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The Critical Access Hospital (CAH) identified a census of 2 swing bed patients. Based on document review and staff interview, the CAH failed to assure a doctor periodically reviewed and signed the medical record entries of the Mid-Level Practitioners for 15 of 15 acute patients (#1, 2, 3, 4, 5, 16, 17, 18, 19, 20, 21, 22, 23, 24, and 25), 5 of 5 Swing Bed patients (#6, 7, 8, 9, and 10), and 8 of 10 Emergency Department patients (#27, 28, 29 30, 32, 33, 34, and 35).

Findings include:

- Critical Access Hospital's Guidelines for Utilization of Physician Assistants dated 6/9/92, reviewed on 10/3/12 indicated duties which may be performed by the Physician Assistant as part of his/her routine work assignment include: histories, physical exams, and other chart entries which must be reviewed and countersigned by the responsible physician(s) as soon as feasible, but normally within 24 hours.

The CAH Medical Staff Bylaws, reviewed on 10/3/12, documented that an Allied Health Practitioner may exercise independent judgment within the areas of his professional competence and participate directly in the medical management of patients under the supervision of a Practitioner who had been accorded Privileges to provide such care.

Review of the medical records revealed the following records which failed to demonstrate physician supervision of the Allied Health Practitioner:

ACUTE PATIENTS:

- Patient #1's medical record reviewed on 9/26/12 revealed an admission date of 8/6/11 with diagnoses of weakness, Diabetes Mellitus, and falls.

Computerized orders between 8/6/11 to 8/9/11 reviewed on 9/26/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 1- Laboratory tests
2. 11- Medications

- Patient #2's medical record reviewed on 9/26/12 revealed an admission date of 12/3/11 with a diagnosis of pneumonia.

Computerized orders between 12/3/11 to 12/7/11 reviewed on 9/26/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 14- Laboratory tests
2. 4- Radiology tests
3. 24- Medications
4. 3-Treatment orders

- Patient #3's medical record reviewed on 10/2/12 revealed an admission date of 11/17/11 with diagnosis of Atrial Fibrillation and Congestive Heart Failure.

Computerized orders between 11/17/11 to 11/23/11 reviewed on 10/2/12 revealed orders lacked a co-signature from the supervising physician as follows:
1.10- Laboratory tests
2. 2- Radiology tests
3. 19- Medications
4. 1-Dietary
5. 10-Treatment

- Patient #4' s medical record reviewed on 10/2/12 revealed an admission date of 12/9/11 with a diagnosis of respite care for Hospice.

Computerized orders between 9/26/12 to 9/30/12 reviewed on 10/3/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 16-Medications

- Patient #5's medical record reviewed on 10/2/12 revealed an admission date of 8/9/12 with diagnosis of Pneumonia and Hypertension.

Computerized orders between 8/9/12 to 8/12/12 reviewed on 10/2/12 revealed orders lacked a co-signature from the supervising physician as follows:
1.9- Laboratory tests
2. 8- Radiology tests
3. 29- Medications
4. 2-Dietary
5. 8-Treatment

SWING BED PATIENTS:
- Patient #6's medical record reviewed on 10/1/12 revealed an admission date of 9/7/12 with diagnosis of Osteomylitis, Chronic Liver failure, and Diabetes Mellitus.

Computerized orders between 9/7/12 and 10/2/12 reviewed on 10/2/12 revealed orders lacked a co-signature from the supervising physician as follows:
1.9- Laboratory tests
2. 39- Medications
3. 24-Treatment

- Patient #7's medical record reviewed on 10/1/12 revealed an admission date of 9/20/12 with diagnosis of Left Hip Fracture repair.

Computerized orders between 9/20/12 and 10/2/12 reviewed on 10/2/12 revealed orders lacked a co-signature from the supervising physician as follows:
1.2- Laboratory tests
2. 3- Medications

- Patient #8's medical record reviewed on 10/2/12 revealed an admission date of 10/28/11 with diagnosis of right hip pain.

Computerized orders between 10/28/11 and 11/10/11 reviewed on 10/2/12 revealed orders lacked a co-signature from the supervising physician as follows:
1.5- Medications
2. 2-Treatments

- Patient #9's medical record reviewed on 10/2/12 revealed an admission date of 7/6/12 with diagnosis of Pneumonia, Diabetes type 2, Hypertension, and chronic Pulmonary embolism.

Computerized orders between 7/6/12 and 8/11/12 reviewed on 10/2/12 revealed orders lacked a co-signature from the supervising physician as follows:
1.17- Medications

- Patient #10's medical record reviewed on 10/2/12 revealed an admission date of 6/19/12 with diagnosis of Klebsiella pneumonia infection of the right hip.

Computerized orders between 6/19/12 and 7/28/12 reviewed on 10/2/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 11- Medications
2. 7-Treatments

- Patient #16's medical record reviewed on 9/27/12 revealed an admission date of 9/26/12 with a diagnosis of pneumonia.

Computerized orders between 9/26/12 to 9/30/12 reviewed on 10/3/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 8- Laboratory tests
2. 4- Radiology tests
3. 17- Medications

- Patient #17's medical record reviewed on 10/2/12 revealed an admission date of 12/14/11 with a diagnosis of back pain after a fall. Physician orders dated 12/14/11 revealed the patient required three pain relievers to treat their back pain.

Computerized orders between 12/13/11 to 12/17/11 reviewed on 10/3/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 8- Laboratory tests
2. 5- Radiology tests
3. 32- Medications
4. 1 Diet order

- Patient #18's medical record reviewed on 10/2/12 revealed an admission date of 12/27/11 with a diagnosis of acute pancreatitis with abdominal pain and alcohol withdrawal.

Computerized orders between 12/27/11 to 12/28/11 reviewed on 10/3/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 7- Laboratory tests
2. 1- Radiology tests
3. 4- Medications

- Patient #19's medical record reviewed on 10/3/12 revealed an admission date of 12/28/11 with a complaint of difficulty breathing and coughing up blood.

Computerized orders between 12/28/11 to 12/30/11 reviewed on 10/3/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 6- Laboratory tests
2. 1- Radiology tests
3. 5- Medications

- Patient #20's medical record reviewed on 10/3/12 revealed an admission date of 3/15/12 with a diagnosis of pneumonia.

Computerized orders between 3/15/12 to 3/19/12 reviewed on 10/3/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 13- Laboratory tests
2. 2- Radiology tests
3. 39- Medications
4. 1- Diet order
5. 1- Admit order
6. 1- Discharge order

- Patient #21's medical record reviewed on 10/3/12 revealed an admission date of 4/4/12 with a diagnosis of a small bowel obstruction.

Computerized orders between 4/4/12 to 4/5/12 reviewed on 10/3/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 7- Laboratory tests
2. 5- Radiology tests
3. 15- Medications

- Patient #22's medical record reviewed on 10/2/12 revealed an admission dated of 4/21/12 with a diagnosis of illus. (an intestinal obstruction, of the illus, due to loss of intestinal movement after abdominal surgery) after an abdominal hernia (a protrusion of an organ or tissue out of a body cavity) repair.

Computerized orders between 4/21/12 to 4/24/12 reviewed on 10/3/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 1- Radiology tests
2. 2- Medications
3. 1- Feeding tube order, flushes and tube management

- Patient #23's medical record reviewed on 10/2/12 revealed an admission dated of 4/27/12 with a diagnosis of acute liver failure and a history of insulin dependent diabetes.

Computerized orders between 4/27/12 to 4/29/12 reviewed on 10/3/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 23- Laboratory tests
2. 3- Medications

- Patient #24 ' s medical record reviewed on 10/2/12 revealed an admission date of 6/27/12 with a diagnosis of decreased blood pressure, urinary tract infection and acute renal failure. Patient #24 also had a history of insulin dependent diabetes.

Computerized orders between 6/27/12 to 7/2/12 reviewed on 10/3/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 9- Laboratory tests
2. 16- Medications

- Patient #25's medical record reviewed on 10/2/12 revealed an admission dated of 7/29/12 with a diagnosis of altered mental status and a history of insulin dependent diabetes.

Computerized orders between 4/27/12 to 4/29/12 reviewed on 10/3/12 revealed orders lacked a co-signature from the supervising physician as follows:
1. 8- Laboratory tests
2. 3- Radiology tests
3. 40- Medications
4. 1- Diet order
5. 1- Urinary catheter

THE FOLLOWING EMERGENCY PATIENTS TREATED BY THE MID-LEVEL PRACTITIONER:

- Patient #27's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 7/11/12 with a complaint of hallucinations.

Computerized orders dated 7/11/12 lacked evidence of the supervising physician's co-signature on the patient discharge orders. Review of the computerized medical record revealed licensed nursing staff V administered Vyvanse 20 milligrams (a medication to treat attention deficit hyperactivity disorder) to the patient. Review of medication orders revealed the computer software noted nursing staff V was the ordering provider and lacked evidence of a medical staff's signature for the medications.

- Patient #28's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 8/26/12 with a complaint of vaginal bleeding, syncope and dizziness.

Computerized orders dated 8/26/12 lacked evidence of a supervising physician co-signature for six medications administered in the emergency department.

- Patient #29's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 6/22/12 with a complaint of nausea and pacemaker concerns,

Computerized orders dated 8/26/12 lacked evidence of a supervising physician co-signature on their discharge orders.

Medical records staff O, interviewed on 10/8/12 at 3:35pm verified the patient left the hospital during treatment and did not sign a consent form.

- Patient #30's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 6/7/12 with a complaint of being under the influence of an unknown substance.

Computerized orders dated 6/7/12 lacked evidence of a supervising physician co-signature and noted "Awaiting signature from hospital analysis pool."

Medical records staff O reported the notation indicated they have not assigned the orders to a physician. Staff reported their computer screen did not indicate this medical record was delinquent and stated "this is another one out in outer space". Staff O stated they did not know how to find the orders to have them signed.

- Patient #32's medical record reviewed on 9/27/12 revealed they presented to the emergency room on 1/5/12.

The orders demonstrated the supervising physician failed to co-sign the following medication orders within 24 hours as follows:
1. Rocephin (a antibiotic medication) 1,000 milligrams intravenously.
2. Toradol (a medication used to reduce pain) 30 milligrams
3. Tylenol (a medication used to reduce pain) 1,000 milligrams
4. Ativan (a medication used to reduce anxiety) 2 milligrams

- Patient #33's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 10/13/11 with a complaint of neck and shoulder pain that extended down their arm after a sports injury.

Computerized orders dated 10/13/11 lacked evidence of a supervising physician co-signature for two radiology tests and order to transfer the patient to another hospital.

- Patient #34's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 7/19/12 in cardiac arrest .

Computerized orders dated 7/19/12 lacked evidence of a supervising physician co-signature for two medications used in patient emergency care.

- Patient #35's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 7/1/12 with a complaint of altered mental status.

Computerized orders dated 7/1/12 lacked evidence of a supervising physician co-signature for two medications, chest x-ray and straight catheterization of the patient.

The Critical Access Hospital reported a census of 2 patients with both patients and 33 closed medical records reviewed. Based on observation, document review and staff interview the hospital failed to ensure the infection control officer had a system for reporting, investigating and controlling infections and communicable diseases of patients and personnel, failed to ensure outpatient services were under the direction of a single designated staff member responsible for outpatient services, failed to ensure orders by the mid-levels were authenticated by the supervising physician, and failed to ensure nursing staff developed individualized plans of care that reflected the patients nursing and health needs.

The cumulative effect of the hospital's failure to ensure the provision of services with Infection Control, Outpatient services, and drugs administered in accordance with written and signed orders from a medical provider and failure to develop and keep current a plan of care resulted in the CAH's inability to ensure the provision of quality health care.

Findings include:

- The Critical Access Hospital failed to ensure the infection control officer developed and maintained a system for reporting, investigating and controlling infections and communicable diseases of patients and personnel. See further evidence at C-0278, CFR 485.635(a)(3)(vi).

- The Critical Access Hospital failed to ensure their outpatient services were under the direction of a single designated staff member responsible for outpatient services. See further evidence at C-0281, 42 CFR 485.635(b)(1).

- The Critical Access Hospital failed to ensure all drugs are administered in accordance with written and signed orders from a medical provider. See further evidence at C-0297, 42 CFR 485.635(d)(3).

- The Critical Access Hospital failed to ensure the staff developed and kept current nursing plans of care for inpatients. See further evidence at C-0298, 42 CFR 485.635(d)(4).

The Critical Access Hospital reported a census of 2 patients with both inpatients and 33 closed medical records. Based on observation document review and staff interview the infection control officer failed to develop and maintain a system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel. The Critical Access Hospital lacked evidence of quarterly infection control meetings with reports of the meeting results discussed with the governing body and medical staff. The infection control officer failed to evaluate the cleaning supplies used by the hospital's cleaning staff to ensure the cleaner was effective against identified microorganisms at the hospital.

Findings include:

- Critical Access Hospital's Medical Staff Bylaws reviewed on 10/3/12, section 8.4.6, directed the hospital to ensure the composition of their infection control committee included: Chief of Staff, Pharmacist, a representative of Nursing Clinical Services, Infection Control Manager, Performance Improvement/Quality Assurance Coordinator, Director of Laboratory, The Medical Staff Coordinator and the hospital President shall serve as advisory staff to the committee and shall attend all meetings.

Review of the CAH's infection control meeting minutes lacked evidence of who attended the meetings.

Critical Access Hospital's Medical Staff Bylaws reviewed on 10/3/12, section 8.4.6.3 Meetings: The Infection Control shall meet quarterly, and shall maintain a record of its proceedings and activity and shall report in writing through its chairperson to the full Medical Staff.

Infection control meeting minutes revealed the committee began to meet once a year in 2010, 2011 and 2012.

Review of the CAH ' s monthly Medical Executive Meetings revealed the infection control officer reported MRSA infections only and lacked evidence of any additional infection control concerns. Review of the Governing body meeting minutes lacked evidence of any infection control committee information.

Infection control officer B interviewed on 10/3/12 at 2:30pm verified they only reported MRSA to the medical staff and failed to track and trend other reported patient infections.

- Critical Access Hospital ' s Medical Staff Bylaws reviewed on 10/3/12, section 8.4.6.2. Duties: The committee shall be responsible for the surveillance of hospital infections, the review and analysis of actual infections, the promotion of a preventative and corrective program, and the supervision of infection control in all phases of the hospital activities, including the operation rooms, recovery room and special care units.

Review of infection control documentation lacked evidence of any tracking, trending and investigation for patient infections.

- Critical Access Hospital Infection Control Surveillance and Reporting Mechanism policy directed the infection control officer to use Center for Disease Control (CDC) for a comparative data analysis on healthcare acquired infections in order to evaluate prevention and control efforts. The policy directs the infection control officer to obtain and review all infectious laboratory results and evaluate incoming patients for the potential for patients with communicable infections being transferred to the CAH. Investigate all patient infections and report the findings to the infection control committee, medical staff and to determine the need for further investigation, analysis, discussion and recommendations.

Infection control officer B interviewed on 10/3/12 at 2:30pm verified they failed to trend and report all infections to the infection control committee, medical staff and to the governing body.

- Infection control officer B's employment record reviewed on 9/27/12 lacked evidence of a job description that outlined their responsibilities, and required qualifications for the position. Staff B's employment record and interview with this staff evidenced they lacked infection control training.

Infection control officer B interviewed on 10/3/12 at 2:30pm verified they lacked infection control training or education to perform the infection control duties.

Staff B reported the CAH ' s infection control program lacked evidenced of a program that used a nationally recognized systems of infection control guidelines to avoid sources and transmission of infections and communicable diseases as recommended by organizations such as the Centers for Disease Control and Prevention (CDC) Guidelines for Prevention and Control of Nosocomial Infections, the CDC Guidelines for Preventing the Transmission of Tuberculosis in Health Care Facilities, the Occupational Health and Safety Administration (OSHA) regulations, and the Association for Professionals in Infection Control and Epidemiology (APIC) infection control guidelines, etc.).

Staff B reported the infection control program lacked policies that address the following:

1. Lacked measures for assessing and identifying patients and health care workers, including CAH personnel, contract staff (e.g., agency nurses, housekeeping staff), and volunteers, at risk for infections and communicable diseases;

2. Lacked measures for the prevention of infections, especially infections caused by organisms that are antibiotic resistant or in other ways epidemiologically important; device-related infections (e.g., those associated with intravascular devices, ventilators, tube feeding, indwelling urinary catheters, etc.); surgical site infections; and those infections associated with tracheostomy care, respiratory therapy, burns, immunosuppressed patients, and other factors which compromise a patient's resistance to infection;

3. Lacked education of patients, family members and caregivers about infections and communicable diseases. Staff B reported the only patient/family education was for MRSA.

4. Lacked techniques for asepsis, disinfection, food sanitation, housekeeping, fabric care, liquid and solid waste disposal, separation of clean from dirty, as well as other means for limiting the spread of contagion;

5. Lacked authority and indications for obtaining microbiological cultures from patients;

6. Lacked an evaluation of the approved disinfectants, antiseptics, and germicides be used by the hospital to ensure manufacturers' instructions for use are followed and ensure the cleaning solutions killed the microorganisms identified at the hospital.
Infection Control officer B and cleaning staff supervisor C interviewed on 9/26/12 at 8:45am reported the hospital lacked policies or procedure for cleaning the operating room. Staff C reported on 10/3/12 at 3:30pm acknowledged the current " Neutral Disinfectant Cleaner " was not effective germicidal cleaner for gram negative bacillus, strep pneumonia, Hemophilia influenza, pseudomonas, and strep agalactiae.

7. Lacked measures for the screening and evaluation of health care workers, including all CAH staff, contract workers such as agency nurses, housekeeping staff, and volunteers, for communicable diseases, and for the evaluation of staff and volunteers exposed to patients with non-treated communicable diseases;

8. Lacked employee health policies regarding infectious diseases and when infected or ill employees, including contract workers and volunteers, must not render patient care and/or must not report to work;

9. Lacked a procedure for meeting the reporting requirements of the local health authority;

10. Lacked procedures for working with local, State, and Federal health authorities in emergency preparedness situations;

11. Lacked policies and procedures developed in coordination with Federal, State, and local emergency preparedness and health authorities to address communicable disease threats and outbreaks.

12. Lacked provision for program evaluation and revision of the program when indicated.

The Critical Access Hospital reported a census of 2 patients with both patients and 33 closed medical records reviewed. Based on observation document review and staff interview the nursing staff failed to develop individualized plans of care that reflected the patients nursing and health needs for 7 of 15 acute care patients (patient #'s 16, 17, 18, 22, 23, 24, 25).

Findings include:

- The policy and procedure for the CAH titled "Admissions of Patients", #04-01-2009, reviewed on 10/4/12, stated "...16. Each patient admitted will have a care plan initiated at time of admission..."

- The medical record for Swing bed patient #8, reviewed on 10/2/12, revealed the patient was admitted to the CAH on 10/28/11 and discharged on 11/10/11. The CAH failed to develop a plan of care for this patient during the 39 days the patient was in the CAH.

Licensed Nurse R, verified the medical record failed to document the CAH developed a plan of care for this patient.

- Patient #16's medical record reviewed on 10/2/12 revealed an admission date of 9/26/12 with a diagnosis of pneumonia. Review of patient #16's plan of care, dated 9/27/12, revealed the nursing staff documented the patient was in isolation. Patient #16 observed on 9/27/12 was not in isolation. Administrative nurse B interviewed on 10/2/12 at 10:00am reported patient #16 was not in isolation and stated the plan of care was incorrect. Staff B reported the computer auto populates the plan of care with information from canned (preprogrammed plans of care) information and nursing staff needs to change the information to reflect patient's current needs.

- Patient #17's medical record reviewed on 10/2/12 revealed an admission date of 12/14/11 with a diagnosis of back pain after a fall. Physician orders dated 12/14/11 revealed the patient required three pain relievers to treat their back pain. Patient # 17's plan of care, dated 12/14/11, lacked evidence of a plan to treat the patient's pain.

- Patient #18's medical record reviewed on 10/2/12 revealed an admission dated of 12/27/11 with a diagnosis of acute pancreatitis with abdominal pain and alcohol withdrawal. Physician orders dated 12/27/12 revealed orders for an alcohol level, and a diet order to give the patient nothing by mouth. Patient #18's plan of care, dated 12/27/11, lacked evidence of interventions to treat alcohol withdraw and to ensure the patient did not eat or drink as ordered by the physician.

- Patient #22's medical record reviewed on 10/2/12 revealed an admission date of 4/21/12 with a diagnosis of illus (an intestinal obstruction, of the illus due to loss of intestinal movement after abdominal surgery) after an abdominal hernia (a protrusion of an organ or tissue out of a body cavity) repair. Admission notes dated 4/21/12 identified patient #22 was incontinent of urine, required a feeding tube for food and had problems with constipation. Physician orders dated 4/23/23 revealed the patient received enemas and laxative suppositories to treat constipation then required transfer to a higher level of care hospital on 4/24/12 to treat complications from their ileus. Patient #22's plan of care, dated 4/22/12, lacked evidence a plan to treat the patient's constipation.

- Patient #23's medical record reviewed on 10/2/12 revealed an admission date of 4/27/12 with a diagnosis of acute liver failure and a history of insulin dependent diabetes. Physician orders dated 4/27/12 directed staff to monitor the patient blood sugars and administer insulin based on the test results and provide a diabetic diet. Patient #23's plan of care, dated 4/27/12, lacked interventions for blood sugar monitoring, insulin use and their diabetic diet.

- Patient #24's medical record reviewed on 10/2/12 revealed an admission date of 6/27/12 with a diagnosis of decreased blood pressure, urinary tract infection and acute renal failure. Patient #24 also had a history of insulin dependent diabetes. Physician orders dated 6/27/12 directed nursing staff to insert a urinary catheter, monitor blood sugars and administer insulin based on the test results and provide a diabetic diet. Patient #24's plan of care lacked evidence of interventions to treat their diabetes with a diabetic diet, monitor blood sugars and administer insulin. The plan of care, dated 6/28/12, lacked interventions to treat their urinary tract infection and use of a urinary catheter.

- Patient #25's medical record reviewed on 10/2/12 revealed an admission date of 7/29/12 with a diagnosis of altered mental status and a history of insulin dependent diabetes. Physician orders dated 7/29/12 directed staff to monitor the patient blood sugars and administer insulin based on the test results and provide a diabetic diet. Patient #25's plan of care, dated 8/1/12, lacked interventions for blood sugars, insulin use and their diabetic diet.

The Critical Access Hospital (CAH) reported a census of 2 patients with both patients and 33 closed medical records reviewed. Based on observation, document review and staff interview, the CAH failed to assure the completeness and accessibility of all medical records, failed to assure all patients completed a timely and properly executed consent, and failed to assure security of medical records stored in a basement storage area.

The cumulative effect of the CAH's failure to ensure completeness, accessibility, and security of the CAH's medical records resulted in the CAH's inability to ensure good continuity of care and created the potential for loss or unauthorized use of the medical record information.

Findings include:

- The Critical Access Hospital failed to assure the accessibility and completeness of patient medical records. See further evidence at C-0302, 42 CFR 485.638(a)(2).

The Critical Access Hospital failed to assure all patients completed a timely consent form prior to treatment. See further evidence at C-304, 42 CFR 485.638(a)(4)(i).

The Critical Access Hospital failed to assure the security of their paper medical records kept in an unlocked and attended basement storage area. See further evidence at C-0308, 42 CFR 485.638(b)(1)

The Critical Access Hospital (CAH) identified a census of 2 swing bed patients. Based on document review, record review and staff interview, the CAH failed to assure 12 Acute care patients (#1, 2, 5, 16, 17, 18, 19, 20, 22, 23, 24, 25), 4 Swing Bed patients (#6, 8, 9, 10) and 6 patients treated in the Emergency Department (#26, 27, 29, 30 32, 35) completed a properly executed consent form.

Findings include:

- The CAH policy for patient consents, B_MRM_ALL_1001_Universal Consent_5/8/12, directed staff that all patients presenting for a Mercy service must have an active Universal Consent on file (scanned into Epic) which is representative of the location of service. A Hospital Universal Consent must be on file for services provided in the hospital setting. The Universal Consent form is effective for one calendar year from the date of execution and is specific to the patient.

Review of the medical records revealed the following:

ACUTE PATIENTS:

- Patient #1's medical record reviewed on 9/26/12 revealed an admission date of 8/6/11.

Patient #1's medical record, reviewed on 9/26/12 revealed a " Universal Hospital Consent " signed on 9/11/12, after the date of this admission on 8/6/11, and used to authorize care for their 8/6/11 hospitalization.

- Patient #2's medical record reviewed on 9/26/12 revealed an admission date of 12/3/11.

Patient # 2's medical record reviewed on 9/26/12 revealed a " Universal Hospital Consent" signed on 5/18/11 and used to authorize hospital care for their 9/26/12 hospitalization.

- Patient #5's medical record reviewed on 10/2/12 revealed an admission date of 8/9/12.

Patient # 5's medical record reviewed on 10/2/12 revealed a " Universal Hospital Consent" signed on 5/24/11 and used to authorize hospital care for their 8/9/12 hospitalization.

- Patient #16's medical record reviewed on 9/27/12 revealed an admission date of 9/26/12.

Patient # 16's medical record reviewed on 10/3/12 revealed a "Universal Hospital Consent" signed on 6/21/12 and used to authorize hospital care for their 9/26/12 hospitalization.

- Patient #17's medical record reviewed on 10/2/12 revealed an admission dated of 12/14/11.

Patient #17's medical record reviewed on 10/3/12 revealed a "Universal Hospital Consent" signed on 10/18/11 and used to authorize hospital care for their 12/13/11 hospitalization.

- Patient #18's medical record reviewed on 10/2/12 revealed an admission date of 12/27/11.

Patient # 18's medical record reviewed on 10/3/12 revealed a "Universal Hospital Consent" signed on 5/3/11 and used to authorize hospital care for their 12/27/11 hospitalization.

- Patient #19's medical record reviewed on 10/3/12 revealed an admission date of 12/28/11.

Patient # 19's medical record reviewed on 10/3/12 revealed a "Universal Hospital Consent" signed on 5/4/11 and used to authorize hospital care for their 12/28/11 hospitalization.

- Patient #20's medical record reviewed on 10/3/12 revealed an admission date of 3/15/12.

Patient # 20's medical record reviewed on 10/3/12 revealed a "Universal Hospital Consent" signed on 5/2/11 and used to authorize hospital care for their 3/15/12 hospitalization.

- Patient #22's medical record reviewed on 10/2/12 revealed an admission dated of 4/21/12.

Patient # 22's medical record reviewed on 10/3/12 revealed a "Universal Hospital Consent" signed on 5/19/11 and used to authorize hospital care for their 4/21/12 hospitalization.

- Patient #23's medical record reviewed on 10/2/12 revealed an admission dated of 4/27/12.

Patient # 23's medical record reviewed on 10/3/12 revealed a " Universal Hospital Consent" signed on 3/14/12 and used to authorize hospital care for their 4/27/12 hospitalization.

- Patient #24 ' s medical record reviewed on 10/2/12 revealed an admission dated of 6/27/12.

Patient # 24's medical record reviewed on 10/3/12 revealed a "Universal Hospital Consent" signed on 2/27/12 and used to authorize hospital care for their 6/27/12 hospitalization.

- Patient #25's medical record reviewed on 10/2/12 revealed an admission dated of 7/29/12.

Patient # 25's medical record reviewed on 10/3/12 revealed a "Universal Hospital Consent" signed on 8/19/11 and used to authorize hospital care for their 4/27/12 hospitalization.


SWING BED PATIENTS:
- Patient #6's medical record reviewed on 10/1/12 revealed an admission date of 9/7/12.

Patient #6's medical record reviewed on 10/2/12 revealed a " Universal Hospital Consent" signed on 5/1/12 and used to authorize hospital care for their 9/7/12 hospitalization.

- Patient #8's medical record reviewed on 10/2/12 revealed an admission date of 10/28/11.

Patient #8's medical record reviewed on 10/2/12 revealed a "Universal Hospital Consent" signed on 5/20/11 and used to authorize hospital care for their 10/28/11 hospitalization.

- Patient #9's medical record reviewed on 10/2/12 revealed an admission date of 7/6/12.

Patient #9's medical record reviewed on 10/2/12 revealed a "Universal Hospital Consent" signed on 5/22/12 and used to authorize hospital care for their 7/6/12 hospitalization.


- Patient #10's medical record reviewed on 10/2/12 revealed an admission date of 6/19/12.

Patient #10's medical record, reviewed on 10/2/12 revealed an "Universal Hospital Consent" signed on 10/16/11 and used to authorize hospital care for their 6/19/12 hospitalization.

PATIENTS TREATED IN THE EMERGENCY DEPARTMENT:

- Patient #26's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 7/12/12.

Patient # 26's medical record reviewed on 9/27/12 revealed a "Universal Hospital Consent" signed on 1/16/12 and used to authorize hospital care for their 7/12/12 emergency room visit.

- Patient #27's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 7/11/12.

Patient #27's medical record reviewed on 9/27/12 revealed a "Universal Hospital Consent" signed on 3/9/12 and used to authorize hospital care for their 7/11/12 emergency room visit.

- Patient #29's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 6/22/12.

Patient #29's medical record reviewed on 9/27/12 lacked evidence of a hospital consent to authorize hospital care for their 7/11/12 emergency room visit.

- Patient #30's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 6/7/12.

Patient #30's medical record reviewed on 9/27/12 revealed a "Universal Hospital Consent" signed on 6/7/12 and used to authorize hospital care for their 6/7/12 emergency room visit.

- Patient #32's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 1/5/12.

Patient #32's medical record reviewed on 9/27/12 revealed a "Universal Hospital Consent" signed on 5/19/11 and used to authorize hospital care for their 1/5/12 emergency room visit.

- Patient #35's medical record reviewed on 9/27/12 revealed they presented to the emergency department on 7/11/12.

Patient #35's medical record reviewed on 9/27/12 revealed a "Universal Hospital Consent" signed on 9/20/11 and used to authorize hospital care for their 7/11/12 emergency room visit.

The Critical Access Hospital (CAH) identified a census of 2 swing bed patients. Based on observation, document review and staff interview, the CAH failed to assure the security of medical records for patients #51, 52, 53, 54, 55, and estimated folders of patient information of greater than 1000 in an unlocked and unattended basement room of the CAH.

Findings include:

- The CAH policy for Medical Record titled-STATISTICS, DATA COLLECTION, INDEXES, REGISTERS, AND REPORTS, reviewed on 10/3/12 documented the CAH would maintain "...The privacy of patients/clients and practitioners shall be protected..." and "...Access to the database shall be strictly controlled in order to achieve the following: protect the confidentiality of the data.." This policy failed to address how the CAH planned to protect the confidentiality of the paper medical record.

During tour of the Laundry/Housekeeping areas of the CAH, on 9/26/12 at 9:00am observation revealed an open and unattended room in the basement of the CAH which contained the paper medical records of patients #51, 52, 53, 54, 55, and estimated folders of patient information greater than 1000 patient records.

Interview with Licensed staff J, on 9/26/12 at 9:10am, verified this room remained open so Laundry and Housekeeping staff could get to their supplies.

The Critical Access Hospital (CAH) reported a census of 2 patients with both patients and 33 closed medial records reviewed. Based on observation, document review, and staff interview, the CAH failed to develop a plan of action to correct practices identified which did not met professional standards of practice with Medical Records , Infection Control, Patient Care Plans, and Quality Assurance were addressed in the CAH's Quality Assurance Program to obtain improvements in patient care and safety.

The cumulative effect of the Critical Access Hospitals failure to assure the review of medical records completeness for plans of care, rights and advanced directives, properly executed consents for treatment, infection control tracking, and planned mid-level oversight through through a comprehensive Quality Assurance/Performance Improvement program resulted in the CAH's inability to ensure patient safety and care.

Findings include:

- The Critical Access Hospital failed to assure a doctor periodically reviewed and signed the medical record entries of the Mid-Level Practitioners. See further evidence at C-0260, 42 CFR 485.631(b)(1)(iv).

- The Critical Access Hospital failed to ensure the infection control officer utilized a system for reporting, investigating and controlling infections and communicable diseases of patients and personnel, failed to ensure outpatient services were under the direction of a single designated staff member responsible for outpatient services, failed to ensure orders by the mid-levels were authenticated by the supervising physician, and failed to ensure nursing staff developed individual plans of care for all patients (acute and swing bed) which reflected the patients nursing and health needs. See further evidence at C-278, 42 CFR 48.635(a)(3)(vi), C-0281, 42 CFR 485.635(b)(1), C-297, 42 CFR 485.635(d)(3), and C-0298, 42 CFR 485.635(d)(4).

- The Critical Access Hospital failed to assure all patients completed a properly executed consent form. See further evidence at C-0304, 42 CFR 485.638(a)(4)(i).

- The Critical Access Hospital failed to assure all patient care services and other services affecting patient health and safety were included in the CAH's Quality Assurance program to obtain improvement. See further evidence at C-0337, 42 CFR 485.641(b)(1).

- The Critical Access Hospital's failed consistently provide Swing Bed patients with their Patient Rights and Advanced Directives information. See further evidence at C-0361 and C-0362, 42 CFR. 485 645(d)(1).

- The Critical Access Hospital failed to complete a plan of care and or failed to complete an individual and comprehensive plan of care for all patients. See further evidence at C-0395, 42 CFR 485.645(d)(6).

The Critical Access Hospital (CAH) reported a census of 2 patients with both patients and 33 closed medical records reviewed. Based on document review and staff interview the CAH failed to assure all patient care services and other services affecting patient health and safety were included in the CAH's Quality Assurance program to obtain improvement.

Findings included:

- The CAH policy titled "SUBJECT:STATISTICS, DATA COLLECTION, INDEXES, REGISTERS, AND REPORTS", reviewed on 10/3/12, documented the Quality Assurance Committee consisted of Physician's, Administration B, Nursing, Medical Records, and the Quality Assurance Coordinator. This policy indicated this committee was to hold meetings quarterly.

On 9/25/12 at 4:20pm Licensed Administrative Nurse B, stated they were able to locate Quality Assurance meeting minutes for 1/24/11, 4/4/11, and 7/11/12. Staff B stated that 1/24/11 only Pharmacy and Laboratory reported Quality Assurance data to them, and on 4/4/11 no departments reported any Quality Assurance data, and on 7/11/12 (15 months later) only Nursing reported data.

Review of the Quality Improvement Schedule provided, for 2012, and documentation of Quality Assurance activities, documented all Departments failed to to report Quality Assurance information as scheduled, and 6 departments lacked any reported information by 10/4/12 (Central Sterile, Social Services, Respiratory Therapy, Medical Records, Laboratory and Physical Therapy).

- Medical records staff O interviewed on 9/27/12 at 4:00pm reported the CAH did not have any delinquent records. Staff O later provided a "Chart deficiency pull list for their HIM (Health Information Management) Analysis pool" which documented the CAH had 645 incomplete medical records. Staff O indicated the medical record department could not access those medical records. Staff O verified these medical records as incomplete.

- Licensed Physician T, interviewed on 10/3/12 at 3:40pm, stated they became aware of the problem with this Physician's ability to pull up the medical records and sign them approximately 2 months ago. Staff T stated Medical Records staff member O ran a report which indicated there were Physicians orders "hanging out in a work que" that needed signed but the computer system failed to notify the Physician of this lack of documentation. Physician T stated that they were working with EPIC computer system to fix this.

The Critical Access Hospital (CAH) identified a census of 2 swing bed patients. Based on document review, record review and staff interview, the CAH failed to assure 3 of 5 sampled swing bed patients were informed of their rights and provided education on their rights.(#6, #8, #10).

Findings included:

- The CAH policy for Patient's Bill of Rights for Swing Bed Patients, reviewed on 10/3/12, stated "...Procedure: 1. The patient is given the Patient's Bill of Rights/Information and Agreement brochure..."

Review of the medical record for swing bed patient's #6, #8 and #10 lacked evidence the CAH provided the patients with a copy of their rights and lacked evidence the CAH educated patients about their rights.

Licensed Nurse R, interviewed on 10/2/12 at 3:30pm, stated the CAH admission staff provided the Bill of Rights to the patients, but verified the medical records for patients , #6, #8, and #10 lacked this information.

The Critical Access Hospital (CAH) identified a census of 2 swing bed patients. Based on document review, record review and staff interview, the CAH failed to assure 3 of 5 sampled swing bed patients were informed of their right to formulate Advanced Directives (#6, #8, #10).

Findings include:

- The CAH policy for Advanced Directives, reviewed on 10/3/12 at 2:35pm stated the Patient Self Determination Act required all Hospitals to inform adult patients of their rights to an Advanced Directive. The policy directed staff to give a copy of the Advanced Directives policy to all adult patients so all patients would have the opportunity to issue Advanced Directives, if desired.

Review of the medical record for swing bed patient's #6, #8 and #10 lacked evidence the CAH determined if the patients had already formulated Advanced Directives and/or if they needed the information in order to do this.

Licensed Nurse R, interviewed on 10/2/12 at 3:30pm, stated belief that the CAH admission staff provided this information to the patients and verified the medical records for patients , #6, #8, and #10 lacked this information.

The Critical Access Hospital (CAH) identified a census of 2 swing bed patients. Based on document review, record review and staff interview, the CAH failed to assure 2 of 5 sampled swing bed patients participated in planning their care and treatment. (#7, #8).

Finding include:

- The Swing Bed Patient Bill of Rights, reviewed on 9/26/12, informed patients of their right to participate in the planning of their care.

Review of the medical records for patients #7 and #8 lacked documentation the patients were afforded this right.

Licensed Nurse R, interviewed on 10/1/12 and 10/2/12, stated staff failed to include patients in planning their care and treatment.

The Critical Access Hospital (CAH) identified a census of 2 swing bed patients. Based on document review, record review and staff interview, the CAH failed to complete a plan of care for 1 of 5 sampled swing bed patients (#8) and failed to complete a comprehensive plan of care for 1 of 5 sampled swing bed patients (#7).

Findings include:

- The policy and procedure for the CAH titled "Admissions of Patients", #04-01-2009, reviewed on 10/4/12, stated "...16. Each patient admitted will have a care plan initiated at time of admission..."

- The closed medical record for Swing bed patient #8, reviewed on 10/2/12, revealed the patient was admitted to the CAH on 10/28/11 and discharged on 11/10/11. The CAH failed to develop a plan of care for this patient during the 39 days the patient was in the CAH.

Licensed Nurse R, verified the medical record failed to document the CAH developed a plan of care for this patient.

- The medical record for current swing bed patient #7, reviewed on 10/1/12, revealed an admission date of 9/20/12 for Physical Therapy.

Observation of care for Patient #7 on 9/25/12 at 4:45pm included a dressing change on a hip surgical wound.

The plan of care reviewed on 10/1/12 lacked a plan for the treatment and plan for patient #7's hip surgical wound.

Licensed Nurse R, on 10/2/12, verified the lack of information regarding the surgical incision and dressing in the plan of care.