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Based on review of hospital policies/procedures, documents, job descriptions, medical records, observation and interviews, it was determined the Critical Access Hospital failed to require in its Provision of Services:

(0276) rules for a drug storage area to be administered in accordance with professional principles;

(0278) policies relevant to the identification, reporting, investigating and controlling of infections and communicable diseases of patients and personnel; and

(0294) nursing services to meet the discharge planning needs of patients.

The cumulative effect of these systemic problems resulted in the inability of the CAH to be in compliance with the federal regulation for PROVISION OF SERVICES which led to the potential for adverse outcomes.

Based on review of hospital policy/procedure, hospital documents and interview, it was determined that the hospital failed to require that the drug storage area be administered in accordance with accepted professional principles, as evidenced by permitting nursing personnel from a separately licensed facility to access medications from the pharmacy, when a pharmacist is not available, for individuals who are not patients in the hospital.

Findings include:

Review of hospital policy/procedure titled Medications, Emergency Dispensing to Nursing Home Patients; reviewed by Pharmacy on 4/12/12; Medical Staff on 7/2/12; and Governing Board on 7/31/12, revealed: "...A Nursing Home nurse on duty may obtain one or more first doses of 'after-hours' medications from the hospital pharmacy, provided he/she does so through the assistance of a hospital floor nurse who has been granted after-hours access to the pharmacy...."

Review of hospital document titled After Hours Pharmacy Log revealed that for the period of time between 4/1/2013 and 6/19/2013, an RN accessed one medication from the pharmacy for a Nursing Home patient on 4/6/13 at an undetermined time, two medications for one Nursing Home patient on 5/4/13 at 2015, and one medication for a Nursing Home patient on 5/9/13 at 0215.

The Director of Pharmacy confirmed during an interview conducted on 6/19/13, that the above listed medications were accessed by an RN for patients located in the Nursing Home which is a separately licensed facility. He also confirmed that the Nursing Home does not have a contract with the hospital pharmacy for the provision of pharmacy services.

Based on review of hospital documents, job description, policy/procedure, observation and interview, it was determined that the hospital failed to:

1) designate in writing a qualified individual as an infection control officer;

2) have a system for identifying, reporting, investigating and controlling infections and communicable diseases of hospital personnel; and

3) include endoscopy services in the organization-wide infection control plan.

Findings include:

Review of the Infection Control Plan, provided by the hospital as the current plan revealed: "...Reviewed by the Governing Board on 1/31/12...Purpose...Have a system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel...Infection Control Coordinator...The hospital's infection control process is managed by a qualified individual. The ICC reports to nursing administration. The ICC's role is combined with employee health...The qualifications of the ICC are met through education, training and experience...The ICC is required to have education, training and knowledge or job experience in the following: patient care practice, epidemiological principles, infectious disease, sanitation, sterilization and disinfecting practices, adult education principles and techniques of continuous performance improvement...Responsibilities:...To assure organization-wide (patient/resident care, employee services and support services) compliance with infection control policies, procedures, regulations and standards...Components of the role include:...Product/procedure evaluation (e.g., consulting in the purchasing of all equipment and supplies used for sterilization, prevention, and control strategies)...Implementation of and compliance with regulatory requirements of standards...One example is the review of sterilization and disinfecting in all areas of the facility and collaborating with department heads to institute changes in practice as needed...Infection Control Committee...The ICC chairs the Infection Control Committee...Staff...All employees, providers, contract staff, students and volunteers are required to:...Report clinically significant infections and communicable diseases at the earliest possible time. Persons to notify include the ICC/practitioner, employee health nurse, nursing supervisor or chair of the infection control committee...Activities...Monitoring and evaluation of key performance aspects of infection control surveillance, prevention and management:...All post-op infections...Device-related infections...Employee health trends...."

Review of Job Description titled Case Manager/Infection Control/Employee Health revealed: "...Summary:...Oversees Infection Control and Employee Health...Employee Health...Develops and implements employee health programs...."

Review of hospital policy/procedure titled Department: Infection Control; Subject: Disinfectants and Cleaning Products Approval Process revealed: "...At least annually and prior to initial use, supplies used for cleaning, disinfection, sterilization and decontamination purposes must be reviewed and approved by the Infection Control Committee...(Name of Hospital) recognizes the need for appropriate disinfection and sterilization to prevent nosocomial infection after improper reprocessing of patient care items...."

1) RN #3 confirmed during interview conducted on 6/18/13, that she is currently employed at the hospital with responsibilities for Case Management, Infection Control, Employee Health and Utilization Review. Review of RN # 3's personnel file on 6/18/13, revealed that it did not contain a job description for Infection Control or Employee Health. It contained a signed RN job description. On 6/19/13, the Manager of Human Resources provided an unsigned job description for RN #3's personnel file. It included responsibilities for Infection Control and Employee Health. RN #3 confirmed that she did not have education in infection control beyond her nursing program. She confirmed that she did not have the required education, training or experience specified in the Infection Control Plan, with the exception of patient care practice. The Manager of Human Resources confirmed that RN #3 was transferred to the position of Infection Control on 10/29/12. Her last date in that position is 6/21/13.

RN # 2 has been orienting to the position for 5 weeks and confirmed during interview conducted on 6/19/13, that she does not have education or experience in infection control.

The hospital did not have documentation that RN #3 was the designated infection control coordinator.

2. RN #3 confirmed, during interview conducted on 6/18/13, that the hospital does not have a system for identifying or monitoring illness of employees or a policy to determine when an employee should refrain from reporting to work due to a communicable illness.

3. Employee # 21 confirmed during interview conducted on 6/19/13 that physicians perform colonoscopies and esophagogastroscopies (endoscopies) in the hospital for outpatients.

During tour of the section of the hospital utilized for endoscopy services, direct observation revealed that hospital staff reprocess the endoscopes via high level disinfection.

The Infection Control Coordinator stated, during interview conducted on 6/19/13, that she does not provide oversight for the disinfection of the endoscopes. She does not have responsibility for infection control surveillance or prevention in the endoscopy services. She stated that the Interim CNO provides oversight of the endoscopy services, including any infection control responsibilities.

The Nurse Manager stated during interview conducted on 6/19/13, that she had communicated with the Interim CNO and confirmed that infection control aspects of the endoscopy services were the responsibility of the Infection Control Coordinator.

The hospital was unable to provide any documentation of infection control policies/procedures related to infection prevention and surveillance for the endoscopy services.

Based on review of hospital policy/procedure, job description, medical record and interviews, it was determined that the hospital failed to require that nursing services meet the patient's needs for discharge planning and referral for post hospital care for 1 of 1 patient with a tracheostomy who required home health services for tracheostomy care (Pt # 15).

Findings include:

Review of hospital procedure for Department: Med Surg; Subject: Discharging a Patient Home from the Med/Surg Department revealed: "...Policy: discharge of a patient from the Med/Surg Department will be completed in a manner which will meet the patients' needs...All patients discharged from the Med/Surg Department will receive age, and condition-appropriate instructions for home care, and appropriate referrals...."

Review of Job Description titled Case Manager/Infection Control/Employee Health revealed: "...Reports to Nurse Officer...Department Nursing Administration...Coordinates health care and other related services for...Observation, Acute...through multidisciplinary care team and physicians...Coordinates patient care with physicians, nursing staff and other health care professionals to ensure patient outcomes...Acts as liaison with local physicians, mid-level providers, nursing staff, community agencies, and tertiary care centers to coordinate admissions and discharges...Performs discharge planning activities in conjunction with local health care agencies...."

Review of Pt # 15's medical records for Emergency Department (ED) admission on 5/27/13, Observation admission on 5/28/13 and ED admission on 5/31/13, revealed:

MD # 2 documented in the ED record on 5/27/13, at 2249: "...Bed requested for Observation...complaints of Breathing Difficulty...The patient has shortness of breath with light activity. The symptoms/episode began/occurred yesterday...The symptoms are continuous...on Jan 1 set herself on fire when her nasal oxygen exploded from a cigarette causing her to have upper respiratory burns from nose to larynx to lungs...ever since she was discharges (sic) from (name of care center) she states that she hasn't been able to clear her secretions well...Exam:...2305...Neck: tracheostomy tube in place...Differential diagnosis: Anxiety Reaction Bronchitis reactive airway disease...ED course: patient's suction machine stopped working at home and she is in great distress. patient has been suctioned and feels better. will do better in hospital where she can have regular suctioning, regular SVN (small volume nebulizer) and p and pd (percussion and postural drainage)...ran out of her SVN today...."

On 5/28/13 at 0125, an RN documented: "...pt has a tracheostomy...cannot use her voice...makes needs and wishes known by using sign language...."

On 5/28/13 at 0720, an RN documented: "...Unable to verbalized (sic) needs. Pen and papers provided to let pt's needs be known...."

MD # 4 dictated a report on 5/28/13: "...The reason for admission is bronchospasm and bronchitis...came to the emergency room last night because her tracheostomy and suctioning equipment was not working at home and the patient needs trach suction...the patient is being admitted overnight for the tracheal suction and respiratory toileting...she was miserable because the secretions were keep coming (sic) and it was spasming her...we did the pulmonary toileting overnight and the patient is feeling better...respiratory technician taught her how to take care of the tracheal wound and continue using the oxygen...Discharge Condition...Stable. We will be discharging her with home health, so the patient should be getting more education with the pulmonary toileting and continue to follow with the primary care physician...The patient is no code right now...."

The medical record contained a prescription dated 5/28/13 and signed by MD #4: "Home Health for Tracheostomy Care."

On 5/28/13 at 1524, RN #2, Case Management, documented: "...Spoke to pts Daughter. Discussed HH (Home Health) referral. Daughter requested to wait for services until AHCCS (sic) application approved. Daughter verbalized understanding and all questions answered."

On 5/28/13 at 1656, RN # 16 documented: "...pt assisted to personal vehicle after verifying discharge instructions. RT (Respiratory Therapist) gave tx (treatment) before discharge to assist with transfer home."

The 5/28/13 medical record for admission to Observation did not contain documentation that the physician was notified of the daughter's desire to delay home health services. It did not contain documentation that the delay was discussed with the patient. The medical record did not contain documentation that the patient's suction machine was working at the time of the patient's discharge or that the patient and her family were able to suction her tracheostomy correctly at the time of discharge. The medical record did not contain documentation that the patient's discharge instructions included instructions regarding tracheostomy care or suctioning, or home health referral.

Review of Pt # 15's medical record for Emergency Department (ED) admission on 5/31/13 revealed:

Documentation by Emergency Medical Services (EMS) on 5/31/13: "...Patient contact 1839...Patient's family stated that during suctioning of her tracheostoma she began having sudden worsening of her work of breathing and shortness of breath...An unknown amount of time passed between that suctioning and the call for an ambulance. During that time the patient's family gave her an Albuterol treatment via small volume nebulizer. Patients (sic) mentation also diminished during this time. Upon arrival Patient was found in a bed room lying on her Right side not responding but her hands were clutching at nearby furniture. Patient had tracheostomy oxygen mask in place but due to body position and neck tissue, mask seal was poor...During transport the Paatients (sic) pallor as well as oxygen saturation improved...."

ED physician # 9 documented on 5/31/13 at 1916: "...Family just arrived and states that she was doing well since discharge 2 days ago. Today, she was suctioning herself out when she suddenly had great difficulty breathing. the family gave her an albuterol treatment and called EMS. When EMS arrived they found her obtunded and acutely dyspneic. O2 sats (Oxygen saturation) were in the 60's...1928...the patient appears diaphoretic, in obvious distress, severely distressed, not responsive to verbal commands, restless and agitated...When family arrived they informed me the patient wished to be DNR/DNI (Do Not Resuscitate/Do Not Intubate)...they decided to continue with her previous wishes and did not want intubation or resuscitation...Placed on BiPap soon after arrival. Patient's condition continued to deteriorate. CXR (Chest X-Ray) shows right lung field completely whited out...2010...Family decided to have BiPap removed...within 15 mins of removal of BiPap the patient expired...."

Review of Chest x-ray, one view revealed: "...Study Date 5/31/13; Comparison: 5/27/13...The lung fields show an extremely dense infiltrate involving the right mid and upper lung zone, and severe patchy infiltrates throughout the remainder...This represents a marked interval change when compared to the prior study...."

RN #2, Case Management, confirmed during interview conducted on 6/20/13, that she did not document notification of the physician regarding the delay in home health services when the patient was being discharged on 5/28/13. She did not recall notifying the physician. She did not ask the family whether the patient's suction equipment was functioning correctly or if the patient/family were operating the equipment correctly at the time of the patient's discharge. She did not ask the patient if she agreed with the delay in home health services.

Employee # 14, a Respiratory Therapist, confirmed during interview conducted on 6/20/13, that the patient's family had told him during her Observation admission on 5/28/13, that they were suctioning the patient at home and weren't sure how to operate the equipment properly or clean it out. He had told the family of the importance to keep the suctioning equipment clean to avoid re-infection. He did not provide instruction regarding suctioning and did not assess the patient's or family's ability to suction the patient correctly, since he did not have a physician's order to do so. He did not document the family's difficulties with the equipment and did not inform the physician.

The Nurse Manager confirmed during interview conducted on 6/20/13, that "Discharge Educational Material" referred to in the patient's "Discharge Instructions" dated 5/28/13, did not include educational material or instructions regarding tracheostomy suctioning or referral to home health.

Physician # 4 confirmed during interview conducted on 6/20/13, that she had not been informed by Case Management or any other nursing personnel of the patient's daughter's desire to delay home health services when the patient was discharged from Observation on 5/28/13. She stated that she would have waited to discharge the patient until she could speak with the daughter and communicate the importance of the patient receiving home health services as soon as possible after discharge.