigerator. Those would be virtual kits (all the same medications found in the kit but in the Pyxis individually). Therefore we had 4 RSI kits available for use. Originally we did not have the RSI kits at (Name of offsite ED). Someone had to request it (the kit).

If the succinylcholine is not refrigerated it has a short shelf life. Anesthesia likes it (succinylcholine) because it has a short half life.

I was not aware dantrolene was not available. MH was not a disease in the top of my mind. I have been employed here 10 years. Originally the (offsite) ED was a part of the Ambulatory Surgical Center (ASC). Dantrolene is available in the ASC. The ASC spun off and no one connected the dots. We don't have access to the dantrolene now."

The Pyxis report dated 2/19/13 showed a discrepancy on 2/18/13 of the amount of succinylcholine available for use. The report noted one available and 2 were in the Pyxis refrigerator. Employee #15 stated, "I don't know why there is a discrepancy."

Employee #15 provided a copy of the High Alert Medications (HAM) last revised on 3/13/12. The policy states, "A list of High Alert Medications (HAMs) will be reviewed annually by the P&T (pharmacy and therapeutic) Committee based on national literature and the potential for causing harm. These medications will be stored separately from other medications and clearly labeled as HAMs....PROCEDURE: I. The following list of High Alert Medications may be easily identifiable by the acronym of GOPPINNCCHMS:
G General Anesthetics
O Oral hypoglycemics
P Potassium infusions
P Pitocin infusions and injections
I Insulin infusions and injections
N Narcotic infusions
N Neuromuscular Blocking Agents (Employee #15 stated, "This is succinylcholine.")....

II. The pharmacy will clearly distinguish the above medications through labeling, and trend data associated with their use....
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.


The findings include:

On 2/19/13 at 3:45 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 (an automated medication dispensing system supporting decentralized medication management)) was observed. The Pyxis contained 2 RSI (rapid sequence intubation) kits which contained one vial of succinylcholine chloride 200 mg/10 ml (milligrams per milliliter). The medication refrigerator also contained 2 vials of succinylcholine chloride. The 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).

On 2/19/13 at approximately 4:10 P.M. Employee #4 was asked how they would treat a case of MH. Employee #4 stated, "I would go to our manual." Employee #4 proceed to a section of the nurses' station that housed several notebooks with various types of information. Employee #4 stated, "It is not here so I would use our Lippincott reference book." Employee #4 proceed to an office down the hallway from the nurses' station and returned stating, "The book is gone. I would then look it up on the computer." In total 3.5 minutes had past once Employee #4 began the computer search. Employee #4 then stated I would call (Name of hospital facility) and ask them. If we need dantrolene I would have them bring it to us."

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."

Per MapQuest. com the hospital is 13 minutes away from the offsite ED.

Employee #4 then stated, "We are going to remove the succinylcholine from our offsite ED."

On 2/21/13 Employee #3 provided a printout from Lippincott Williams & Wilkins "[DIAGNOSES REDACTED] Patient Care, PACU; October 6, 2012"

The printout stated "[DIAGNOSES REDACTED] (MH) is serious genetic, and potentially life threatening condition. It's characterized by a hypermetabolic state and rigidity of the skeletal muscles, and is triggered by several common inhaled anesthetic agents and some muscle relaxants. Unsafe drugs for MH-susceptible (MHS) patients are succinylcholine (Quelicin), sevoflurane (Ultane), desflurane (Suprane), isoflurane (Forane), and enflurane (Ethrane). Safe drugs for use in MHS patients include local and regional anesthesia, and IV drugs such as propofol, barbiturates, benzodiazepines, ketamine, droperidol, and edomidate. Nitrous oxide also is safe.

MH can occur during induction of anesthesia, during maintenance, or postoperatively in the patient who's susceptible. The tine it takes for symptoms of [DIAGNOSES REDACTED]"

This medication (succinylcholine) was available for administration in the outpatient ED since at least August 31, 2012. The hospital staff could not determine the original date of availability.

On 2/19/13 at 4:55 P.M. Employee #4 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 6:00 P.M. to include the observed removal of medications at the offsite ED by the pharmacist.

Employee #15 was interviewed on 2/21/13 at approximately 10:43 A.M. He stated, "I am the PIC (Pharmacist in Charge) for (Name of hospital and Name of offsite ED). I knew the succinylcholine was in the RSI kits. It is standard in all our RSI kits. Anesthesia assisted us in putting the kits together and we standardized the contents of the RSI kits. I did not know there were 2 loose vials in the Pyxis refrigerator. Those would be virtual kits (all the same medications found in the kit but in the Pyxis individually). Therefore we had 4 RSI kits available for use. Originally we did not have the RSI kits at (Name of offsite ED). Someone had to request it (the kit).

If the succinylcholine is not refrigerated it has a short shelf life. Anesthesia likes it (succinylcholine) because it has a short half life.

I was not aware dantrolene was not available. MH was not a disease in the top of my mind. I have been employed here 10 years. Originally the (offsite) ED was a part of the Ambulatory Surgical Center (ASC). Dantrolene is available in the ASC. The ASC spun off and no one connected the dots. We don't have access to the dantrolene now."

The Pyxis report dated 2/19/13 showed a discrepancy on 2/18/13 of the amount of succinylcholine available for use. The report noted one available and 2 were in the Pyxis refrigerator. Employee #15 stated, "I don't know why there is a discrepancy."

Employee #15 provided a copy of the High Alert Medications (HAM) last revised on 3/13/12. The policy states, "A list of High Alert Medications (HAMs) will be reviewed annually by the P&T (pharmacy and therapeutic) Committee based on national literature and the potential for causing harm. These medications will be stored separately from other medications and clearly labeled as HAMs....PROCEDURE: I. The following list of High Alert Medications may be easily identifiable by the acronym of GOPPINNCCHMS:
G General Anesthetics
O Oral hypoglycemics
P Potassium infusions
P Pitocin infusions and injections
I Insulin infusions and injections
N Narcotic infusions
N Neuromuscular Blocking Agents (Employee #15 stated, "This is succinylcholine.")....

II. The pharmacy will clearly distinguish the above medications through labeling, and trend data associated with their use....