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Tag No.: A0049
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 was identified. Medication available for use did not include rescue agents and equipment, and staff were not knowledgeable of the risk of use of the medication-succinylcholine. This resulted in the finding of an immediate jeopardy situation on 2/26/2013 at 12:47 p.m. The immediacy was relieved on 2/26/2013 at 5:07 p.m. as evidenced by modified policies, inclusion of equipment/medication and staff training.
The findings included:
A Medical Facilities Inspectors conducting observations at the facility's free standing off campus Emergency Department on February 26, 2012 at 9:50 a.m. discovered a medication, Succinylcholine, was accessible without the needed medications and supplies to treat its potentially fatal adverse side effect. The Medical Facilities Inspector observed the following findings:
? The free standing off campus Emergency Department had three vials of the medication Succinylcholine available for use, contained in rapid intubation kits. [According to www.drugs.com "Succinylcholine is a muscle relaxant that is used for surgeries. It is also used for bringing on anesthesia or for the insertion of tubes into windpipes. The medication is classified as being a depolarizing muscle relaxant, and prevents the muscles from contracting. The contraction of muscles can lead to paralysis of the facial muscles, including those that are vital for movement and breathing. There are possible side effects that are occasionally associated with Succinylcholine use."]
? The free standing off campus Emergency Department did not have immediate access to the necessary medication, Dantrolene, needed to treat Malignant Hyperthermia a life threatening condition associated with the use of Succinylcholine. [According to www.drugs.com "Possibly fatal Malignant Hyperthermia; manifested by a rapid, profound elevation in body temperature and sometimes extreme muscular rigidity. Risk increases with concomitant administration of inhalation anesthetics. If Malignant Hyperthermia occurs, discontinue all anesthetic agents and initiate IV dantrolene therapy in conjunction with supportive measures (e.g., administering oxygen, treating metabolic acidosis, instituting cooling procedures); maintain urinary output and monitor serum electrolytes."] [According to www.askhealth.com "DANTROLENE (DAN troe leen) helps to relieve spasms and stiffness of muscles in conditions such as multiple sclerosis, cerebral palsy, stroke, or injury to the spine. This medicine can also help prevent and treat a condition called Malignant Hyperthermia, which may occur after surgery or anesthesia."]
Review of the free standing off campus Emergency Department (ED) records documented Succinylcholine had been administered to a patients at the free standing Emergency Department on January 19, 2013 at 5:06 p.m. (1 vial for one patient #31), January 19, 2013, at 10:41 p.m., 1 vial for Patient #32), and January 19, 2013, at 10:44 p.m. (for Patient #32). Lee's Hill free standing Emergency Department was restocked with with 2 vials of succinylcholine on January 20, 2013 and again on January 20, 2013, at 11:38 a.m.
On February 26, 2012, at 9:50 a.m. the hospital's off-site Emergency Department (ED), at Lee's Hill, was inspected by one Medical Facilities Inspector from the Virginia Department of Health. The Emergency Department's medication storage unit (Acudose) was observed, and the content list ("Acudose-Rx Station Inventory") was reviewed. The medication "Succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter)", one vial each - were listed on the inventory of the two Rapid Sequence Intubation Boxes. Observation of the stock medications revealed the presence of Succinylcholine. The inventory list did not evidence the presence of Dantrolene, a medication used in the event of an adverse reaction to the Succinylcholine-malignant Hyperthermia (MH). A registered nurse present in the ED were interviewed at 10:30 a.m. (Employee #26). RN #26 did not have knowledge of the potential adverse event related to the administration of a triggering agent-Succinylcholine. The policy for the use and administration of Succinylcholine was requested by the Surveyor. The ED Manager #25 stated that the nearest Malignant Hyperthermia Cart was at the main campus operating room. Staff #11, the Licensure and Certification Specialist had verified during interview that it took approximately fifteen minutes to transport patient's to the main campus in the Post Anesthesia Care Unit, on February 26, at 09:55 a.m., for a higher level of care.
The policy for Malignant Hyperthermia, Care of Patients with, listed the priority as critical, dated January 28,2008, and stated: "Objective: To provide an overview of Malignant Hyperthermia (MH) and a plan of action during an MH crisis. Policy: The Malignant hyperthermia cart will be maintained in order to insure the timely availability of supplies to treat a Malignant Hyperthermia Crisis. 2. The MH cart with emergency treatment supplies will be housed in the PACU (Post Anesthesia Care Unit located at the main hospital campus.). 3. Its contents will be verified monthly and after utilization..."
This policy did not include the provision of services and rescue, where the event to occur in different areas of the hospital in which succinylcholine was available for use-including the off site emergency department.
Meeting minutes notes form the Pharmacy and Therapeutic Committee, Mary Washington Hospital, dated November 9, 2012, stated: Malignant Hyperthermia Protocol The Committee reviewed and approved the pharmacy procedure, policy, and changes to the medication cart. At this same interview, Employee #30, the Pharmacy Director on January 27, 2013, at 09:45 a.m., stated that the P&T committee reported to the Medical Executive Committee.
Tag No.: A0353
Based on observation, document review and interview, the medical staff failed to enforce its own by-laws to ensure the off-site emergency department was sufficiently equipped to respond to a potential adverse reaction to a medication (Succinylcholine). The medication was available for administration without sufficient staff training, rescue medications or supplies.
Findings:
The medical staff did not ensure the offsite emergency department was sufficiently equipped and maintained to ensure patient safety. The off site emergency department was observed on 2/25/13 to have the triggering agent medication-succinylcholine available for administration in rapid intubation kits. The emergency department staff were not knowledgeable of the potential adverse reaction to the medication-malignant hyperthermia crisis (MH). The rescue medication-dantrolene- was not available to the staff. The hospital policy regarding MH could not be implemented at the offsite location, as no medication or other supplies were available. (See A 490 for additional information.)
The hospital's off-site Emergency Department, at Lee's Hill 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 February 26, 2013, at 12:47 p.m. The immediacy of the situation was lifted on February 26, 2013, at 5:07 p.m., as evidenced by the delivery of appropriate equipment and medications to the off-site Emergency Department, a revision of the hospital policies, and documented training of the appropriate employees on duty.
Tag No.: A0358
Based on document review and interview the facility failed to ensure the physician performed and documented a current medical history/physical examination (H & P) for two of two scheduled surgical delivery (Cesarean deliveries or C- sections) patients included in the survey sample. (Patient #18 and Patient #24).
The findings included:
1. Review of Patient #18's medical record revealed the patient was admitted to the facility on 02/25/2013 for a scheduled C-section. Patient #18's "H & P Update" form dated "2-25-13" at 5:28 p.m.; the physician checked the box next to "NO changes to H & P." Review of Patient #18's paper and electronic medical record did not contain a H & P performed within the 30-day time frame or for the day of the scheduled surgery.
An interview was conducted on 02/27/2013 at 10:55 a.m., with Staff #10 and Staff #20. Staff # 10 reviewed Patient #18's prenatal documents, physician notes, and medical record (both paper and electronic). Staff #10 did not find a H & P performed within the required 30-day time frame. Staff #10 and Staff #20 verified the H & P Update" form dated "2-25-13" did not have additional medical history or evidence of a physical examination.
2. Review of Patient #24's medical record revealed the patient was admitted to the facility on 02/20/2013 for a scheduled C-section on 02/21/2013. Patient #24's "H & P Update" form dated "2-21-13" revealed the physician had checked the box next to "NO changes to H & P." Review of Patient #24's electronic medical record did not contain a H & P performed within the 30-day time frame or on the day of the scheduled surgery. Review of Patient #24's prenatal documents revealed an "Initial Physical Examination" dated "8-15-12." A prenatal document dated "1-9-13" indicated the scheduled date/time as "2-21-13 @ (at) 7:30 Am" for Patient #24's C-section.
An interview was conducted on 02/27/2013 at approximately 2:28 p.m., with Staff #10. Staff # 10 reviewed all the components of Patient #24's electronic medical record. Staff #10 did not find an H & P performed within the required 30-day time frame. Staff #10 verified the H & P Update" form dated "2-21-13" did not have additional medical history or evidence of a physical examination.
An interview was conducted on 02/28/2013 at 9:20 a.m., with Staff #10. Staff #10 reported no additional information related to the H & Ps for Patients #18 and #24 had been located. Staff #10 verified both patients (Patients # 18 and #24) had a surgical procedure without a current history and physical (H & P) performed within 30-days of the scheduled surgery.
Review of the facility's medical by-laws read in part "... for all patients admitted to the hospital and patients scheduled for surgery (procedures performed in the main OR (operating room) and C-section Suite). The H&P for an admitted patient must be performed no later than 24 hours after admission. If a medical history and physical examination have been performed within 30 days before the admission (calculated from the date the H&P was originally dictated/documented) the H&P may be used conditioned upon the patient being evaluated by an individual authorized/privileged to perform a H&P and documented in the medical record no later than 24 hours after admission that the H&P is unchanged or noting updates and/or additions to the H&P ..."