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The Critical Access Hospital (CAH) located on two campuses had one surgical suite on each campus. Based on observation, document review and staff interview the CAH failed to meet the Provision of Services for infection control. The infection control officer failed to track and trend patient infections as required by the CAH's infection control plan. The CAH failed to develop cleaning policies for the surgical suites based on professional standards, and manufactures directions for efficacy and failed to ensure the cleaning staff followed the manufacturer's directions for use of the cleaning supplies used in the surgical suites.

The cumulative effect of the CAH's failure to follow the infection control plan, failure to establish cleaning policies and failure to follow manufacture's directions for use with chemicals resulted in a failure to maintain a sanitary surgical environment and avoid potential transmission of infection and communicable diseases for surgical patients at the hospital.

Findings include:

- The Critical Access Hospital failed to ensure infection control staff developed and followed a system to identify, track and trend patient infections, failed to ensure the infection control officer developed cleaning policies for the surgical suites based on professional standards, and failed to ensure the cleaning staff followed the manufacturer's directions for use of the cleaning supplies used in the surgical suites. See further evidence at C- 278, 42 CFR 485.635(a)(3)(iv).

- The policy/procedure titled-"...Subject: Clostridium Difficile in Acute Care...", last revised by the CAH on 5/12, reviewed on 9/20/12, stated "...Nursing will: Ensure all Patients/Resident with suspected or confirmed Clostridium Difficile are managed per policy/procedure....Contact Precautions shall be used for Patient/Residents with known or suspected C. Difficile-associated disease;... Full barrier precautions (gowns and gloves) shall be worn when staff is in contact with Patients/ Residents with CDI (Clostridium Difficile Infection) for potential contact with body fluids and environment...Dedicated Patient/Resident care equipment shall be used..."

The medical record for patient #11, reviewed on 9/17/12, revealed the patient was admitted to the CAH on 9/14/12 with a diagnosis of small bowel obstruction, urinary tract infection and complaint of loose stools. The CAH tested for Clostridium Difficile (C-Diff) and placed the patient in precautionary contact isolation on 9/17/12, three days after the patient's admission.

The medical record for patient #14, reviewed on 9/19/12, revealed the patient was admitted to the CAH on 7/30/12 as a swing bed patient with a diagnosis of post repaired broken right hip. The medical record on 8/6/12 documented the patient had multiple loose stools. A Clostridium Difficile (C-Diff) test was positive on 8/6/12. The CAH treated the patient with Intravenous (IV) Flagyl for 10 days and oral Vancomycin for 14 days. The patient completed the antibiotics started having loose stools again. The patient tested positive for C-Diff again on 8/29/12. The patient patient received oral Vancomycin (antibiotic) for 14 days.

Documentation provided by infection control staff of the CAH's patients with infections reviewed on 9/20/12 failed to included patient, #10 and #14.

Licensed Nurse F, interviewed on 9/20/12, stated the CAH completed a listing of infections on 6/3/12, and 7/6/12. Staff F stated the CAH no longer maintained an infection control log (listing) for all infections. Staff F reported the CAH tracked nosocomial (facility acquired) infections related to Methicillin Resistant Staphylococcus Aureus (MRSA), Vancomycin Resistant Enterococcus (VRE), Foley catheter infections, Gastroenteritis, and Influenza.


- The CAH policy for "Attire in the Operating Room", reviewed on 9/19/12, revealed a plan for staff to wear shoe covers in the restricted area of the surgical suite and to remove them whenever leaving the surgical suite.

The 2012 Perioperative Standards and Recommended Practices, Recommendation III, stated-"...All individuals who enter the semirestricted and restricted areas should wear freshly laundered surgical attire that is laundered at a health care accredited laundry facility or disposable surgical attire provided by the facility and intended for use within the perioperative setting..."

Licensed Nurse H and Nursing Student I were observed, on 9/19/12 at 6:50am sitting in the CAH nursing break room, outside of the CAH's sterile and substerile areas, dressed in disposable surgical clothing (bunny suits), and hair covers. The staff left the common break room area and returned into the Operating Room to transport a newborn baby to the nursery and provided care to the baby without changing their disposable surgical clothing. Licensed Nurse J on 9/19/12 at 7:00am verified Staff H and Student I changed their face masks and booties, but failed to change the disposable bunny suit and hat worn from the break room into the Operating room and Nursery.

Licensed staff J was observed on 9/20/12 at 9:45 am outside the surgical suite dressed in surgical clothing, shoe covers and a bouffant cap in their right hand. Licensed nurse J reentered the surgical suite, stopped at the line which separated sub-sterile and sterile, put on the same bouffant hat and kept on the same shoe covers. Licensed staff F proceeded into the Operating room. Staff F failed to put on clean surgical clothing. The CAH's Infection Control Nurse, staff F on 9/20/12 acknowledged nursing staff failed to follow policies and professional standards with surgical clothing.



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The Critical Access Hospital (CAH) located on two campuses had one surgical suite on each campus. Based on observation, document review and staff interview the infection control officer failed to track and trend patient infections as required by the CAH's infection control plan and develop and implement a method to evaluate the effectiveness of the program and provide corrective action if needed. The CAH failed to develop cleaning policies for the surgical suites based on professional standards, and manufactures directions for efficacy and failed to ensure the cleaning staff followed the manufacturer's directions for use of the cleaning supplies used in 2 of 2 surgical suites.


Findings include:

- The Infection Control Officer's job description reviewed on 9/20/12 directed the Infection Control Officer to conduct regular rounds in all hospital and outpatient departments to discuss, monitor and follow the infection control practices of the staff. Collect data on healthcare acquired infections from all hospital departments and maintain records for each infection. The infection control officer should conduct continuous surveillance to detect the source of infection for prevention purposes and periodic infection control meetings to discuss infection control reports, findings and recommendations.

- The CAH's policy for Infection Control Plan 2012 reviewed on 9/20/12 stated the purpose of the hospital's program was to minimize the transmission off healthcare and community acquired infections within the hospital. The plan directed the infection control staff to focus on the detection, prevention, treatment, and control of infections through utilization of surveillance, health promotion activities and education. The plan directed the infection control staff to include:

A. Surveillance to determine hospital infection rate as determined by the prevalence rates of infections within the hospital.

B. Surveillance for unusual occurrences and their epidemic potential within the hospital.

C. Provide the best possible protection against transmission of infections and blood borne pathogens within the hospital through education programs over the means of transmission.

D. Utilize personal protective equipment and engineering controls such as sharps safety with the evaluation of their effectiveness.

E. Report: state reportable, Hospital-Acquired Infection Log sheets and monthly infection reports.

The plan specified each department of the hospital be included in the hospital's infection control program. "Each department shall develop written infection control policies to reduce the risk of infection, care of equipment and cleaning and disinfection. Each department must develop policies and procedures for staff attire and traffic control."

- The CAH's policy revised by the CAH 8/1/12 for cleaning the surgical department reviewed on 9/19/12 directed "equipment and supplies used in the surgery department will not be used anywhere else in the hospital, including mop heads, mop bucket, ject." The policy directed cleaning staff to follow the surgical department's dress code and wear scrubs, shoe covers, cap and mask when cleaning the surgical suite. The cleaning policy identified daily cleaning, between case cleaning, and directed a terminal clean of the operating room at the end of the scheduled surgical day. Other cleaning included nightly cleaning and cycle cleaning. The terminal cleaning included:

1. Furniture is thoroughly scrubbed with disinfectant using effective mechanical friction.
Table wheels and casters are cleaned and inspected for debris. Surgical lights and tracks are cleaned. All wall-mounted equipment, view boxes, etc, are cleaned with a detergent germicide solution and disposable wipes.

2. Kick buckets are thoroughly cleaned with detergent germicide, new liner is inserted.

3. Walls are cleaned as necessary.

4. Cabinet doors and handles are cleaned.

5. Entire floor space is mopped with a detergent germicide.

6. Scrub sinks, faucets, soap dispensers and surrounding walls are cleaned.

7. Operating room floors shall be wet-vacuumed with a hospital approved disinfectant.

- St. Mary's surgical suite observed on 9/18/12 revealed the medical gas hoses and drawer pulls on th anesthesia car had a build-up of dust and build-up of dust. The arm board of the surgical table had worn areas which exposed the cloth threads of the underneath vinyl. The worn area rendered the surface un-cleanable and an infection control risk.

- Housekeeping staff B and C were observed cleaning the emergency department at the Onaga campus on 9/19/12 at 8:00am. Staff B and C indicated they were ready to clean Onaga's surgical department. Staff B and C at 8:00am pushed the housekeeping cart from the emergency department to the northeast janitor's closet on the opposite side of the hospital. Staff B and C took the cart passed the patient care areas, and thorough the main clinic lobby to reach the northeast janitor closet. Staff C removed the mop bucket from the cart and dumped the dirty mop water into a sink without wearing personal protective equipment (PPE) to prevent splash contamination on their uniform. Staff C rinsed the mop bucket and filled the bucket half way with "Triple" (a cleaning solution) from a automated chemical proportioning system. Staff C used chemical test strips that changed to a green color to indicate the chemical was at 600ppm (parts per million) as required for disinfection and placed the dirty mop handle back into the clean chemical solution.

Staff B and C (housekeeping) pushed the soiled cart to the operating room, and across the red line (indicated the separation between clean and sterile areas of the department). Staff put surgical attire on and proceeded into the operating room to clean at 8:15am. Staff B sprayed triple disinfectant on the door and frame and immediately wiped the surface dry with a reusable terry cloth. Staff did not keep these surfaces wet for 10 minutes as required by the manufacturer. Staff B sprayed the adjacent walls and cabinets and carefully wipe each surface dry before cleaning the next area (not allowing the 10 minutes wet contact time). Staff C sprayed the stainless steel table and dried the surface with a re-useable terry cloth. Staff C sprayed the surgical table with triple disinfectant cleaner and immediately wiped the surface. Staff C removed the table mattresses to clean the table by spraying and immediately wiping the surface dry with the same cloth.

Staff referred to a letter dated September 1, 2010 from a technical director with the laboratory who manufactures "Triple Disinfectant Cleaner" when asked about the wet contact time for Triple Disinfectant Cleaner. The letter stated " The label instructions require properly diluted solution ....be applied with a cloth, mop, sponge, or coarse spray or soaking. For sprayer applications, use a coarse spray divide. Spray 6-8 inches from the surface, rub with a brush, cloth or sponge....Let solution remain on surface for a minimum of 10 minutes. Rinse or allow to air dry. If Triple is applied with a trigger spray device, the cloth used to wipe the surface should be saturated with disinfectant so as to leave a wet surface. The cloth needs to be wet enough to avoid wiping the surface dry. The cloth should be as wet as a dish cloth that has been wrung out to the point where it is wet (but not sloppy wet and not simply damp). The surface may not be wet to touch for 10 minutes, but the disinfectant will leave an active residual film if the surface is allowed to air dry." Housekeeping staff failed to follow the manufactures recommendations and instructions provided by a technical director for the manufacturer.

The infection control office lacked evidence of an evaluation of housekeeping staff to monitor for adherence to manufactures recommendations and provide corrective action when necessary.

- The CAH policy for traffic patterns in the surgical suites dated 8/1/12 reviewed on 9/24/12 directed staff to limit the traffic in the surgical suite. The policy directed all staff in the surgical areas to wear surgical scrubs, hair covers and masks when in the restricted surgical areas such as the scrub sinks and surgical suite.

Cleaning staff A on 9/19/12 at 8:37am was observed opening the surgical suite door in their street clothes, walked beyond the red line (that indicated the start of the sterile area). Cleaning staff A failed to change into the required surgical scrubs, hair cover and apply a mask prior to entering the restricted area.

- The surgical table arm boards at Onaga's surgical suite had worn areas that exposed the cloth threads of the underneath vinyl. The worn area rendered the surface un-cleanable and an infection control risk.

- The CAH's policy for cleaning the surgical department policy dated 8/1/12, reviewed on 9/19/12 directed cleaning staff to complete cycle cleaning weekly:

1. remove portable equipment from the surgical suite.

2. Wash all fixtures attached to the ceiling, walls, doors, door jambs, electrical outlets, rubber hoses, fixtures attached to the walls, the outside surface of cabinets and shelves with a hospital-approved germicidal solution.

3. Pour a hospital-approved germicidal solution onto the entire floor surface and scrub mechanically. Remove solution with a wet vac.

Cleaning staff B interviewed on 9/19/12 at 9:00am reported the cleaning staff, do not follow the CAH's policy for weekly cycle cleaning in the surgical department. Staff B reported the hospital did not have a wet vacuum for use in the surgical suites at either campus.

The Infection Control Plan and annual Infection Control meetings dated 9/11/12, 4/26/11 and 8/31/10 reviewed on 9/20/12 lacked evidence of monitoring for surgical infections. Quality Assurance Performance Improvement (QAPI) committee meeting minutes for infection control department reviewed on 9/20/12 revealed the committee met quarterly and lacked evidence of any data from infection control for surgical infections. QAPI staff G on 9/20/12 at 4:00pm verified the hospital's infection control data in the QAPI program lacked evidence the hospital monitored and collected data for surgical site infections.

- The Infection control log dated between 11/11/11 to 7/31/12 (last entry into the log) reviewed on 9/20/12 lacked evidence that the infection control officer tracked and trended surgical infections. A comparison of patient infections monitored by the CAH with data collected by the CAH's sponsoring hospital did not match. The CAH's infection log reported a total of 17 infections between 1/1/12 to 9/20/12. Review of the sponsoring hospital's infection data for the CAH totaled 201 patient infections. The CAH's information lacked 184 infections as reported by the CAH's sponsoring hospital.

Infection control officer F interviewed on 9/20/12 at 2:00pm reported the infection control program did not track patient surgical infections at the CAH.

Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) failed to ensure 6 physicians who read Mammogram films followed acceptable Standards of Practice and the CAH's policies for the use of rubber signature stamps used by personnel other the the physician to authenticate their medical records (L,M,N,O,P,Q).

Findings include-

- Observation in the Radiology Department, on 9/18/12 at 10:10am revealed a drawer which contained the rubber signature stamp for Physicians L, M, N, O, P, and Q.

The radiology department on 9/18/12 at 10:10am contained letters which informed patients #29, #30, #31, and #32 of their Mammography results, which contained Physician signature stamps.

Review of the Medical Staff Rules and Regulations revealed a CAH Rubber Stamp Policy which stated-"...1. Signature Stamps only permitted with the approval of Administration. 2. A signed copy of the attached letter must be kept in the Administration Office and also in the Health Information Office. 3. In conformity with the Rules and Regulations of Community CAH...concerning the use of such a signature stamp, I affirm that I will be the sole user of my signature stamp and will retain said stamp in my possession at all times...4. There will be no delegated use of said stamp to any other individual...

Radiology staff member K, interviewed on 9/18/12 at 10:15 am stated they were employed by the CAH for the last 5 years, and verified they used the Physician's signature stamps on the letters sent out to patients by the CAH informing patients of the results of tests. Staff verified they used the stamps on the letters for patients #29, #30, #31,and #32.