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Based on interview and record review, the facility failed to adopt Medical Staff Bylaws that give only the Governing Body the authority to grant medical staff privileges. This deficient practice had the potential for all patients admitted to the facility to receive substandard care. The facility census was three.

Findings included:

1. Record review of the facility's undated Medical Staff Bylaws showed in Article VI, The Delineation of Clinical Privileges, 10. (b) After reviewing the favorable recommendation of the Chief of Staff, the Chief Executive Officer may grant temporary privileges.

2. During an interview on 09/10/14 at 11:15 AM, Staff A, Chief Executive Officer (CEO), stated that he had not granted any physicians temporary privileges since being appointed CEO in 03/13.

Based on observation, interview and policy review the facility failed to ensure that staff followed facility policy for outdated, mislabeled, or otherwise unusable drugs available for patient use. These failed practices impacted the medication safety of all patients seeking care at the facility. The facility census was three.

Findings included:

1. Record review of the facility's policy titled, "Labeling of Medications" dated 06/04/13, showed medication containers shall have a label showing the drug trade name (if any), the generic name, the strength (if any), the lot number and the expiration date. For insulin that belongs to the patient the prescription labels shall show the patient name, medication direction, doctor name, and NDC # (National Drug Code, a unique 10-digit, 3-segment number and universal product identifier for human drugs.) of pharmacy filling-doctor.

Record review of the facility's policy titled, "Disposition of Discontinued and Out-Dated Drugs" dated 06/04/13, showed no outdated drugs shall be stocked or used. Open vials are considered out-dated 30 days after opening or puncturing.

2. During an interview on 09/10/14 at 8:35 AM, Staff O, Pharmacist, stated that it was the facility policy that all multi-dose vials be labeled with an expiration date of 30 days when the seal on the vial was broken.

Observation of the pharmacy medication refrigerator on 09/10/14 at 9:30 AM showed two multi-dose vials of Lantus Insulin,100 units/ml (milliliter, unit of measure), with a patient label on the boxes the vials were sitting in but the vials were not labeled and did not have expiration dates. The refrigerator also contained two floor stock multi-dose vials of Humalog Insulin, 100 units/ml, opened with no expiration dates labeled.

During an interview on 09/10/14 at 9:30 AM, Staff G, Pharmacy Technician, confirmed that two multi-dose vials of Insulin had the caps removed. Staff G stated that she did not know why the floor stock Insulin had been opened and not labeled with an expiration date.

During an interview on 09/10/14 at 2:10 PM, Staff B, Registered Nurse (RN), Director of Nursing (DON), stated that she would expect all multi-dose vials of medications to be labeled with the expiration date of 30 days from when the cap was removed.

3. Observation of the medication storage cabinet in Emergency Department (ED) room #1 on 09/09/14 at 1:20 PM showed an open bottle of Lidocaine viscous (stomach pain relief) with no label of date opened and an open bottle of Donnatal (stomach pain relief) with no label of date opened.

During an interview concurrent with medication observation, Staff L, RN, stated that the medication should be labeled with the date staff opened the bottle of medication.

During an interview on 09/09/14 at 4:00 PM Staff E, RN, ED staff, stated that she would have to look up how long the medication was good after opening.

During an interview on 09/09/14 at 4:20 PM with Staff B, DON, stated that the medication should be labeled. Staff B stated that the medication was good for 30 days after opening.

4. Record review of the facility's policy titled, "Storage of Medications and Supplies" dated 06/07/13, showed drugs stored within the pharmacy and throughout the hospital shall be stored under the supervision of the pharmacy department under proper conditions of sanitation, temperature, light, moisture ventilation, segregation and security. All medications, except those requiring refrigeration, shall be locked in the medicine cart.

Observation on 09/09/14 at 11:00 AM in the ED storage cabinet in room #2 showed medication vial of Diphenhydramine (used for allergic reactions) with a label stating "protect from light". Observation showed medication in clear vial directly under a light source.

During an interview concurrent with medication observation, Staff L, RN, stated that the medication should not be exposed to the overhead light and that the medication should probably be in a bag to protect from light.

Observation of ED rooms #1 and #3 on 09/09/14 at 3:00 PM showed vials of Diphenhydramine exposed to light source also with no protective packaging to protect from the light source.

During an interview on 09/09/14 at 4:20 PM, Staff B, DON, stated that the medication should not have been in the cabinet without protection from light.




15697

Based on interview, the facility failed to have in place, an established policy related to reporting adverse drug reactions (ADR) that occurred, in the facility, to the Food and Drug Administration (FDA) MedWatch Program (the FDA's reporting system for an adverse event, which is an unexpected or unanticipated outcome, death, or serious physical or psychological injury, or the risk thereof). This had the potential to affect all patients that received medication therapy throughout the facility. The facility census was three.

Findings included:

During an interview on 09/10/14 at 2:10 PM , Staff O, Pharmacist, stated that to his knowledge the facility did not have a process or policy to report ADR that occurred in the facility to the FDA MedWatch program. Staff O stated that he had never reported an ADR to the FDA. Staff O stated that ADR were tracked using an event reporting system. He stated that the event reports were sent to the Director of Nursing (DON).

During an interview on 09/10/14 at 2:15 PM, Staff B, Registered Nurse (RN), DON, stated that she received all medication related event reports and discussed them with the pharmacist. Staff B stated that to her knowledge there was no process to report them outside the facility. Staff B stated that she had never reported an ADR event to the FDA.

Based on observation, interview and policy review, the facility failed to ensure:
- Staff followed handwashing policies when giving care to four patients (#8, #9, 26, #29) of six patients observed.
- Staff maintained the cleanliness of laryngoscope blades (equipment used to insert a breathing tube in the mouth and throat) stored in two of two emergency carts (contain emergency medications and supplies).
- Staff maintained Emergency Department (ED) supplies in a manner to prevent water contamination for three of three ED rooms.
- Staff maintained ED mattress surface free from tears to allow proper cleaning for one of three ED mattresses observed.
- Staff maintained the surface integrity of lead aprons used on patients receiving radiology tests to allow proper cleaning for three of six aprons observed.
These failures increased the risk for hospital acquired infection for all patients admitted to the facility, staff and visitors. The facility census was three.

Findings included:

1. Record review of the facility policy titled, "Control of Nosocomial Infections: Handwashing," revised on 02/10/12, showed direction for facility staff:
- To protect the patient from nosocomial infection (infection acquired while hospitalized), hand washing must be performed routinely and thoroughly.
- All personnel should wash their hands before and after each direct contact with the patient or patient care items.
- The use of gloves does not negate the need for hand washing before and after using gloves.

2. Observation on 09/09/14 at 10:35 AM showed Staff K, Lab Technician, failed to remove her gloves and wash her hands after drawing blood for Patient #26 and proceeded to the laboratory without removing gloves and doing hand hygiene.

During an interview on 09/10/14 at 10:30 AM, Staff K stated that she should have removed her gloves and washed her hands after drawing Patient #26's blood.

3. Observation on 09/09/14 at 10:45 AM showed Staff L, Registered Nurse (RN), failed to remove her gloves and wash her hands after picking up a needle from the floor. The needle had been used to insert an intravenous (IV, into a blood vessel) catheter (tube) for Patient #26.

During an interview immediately following IV insertion, Staff L stated that she should have removed her gloves and performed hand hygiene after picking up the IV needle.

4. Record review of the facility policy titled, "Administration of Medication," reviewed 03/12/14, showed direction for nurses to wash hands before and after each administration of medication.

5. Observation on 09/09/14 at 11:20 AM showed Staff F, Licensed Practical Nurse (LPN), failed to wash her hands before she poured liquid medications into cups to administer to Patient #8.

Observation on 09/09/14 at approximately Noon showed:
- Staff F prepared to perform glucometer testing (check blood sugar level) on Patient #9.
- Staff F failed to wash her hands before setting up the glucometer, upon entering the patient's room and before putting on gloves.
- Staff G, LPN, entered Patient #9's room to assist with repositioning the patient.
- Staff G failed to wash her hands upon entering the patient's room and before putting on gloves.

During an interview on 09/09/14 at approximately 1:45 PM, Staff F stated that:
- Facility policy was to wash hands upon entering and exiting patient rooms.
- She had failed to wash her hands before entering Patient #9's room.
- She did not know what the facility policy was regarding washing hands before preparing patient medications.

6. Observation on 09/10/14 at 8:45 AM showed Staff M, RN, failed to remove her gloves and wash her hands after starting a blood transfusion for Patient #29. Staff M left Patient #29's room and went into the hallway.

During an interview on 09/10/14 at 10:00 AM, Staff M stated that she should have removed her gloves and washed her hands after starting the blood transfusion.

During a concurrent interview on 09/09/14 at approximately 1:30 PM, Staff B, DON (Director of Nursing), and Staff D, RN, Infection Control Coordinator (ICC), stated that:
- The infection control policy was that all personnel, contract staff and volunteers perform hand washing before and after direct contact with the patient, before and after gloving and before leaving a patient's room and after using the bathroom or coughing/sneezing.
- Staff D stated that her expectation was that all staff followed the Infection Control (IC) policy for hand washing.
- Staff B stated that gloves were to be removed after patient contact and hand washing performed before moving to a clean procedure or leaving a patient's room.
- Staff B stated that no soiled gloves were to be worn in the hallways.

7. Record review of the 2014 sterilization and packaging guidelines by the American Association of periOperative Nurses (AORN) showed laryngoscope blades require high level disinfection and individual sealed packaging to ensure continued sterility.

8. Observation on 09/09/14 at approximately 11:00 AM showed the emergency cart at the nursing station contained one laryngoscope blade along with a laryngoscope handle in a re-sealable plastic bag. The laryngoscope was not in packaging that indicated it had been disinfected.

9. Observation on 09/09/14 at 1:20 PM showed multiple laryngoscope blades and handles stored on the top of the ED emergency cart in a re-sealable bag.

During an interview at the time of the observation of emergency cart, Staff L, RN, stated that the laryngoscope blades should be packaged separately.

During an interview on 09/09/14 at approximately 11:00 AM, Staff B, DON, stated that she was unaware that laryngoscope blades needed to be sealed in individual packages after being disinfected.

10. Record review of the facility policy titled, "Cleaning and Inventory," approved 03/22/11, showed direction to staff to clean all equipment after each use, clean each ED room after each patient use and to store supplies in cabinets.

11. Observation on 09/09/14 at 10:35 AM of the mattress on the ED bed in Room #2 showed a tear in the corner of the mattress cover exposing the foam padding under the mattress cover. The breaks in integrity of the mattress did not allow staff to clean away organisms (a living thing) that could cause infection.

During an interview on 09/10/14 at 10:20 AM, Staff A, Chief Executive Officer (CEO) stated that the mattress needed to be replaced.

During an interview on 09/09/14 at approximately 1:30 PM, Staff D, RN, Infection Control Coordinator (ICC), stated that when a mattress was torn Maintenance was to be called to switch it out and remove it from service.

12. Observation of the cabinet directly under the sink in ED rooms #1, #2 and #3 on 09/09/14 at 3:00 PM showed miscellaneous supplies stored there. The supplies showed evidence of water contamination (evidence of package with water spots that had dried over time, causing concern for package content).

During an interview concurrent with observations, Staff L, RN, stated that no supplies should be under the sink and that she will check with the DON.

13. Concurrent observation with interview in the Radiology (x-ray) Department on 09/10/14 at approximately 2:30 PM showed:
-A lead apron (protective device worn to decrease exposure to radiation) in the computed tomography (CT, a test that shows detailed images of internal organs) room had torn binding around the entirety of each arm hole.
-A lead apron in the x-ray room had multiple eraser-sized holes and a taped area approximately five inches long by two inches wide.
-Another lead apron in the x-ray room had torn binding on each arm hole and on the neck hole with each open area approximately one inch long.
- Staff AA, Radiology Technician, stated that the aprons were used on patients and confirmed the findings.
The breaks in integrity of the aprons did not allow staff to clean away organisms that could cause infection.








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29117

Based on interview, policy review and online review, the facility failed to make a current diet manual available to dietary and nursing staff. This failure had the potential to affect the accuracy of therapeutic diets for all patients admitted to the facility. The facility census was three.

Findings included:

1. Record review of the facility policy titled, "Nutrition Care Manual and Resources & Diet Manual and Resources," revised 07/30/13, showed the following staff direction:
- The Nutrition Care Manual gives guidelines for regular diets and special diet modifications to meet patient needs.
- The Dietary Department will adopt the Academy of Nutrition and Dietetics online manual.
- The Nutrition Care Manual will be located in the Dietary Department and at each nursing station.

2. During an interview on 09/10/14 at 9:30 AM, Staff E, Registered Nurse, stated that she was unaware of any diet manual available to staff nurses. She stated that nurses take any questions regarding patient diets to the Dietary Department.

During an interview on 09/10/14 at approximately 9:45 AM, Staff B, Director of Nursing, stated that there was no diet manual for nurse reference at the nursing station.

During interviews on 09/10/14 at approximately 10:00 AM and 2:00 PM, Staff U, Dietary Cook, stated:
- The Dietary Manager was on leave and unavailable for interview.
- Staff U was being trained to act as supervisor when the Dietary Manager was gone.
- The Dietary Manager and dietitian used an online diet manual but Staff U did not have access to that manual.
- The Dietary Department purchased meal plans from a company that provided a diet manual published in 2007.
- There was a copy of the 2003 Missouri Diet Manual in the Dietary Manager's office.

3. Review on 09/11/14 of the website at www.nutritioncaremanual.org showed the online Nutrition Care Manual (accessible in the facility only by the Dietary Manager and the dietitian) provided current nutrition information and was published by the Academy of Nutrition and Dietetics.

Review on 09/11/14 of the website of the company that provided meal plans to the facility showed its current diet manual was published in 2012.

Review on 09/11/14 of the website at health.mo.gov showed the Missouri Diet Manual was discontinued in 2008.

Based on record review and interviews the facility failed to include the scope (defines what services are expected to be received) of services for 17 of 17 contracts on the list of facility contracts and failed to include three agreements (Teleradiology (electronic transmission of radiological patient images, such as x-rays, from one location to another for the purposes of sharing studies with other radiologists and physicians), EKG (record of the electrical activity of a patient's heart) interpretation, and blood and blood banking (maintaining an inventory of blood for transfusion) on the list of services provided. These failures increased the potential for patient care services by arrangement to be inappropriately utilized and reviewed. The facility census was three.

Findings included:

1. Record review of the facility's list, "Contract Services (Patient Care Services)" dated 09/09/14, showed a list of 17 contracts with the name of the contractor and the nature (type of business provided) of the services. The list did not contain the scope of the services provided.

Further review of contracted patient care services provided to the facility showed the facility list did not include services for Teleradiology, EKG interpretation, or blood and blood banking services.

During an interview on 09/10/14 at 2:30 PM, Staff C, Chief Operating Officer (COO), stated that the facility did not maintain an on-going list of contracted services and that the list presented was updated on 09/09/14 from a previous survey. Staff C stated that not including Teleradiology, EKG and blood and blood banking services was an oversight. Staff C stated that she was not aware the list of contracts and agreements for patient related services should have included the scope of those services provided.

32281


Based on interview and record review, nursing staff failed to develop individualized nursing care plans for two patients (#7 and #9) of three patients whose care plans were reviewed. This failure increased the potential for miscommunication among nurses with increased potential for patients to receive substandard care. The facility census was three.

Findings included:

1. Record review of Patient #7's medical record showed:
- The physician documented in the History and Physical (H&P) the patient was admitted to the facility on 08/27/14 for rehabilitation following hip fracture repair.
- The physician ordered laxatives, pain medications, and blood thinner.
- In nursing progress notes on 08/27/14, manual removal of stool (feces) was performed.
- The physician ordered dose change of the blood thinner on 09/08/14.
- In nursing progress notes on 09/09/14, the patient's pain was severe.
- The care plan did not include problems and goals related to constipation, anti-coagulation therapy and pain.

During an interview on 09/09/14 at approximately 10:30 AM, Staff D, Registered Nurse (RN) and Day Supervisor, stated that nursing staff should have included problems and goals related to constipation, anti-coagulation therapy and pain on the care plan.

2. During an interview on 09/09/14 at approximately 11:00 AM, Staff B, Director of Nursing (DON), stated that there was no facility policy on care plans since the facility instituted the electronic medical record system.

3. Record review of Patient #9's medical record showed:
- The physician documented in the H&P the patient was admitted to the facility for weakness, pneumonia and hypokalemia (low potassium). The physician also noted the patient shuffled with gait (movement characterized by small shuffling steps) and had a urinary tract infection (UTI).
-The nursing Problem List included fall risk due to decreased mobility and weakness, impaired physical mobility due to weakness and risk for infection due to UTI and pneumonia.
- The care plan did not include interventions (preventative measures) to reduce the risk of falls, improve physical mobility or prevent or reduce the risk of infection.

During an interview on 09/10/14 at 3:05 PM, Staff D, RN, stated that nursing staff should have identified interventions and linked them to the identified problems on the care plan.

32281


Based on interview and record review the facility failed to evaluate the quality and appropriateness of diagnosis and treatment and of treatment outcomes for services provided under contract or agreement for eight (Teleradiology (electronic transmission of radiological patient images, such as x-rays, from one location to another for the purposes of sharing studies with other radiologists and physicians), reference laboratory (laboratory that receives a specimen from another laboratory and that performs one or more tests on such specimen), nuclear medicine (medical specialty involving the application of radioactive substances in the diagnosis and treatment of disease), cardiac monitoring services, pulmonary function testing (measure how well your lungs are functioning), physical therapy, blood and blood products, and ultrasound (uses sound waves to develop ultrasound images of what's going on inside the body) of 13 services reviewed. This deficient practice failed to ensure safe and quality services were provided for all patients receiving care through contractor services. The facility census was three.

Findings included:

1. Record review of the facility's "Performance Improvement (PI) Plan 2014" dated 08/14/13, showed the following:
- The Chief Executive Officer (CEO) will support performance improvement by requiring all departments/programs/services participate in the continuous quality improvement program (CQI) activities.
- The Quality Improvement (QI) Committee will be responsible for the overall surveillance of the quality of patient care and patient safety and assure that the organization's PI Plan is comprehensive and that all departments/specialties/practitioners are evaluated and Critical Access Hospital (CAH) requirements are met in the area of quality improvement.
- The quality assessment (QA) component is designed to systematically assess the performance of all departments and services. Indicators are developed to measure the level of care provided in accordance with the organization's scope of care and services.
- Reports pertinent to the function of a Department (including services) will be compiled monthly.

2. Record review of the facility's agreement for "Teleradiology Services" dated 11/01/08, showed:
- The contractor would provide radiology interpretation services via Teleradiology twenty-four hours a day, seven days a week;
-The contractor would provide written protocol for the receiving and reporting of Teleradiology interpretations and hours of coverage;
- The contractor shall help establish procedures to promote consistency and quality of medical services provided to the facility and participate in the facility's Quality Assurance Programs.

3. Record review of the facility's agreement for the provision of "Reference Laboratory Services" dated 08/26/04, showed the contractor would furnish testing services at a reduced, scheduled price. The agreement did not contain requirements for reviewing the quality or appropriateness of services provided or participation in the facility's quality assurance performance improvement (QA/PI) program.

4. Record review of the facility's agreement for "Mobile Nuclear Medicine Services" dated 02/22/07, showed the contractor would provide diagnostic imaging services for nuclear medicine, be responsible for the maintenance and operation of the equipment and follow maintenance schedules recommended by the manufacturers of the equipment. The agreement did not contain requirements for reviewing the quality or appropriateness of services provided or participation in the facility's QA/PI program.

5. Record review of the facility's agreement for the provision of "Cardiac Monitoring Services" dated 08/25/14, showed:
- The contractor would provide Holter monitoring services (continuous 24 hour monitoring of an electrocardiogram (EKG) in a symptomatic patient and provides a continuous record of the electrical activity of a patient's heart while engaged in daily activities).
- The contractor would be available 24 hours a day, 365 days of the year to receive the transmission of data as to patient arrhythmic events (an identified problem with the rate or rhythm of the heartbeat), edit any artifacts (electrical interference that is recorded from sources other than the electronic signals of the heart) from the data, and report such events to the facility consistent with the orders of the attending physician and store the data at a secure site.
- The agreement did not contain requirements for reviewing the quality or appropriateness of services provided or participation in the facility's QA/PI program.

6. Record review of the facility's agreement for "Respiratory Services" dated 04/01/10, showed the contractor was to perform Pulmonary Function Testing for the facility on an appointment basis. The agreement did not contain requirements for reviewing the quality or appropriateness of services provided or participation in the facility's QA/PI program.

7. Record review of the facility's PI plan, meeting minutes and reports showed the facility did not have QA/PI data for the following services provided through contract/agreement::
- Teleradiology;
- Reference Laboratory;
- Mobile Nuclear Medicine;
- Cardiac Monitoring;
- Respiratory Services;
- Physical therapy services;
- Blood and blood products; and
- Ultrasound services.

8. During an interview on 09/09/14 at 3:30 PM Staff S, Director of Radiology and Quality Assessment and Quality Improvement Coordinator, stated that QA/PI for contracted services was not a part of the hospital wide quality program.

During an interview on 09/10/14 at 2:10 PM, Staff B, Registered Nurse (RN), Director of Nursing (DON), stated that the facility did not receive QA/PI data for any of the services provided through contract or agreement. Staff B stated that the PI Plan did not include quality monitoring for services provided through contract or agreement.

Based on interview and policy review the facility failed to ensure staff followed the facility policy and utilized a methodology to evaluate medication usages for infections. This failure had the potential to affect all patients, staff, volunteers and visitors from possible exposure to infectious organisms that could be resistant to antibiotic therapy. The facility census was three.

Findings included:

1. Record review of the facility policy titled, "Surveillance of Infections," reviewed on 05/20/14, showed direction for a yearly antibiotic sensitivity report that may be helpful in documenting changing patterns of antibiotic resistance to specific organisms and in the prescribing of antibiotics. The review of the clinical use of antibiotics was a function of the medical staff. Results of this review would be reported to the Infection Control Committee for its information and use.

2. During an interview on 09/10/14 at 8:30 AM, Staff O, Pharmacist, stated that to his knowledge the facility did not have a method for evaluating the effectiveness of treatment for infections or antibiotic use by the medical staff. Staff O stated that he was member of the Pharmacy and Therapeutics Committee and that the committee did not receive any data to support the evaluation of medication therapy.

During an interview on 09/10/14 at 9:50 AM Staff D, Day Nurse Manager, Infection Control Coordinator, and Staff B, Director of Nursing, both stated that no staff in the facility tracked the antibiotic usage so the information could be reviewed on an annual basis for trends.

Based on interview and record review, the Activities Director failed to perform activity assessment (e.g. preferred activities) and develop activity plan based on assessment for two patients (#7 and #8) of two patients in the Swing-Bed Program (Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing care in the same facility). These failures increased the potential for all Swing-Bed patients to be offered inadequate and inappropriate activities with the potential to negatively affect patient well-being. The facility census was three that included two Swing-Bed patients.

Findings included:

1. Record review of Patient #7 and Patient #8's medical records showed no activity assessment or plan.

2. During an interview on 09/09/14 at approximately 10:30 AM, Staff D, Registered Nurse and Day Supervisor, stated that she was not aware of individual activity plans for the Swing-Bed patients that the nurses could view and assist with implementation.

During an interview on 09/09/14 at 2:00 PM, Staff I, Activities Director, stated that she does not perform activity assessment and plan development for Swing-Bed patients. She didn't know why those were not done.

During an interview on 09/09/14 at approximately 2:30 PM, Staff B, Director of Nursing and Swing-Bed Coordinator, stated that she didn't know why activity assessment and planning weren't done for Swing-Bed patients. She stated that there was no facility policy for the Swing-Bed Activities Program.