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Based on interview, record review and policy review, the facility failed to ensure that the pharmacy maintained restricted access from individuals that should not have authorized badge access. This had the potential to compromise the integrity of medications and supplies in the pharmacy. The facility census was eight.

Findings included:

1. Record review of the facility's policy titled, "Pharmacy Entry," dated 07/14/16, showed the following directives for staff:
- The pharmacy director will grant permission for badge access to be given.
- The pharmacy personnel will be granted badge access.
- Other personnel authorized to have badge access include the Director of nursing, Nurse managers for medical-surgical, obstetric, labor-delivery-recovery, emergency room and operating rooms and house supervisors. [The facility does not offer obstetric or labor-delivery services.]

2. Record review of the facility's All Cardholders to Door Report dated 05/02/17 and timed 2:33 PM showed a total of 33 staff had badge access to the pharmacy. The list included the following staff:
- Vice President (VP) of Facilities Construction;
- Chief Executive Officer;
- Bio Med;
- VP of Finance System;
- RX (Pharmacist) Temp Badge;
- Director of Safety and Emergency Preparedness;
- VP, Chief Executive Officer (CEO) Regional Services; and
- Utilization Review Nurse.
According to the facility's policy related to pharmacy entry the above staff should not have badge access to the pharmacy.

During an interview on 05/04/17 at 11:25 AM, Staff O, Director of Pharmacy, stated that only nurses that have been trained and have passed the aseptic testing can access the pharmacy after hours. Staff O stated that it is mainly house supervisors that access the pharmacy. Staff O stated that staff use their badge to access the pharmacy. Staff O stated that the following staff have badge access to the pharmacy:
- Pharmacist;
- Pharmacy technicians; and
- Nursing staff that have passed the aseptic testing.
The facility's policy for pharmacy access did not include nursing staff that passed aseptic testing.

During an interview on 05/04/17 at approximately 12:30 PM, Staff V, Chief Nursing Officer (CNO), stated that the facility noticed a problem on 05/03/17, which authorized badge access to Pharmacy when staff should not have access. Staff V stated that when staff were employed, or hired into a position, the staff member was assigned to a group of like staff based on their position. Access to specific areas, which included restricted areas, was granted by assigned group and not by the individual employee based on need for authorized access.

During an interview on 05/04/17 at 4:05 PM, Staff O, Director of Pharmacy, stated that executive staff, systems CEO and a few other staff did have badge access to the pharmacy. Staff O stated that she thought their access had been removed in March of 2015 and that was the last time a badge access report for the pharmacy had been run.




29047

Based on observation, interview, and policy review, the facility failed to ensure that staff:
- Followed the facility's hand hygiene policy during medication administration for three (#1, #3 and #5) patients out of five observed during medication pass.
- Followed the facility's staff responsibilities for cleaning after equipment had been used in one (#3) patient's room out of one that was in contact isolation.
- Followed the facility's procedure for drawing up medication for injection during medication administration for one (#5) patient out of one observed who received an injection.
- Wore gloves when they administered medication into a vascular (vessel that carries blood) access for one (#13) of one patient observed in the Outpatient Infusion Unit.
These failed practices had the potential for spreading infections and increased the risk for hospital acquired infection exposure to patients and staff. The facility census was eight, which included five Swing Bed (Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing care in the same facility) patients.

Findings included:

1. Record review of the facility's policy titled, "Hand Hygiene," dated 11/01/16, showed directives for staff to perform hand hygiene after removal of gloves.

2. Observation on 05/01/17 at 2:40 PM showed Staff A, Registered Nurse (RN), prepared to administer a Bisacodyl (medication used to stimulate a bowel movement) suppository (medication inserted into the rectum/bottom) for Swing Bed Patient #1. Staff A put on non-sterile gloves and administered the medication. After Staff A finished inserting the medication into the patient's rectum, she removed the non-sterile gloves. Staff A did not perform hand hygiene after she removed the gloves. Staff A placed a pillow under the patient's heels, touched a Kleenex box and placed the call light onto the over the bed table. Staff A then performed hand hygiene and exited the room.

During an interview on 05/04/17 at 2:30 PM, Staff D, RN, Program Manager Quality and Infection Control, stated that she expected staff to perform hand hygiene before putting gloves on and after their removal.

3. Record review of the facility's policy titled, "Staff Roles and Responsibilities for Cleaning Clinical Areas," dated 11/25/15 showed direction for staff that providing a clean, disinfected and safe environment is the responsibility of all hospital staff. The Cleaning in Clinical Areas "Roles & Responsibilities Grid," undated, showed and defined responsibilities with a detailed list of assignments for all hospital staff. The grid showed direction for staff to clean keyboard and screen of stationary bedside computers.

4. Observation on 05/02/17 at 9:30 AM showed Staff G, Respiratory Therapy (RT) Manager, prepared to administer Breo (medication that is inhaled into the lungs to treat asthma) to Patient #3. Posted by the door to the patient's room was an alert that informed staff and visitors that the patient was in contact isolation (contact isolation precautions-used for infections, diseases, or germs that are spread by touching the patient or items in the room. Healthcare workers should: Wear a gown and gloves, also known as personal protective equipment (PPE) while in the patient's room) precautions. Observation showed Staff G:
- Performed hand hygiene, put on gloves and PPE before going into the patient's room.
- Brought into the patient's room a computer on wheels to scan the medication to be administered, scan the patient's identification band and to document administration of the medication into the electronic medication administration record.
-After she scanned the patient's identification band, she removed her gloves but did not perform hand hygiene before putting on another pair.
- She then administered the inhaler to the patient.
- She removed the PPE and gloves, performed hand hygiene and left the patient's room.
-At the entry way of the patient's room, Staff G took a Bleach Germicidal wipe and wiped down the outer edges of the base where the computer sat , keyboard and mouse. Staff G did not clean the entire computer base, stand, bottom base where the wheels were or the scanner after being in a room with a patient on contact isolation precautions.

During an interview on 5/04/17 at 2:30 PM, Staff D, RN, Program Manager Quality and Infection Control stated that she expected staff to clean the entire computer on wheels after being used in a contact isolation room. Staff D stated that she expected staff to wipe down the base where the computer sat and computer keyboard. Staff D stated that Staff G, RT, did not clean the computer on wheels properly after she brought it out of a patient's room who was on contact isolation precautions due to a diagnosis of C-Diff (a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon).

During an interview on 05/04/17 at 3:15 PM, Staff G, RT Manager, stated that hand hygiene should be performed before putting on gloves and after removal. Staff G stated that hand hygiene needed to be done every time gloves came off. Staff G stated that she used a bleach wipe and cleaned the computer keyboard, mouse and around the base where the computer sat. Staff G stated that she did not wipe down the scanner, base or area where the wheels are attached. Staff G stated that she should have cleaned the entire computer stand and scanner with a bleach wipe.

5. Record review of the facility's Lippincott Procedures dated 2017, showed direction for staff to wipe the stopper of medication vial/bottle with an alcohol pad and allow it to dry completely.

6. Observation on 05/02/17 at 10:00 AM showed Staff L, RN, prepared to administer Heparin (medication used to thin the blood) subcutaneous (SQ-under the skin) to Swing Bed Patient #5. Staff L removed the protective top off the medication bottle but did not wipe the rubber stopper off with an alcohol pad before she pierced it with a needle.

During an interview on 05/02/17 at 2:10 PM, Staff L, RN, stated that after gloves are removed, hands should be either washed with soap and water or hand sanitizer should be used. Staff L stated that she did not wipe off the rubber stopper after she removed the top with alcohol on the Heparin bottle before she pierced it with a needle. Staff L stated that she had been taught in nursing school that the rubber stopper did not have be wiped off with alcohol before inserting a needle because of the protective top.

During an interview on 05/04/17 at 12:55 PM, Staff O, Pharmacy Director, stated that she expected staff to wipe off the rubber stopper of bottles after popping off the top with alcohol and before staff inserted a needle into it.

During an interview on 05/04/17 at 2:30 PM, Staff D, RN, Program Manager Quality and Infection Control, stated that she expected staff to follow the facility's policy and procedures for infection control.

7. Record review of the facility's policy titled, "Intravenous (IV, in a vein) Access Device Care and Maintenance," dated 08/15/16, showed directive for staff to use clean gloves when working with a vascular access except when sterile gloves are indicated.

8. Observation with concurrent interview on 05/03/17 at 10:20 AM in the Outpatient Infusion Unit, showed Staff WW, RN, administered an IV antibiotic (medicine that inhibits the growth of or destroys bacteria) through a Peripherally Inserted Central Catheter (PICC) to Patient #13 and failed to wear gloves when she manipulated the catheter. Staff WW stated that she probably should have worn clean gloves.

During an interview on 05/03/17 at 10:40 AM, Staff VV, Manager of Outpatient Specialty Clinic and Infusion Unit, stated that Staff PP should have worn gloves when administering the antibiotic.




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Based on interview and record review the facility failed to ensure the Health Information Management (HIM, patient medical records and documents) was involved in hospital wide Quality Assessment Performance Improvement (QAPI). This deficient practice had the potential to adversely affect the clinical accuracy and completeness of the patient records. The facility census was eight.

Findings included:

1. Record review of the facility's document titled, "Performance Improvement Plan," dated 2017, showed directives for the hospital leaders (managers/supervisors) to establish priorities to ensure important internal processes and activities in their areas were continuously and systematically assessed and improved in collaboration with other departments and services whenever appropriate.

2. During an interview on 05/02/17 at 10:00 AM, Staff P, Manager of HIM, stated that she failed to track or trend data she collected and failed to report data through hospital wide QAPI.

This failure to collect data and monitor for trends affects the clinical accuracy and completeness of the documentation. It also impacts the effectiveness and safety of the facility's services and quality of care.

Based on observation, interview, record review, and policy review the facility failed to ensure the confidentiality of patients' medical records was safeguarded and protected from the possibility of loss, destruction, or unauthorized access in the main Medical Records department and in two (Specialty Clinic and Outpatient Infusion) of two areas observed. The facility also allowed an additional 24 staff, beyond Health Information Management (HIM, patient medical records and documents) staff, badge access to the HIM department.

This failure had the potential of confidential patient information to be disseminated inappropriately by staff who were not involved in the patient's care. The facility census was eight.

Findings included:

1. Record review of the facility's policy titled, "Protected Health Information," dated 07/27/2016, showed the following:
- PHI was any individually identifiable health information that would identify an individual.
- There must be a working need to access PHI.
- Access to storage areas containing health information shall be limited to authorized personnel.

2. Observation on 05/03/17 at 3:25 PM in the HIM department showed:
- Multiple (estimated to be greater than 30) medical records that contained PHI sat on unsecured shelves.
- There were upright folders behind the reception desk with PHI that were unsecured and available to staff that accessed HIM.
- There were 40 to 50 patient records on a desk for analysis (ensure the records were complete) that were unsecured and available to staff that accessed HIM.

3. Record review of three folders obtained from the unsecured shelves showed information included in the paper records were:
- Patient identification stickers (patient name, date of birth, date of service, gender, account number, and medical record number, and physician);
- Patient demographic information (name, address, telephone number, emergency contacts, insurance information, last four digits of the social security number and other identifiable information);
- Discharge instructions and vital signs (temperature, pulse, respirations, and blood pressure);
- Consent for treatment, History and Physical and medical history;
- Laboratory results (blood tests);
- X-ray results; and
- Nursing assessments, patient diagnoses, patient medications, diet, and allergies.

During an interview on 05/02/17 at 3:30 PM with Staff T, Health Information Technician; Staff S, Interim Supervisor; and Staff R, Release of Information Clerk, stated that they left unsecured PHI on their desks overnight.

During an interview on 05/02/17 at 10:00 AM and 05/03/17 at 9:40 AM Staff P, Manager of HIM, stated that approximately four or five months ago she requested a report of staff that used their badge to access HIM. The report showed Staff CCC, House Supervisor, accessed HIM with her badge after HIM hours. She reported that Staff CCC accessed HIM to let a housekeeper into the St. Staff P also stated that she failed to have a process for staff to document any paper records that were removed from HIM.

4. Record review of the facility's document titled, "Cardholder Transaction History-Simple Report," showed on 11/28/16 at 6:47 AM, Staff CCC, accessed HIM with her badge.

During an interview on 05/03/17 at 9:25 AM, Staff CCC, House Supervisor, stated that she used a badge to unlock the door to allow housekeeping into HIM and left the housekeeper unsupervised. She was not aware, at that time, that she was not to leave housekeeping unsupervised in HIM.

During an interview in the Outpatient Specialty Clinic on 05/04/17 at 10:00 AM Staff WW, Registered Nurse (RN), stated that she placed patient PHI in an unlocked drawer where it remained overnight. Housekeeping staff accessed the area after clinic hours and without supervision.

During an interview on 05/04/17 at 10:10 AM, Staff VV, Nurse Manager of the Outpatient Specialty Clinic and Infusion Unit, stated that the PHI should be secured.

During an interview in Outpatient Infusion Unit on 05/04/17 at 10:15 AM Staff XX, RN, stated that the key to the cabinet, which contained PHI, was left in an unlocked drawer at the nurse's station overnight. She also left PHI in a bin on the nurse's station counter and it remained unsecured overnight. Housekeeping staff accessed the area after clinic hours and without supervision.

5. Record review of the facility's document titled, "All Cardholders to Door Report-Delayed," showed the facility granted access to HIM to an additional 24 other staff, beyond the HIM staff.

During an interview on 05/02/17 at 4:00 PM, Staff V, Chief Nursing Officer, stated that the facility failed to remove her access when she no longer supervised HIM. She stated that there was an issue with access. If the facility removed access for one staff in a group (House Supervisors or executives) the system denied the whole group.

Based on interview and record review, the facility failed to ensure that:
- A tracheotomy set (set of instruments used to create a surgical opening into the trachea, or windpipe, for the passage of oxygen, in emergency situations) was available in the Operating Room (OR);
- The OR restricted access from individuals who should not have authorized access; and
- The operative report contained the times of surgery for five patients (#14, #15, #16, #17 and #18) of five patients' medical records reviewed who had surgical procedures. This had the potential to affect the health and safety of all patients who underwent surgical procedures. The facility performs 20-30 surgical procedures per month. The facility census was eight.

The severity and cumulative effect of these deficient practices resulted in the facility's overall non-compliance with the requirements found at 42 CFR 485.639 Condition of Participation: Surgical Services.

Findings included:

1. Although requested, the facility failed to provide a policy related to the availability of a tracheotomy set in the OR.

2. Observation and concurrent interview on 05/02/17 at approximately 1:00 PM, showed that a tracheotomy (trach) set was not available in the operating suites (rooms where surgery is performed, located within the OR), or the pre or post-surgical care areas. Staff GG, Surgical Services Director, verified that a tracheotomy set was not available, and stated that a tracheotomy set was kept in the Emergency Department (ED).

3. Observation and concurrent interview on 05/03/17 at approximately 1:45 PM, showed there was no tracheotomy set available in the ED. This was verified by Staff BB, ED Registered Nurse (RN).

4. Observation and concurrent interview on 05/04/17 at 9:55 AM, showed there was no tracheotomy set in the materials management stock area. Staff NN, Director of Materials Management, verified that materials management did not have a tracheotomy set available, that the facility did not have the instruments necessary to create a tracheotomy set, and was unable to determine the last time the facility had a tracheotomy set or instruments contained in a tracheotomy set, based on review of his inventory control and supply order history.

5. Observation on 05/04/17 at approximately 11:15 AM, showed Staff KK, Certified Registered Nurse Anesthetist (CRNA), entered the OR carrying two clear plastic bags in his hand.

During an interview on 05/04/17 at approximately 11:15 AM, Staff KK, CRNA, stated that he brought supplies for a trach kit with him to the facility from a sister facility down the road. Staff KK stated that he knew that the OR regulations for Critical Access Hospitals required the OR to have a trach kit available and not a cricothyrotomy kit. (A trach kit is used in a surgical procedure in which an incision is made into the trachea, through the neck, and a tube inserted to make an artificial opening in order to assist breathing. A cricothyrotomy kit is used in an emergency procedure in which a hole is cut through the neck into the windpipe in order to allow air into the lungs.)

During an interview on 05/04/17 at 11:25 AM, Staff D, RN, Program Manager Quality and Infection Control, stated that Staff KK brought the supplies for a trach kit because he knew the OR did not have one per the regulations, therefore, he brought the supplies for one with him.

6. Record review of the facility's policy titled, "Traffic Control, Infection Prevention & Control," dated 01/2015, showed that the OR was a restricted area, and that guidelines should be followed in order to maintain an aseptic (free from contamination) patient environment.

7. Record review of a report titled, "All Cardholders to Door Report - Delayed," dated 05/04/17 at 10:05 AM, showed (in part) the following hospital and non-hospital (part of the network hospitals) staff or types of staff, had access to the facility's OR:
- Chief Financial Officer;
- Marketing Staff;
- Vice President of Construction;
- Information Technology Contractor;
- Network Services;
- Biomedical Staff;
- Administrative Secretary; and
- Staff who were no longer employed by the facility or network hospitals.

During an interview on 05/04/17 at approximately 12:30 PM, Staff V, Chief Nursing Officer (CNO), stated that the facility noticed a problem on 05/03/17, which authorized badged access to restricted areas of the hospital where staff should not have access. Staff V stated that when staff were employed, or hired into a position, the staff member was assigned to a group of like staff based on their position. Access to specific areas, which included restricted areas, were granted by assigned group and not by the individual employee based on need for authorized access. Staff V stated that they had not yet restricted badged access by staff who should not have access to the OR.

8. Record review of the facility's "Medical Staff Rules and Regulations," dated 09/25/16, did not indicate that the operative report required the times of surgery to be included in the report.

9. Although requested, the facility failed to provide a policy related to the required contents of the operative report.

10. Record review of the following current operative reports, completed by Staff BB, General Surgeon, showed the following:
- Patient #14, who underwent a colonoscopy (to visualize the inner lining of a patient's large intestine, through the use of a thin, flexible tube which contains a small camera) on 05/02/17, showed the operative report did not contain the times of surgery.
- Patient #15, who underwent a cholecystectomy (removal of the gallbladder) on 05/02/17, showed the operative report did not contain the times of surgery.
- Patient #16, who underwent the excision of a lipoma (removal of a fatty lump of tissue located between skin and muscle) on 05/02/17, showed the operative report did not contain the times of surgery.
- Patient #17, who underwent a esophagogastroduodenoscopy (to visualize the inner lining of a patient's esophagus, stomach, and first part of the small intestine, through the use of a thin, flexible tube which contains a small camera) on 05/02/17, showed the operative report did not contain the times of surgery.
- Patient #18, who underwent a left inguinal herniorrhaphy (to surgically correct a hernia, a bulging of internal organs or intestine, through the muscle that contains it) on 05/02/17, showed the operative report did not contain the times of surgery.

During an interview on 05/04/17 at 3:57 PM, Staff P, Health Information Manager, stated that:
- Times were not required to be documented on the operative report;
- The facility's Medical Staff Rules and Regulations did not require the operative report to contain the times of the surgery; and
- The facility's Medical Staff Rules and Regulations were aligned with regulations.





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