The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

LAKE CHELAN COMMUNITY HOSPITAL 503 EAST HIGHLAND CHELAN, WA 98816 Sept. 13, 2018
VIOLATION: PROVISION OF SERVICES Tag No: C0270
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Based on observation, interview, and review of hospital policies, procedures, and documents, the Critical Access Hospital failed to meet the requirements for the Condition of Participation for Provision of Services.

Failure to meet established service requirements and responsibilities impaired the hospital's ability to provide quality care in a safe environment.

Findings included:

1. The hospital failed to develop, implement, and maintain a written infection control and surveillance program.

2. The hospital failed to develop a hospital-wide system for maintaining a sanitary environment to avoid sources of infection and communicable diseases.

3. The hospital failed to develop and implement policies and procedures to approve and properly use disinfectants, and Sanitation Procedures.

4. The hospital failed to maintain a sanitary physical environment with non-absorbent, cleanable surfaces.

5. The hospital failed to correctly install an ice machine drain line.

6. The hospital failed to implement the Plan of Correction and ensure ongoing compliance for previously cited non-compliance following a state licensing survey (Cross-reference: Tag C-0278 Item #1, Item #4, Item #5, Item #6 and Tag C-0292).

Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 485.635 Provision of Services was NOT MET.

Cross-reference: Tags C0278, C0292

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VIOLATION: POLICIES - INFECTION CONTROL Tag No: C0278
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ITEM 1 - INFECTION CONTROL PLAN

Based on observation, interviews, and document review, the hospital failed to ensure the staff developed a written infection control plan to prevent, investigate, and control infectious and communicable diseases; and to implement the plan throughout the hospital.

Failure to develop and implement a comprehensive infection control plan risks transmission of communicable diseases to patients, visitors, and staff.

THIS IS A REPEAT CITATION - PREVIOUSLY CITED MARCH 2017

Findings included:

1. On 09/12/18 at 9:30 AM, Surveyor #8 asked the Infection Preventionist (IP) (Staff #804) for a copy of the current infection control (IC) plan and the most recent IC committee meeting minutes. At the time of the request, the IP stated that the hospital did not have a written infection control plan, but provided the infection control meeting minutes for 2018.

2. On 9/12/18 at 9:30 AM, Surveyor #8 met with the IP and the Director of Quality and Patient Safety (Staff #805) to discuss how the IC program operates without an IC plan. The IP stated he had completed an Infection Control Risk Assessment about a year ago and thought that was sufficient. The Director of Quality and Patient Safety (Staff #805) stated that the hospital conducts hand hygiene surveillance which is handled by nurse managers, and the lab notifies the patient's physician and nurse managers when there is a patient with an infection.

3. On 09/13/18 between 12:55 PM and 2:15 PM, Surveyor #6 and Surveyor #8 held a meeting with hospital staff and department heads to review the IC Program. The surveyors interviewed the Director of Quality (Staff #605), the Chief Nursing Officer (Staff #615), and the Infection Preventionist (Staff #613) about the IC Program at the hospital. The staff were not able to identify processes as part of the IC Program. The IP (Staff #613) stated that he was researching infection control plans adopted by similar hospitals.

Review of the IC committee 2018 meeting minutes (01/18/18 and 07/19/18) showed discussion agendas. There was no documentation of action items to prevent, control, or investigate infections and communicable diseases; no proposed surveillance, data collection, or analysis; no monitoring or evaluation of prevention interventions.

ITEM #2 - STORAGE OF SOILED AND CLEAN OBJECTS

Based on observation, and interview, the hospital failed to ensure that soiled and clean items were stored in separate utility rooms.

Failure to store soiled and clean items in separate utility rooms risks cross-contamination of clean supplies, which places patients and staff at increased risk of infection.

Reference: Guidelines for Design and Construction of Health Care Facilities 2006; The Facility Guidelines Institute. Section 2.3 Support Areas for Patient Care: 2.3.7 Clean Workroom or Clean Supply Room shall be separate from and have no direct connection with soiled workrooms or soiled holding rooms; 2.3.8 Soiled Workroom or Soiled Holding Room shall be separate from and have no direct connection with clean workrooms or clean supply rooms.

Findings included:

1. On 09/11/18 at 8:30 AM, Surveyor #8 observed 40 to 50 sharps containers, both empty (clean) and full (contaminated), stored together on shelves in a hallway outside a conference room on the first floor.

2. On 09/11/18 at 8:30 AM, Surveyor #8 asked the Patient Safety Coordinator (Staff #806) about the empty and full sharps containers being stored together at this location. Staff #806 Stated that she was not aware of the reasoning for storing all the containers together. Surveyor #8 asked the following staff members about the disposable sharps container storage location:
- the Chief Nursing Officer (Staff #803), on 09/11/18 at 11:30 AM;
- the Director of the Emergency Department and Perioperative Services (Staff #801), on 09/11/18 at 1:30 PM;
- the Patient Safety Coordinator (Staff #806), on 09/12/18 at 11:30 AM;
- the Clinical Informatics Manager (Staff #807), on 09/12/18 at 1:30 PM.

3. On 09/11/18 at 1:05 PM, Surveyor #6 observed the following clean supplies and soiled items stored together in room #216B, a soiled utility room: four empty (clean) sharps disposal containers, six full (contaminated) sharps disposal containers, clean cloth towels, clean plastic liner bags, new, un-used boxes of disposable medical gloves, and new, un-opened bottles of chemical developer for blood test kits.

On 09/11/18 at 1:40 PM, Surveyor #6 observed the following clean supplies and soiled items stored together in room #241, a soiled utility room: two clean sharps disposal containers, six full sharps cylinders (disposable sharps containers used by Emergency Medical Services).

4. At the time of the observations, Surveyor #6 asked the Environmental Services Manager (Staff #602) about the use of the soiled utility rooms. Staff #602 stated that the soiled utility rooms should not be used to store clean supplies.

5. On 09/12/18 at 3:20 PM, Surveyor #6 asked the Environmental Services Manager (Staff #602) about the empty and full disposable sharps containers being stored together outside the conference room. Staff #602 stated that a few empty containers are available with the full containers for staff convenience.

ITEM #3 - CLEANING PATIENT CARE AREAS

Based on observation and interview, the hospital failed to develop and implement infection control procedures that prevented cross contamination of soiled and clean items during cleaning of patient care areas.

Failure to prevent cross contamination during cleaning and disinfection procedures places patients, staff, and visitors at increased risk of infection.

Findings included:

1. On 09/11/18 between 11:00 AM and 11:40 AM, Surveyor #6 observed two Environmental Services Technicians (Staff #603 & Staff #604) perform a discharge cleaning of room #208. The observation showed that Staff #603 disinfected a DVT (deep vein thrombosis) pump while holding it against her uniform, thereby re-contaminating the pump.

2. At the time of the observation, Surveyor #6 interviewed Staff #603 about cross-contamination. Staff #603 stated that she should not hold clean items against her uniform.

3. On 09/12/18 between 9:40 AM and 10:20 AM, Surveyor #6 observed Environmental Services Technicians (Staff #603 & Staff #604) clean and disinfect Operating Room (OR) #1. The observation showed that Staff #604 missed wiping an area of approximately 12 square inches when disinfecting a stainless steel table. After disinfecting a strap from the procedure table, Staff #604 placed it on the unclean area of the table.

4. On 09/12/18 between 9:40 AM and 10:00 AM, while Staff #603 & Staff #604 were cleaning OR #1, a Certified Registered Nurse Anesthetist (Staff #606) set up the anesthesia machine for the next procedure. There was visible debris on the machine surface while Staff #606 connected hoses and replaced the absorber canister.

5. On 09/12/18 at 10:20 AM, Surveyor #6 interviewed Staff #603 about cross-contamination from the stainless steel table to the bed straps. Staff #603 stated that the entire table surface should have been disinfected prior to placement of the disinfected bed straps.

6. At 10:45 AM, the surveyor asked the Patient Safety Coordinator (Staff #605) about Staff #606's set-up activities while OR #1 was being cleaned. Staff #605 stated that OR #1 should have been completely cleaned and disinfected prior to any preparations for the next procedure.

ITEM #4 - IMPROPER USE OF DETERGENT

Based on observation, document review, and interview, the hospital failed to implement policies and procedures to ensure that staff used an appropriate disinfectant product on medical instruments that require high-level disinfection (HLD) prior to sterilization.

Failure to properly disinfect medical instruments prior to sterilization places patient's at increased risk of infection due to ineffective sanitation and sterilization of medical instruments.

THIS IS A REPEAT CITATION - PREVIOUSLY CITED MARCH 2017

Reference: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Healthcare Infection Control Practices Advisory Committee (HICPAC). "Semicritical items contact mucous membranes or nonintact skin." "Semicritical items minimally require high-level disinfection using chemical disinfectants."

Findings included:

1. Product information for AprilGuard Powdered Organisol Detergent states, "Organisol is not for disinfecting instruments."

2. On 09/12/18 between 1:30 PM and 1:45 PM, Surveyor #6 toured the hospital's outpatient clinic. The surveyor observed a container of AprilGuard Powdered Organisol Hospital & Laboratory Ware Detergent on the counter at a utility sink near the Nurses' Station.

3. At the time of the observation, Surveyor #6 interviewed a Certified Medical Assistant (Staff #607), about use of Organisol. Staff #607 stated it was used to soak medical instruments, such as suture sets and gynecological exam instruments [semicritical items], prior to wrapping for sterilization. The Chief Operations Officer (Staff #608) stated that the product had probably been used at the clinic before the hospital acquired the clinic services.

4. On 09/12/18 at 4:00 PM, Surveyor #6 interviewed the Safety Officer (Staff #609) about the use of Organisol. Staff #609 stated that Organisol had not been approved for use by the hospital, and that all chemicals should be approved by the Materials Management Department prior to purchase.

ITEM #5 - SANITARY ENVIRONMENT

Based on observation and interview, the hospital failed to provide non-absorbent, cleanable materials and furnishings that support a hygienic environment.

Failure to maintain an easily cleanable environment places patients, staff, and visitors at risk for infection.

THIS IS A REPEAT CITATION - PREVIOUSLY CITED MARCH 2017

Reference: Association of Perioperative Registered Nurses. Guidelines for Perioperative Practice. Vol 1, 2017. "Guideline for a Safe Environment of Care, Part 2. Recommendation V: The integrity of structural surfaces (e.g. doors, floors, walls, ceilings, cabinets) should be maintained, and surfaces should be repaired when damaged."

Findings included:

1. On 09/11/18 at 9:30 AM, Surveyor #8 toured patient care areas with the Chief Nursing Officer (CNO) (Staff #803). Surveyor #8 observed a large volume of supplies stored in hallways, alcoves, and on shelves in the emergency room and x-ray area, operating rooms, medical and obstetrics areas. The observation showed that many storage containers were constructed of un-sealed, corrugated cardboard, which is absorbent and not cleanable.

2. At the time of the observations, Surveyor #8 asked the CNO (Staff #803) about hygienic storage of supplies in the areas listed above. The CNO stated that cardboard containers and over-full shelves were not cleanable surfaces.

3. On 09/11/18 between 11:45 AM and 1:40 PM, Surveyor # 6 toured patient care areas with the Environmental Services Manager (Staff #602). The surveyor observed that patient care supplies are stored in containers constructed of un-sealed, corrugated cardboard. Cardboard is absorbent and not cleanable.

4. At the time of the observations, Surveyor #6 asked Staff #602 about storage of patient care supplies in cardboard containers. Staff #602 stated that he was not aware that cardboard containers were a problem.

5. On 09/12/18 between 9:40 AM and 10:20 AM, Surveyor #6 observed a between case cleaning of Operating Room (OR) #1. The observation showed that built-in cabinets were constructed of wood and that the edges of the veneer were chipped and cracked in several places. The chipped edges exposed bare wood, which is absorbent and not cleanable.

6. On 09/12/18 at 10:45 AM, Surveyor #6 asked the Patient Safety Coordinator (Staff #605) about the bare wood surfaces on the cabinets. Staff #605 confirmed the observation and stated that wood surfaces create a challenge for Environmental Services staff.

ITEM #6 - EQUIPMENT NOT CORRECTLY PLUMBED

Based on observation and document review, the hospital failed to install ice machine drain lines according to manufacturer's instructions.

Failure to install ice machine drain lines properly risks contamination of the water and ice supply.

THIS IS A REPEAT CITATION - PREVIOUSLY CITED MARCH 2017

Findings included:

1. The manufacturer's instructions for installation of the Follett Symphony series ice machines states, "Plumbing - Note: Drain to be hard-piped and insulated, and maintain slope of at least inch per foot."

2. On 09/13/18 at 10:40 AM, Surveyor # 6 inspected a nourishment room on the medical-surgical unit, room #206. The surveyor observed the drain line from a Follett Symphony series ice machine. The observation showed that the drain line from the ice machine ran slightly upward before connecting to the building plumbing system.

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VIOLATION: AGREEMENTS - CEO RESPONSIBILITIES Tag No: C0292
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Based on interview and review of the hospital's quality and performance improvement program, the hospital failed to ensure that performance measures for patient care contractors were developed and evaluated through the hospital's quality program.

Failure to oversee the performance of all patient care services and departments risks provision of improper or inadequate care and adverse patient outcomes.

THIS IS A REPEAT CITATION - PREVIOUSLY CITED MARCH 2017

Findings included:

1. Review of the hospital's Quality plan titled, "Continuous Quality Improvement Plan 2018" adopted 03/01/18 showed that the plan's objectives include provision of patient care to professional standards; proactive evaluation of systems and patient care delivery; provision of continuous, interdisciplinary process and outcome assessment, monitoring, and improving across the scope of services.

2. On 09/13/18 between 12:55 PM and 2:15 PM, Surveyor #6 and Surveyor #8 interviewed the Director of Quality (Staff #605), the Chief Nursing Officer (Staff #615), and the Infection Preventionist (Staff #613) during a meeting that included 6 other staff and department heads (Staff #608, Staff #616, Staff #617, Staff #618, Staff #619, and Staff #620). The interview and plan review showed the following:

a. Patient care contracted services, such as laundry are not evaluated for quality and performance. A Quality Assurance checklist had been developed but not been completed to date.

b. Review of the Quality plan, Appendix 2, "Process/Performance Review Functions Matrix" showed that there were no quality indicators to measure the contracted services performance.

3. At the time of the interview, the Director of Quality (Staff #605) and the Chief Nursing Officer (Staff #615) stated that the hospital did not have a process in place to evaluate contracted services.