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Based on observations, review of facility's policies/procedures and staff interview the facility failed to ensure that drugs and biologicals available for patient use were appropriately stored.

This failure created the potential for negative patient outcome.

Findings:

1. The facility failed to remove expired supplies and medications from patient care areas.

a) On 03/12/13 a review of facility policy titled, "Checking Outdated Medications in Specific Locations: 1. Medication Room, 2. Emergency Room, 3. Birthing Room, 4. Nursery, 5. Operating Room", stated the following: "Pharmacy personnel will check outdates and take outdated medications from the above departments and replace the medications with in-date medications signed out from the medication room in the hospital."

b) A position paper from the Association of Professionals in Infection Control and Epidemiology (APIC) titled, "Safe Injection, Infusion and Medication Vial Practices in Healthcare" published July 30th, 2009 stated the following:

"The transmission of bloodborne viruses and other microbial pathogens to patients during routine healthcare procedures continues to occur due to unsafe and improper injection, infusion and medication vial practices being used by healthcare professionals within various clinical settings throughout the United States ...

APIC strongly supports adherence to the following safe injection, infusion and medication vial practices...Dispose of opened multidose medication vials 28 days after opening..."

c) On 03/12/13 at 8:45 a.m., a tour of the facility's operating room was conducted and revealed the following: in the top compartment of the blanket warmer located in the operating room there were 14 one liter bags of Lactated Ringers intravenous (IV) solution with no date indicating when they were placed in the warmer. There were also 14 one liter bottles of sterile water for irrigation with no date indicating when they were placed in the warmer. These findings were confirmed with the Assistant Director of Nursing (ADON).

d) On 03/12/13 at 9:10 a.m., a tour of the facility's endoscopy room was conducted and revealed the following: 18 hemoccult cards with a manufacturer's expiration date of 2/08. These findings were confirmed with ADON and the items were removed.

e) On 03/12/13 at 10:30 a.m., a tour of the facility's nurses station revealed the following: two opened bottles of hydrogen peroxide with a manufacturer's expiration date of 12/12. Two opened bottles isopropyl alcohol with a manufacturer's expiration date of 11/12. The high and low quality controls for the glucometer were opened with no date indicating when they were opened. The facility's ADON stated that the controls are changed at the end of each month.

f) On 03/12/13 at 10:40 a.m., a tour of the facility's labor and delivery room revealed the following: two yellow top laboratory tubes with a manufacturer's expiration date of 6/12, two sterile swab applicator with a manufacturer's expiration date of 1/13, one sterile swab applicator with a manufacturer's expiration date of 2/13. These findings were confirmed with the facility's ADON and the items were removed.

g) On 03/12/13 at 12:10 p.m., a tour of the facility's emergency department was conducted and revealed the following: a central line kit with a manufacturer's expiration date of 9/12, an opened vial of lidocaine/epinephrine with no date indicating when it had been opened. These findings were confirmed with the ADON and the items were removed.

h) On 03/12/13 at 12:20 p.m., a tour of the facility's radiology department was conducted and revealed the following: one 20 gauge IV catheter with a manufacturer's expiration date of 3/09, one luer lock adapter with a manufacturer's expiration date of 7/02, one bottle of barium "E-Z Disk" tablets with a manufacturer's expiration date of 6/99, two bottles of gastografin with a manufacturer's expiration date of 11/11. In a plastic tray under the sink in the X-ray room there were three IV start kits that were open and dirty.

i) On 03/12/13 at 12:40 p.m., a tour of the facility's cat scan (CT) room was conducted and revealed the following: one 24 gauge IV catheter with a manufacturer's expiration date of 5/02, one purple top laboratory tube with a manufacturer's expiration date of 6/05, one orange top laboratory tube with a manufacturer's date of 1/05, one bottle of Oxilcan-300 for injection with a manufacturer's expiration date of 8/04. There were two 18 gauge IV catheters with a manufacturer's expiration date of 5/06 and one vial of Narcan with a manufacturer's expiration date of 10/12 found in the anaphylaxis kit located in the CT room.

j) On 03/12/13 at at 3:10 p.m., a tour of the facility's Gordon Clinic was conducted and revealed the following: located in the nurses work room there was an open multi dose vial of Kenolog, one open vial of Cyanocobalamin, one open bottle of Albuterol Sulfate solution, one open vial of Depoprovera, one open vial of lidocaine, and one vial of Xylocaine with no dates indicating when they were opened. Also found in the nurses work room was one vial of marcaine with a manufacturer's expiration date of 3/12, two tubes of bactroban with a manufacturer's expiration date of 2/12, two epinephrine injections with a manufacturer's expiration date of 7/12, two vials of vitamin K with a manufacturer's date of 2/12, one vial of solumedrol with a manufacturer's expiration date of 4/12, three tablets of Clonidine with a manufacturer's expiration date of 4/12, one bottle of isopropyl alcohol with a manufacturer's expiration date of 7/12, three bottles of hydrogen peroxide with manufacturer's expiration dates of 2/11, 7/12, 9/11. In an IV tray located in exam room #3 there was one vial of normal saline with a manufacturer's expiration date of 1/21/12, one vial of lidocaine with a manufacturer's expiration date of 2/09, one blue top laboratory tube with a manufacturer's expiration date of 7/07, and four 24 gauge IV catheters with a manufacturer's expiration date of 2/10. In exam room #1 there were two tubes of water based lubricant with a manufacturer's expiration date of 4/10 and 1/11. These findings were confirmed with the facility's ADON and the items were removed.

k) On 03/12/13 at 3:40 p.m., a tour of the facility's Hugo clinic was conducted and revealed the following: exam room #3 had five packets of lubricating jelly with a manufacturer's expiration date of 12/12, one 30 milliliter vial of bacteriostatic normal saline with a manufacturer's expiration date of 2/1/11, one 10 milliliter vial of bacteriostatic normal saline with a manufacturer's expiration date of 10/1/11, one packaged Bovie with an expiration date of 8/07, three bottles of alphagan eye drops with a manufacturer's expiration date of 12/12, six biopsy punches with a manufacturer's expiration date of 2/06, three biopsy punches with a manufacturer's expiration date of 7/05, fifteen 30 gauge IV catheters with a manufacturer's expiration date of 8/11, four 18 gauge IV catheters with a manufacturer's date of 4/09, twenty iodine swabs with a manufacturer's expiration date of 1/12. In exam room #2 there were six tubes of triple antibiotic ointment with a manufacturer's date of 1/12, seventeen hemoccult cards with a manufacturer's date of 3/10, one tube of petroleum jelly with a manufacturer's date of 4/09, fifteen iodine swabs with an expiration date of 1/09, eight with an expiration date of 1/11 and 3 with an expiration date of 12/11, two containers of plain packing strips with a manufacturer's date of 9/11 and 2/10, four biopsy punches with a manufacturer's date of 7/05, four 30 gauge needles with a manufacturers expiration date of 8/11, fourteen packages of steri strips with a manufacturer's expiration date of 2/07, fourteen saline bullets with a manufacturer's expiration date of 7/08. In exam room #1 there was one bottle of hydrogen peroxide with a manufacturer's expiration date of 2/12, one bottle of hydrogen peroxide with a manufacturer's expiration date of 2/06, eleven packages of steri strips with a manufacturer's expiration date of 2/07, seven benzoin tincture swabs with a manufacturer's expiration date of 1/11, sixteen 30 gauge needles with a manufacturer's expiration date of 8/11, two biopsy punches with a manufacturer's expiration date of 7/05 and four with a date of 2/06, twenty betadine swabs with a manufacturer's expiration date of 12/11, nine with a date of 1/09 and six with a date of 8/12. These findings were confirmed with the ADON and the items were removed.

l) On 03/13/13 at 4:00, p.m., a tour of the Flagler clinic was conducted and revealed the following: in the laboratory area there were thirteen TB syringes that had been removed from the package, one vial of cyanocobalamin with an open date of 1/25/13, one vial of 1% Xylocaine with an open date of 11/29/12, one vial of 1% lidocaine with an open date of 9/20/12 and one with an open date of 11/6/12, two vials of levephed with a manufacturer's date of 12/12, one vial of 2% lidocaine with an open date of 12/20/12, one vial of lidocaine/epinephrine with an open date of 1/10/13. Located in the clinic's emergency bag was one bottle of nitroglycerin in dextrose with a manufacturer's expiration date of 6/12, one 500 milliliter bag of lidocaine with a manufacturer's date of 3/12, two dextrose injections with a manufacturer's date of 10/12, one Adenocard injection with a manufacturer's date of 3/01/13, two vials of 2% lidocaine with a manufacturer's expiration date of 9/12, three vials of atropine sulfate with a manufacturer's expiration date of 9/12, three vials of epinephrine with a manufacturer's expiration date of 6/12. Located in the clinic's physical therapy room was eleven saline bullets with an expiration date of 6/12 and one bottle of hydrogen peroxide with a manufacturer's expiration date of 10/98. Located in a cabinet across from the nurses station in a tray labeled joint injection there was one opened vial of 2% lidocaine with no date indicating when it was opened, one vial of 0.5% marcaine with an open date of 1/31/13, one opened vial of kenalog with an open date of 1/25/12. In the lesion removal tray there was one vial of lidocaine/epinephrine with an open date of 11/22/12, one vial of 2% lidocaine with an open date of 1/19/13 and one biopsy punch with a manufacturer's expiration date of 1/13. In the eye tray there was one bottle of tetracaine with an open date of 1/31/13 and a manufacturer's expiration date of 2/13 and one bottle of cortisporin with a manufacturer's expiration date of 2/13. These findings were confirmed with the Director of Nursing and the items were removed.

2. The facility failed to label containers of cleaning solutions identifying what the contents were inside the container.

a) On 03/12/13 at 8:45 a.m., a tour of the facility's operating room was conducted. A spray bottle with yellow liquid inside was noted in the decontamination room. The spray bottle did not have a label identifying what the contents inside the container were.

b) On 03/12/13 at 9:00 a.m., a tour of the facility's endoscopy room was conducted. A spray bottle with a yellow liquid inside was noted in the room. The spray bottle did not have a label identifying what the contents inside the container were.


c) On 03/12/13 at 10:40 a.m., a tour of the facility's labor and delivery room was conducted. A spray bottle with a yellow liquid in it was noted in the room. The spray bottle did not have a label identifying what the contents inside the container were.

d) On 03/12/13 at 12:20 p.m., a tour of the facility's radiology department was conducted. A spray bottle with a yellow liquid in it was noted in the xray room, and in the CT room. The spray bottles did not have a label identifying what the contents inside the constainers were.

e) During the tour an interview with the facility's ADON was conducted. S/he stated that the contents were "Lemon Q" a germicidal solution. When asked how the staff was able to identify what was in the spray bottles s/he stated "they just know."

Based on the manner and degree of deficiencies cited the facility failed to be in compliance with the Condition of Participation of Organizational Structure. The facility failed to have a governing body or responsible individual that ensured the hospital was in compliance with applicable standards and conditions of participation. Specifically, the facility's governing body failed to ensure that the hospital's medical staff was appointed and reappointed on a regular basis.

The facility failed to be in compliance with the following standard under the Condition of Participation of Organizational Structure:

C0241 - Governing Body or Responsible Individual: The facility failed to ensure that the facility's Governing Body implemented and monitored the facility's adherence to policies governing the facility's medical staff. The facility had failed to ensure that the facility's medical staff had been granted privileges and were appointed in accordance with the facility's established policies and procedures. The failure to adhere to those procedures had the potential to lead to patients being cared for by medical staff that had not been recently evaluated for appropriateness to care for patients in the hospital and thus failed to ensure that patient care was delivered in a safe environment.

In addition, the Governing Body of the facility failed to ensure the following other Conditions of Participations were met:

C0270 - Condition of Provision of Services: The facility failed to ensure that services provided to patients were performed in a safe and effective manner that adhered to facility policies/procedures and standards of practice.

Based on credential file review, facility document review, and staff interview the facility failed to ensure that the facility's Governing Body implemented and monitored the facility's adherence to policies governing the facility's medical staff. The facility had failed to ensure that the facility's medical staff had been granted privileges and were appointed in accordance with the facility's established policies and procedures. The failure to adhere to those procedures had the potential to lead to patients being cared for by medical staff that had not been recently evaluated for appropriateness to care for patients in the hospital and thus failed to ensure that patient care was delivered in a safe environment.

Findings:

1. The facility did not maintain up to date credential files for all providers.

a. A review was completed of 12 credential files of providers for the facility on 03/13/13. The review revealed that 9 of the 12 credential files contained expired items without updated information.
Physician #2's credential file contained an expired medical license (05/31/11), an expired DEA certificate (09/30/09), and an expired liability insurance policy (07/01/10).
Physician #3's credential file contained an expired DEA certificate (03/31/12), and an expired liability insurance policy (03/01/12).
Allied Health Professional #1's credential file did not contain a liability insurance policy.
Physician #5's credential file did not contain a liability insurance policy.
Physician #6's credential file contained an expired liability insurance policy (08/15/12).
Physician #7's credential file contained an expired liability insurance policy (08/15/12).
Physician #8's credential file contained an expired liability insurance policy (08/15/12).
Physician #9's credential file contained an expired liability insurance policy (08/15/12).
Physician #10's credential file contained an expired DEA certificate (05/31/12).

b. An interview conducted with the facility's Administrative Assistant, who was responsible for the maintenance of the credential files, on 03/13/13 at 1:16 p.m. revealed that s/he had not placed updated information into the credential files when s/he received it. S/he stated that s/he would have to look to see if the facility had received updated information for the practitioners listed above. S/he confirmed the above items as being expired and confirmed that the files did not contain updated information.

2. The facility did not reappoint medical staff at least every two years as required in the facility's Medical Staff Bylaws.

a. A review of the facility's Medical Staff Bylaws, completed on 03/13/13, revealed that "reappointments shall be for a period of two (2) Medical Staff years."

b. A review was completed of 12 credential files of providers for the facility on 03/13/13. The review revealed that 6 of the 12 credential files did not contain documentation that the provider had been reappointed within the last two years.
Physician #1's credential file contained documentation that the last reappointment had been completed in 2007 (6 years ago).
Physician #2's credential file contained documentation that the last reappointment had been completed in 2009 (4 years ago).
Physician #3's credential file contained documentation that the last reappointment had been completed in 2008 (5 years ago).
Physician #4's credential file contained documentation that the last reappointment had been completed in 2008 (5 years ago).
Allied Health Professional #1's credential file contained documentation that the last reappointment had been completed in 2009 (4 years ago).
Allied Health Professional #2's credential file contained documentation that the last reappointment had been completed in 2008 (5 years ago).

c. An interview conducted with the facility's Administrative Assistant, who was responsible for the maintenance of the credential files, on 03/13/13 at 1:16 p.m. revealed that s/he had heard that the hospital was performing reappointments every 4 years. S/he confirmed that the facility's bylaws had specified that reappointments were performed every 2 years and she stated that s/he was not aware of any previous versions of the bylaws which stated a longer period of time. S/he confirmed the above findings that providers had exceeded 2 years for reappointment and that the longest period of time had been 6 years.

3. The facility's governing body failed to ensure that the facility was in compliance with other requirements for Critical Access Hospitals.

a. Cross Reference to C-0224 Maintenance:
The facility failed to ensure that drugs and biologicals available for patient use were appropriately stored.

b. Cross Reference to C-0270 - Condition of Participation - Provision of Services:
The facility failed to be in compliance with the Condition of Participation of Provision of Services. The facility failed to ensure that services provided to patients were performed in a safe and effective manner that adhered to facility policies/procedures and standards of practice.

c. Cross Reference to C-0308 - Protection of Record Information:

Based on the manner and degree of deficiencies cited, the facility failed to be in compliance with the Condition of Participation of Provision of Services. The facility failed to ensure that services provided to patients were performed in a safe and effective manner that adhered to facility policies/procedures and standards of practice.

The facility failed to meet the following standards under the Condition of Participation of Provision of Services:

C0273 - Patient Care Policies: The CAH failed to have a policy which described the services furnished directly by the CAH and those which were furnished through agreements or arrangements.

C0278 - Patient Care Policies: The facility failed to ensure that facility practices were performed in a manner that would prevent communicable diseases.

C0291 - Services Provided Through Agreement or Arrangement: The facility failed to maintain a complete list of contracts/agreements, which described the nature and scope of the services provided and any evidence of review, as required.

Based on interviews, facility document and policy reviews, the CAH failed to have a policy which described the services furnished directly by the CAH and those which were furnished through agreements or arrangements.

Findings:

1. The facility did not have a policy which described the services provided by the CAH and those provided under agreements or arrangements.

a. A review of the facility's policies and procedures on 03/13/13 revealed that the facility's policies did not include a policy which described the services furnished directly by the CAH and those provided under agreements or arrangements.

b. An interview was conducted on 03/13/13 at 3:30 p.m. with the facility's Director of Nursing and the facility's Assistant Director of Nursing. They confirmed that the facility did not currently have a policy which described the services provided directly by the CAH and those provided through agreements or arrangements.

Based on observations, staff interview and review of facility policies/procedures, the facility failed to ensure that facility practices were performed in a manner that would prevent communicable diseases.

This failure had the potential to result in nosocomial infections.

Findings:

1. The facility did not ensure that endoscopes were decontaminated in a separate area where patient procedures were performed.

a) A review of the 2011 Edition of the Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Setting by the Association of periOperative Registered Nurses (AORN) stated the following within "Recommended Practices for Cleaning and Processing Endoscopes," pages 422 and 423, stated: "Flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed."

b) A review of a document titled Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes published by the Society of Gastroenterology Nurses and Associates, Inc. stated the following within: "3.2.1 Processing Rooms," page 235, stated "Reprocessing of contaminated patient equipment must be done in an area designated and dedicated for this function. This must be a room separate from where endoscopic procedures are performed (AAMI, 2010)."

c) A review of the 2006 edition of the Guidelines for Design and Construction of Health Care facilities stated the following: "Dedicated processing room(s) for cleaning and decontaminating instruments shall be provided."

d) On 03/12/13 at 9:10 a.m., a tour of the facility's endoscopy room was conducted. It was noted that the supplies and instruments to clean and disinfect endoscopes was in the same room where the endoscopy's were being performed. The Assistant Director of Nursing stated that the scopes are cleaned between patient procedures not while a patient is in the room.

2. The facility staff that was responsible for the disinfection of surgical instruments did not follow the manufacturer's instructions for use of enzymatic detergent in the precleaning of instruments.

a) On 03/12/13 a review of facility policy titled, "Cleaning Disinfection and Sterilization" stated the following: "By law, all applicable label instructions on EPA-registered products must be followed."

b) On 03/12/13 at 8:45 a.m., a tour of the facility's endoscopy room was conducted with the facility's Assistant Director of Nursing (ADON). An interview with the ADON regarding precleaning of the scopes was conducted during the tour. The ADON stated that s/he fills the sink with water and four squirts of detergent. When asked what the manufacturer's directions for use were s/he stated that s/he did not know.

c) On 03/12/13 at 9:40 a.m., an interview with the director of central processing was conducted in the area used to preclean the surgical instruments prior to central sterilization. S/he stated that s/he would fill the sink about half way and add a couple of caps full of detergent. When asked what the manufacturer's directions for use were s/he did not know. A review of the detergent's label was conducted with the director of central processing. The label stated 1/8 to 1 fluid ounce was to be added to 1 gallon of water uses.

3. Cross Reference to C0224 - Maintenance for findings related to the facility's failure to ensure that multidose intravenous medication vials were used in accordance with accepted standards of infection control practices.

Based on a review of facility documents and staff interview the facility failed to maintain a complete list of contracts/agreements, which described the nature and scope of the services provided and any evidence of review, as required. Failure to maintain a complete/accurate list that was reviewed annually by administration for appropriateness of services, created the potential for negative patient outcome.

Findings:

1. The facility did not maintain a list of all contracted services furnished under arrangements or agreements that described the nature and scope of the services provided.

a. Upon entering the facility on 03/11/13 at 1:00 p.m., the Assistant Director of Nursing was provided a list of requested documents for review. Included on the list was a request for a "List of services provided by agreement/contract."

b. As of 03/13/13 at 3:20 p.m. a list of services provided under contract or agreement was not available for review. Another request was made to the facility's Director of Nursing and the facility's Assistant Director of Nursing for the requested list. They stated that they were not aware of such a list, but would check with the facility's Administrative Assistant to see if there was such a list.

c. On 03/13/13 at 6:00 p.m., the Director of Nursing stated that there had not been a list of contracted services maintained by the facility. S/he stated that the facility's Administrative Assistant had created one, but that the list did not contain the scope and nature of the services provided.

d. On 03/13/13 at 6:00 p.m. a review was completed of the list of contracted services provided to the hospital which included 16 contracts for services which included pharmacy consultants, physician and CRNA coverage, pathology services, laboratory services, and other services.

Based on observations and interviews and review of facility policies/procedures the facility failed to ensure that confidentiality of medical record information by providing safeguards against loss and unauthorized use.

This failure did not restrict access to medical records to those individuals accessing confidential records or for records to be lost.

Findings

1. The facility did not restrict access to medical records to those individuals with a need for access of medical records.

a) A review of facility policy titled, "Security & Safeguarding of Health Information-Policy & Procedure" stated the following: "Only authorized personnel shall have access to these areas. Employees of the HIM department, charge nurse and administration have keys for access to the HIM department when a health information employee is not in attendance."

b) On 03/12/13 at 12:20 p.m., a tour of the radiology department was conducted. It was noted that xray films containing patient information were being stored on shelves in an open area in the office area of the radiology department. The door to enter the office area was open. When asked if they can secure the room when no staff are present, staff stated that the door to enter the office does not lock.

c) On 03/12/13 at 12:35 p.m., during a tour of the facility's cat scan area, it was noted that xray films containing patient information were being stored in an open area. There was no door to secure this area.

d) On 03/12/13 at 3:15 p.m., during a tour of the medical records department in the Gordon Clinic was conducted. When asked who had access to this area, staff stated just the people that work in medical records. Facility staff stated that housekeeping does have a key due to the fact that they clean at night when no other staff are present.