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Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) staff failed to maintain the required 36 vials of Dantrium within the hospital for management of a malignant hyperthermia crisis during surgery requiring general anesthesia. The CAH surgery staff identified 2 of 2 surgical cases requiring general anesthesia during the time the CAH lacked a total 36 vials of Dantrium (Patient #2 and #3) . The CAH surgery staff identified an average of 11 surgical cases that required general anesthesia per month.

Failure to maintain the required amount of Dantrium for the management of a malignant hyperthermia crisis could potentially result in harm or the death of a surgical patient.

Findings include:

1. Observation on 6/3/14 at 8:30 AM, with Staff B, during the initial tour of the surgical unit revealed the hyperthermia cart contained only 32 vials of Dantrium. According to the package insert information, Dantrium is indicated along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrium intravenous should be administered by continuous rapid intravenous push beginning at a minimum dose of 1 mg/kg, and continuing until symptoms subside or the maximum cumulative dose of 10 mg/kg has been reached.

2. On 6/3/14 at 8:30 AM, Staff B, a certified registered nurse anesthetist, verified the CAH was short 4 vials of Dantrium to treat malignant hyperthermia if the condition develops during surgery. The intent is for the CAH to start with the minimum dose of Dantrium and increase the dose, as the patient's condition warrants. Extra Dantrium beyond the 36 vials would be obtained from nearby sources and the patient would be transferred to a higher level of care.

On 6/3/14 at 11:45 AM, Staff A, the Surgery Director stated it was a standard of practice to keep 36 vials of Dantrium available to Surgery.

3. Review of Patient #1's medical record revealed an admitting diagnosis for the surgical procedure TIF (Transoral Incisionless Fundoplication) with general anesthesia completed on 5/16/14. Patient #1 had a positive family history for malignant hyperthermia, and had received Dantrium as a pre-treatment prior to 2 previous surgical interventions. A pre-treatment dose of Dantrium was ordered prior to the surgery on 5/16/14 and 80 mg of Dantrium was administered. Four vials of Dantrium were used leaving a supply of only 32 vials available for additional use.

Review of Patients #2 medical record revealed an admitting diagnosis for the surgical procedure hiatal hernia herniopasty with TIF requiring general anesthesia on 5/16/14. Patient #2 weighed 100.422 kgm (kiligram) and would require 5-50 vials of Dantrium if a malignant hyperthermia crisis occurred.

Review of Patient #3 medical record revealed an admitting diagnosis for the surgical procedure of a left breast lumpectomy with general anesthesia on 6/4/14. Patient #3 weighed 85.427 kgm and would require 4-40 vials of Dantrium if a malignant hyperthermia crisis occurred.

2. Review of the CAH policy titled Malignant Hyperthermia Episode dated January 2014, lacked information related to the amount of Dantrium that the CAH should maintain at all times.

Review of the inventory sheet found in the Malignant Hyperthermia Cart shows Dantrium 20 mg x 6 boxes of 6 vials each is to be kept on the Hyperthermia Cart. Review of additional information, with no title or date, found in the Hyperthermia Cart revealed Dantrium-36 vials should be available in each institution where Malignant Hyperthermia can occur.

Review of the Operating Charge Form dated 5/16/14 showed 4 bottles of Dantrium 20 mg was charged to Patient #1.

Review of the Direct Order Form for Dantrium IV (intravenous) dated 6/3/14 showed 6 vials were ordered with approximate arrival date of 6/6/14.

3. During an interview on 6/3/14 at 8:30 AM, with Staff B, CRNA revealed 4 vials of Dantrium were used on 5/16/14 to pre-treat Patient #1 prior to general anesthesia. A charge slip was completed and delivered to pharmacy for replacement of the Dantrium.

During an interview on 6/3/14 at 10:00 AM, with Staff C, Pharmacist, Director of Pharmacy, revealed she was aware Dantrium had recently been used. The Director of Pharmacy lacked information regarding the amount of Dantrium that was required for the CAH to maintain at all times.

Based on observation, document review, and staff interview, the CAH (Critical Access Hospital) failed to separate clean and dirty items in the soiled room located in the PACU (Post Anesthesia Care Unit). The CAH surgery staff identified an average of 75 surgical procedures were performed each month.

Failure to maintain separation of clean items from dirty items could potentially result in cross-contaminated items used in the surgical suites.

Findings include:

1. Observation on 6/3/14 at 8:35 AM, revealed a soiled room in the PACU. The soiled room contained multiple soiled items and the following clean items on the top shelves :
12 suction canisters; 6 containers of hand sanitizer; 1 Formaldehyde Spill Kit; 10 boxes of gloves; and 6 containers of sanitary wipes.

2. Review of policy/procedure manual for the Operating Room (OR) revealed the administrative staff failed to develop and implement a policy addressing the separation of clean and dirty items located in the soiled room.

3. During an interview on 6/3/14 at 8:35 AM, with Staff A, RN Surgery Director, agreed clean items should not be stored with dirty items in the soiled room. The clean items were stored for later use in the OR were destroyed.

During an interview on 6/4/14 at 1030, with Staff E, Infection Control Officer, verified that the administrative staff of the CAH failed to develop and implement a policy/procedure for the separation of clean and dirty items in the hospital.

The Iowa Administrative Code 481-51.20(3)b. includes the following requirement: If a licensed dietitian is not employed full-time, then one must be employed on a part-time or consultation basis with an additional full-time person who has completed a 250-hour dietary manager course and who shall be employed to be responsible for the operation of the food service.

Based on record review and staff interviews the Critical Access Hospital (CAH) failed to provide a qualified employee responsible for the operation of the food service department, as required by state licensure requirements. The facility identified a census of 14 patients and an average of approximately 30 patient meals served daily.

Failure to ensure a qualified person managed the food service department could result in inadequate management and potentially lead to poor dietary practices impacting the health and nutritional needs of the patients.


Findings include:

1. During an interview on 6/2/14 at 9:30, Staff F, Dietary Leader, reported the CAH previously had a full-time dietitian, responsible for the department management. Staff F relayed the full-time dietitian left about 1 year ago, and she is currently the working manager for the department, until the CAH can recruit a certified dietary manager to assume the duties. Staff F reported she is a long-term employee of the department but is not a Certified Dietary Manager, nor has she completed the Dietary Manager coursework.

During an interview on 6/2/14 at 2:40 p.m., Staff G, Human Resources Director, acknowledged the CAH has been without a qualified employee responsible for the food service operation. She confirmed the CAH previously employed a full-time dietitian, who left employment in April 2013. Staff G reported they did not attempt to recruit a replacement because they had a current employee who had enrolled in the dietary manager program and made the decision to retain a part-time contracted dietitian. Staff G reported the employee did not make sufficient progress in the dietary manager program so the CAH began actively recruiting a qualified person in November 2013, and thus far have not had any candidates accept an offer.

2. Review of Staff F's personnel record confirmed she lacked the completion of a 250 hour dietary manager course.

Based on document review and staff interview, the Critical Access hospital (CAH) failed to delineate privileges for 1 of 1 surgical technician, who was not an employee of the CAH, to assist with surgical procedures. The surgical technician (Surgical Technician A) assisted with 222 of 222 surgical procedures in 2013 and 100 of 100 surgical procedures from January through May 2014 completed by associated practitioner.

Failure to privilege all assistants that accompany providers could potentially result in patients receiving surgical interventions from unqualified professionals.

Findings include:

1. Review of Operating Room Policies/Procedure titled, "General Policies", dated May 2007, revealed, in part, ". . . Surgical procedures will be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body. Surgical services must maintain a roster of these individuals specifying the surgical privileges of each. . . ."

Review of the Operating Room Log on 6/3/14 at 8:50 AM revealed Surgical Technician A, provided surgical assistance for Practitioner C during surgical interventions for patients. The surgical technician assisted with 222 of 222 surgical procedures in 2013 and 100 of 100 surgical procedures from January through May 2014 completed by Practitioner C.

Review of the Surgical Procedures Manual kept in the Surgery area on 6/3/14 lacked documentation of privileges for Staff A.

Review of Surgical Technician A's, personnel file on 6/3/14 showed it lacked documentation of privileges for Surgical Technician A.

2. During an interview on 6/3/14 at 8:50 AM, the Surgery Director, verified that Surgical Technician A lacked surgical privileges to provide assistance during surgical procedures with Practitioner C.

During an interview on 6/4/14 at 2:40 AM, Staff H, Interim Chief Nursing Officer, verified that Surgical Technician A lacked surgical privileges to provide assistance during surgical procedures with Practitioners C.
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Based on review of swing bed policies, review of medical records, and interviews with staff, the swing bed interdisciplinary team and nurse manager failed to ensure the attending physician participated in the interdisciplinary care conferences for the development and review of the patient's individualized care plan. The Interim Chief Nursing Officer (CNO) reported a current census of 4 Swing Bed patients with an average daily census of 4 Swing Bed patients. Concerns were identified for 3 of 4 swing bed inpatients (Patients #5, #6, and #7) and 4 of 5 closed swing bed inpatients (Patients #8, #9, #10, and #11).
Failure to obtain input from the attending physician while formulating and revising the patient's individualized care plan could result in delays in implementing treatment modalities to improve the patient's functional abilities, to enhance healing, and to shorten the stay at the hospital.

Findings include:

1. Review of swing bed policy titled, "Comprehensive Assessment and Discharge Summary", effective date 2/14, revealed the following in part, ..."a comprehensive care plan for each patient that is admitted to swing bed developed to include measurable approaches to meet a patient's medical, nursing, mental and psychosocial needs...the care plan is developed by...a multidisciplinary team...the attending physician may participate by attendance at the conference or provide input through one-on-one discussions during daily rounds on the unit...the registered nurse works collaboratively with the medical practitioner and other members of the health care team."

Review of swing bed policy titled, "Patient Care Arrangements", effective date 2/14, revealed the following in part, ..."The attending physician must...participate in the initiation and review of the plan of care for skilled or rehab services."

2. Review of 3 of 4 swing bed inpatient medical records (Patient #5, #6, and #7) revealed the following:

a. A physician's order, dated 5/22/14, for skilled nursing services, and Physical/Occupational (PT/OT) therapy evaluation and treatment for Patient #5. A history and physical dated 5/23/14 revealed admitting diagnosis included but was not limited to right total knee replacement.

A review of the patient's medical record revealed an interdisciplinary care conference/rounds form dated 5/29/14 at 11:10 AM. Staff K, Registered Nurse (RN) and Interim swing bed nurse manager, OT and PT staff, the dietitian and a registered nurse attended. The form lacked evidence demonstrating the physician participated, signed, and/or was updated by Staff K by on the care plan developed and reviewed at the care conference form.

b. A physician's order, dated 5/26/14, for skilled nursing services, and PT, OT and Speech Therapy (ST) evaluation and treatment for Patient #6. A history and physical dated 5/26/14 revealed admitting diagnosis included but was not limited to Ischemic Stroke (occurs when an artery to the brain is blocked. The brain depends on its arteries to bring fresh blood from the heart and lungs) and a history of Cerebral Hemorrhage (uncontrolled bleeding in the brain).

A review of the patient's medical record revealed an interdisciplinary care conference/rounds form dated 5/29/14 at 11:46 AM. Staff K, OT and PT staff, the dietitian and a registered nurse attended. The form lacked evidence demonstrating the physician participated, signed, and/or was updated by Staff K on the care plan developed and reviewed at the care conference.

c. A physician's order, dated 5/23/14, for skilled nursing services, and PT and OT evaluation and treatment for Patient #7. A history and physical dated 5/29/14 revealed admitting diagnosis included but was not limited to left foot cellulitis (a bacterial skin infection), likely from an osteomylitis (infection of the bone caused by bacteria), of the left second phalanx (toe).

A review of the patient's medical record revealed an interdisciplinary care conference/rounds form dated 6/4/14 at 7:39 AM. Staff K, OT staff, the dietitian and a registered nurse attended. The form lacked evidence demonstrating the physician participated, signed, and/or was updated by Staff K on the care plan developed and reviewed at the care conference.

3. During an interview on 6/2/14 at 2:00 PM, Staff K acknowledged physicians do not attend interdisciplinary care plan conferences and the medical records for Patient's #5, #6, and #7 lacked evidence demonstrating the physician was updated by Staff K on the care plan developed and reviewed at the care conference. Staff K said she typically reviews the care plans for all swing bed patients prior to care conferences but does not document this in the patient's medical record.

During an interview on 6/4/14 at 9:40 AM, the Interim CNO acknowledged physicians were not involved in the interdisciplinary care plan conferences and the medical records for Patient #5, #6, and #7 lacked evidence demonstrating Staff K conversed with the physician concerning the care plan and any review or revisions. The CNO said moving forward, [Staff K] who is responsible for oversight of skilled nursing services and the interdisciplinary care plan conferences will document discussions with the physician prior to the care plan conference in the patient's medical record.

4. Review of 4 of 5 closed swing bed medical records (Patient #8, #9, #10, and #11) revealed the following:

a. A physician's order, dated 4/11/14, for skilled nursing services, and PT and OT evaluation and treatment for Patient #8. A history and physical dated 4/11/14 revealed admitting diagnosis including but was not limited to right total knee arthroplasty (surgical repair or replacement of a joint).

A review of the patient's medical record revealed an interdisciplinary care conference/rounds form dated 4/15/14 at 10:59 AM and 4/22/14 at 11:46 AM. Staff K, PT and OT staff, the dietitian and a registered nurse attended. The form lacked evidence demonstrating the physician participated, signed, and/or was updated by Staff K on the care plan developed and reviewed at the care conference.

b. A physician's order, dated 4/5/14, for skilled nursing services, and PT and OT evaluation and treatment for Patient #9. A history and physical dated 4/5/14 revealed admitting diagnosis included but was not limited to right total knee replacement.

A review of the patient's medical record revealed an interdisciplinary care conference/rounds form dated 4/8/14 at 11:05 AM and 4/15/14 at 11:08 AM. Staff K, PT and OT staff, the dietitian and a registered nurse attended. The form lacked evidence demonstrating the physician participated, signed, and/or was updated by Staff K on the care plan developed and reviewed at the care conference.

c. A physician's order, dated 2/16/14, for skilled nursing services, and PT and OT evaluation and treatment for Patient #10. A history and physical dated 2/13/14 revealed admitting diagnosis included but was not limited to advanced metastatic colon cancer to the lung, bronchitis flare, and generalized weakness.

A review of the patient's medical record revealed an interdisciplinary care conference/rounds form dated 2/18/14 at 10:59 AM and 2/27/14 at 11:38 AM. Staff K, PT and OT staff, the dietitian and a registered nurse attended. The form lacked evidence demonstrating the physician participated, signed, and/or was updated by Staff K on the care plan developed and reviewed at the care conference.

d. A physician's order, dated 10/11/13, for skilled nursing services for intravenous (IV) therapy and treatment for Patient #11. A history and physical dated 10/9/13 revealed admitting diagnosis included but was not limited to sepsis (an illness in which the body has a severe response to bacteria), probably urinary tract source.

A review of the patient's medical record revealed an interdisciplinary care conference/rounds form dated 10/15/13 at 12:45 PM and 2/27/14 at 11:38 AM. Staff K, the dietitian and a registered nurse attended. The form lacked evidence demonstrating the physician participated, signed, and/or was updated by Staff K on the care plan developed and reviewed at the care conference.

5. During an interview on 6/4/14 from 2:45 to 3:30 PM, Staff J, Registered Nurse (RN)/Infection Control, Quality Assurance and Safety Manager acknowledged the medical records for Patient #8, #9, #10, and #11 lacked evidence the physician attended and/or participated in the interdisciplinary care plan conferences. Additionally, Staff J stated the physician's progress notes did not reference the interdisciplinary plan of care.

Based on review of policies, documents, and medical records and staff interview the Critical Access Hospital (CAH) failed to ensure physicians ordered specialized rehabilitation (rehab) services for swing bed patients. Problem identified with 1 of 4 active medical records (Patient #4). The Interim Chief Nursing Officer (CNO) identified an average daily census of 4 swing bed patients.

Failure to ensure a physician ordered specialized rehab services could result in swing bed patients not receiving specialized rehab services appropriate to their medical condition.
Findings include:

1. Review of nursing policy titled, "Patient Care Arrangements" dated 2/14, revealed the following in part, ..."The attending physician must provide a written order for skilled nursing care or rehab services."

Review of nursing policy titled, "Rehab Services" dated 2/14, revealed the following in part,..."Rehab services are provided upon written order of the client's physician."

2. Review of Patient #4's medical record showed:

-The patient was readmitted to skilled nursing services after a failed trial at home on 5/30/14, the patient was diagnosed with abdominal cancer and had increasing pain and returned to the hospital for pain control.

- An order entry sheet dated 5/30/14 at 11:25 AM, revealed, in part, Practitioner B, Advanced Registered Nurse Practitioner (ARNP) ordered specialized rehab services for physical therapy (PT) evaluation and treatment and occupational therapy (OT) evaluation and treatment.

- PT goals grid notes dated 6/3/14 revealed after evaluating the patient, the PT staff formulated a treatment plan that included gait (a particular way or manner of moving on foot) and ambulation, transfer training and strength training. At the time of survey the patient was still receiving PT services.

- OT goals grid notes dated 5/30/14 revealed after evaluating the patient, the OT staff formulated a treatment plan that included tub-shower transfers and leisure education. At the time of survey the patient was still receiving OT services.

3. During an interview on 6/2/14 at 5:00 PM, the CNO acknowledged Patient #4's medical record lacked a physician's order for specialized rehab services, and in fact, ARNP B ordered the swing bed nursing and specialized rehab services for the patient and the attending physician failed to co-sign the orders. The CNO said they failed to forward the original orders for swing bed and specialized rehab services to the physician and failed to follow hospital policies for specialized rehab services.

4. Review of documentation dated 6/3/14 from the CNO revealed the following in part..."Skilled nursing patient charts. One out of four admissions and therapies were ordered by a physician. Our protocol when a mid-level admits a patient is to have the physician, within 24 hours, review all orders and cares. This one fell out. I immediately put a plan into place so that the protocol is followed 100% of the time."

Based on review of policies/procedures and documents, and staff and family interviews, the Critical Access Hospital (CAH) failed to ensure patients and visitors were informed of their visitation rights, including the ability to receive designated visitors, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or friend for 4 of 4 swing bed patient records reviewed (Patient #4, #5, #6, and #7). The Medical/Surgical Nurse Manager identified a current census of 4 swing bed patients at the time of survey entrance. Additionally the Interim Chief Nursing Officer (CNO) and Cluster Manager of inpatient and outpatient services identified patient encounters for the following inpatient and outpatient areas:

Therapy: 47 patients daily (Physical, occupational and speech therapy)
Scopes: 32 patients monthly
Sleep lab: 4 patients weekly
Lab: 85 patients daily
Swing bed patients: 4 patients daily
Acute and/or Medical Surgical: 7 patients daily
Observation: 3 patients daily
Women's Health Center: 20 patients weekly
Surgical Clinic: 95 patients monthly
Behavior Health Clinic: 300 patients monthly
Main Clinic: 1,850 patients monthly
2 Offsite clinics: 40 patients daily
Infusion clinic: 85 patients monthly
OB: 16 patients (includes mother and infant) monthly
Cardiac rehab: 141 patient monthly
ER: 500-600 patients monthly

Failure to inform patients of their visitation rights could potentially result in the staff failing to extend visitation rights to all patient populations and their visitors.

Findings include:

1. Review of policy titled, "Visitation", effective date 2/14, superseding the previous policy for visitation dated 2/12, revealed the following in part, ..."Hansen Family Hospital recognizes that a key component in ensuring patient excellence in care involves respecting the rights of patient and their rights...to ensure patient, patient's support persons, family members, significant others, domestic partners, visitors and community are informed of the Visitation Rights policy, and will: include the Visitation rights policy references in various venues deemed appropriate, which may include, but is not limited to admission packets, brochures..."

During an interview on 6/2/14 at 10:02 AM, the CNO said nursing and/or registration staff are educated to provide the Visitation policy at the time of admission to the hospital for all inpatient and outpatient services when they arrive at the hospital.

Review of the brochure titled, "Your Rights and Responsibilities as a Patient", undated, provided to all patients upon admission to swing bed services, inpatients and outpatients, did not include the patient's rights to receive designated visitors, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend. During an interview on 6/2/14 at 10:40 AM, the CNO acknowledged the brochure failed to include the regulatory changes to the patient bill of rights.

Review of the "Patient Rights and Responsibilities" brochure provided to all patients upon admission to swing bed services and inpatient and outpatients, (the patients attest they have received this information and it is a permanent part of their medical record), did not included patient's rights to receive designated visitors, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend.
Although the medical records for Patient #4, #5, #6 and #7 lacked acknowledgement of receipt of patient rights and responsibilities the CNO provided documentation to the surveyor on 6/4/14 at 10:00 AM stating, "All patients receive information about patient rights whether via packet, poster, or hand out. Our process is to give and inform the patient at the point of registration. There is currently no electronic tracking device."

2. During an interview on 6/2/14 at 1:50 PM, Patient #4's significant family member said they received a packet that included the patient rights and responsibilities hand out. The patient's significant family member said he/she did not recall that they reviewed the visitation policy or mention anything about designated visitors, a spouse or a domestic partner.

During an interview on 6/2/14 at 2:35 PM, Staff M, Registered Nurse (RN) on the medical-surgical unit stated they provided all patients with a patient rights information sheet at the time they are admitted. Staff M said it was their responsibility to review the visitation rights with the patient. Staff M said she did not know the information sheet lacked the patient right to receive designated visitors, including but not limited to a spouse, a domestic partner (including a same-sex partner), another family member, or a friend.

Review of documentation provided by the CNO on 6/3/14 at 7:00 AM, revealed the following, "This section (referring to visitation rights) was added immediately to our patient rights. I realized it lacked this component (the regulatory changes to patient rights). I revised it on 6/2/14, I changed the swing bed packets, and gave an updated copy to the swing bed patients. I also updated immediately outpatient, endoscope, radiology, lab patient rights and process and patient right posters for Iowa Falls Clinic, Ellsworth Family Medical Clinic and Ackley Clinic immediately. I also updated outpatient services for patient rights immediately now to include the appropriate language."

During an interview on 6/3/14 at 8:10 AM, Staff U, RN on the OB unit acknowledged their unit was notified by the CNO on 6/2/14 of changes in the patient rights and responsibilities hand out and they received new rights and responsibilities hand outs that are presented to patients at the time of registration to the hospital or by the nursing staff on the OB unit when a patient is admitted.

During an interview on 6/3/14 at 11:30 AM, Staff P, Registration Clerk acknowledged they had been notified by the CNO on 6/2/14 of changes in the patient rights and responsibilities hand outs and their department received new hand outs that reflected changes in visitation rights. Staff P said their department is responsible for providing all patients that arrive to their hospital for labs, procedures, admissions, or any other hospital services that are provided.