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Based on staff interview and review of meeting minutes and quality documents, it was determined the CAH's governing body failed to assume responsibility for governing the CAH's total operation. This resulted in a lack of transparency regarding oversight of the CAH. Findings include:

The CAH was part of a health system that included several hospitals. Oversight and control of the McCall CAH was not documented.

For example, a document titled, "St. Lukes McCall FY 2017 Annual CAH Quality Report," dated February 2018, was purported to be an evaluation of the CAH's total program. However, the report did not evaluate the CAH's utilization of services. The report did not include specific information about record reviews conducted by the CAH. Also, the report stated the CAH completed policy reviews but did not present information regarding any findings.

QSSEC minutes, dated 2/06/18, stated an annual quality report was presented to the QSSEC. The report stated a quality scorecard was presented. The report did not include an evaluation of the utilization of services, an evaluation of clinical chart audits. or an evaluation of policies as required by regulation. The minutes did not include any value judgements regarding the evaluation.

Minutes of the QSSEC, from 5/2/17 through 5/01/18, were reviewed. The minutes discussed credentialing for the McCall CAH. Otherwise, there was no mention of oversight or evaluation of the CAH by the committee.

"MINUTES OF THE BOARD OF DIRECTORS GENERAL SESSION ST. LUKES WEST REGION," dated 4/25/17 to 4/24/18, were reviewed. No mention of the McCall CAH was included in the minutes.

No documentation of oversight or decision making, by those responsible for the operation of the McCall CAH, was documented.

A member of the CAH's Community Board was interviewed on 5/17/18 beginning at 1:20 PM. She stated the Community Board did not have responsibility for operation and oversight of the CAH.

A member of the CAH's Community Board and the health system's Western Regional Board was interviewed on 5/17/18 beginning at 1:20 PM. She stated neither board had responsibility for operation and oversight of the CAH.

The CEO of the McCall CAH was interviewed on 5/16/18 beginning at 1:20 PM. He stated 3 boards were involved with the CAH. Documentation of oversight of the CAH was requested at that time. Despite multiple requests from different staff members, the documentation was not provided.

The CAH failed to maintain evidence of oversight by a governing body.

Based on observation, staff interview, and review of CAH policy, IUSS logs, and staff training material, it was determined the CAH failed to ensure policies were sufficiently developed related to infection control standards for IUSS use and labeling of open products. It also failed to ensure handwashing was followed in accordance with CAH policy. These failures had the potential to increase the risk of patient infection. Findings include.

1. Staff training material, "Skills - Immediate-Use Steam Sterilization (Perioperative) Quick Sheet," undated, stated:

- "Immediate-use steam sterilization (IUSS) may be associated with an increased risk of infection to a patient because of the elimination of one or more steps in the cleaning and sterilization process."

- "Use IUSS only when absolutely necessary and when there is insufficient time to process an item using the wrapped or container steam sterilization method in the sterile processing department."

- "Do not use IUSS as a substitute for insufficient instrument inventory."

Surveyors requested a CAH policy that addressed IUSS. CAH policy, "Sterilization & High Level Disinfection of Surgical/Procedural Items/ dated 5/31/17, referenced the need to avoid IUSS for implantable items except in an emergency. However, the policy did not mirror staff training material in that it did not state to avoid IUSS as a substitute for insufficient instrument inventory. It did not state IUSS should only be used when absolutely necessary. The policy for IUSS use was insufficiently developed and inconsistent with staff training material.

IUSS was used as a substitute for insufficient instrument inventory, which was inconsistent with staff training. An example includes:

During an observation of central processing on 5/16/18 at 2:00 PM, surveyors requested the IUSS log for review. The "STEAM LOT & LOG CONTROL RECORD," dated 4/27/18, documented IUSS was used on "cataract instruments" for 10 ophthalmic patients. When asked for the prior date the ophthalmologist did surgery, CAH staff provided a second log, dated 3/02/18. It documented IUSS for cataract instruments for 14 ophthalmic patients.

Three CAH staff members were present during review of the logs, including an Infection Preventionist, an RN, and a Surgical Technician who was certified in sterile processing. They explained an ophthalmologist did surgery one day every other month. He brought two sets of his own instruments with him and, after the first two surgeries, had CAH staff clean his instruments by IUSS throughout the day until he completed all scheduled surgeries.

During an interview on 5/17/18 at 8:30 AM, the Manager of Quality & Patient Safety confirmed it was not a standard of practice to use IUSS in a routine matter. She stated the surgical policy was currently being revised.

The CAH policy for IUSS was insufficiently developed to guide staff. The use of IUSS for ophthalmic patients was not used in accordance with CAH training.

2. A CAH policy, "Infection Prevention, Facility-Wide," dated 2/28/18, addressed expectations for handwashing. Indications for hand hygiene included:

- "Upon entry and exit from patient rooms/bays (occupied and unoccupied)"
- "Before and after glove use."

This policy was not followed. Examples include:

a. While in the pre-operative area with Patient #22, on 5/15/18 at approximately 1:35 PM, surveyors observed a CRNA don gloves, scrub Patient #22's neck, remove gloves, leave the room, and return with a syringe. Handwashing was not observed to occur after removing gloves, prior to leaving the pre-operative area.

During an interview on 5/15/18 at 4:30 PM, the Director of Peri-Operative Services confirmed the observation.

b. While Patient #22 was undergoing shoulder surgery on 5/15/18, surveyors observed the CRNA, between approximately 1:50 PM and 2:45 PM. During this time, the CRNA was observed to don gloves, intubate Patient #22, remove gloves, type on a computer, fill and label syringes, adjust pants and glasses, apply telemetry leads, don gloves, pick up a syringe, touch the computer, remove supplies out of a drawer, suction Patient #22, remove a mouth tube, apply oxygen, and remove gloves. Hand sanitizer was located behind a computer monitor on the wall near the CRNA's work area. During and after the course of these activities, surveyors did not observe the CRNA perform hand hygiene.

During an interview on 5/15/18 at 4:00 PM, the Manager of Quality and Patient Safety stated it was her expectation hand sanitizer would be used before and after glove use and before and after direct care.

Hand hygiene did not occur in accordance with agency policy.

3. Surveyors requested a policy that described the CAH's procedure for labeling expiration dates or use-by dates of open containers. None was provided.

There were inconsistent practices observed within the CAH. This had the potential to lead to inadvertent use of expired items. Examples include:

a. During a tour of the ED on 5/16/18 at 9:15 AM, an alcohol bottle was observed to be labeled to expire on "3/21." When asked whether 3/21 meant March 21st or March 2021, staff escorts, including the CNO and a DNS, stated they did not know. The DNS removed the alcohol from use. At 9:45 AM, the Lab Supervisor clarified the date 3/21 meant March of 2021.

It was not universally understood by CAH staff, based on the comments of the CNO and DNS, that two sets of numbers referred to month and year as opposed to month and day.

b. Surveyors toured the Laboratory on 5/14/18 at 3:00 PM and made the following observations:

i. "Sani Hands" wipes, stated "expired 4/18." It could not be determined whether the label meant April 18th, or April, 2018. Either way, the product was expired and available for use.

ii. "Reagent Grade Water," stated "open date 5/10/18." There was no expiration or use-by date. When asked regarding the expiration or use-by date, surveyors received differing answers. The Manager stated they would discard it based on the expiration date on the bottle. The Director of Operations stated it would be discarded within 30 days. The expiration date of the bottle was more than 30 days.

iii. The label on "Avagard Hand Antiseptic," sitting beside a sink in the laboratory was dated "Exp 8/26/17." It was still in use.

Expiration and use-by dates were not addressed in CAH policy. Additionally, infection prevention items available for staff use were beyond their expiration dates.











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Based on review of CAH policy, clinical records and staff interview, it was determined the CAH failed to ensure nutritional needs were identified and met for 3 of 20 inpatients (Patients #21, #24, and #33), excluding obstetric and newborn patients. The CAH failed to ensure a system was in place to identify patients with significant nutritional needs and refer those patients for dietary evaluations. This created the potential for patients' nutritional needs to be unmet. Findings include:

1. Patient #24 was a 72 year old male admitted to a swing bed on 5/11/18, for wound care to an infected pacemaker site. His diagnoses included insulin dependent DM, COPD, HTN, and history of Hepatitis C. He was discharged on 5/16/18.

The hospital's policy, "Nutrition Screening and Assessment" revised 1/12/18, stated "Nutrition screening, warranted by the patients' needs or condition, is performed to identify with nutritional problems and risk factors for malnutrition within 24 hours of admit. A Registered Dietitian will perform a nutritional assessment for patient who are found to be at nutritional risk through the nutrition screening process or otherwise identified at nutritional risk." The policy did not identify what score on the nutrition screening would trigger a nutrition assessment by an RD.

Patient #24's electronic medical record was reviewed with a DNS. His admission assessment, completed on 5/11/18, signed by an RN, included a "Nutrition Screen." A DNS stated he received a score of 3 on his nutrition screen because he stated he was eating poorly and was unsure if he had lost weight recently. A DNS stated she did not know what score on the nutrition screening would trigger a nutrition assessment by an RD. She stated Patient #24's record did not include documentation of a nutrition assessment by an RD.

During a review of medical records on 5/17/18 at 4:45 PM, the Manager of Quality and Patient Safety stated a score of 2 or more on a nutrition screening required a nutrition assessment by an RD. On 5/18/18 at 9:50 AM, she provided a screen shot of Patient #24's nutrition screen that stated "Any score > or equal to 2 = RD consult to be automatically sent." The Manager of Quality and Patient Safety confirmed Patient #24's nutrition screen score of 3 should have resulted in a nutrition assessment by an RD.

Patient #24 did not receive a nutrition assessment by an RD, as indicated by his nutrition screen.

2. Patient #21 was a 61 year old male who was admitted to the CAH on 2/09/18 and discharged on 2/13/18.

Patient #21's History and Physical, dated 2/09/18 at 7:00 PM, stated his chief complaint was a "...history of severe alcohol withdrawals and recent severe metabolic derangements." The History and Physical stated he initially presented to the ED on 2/02/18 with very low blood potassium and sodium levels and a low magnesium level. He was then transferred to another hospital's intensive care unit before returning to the CAH. The History and Physical stated he had a history of esophageal strictures. These interfered with swallowing and resulted in 22 dilation procedures. The History and Physical also stated Patient #21 had "Severe Protein Calorie Malnutrition."

A nutrition screen by the admitting nurse on 2/09/18 at 4:01 PM, stated Patient #21 had not lost weight and did not eat poorly. He scored 0 points on the nutrition screen. No dietary referral was made. Further dietary evaluation was not documented.

After discharge, Patient #21 was readmitted to the CAH on 2/16/18 following an accidental drug overdose. His nutrition screen, dated 2/16/18 at 10:41 PM, stated he did not know if he had lost weight. The screen stated he had a poor appetite. This time the nutrition screen assigned a maximum score of 5 points, indicating major nutritional problems. Patient #21's clinical record did not include a referral to a dietician. No dietary assessment was documented beyond the initial screen.

The Director of the Medical/Surgical unit reviewed the record on 5/18/18 beginning at 9:05 AM. She confirmed the documentation. She stated a score of 2 or more on a nutrition screen required a nutrition assessment by an RD. She confirmed Patient #21 did not have an evaluation by a dietitian.

The CAH did not conduct a dietary evaluation for Patient #21.

3. Patient #33 was a 43 year old female who was admitted to the hospital on 1/31/18 and was discharged on 2/02/18.

The ED physician note, dated 1/31/18 at 5:14 PM, stated Patient #33 had chronic alcoholism and a severe low potassium level and a moderate low sodium level. The note also stated she had "significant chronic malnutrition."

Patient #33's nutrition screen by the nurse was dated 1/31/18 at 9:00 PM. The screen stated Patient #33 had lost between 13.2 pounds and 22 pounds because of decreased appetite. She scored a 3 on her nutrition screen. No referral for a dietary evaluation was present in her record.

The Director of the Medical/Surgical unit reviewed the record on 5/18/18 beginning at 9:05 AM. She confirmed the documentation. She stated a referral for a dietary evaluation was not ordered.

The CAH did not conduct a dietary evaluation for Patient #21.

Based on record review and staff interview, it was determined the CAH failed to ensure nursing care plans were sufficiently developed and kept current for 3 of 20 inpatients (#29, #30, and #31) whose records were reviewed. This had the potential to negatively impact quality and coordination of patient care. Findings include:

Surveyors requested a copy of CAH policy for nursing care plans. None was provided. During an interview on 5/17/18 at 3:30 PM, the Manager of Quality & Patient Safety" stated the hospital did not have one.

Nursing care plans were incomplete. Examples include:

1. Patient #30 was a 74 year old female admitted on 12/25/17 for evaluation of cough, wheezing, and abdominal pain. She was discharged on 12/27/17 with diagnoses of hyponatremia, pneumonia, hypertension, RLQ abdominal and flank pain, urinary retention resolved.

Nursing notes, dated 12/25/17 at 9:00 AM, documented Patient #30 was short of breath with expiratory wheezes and a moist, non-productive cough.

Nursing care plans did not address Patient #30's respiratory status.

Although a nursing care plan addressed a goal to improve sodium levels to normal, it did not include nursing interventions to monitor or achieve this nursing goal.

During an interview on 5/17/18 at 9:40 AM, a DNS reviewed Patient #30's medical record and confirmed her nursing care plan did not address respiratory status or include interventions related to sodium levels.

Patient #30's care plan was incomplete.

2. Patient #29 was a 52 year old female admitted on 1/05/18 for evaluation of black stools, nausea, and diffuse swelling. She was discharged on 1/07/18 with diagnoses that included gastrointestinal bleed, gastritis, esophagitis, and liver disease with ascites.

The initial nursing assessment, dated 1/05/18 at 4:45 PM, documented widespread edema and intermittent tarry stools. Physician orders, dated 1/05/18, included daily weights, and monitoring of intake and output.

Nursing care plans did not address goals or interventions related to gastrointestinal or fluid status.

During an interview on 5/17/18 at 10:10 AM, a DNS reviewed Patient #29's medical record and confirmed the nursing care plan did not address gastrointestinal or fluid status.

Patient #29's care plan was incomplete.

3. Patient #31 was a 59 year old female admitted on 1/23/18 through the ED for evaluation of chest pain and heart palpitations. She was discharged on 1/25/18 with diagnoses that included CAD, MI, CHF, COPD.

Nursing notes, dated 1/24/18, at 8:00 AM, documented Patient #31 was SOB, had crackles and rales, and an irregular heart rate.

Physician orders, dated 1/24/18, included oxygen therapy for Patient #31.

Nursing care plans did not address goals or interventions related to Patient #31's respiratory status.

During an interview on 5/17/18 at 9:55 AM, a DNS reviewed Patient #31's medical record and confirmed nursing care plans did not address respiratory status.

Patient #31's care plan was incomplete.

During an interview on 5/17/18 at 9:40 AM, a DNS stated the Epic system (the CAH's EMR) was not user friendly and it was difficult to make meaningful nursing care plans.

There was no CAH policy to guide nursing staff on developing and maintaining nursing care plans. Nursing care plans were incomplete.

Based on medical record review and staff interview, it was determined the CAH failed to ensure patients' medical records included all physician orders necessary to determine appropriate wound care was provided for 1 of 2 patients (Patient #24) who received wound care and whose records were reviewed. This failure resulted in wound care provided without physician orders. Findings include:

Patient #24 was a 72 year old male admitted to a swing bed on 5/11/18, for wound care to an infected pacemaker site. His diagnoses included insulin dependent DM, COPD, HTN, and history of Hepatitis C. He was discharged on 5/16/18.

Patient #24's record included a history and physical dated 5/11/18, signed by an MD. The document stated "He is admitted for skilled nursing wound care 7 days a week..." Patient #24's record included documentation of wound care provided, using negative-pressure wound therapy, a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds. However, his record did not include physician's orders for the wound care provided.

During an interview on 5/17/18 at 9:55 AM, a DNS reviewed Patient #24's record and confirmed it did not include orders for the wound care provided by the nursing staff.

Patient #24's record did not include orders for the wound care he received.

Based on staff interview and review of quality documents, it was determined the CAH failed to ensure an evaluation was done at least once a year and included a review of active and closed clinical records. This prevented the CAH from determining whether its clinical records were complete and accurate. Findings include:

A document titled, "St. Lukes McCall FY 2017 Annual CAH Quality Report," dated February 2018, stated "...over 10% of inpatient, emergency room, and ambulatory patient records were reviewed in 2017. Both open and closed medical records were reviewed for completeness accuracy, proper documentation, informed consent, timeliness, consistency, clarity, legibility, and adherence to protocols and standards of care." The report listed triggers for chart audits.

The quality report did not state how many chart audits were conducted or the findings of those audits. The quality report simply stated the CAH conducted chart audits. No results of the audits were reported.

The Manager of Quality & Patient Safety was interviewed on 5/16/18 beginning at 2:25 PM. She stated the quality report did not contain the number of chart audits conducted nor the results of the audits. She stated she did not realize the annual evaluation needed to include more information.

The CAH evaluation did not include a review of active and closed clinical records.

Based on staff interview and review of quality documents, it was determined the CAH failed to ensure an evaluation was done at least once a year and included a review of the CAH's health care policies. This prevented the CAH from determining whether its policies were complete and reflected the care staff provided to patients. Findings include:

A document titled, "St. Lukes McCall FY 2017 Annual CAH Quality Report," dated February 2018, stated "...patient care related policies are reviewed annually based on last revision date to assure that policies and procedures are in compliance with applicable licensing and accreditation standards, and updated national evidence-based standards of care are being followed throughout the hospital."

The quality report did not state which policies were reviewed in 2017 or whether those policies reflected current practices.

The Manager of Quality & Patient Safety was interviewed on 5/16/18 beginning at 2:25 PM. She stated the quality report did not contain information regarding the policies that were reviewed in 2017 or whether those policies reflected current practices.

The CAH evaluation did not include a review of health care policies.

Based on staff interview and review of quality documents, it was determined the CAH failed to ensure an evaluation was done to determine whether the utilization of services was appropriate and established policies were followed. This resulted in a lack of feedback to persons responsible for the operation of the CAH. Findings include:

A document titled, "St. Lukes McCall FY 2017 Annual CAH Quality Report," dated February 2018, included a statement about scope of services and policies. However, the report did not include any determinations regarding services at the CAH or whether policies were followed. The surveyor was not able to tell, from the report, what the purpose of the evaluation was.

The Manager of Quality & Patient Safety was interviewed on 5/16/18 beginning at 2:25 PM. She stated the quality report did not contain an evaluation of services or of policies.

The CAH evaluation did not include determinations regarding the utilization of services or the CAH's policies.

Based on review of medical records and staff interview, it was determined the CAH failed to ensure comprehensive POCs were developed by an interdisciplinary team for 3 of 4 swing bed patients (#18, #23, and #24) whose records were reviewed. This resulted in a lack of direction to staff caring for these patients. Findings include:

1. Patient #23 was a 68 year old female admitted to the hospital on 1/30/18, with a diagnosis of recurrent falls. She was admitted to a swing bed on 2/01/18. Additional diagnoses included fractured right ankle, COPD, poorly controlled insulin dependent DM, and chronic pain. She was discharged on 2/04/18.

Patient #23's record included a swing bed admission history and physical, dated 2/01/18, signed by an MD. The document included the following medical problems:

a. The document stated Patient #23's most recent A1C result was 16.2. The Mayo Clinic website, accessed on 5/21/18, stated "The A1C test is a common blood test used to diagnose type 1 and type 2 diabetes and then to gauge how well you're managing your diabetes...The A1C test result reflects your average blood sugar level for the past two to three months...The higher your A1C level, the poorer your blood sugar control and the higher your risk of diabetes complications...For most people who have previously diagnosed diabetes, an A1C level of 7 percent or less is a common treatment target." Patient #23's interdisciplinary care plan did not include interventions or goals related to DM.

b. The document stated Patient #23 had COPD with dependence on supplemental oxygen. Her interdisciplinary care plan did not include interventions or goals related to COPD.

c. The document stated Patient #23 had a history of an ischemic stroke and was treated with Coumadin, an anticoagulant. Patients on anticoagulants have an increased risk of bleeding. Her interdisciplinary care plan did not include interventions or goals related to her anticoagulant or bleeding precautions.

During an interview on 5/17/18 at 9:25 AM, the DNS reviewed Patient #24's interdisciplinary care plan and confirmed it did not include interventions or goals related to her DM, COPD, or anticoagulant therapy.

Patient #23's care plan was not comprehensive to include interventions or goals related to her DM, COPD, and anticoagulant therapy.

2. Patient #24 was a 72 year old male admitted to a swing bed on 5/11/18, for wound care to an infected pacemaker site. His diagnoses included insulin dependent DM, COPD, HTN, and history of Hepatitis C. He was discharged on 5/16/18.

Patient #24's record included a history and physical, dated 5/11/18, signed by an MD. The document stated he was diabetic and used insulin to control his blood glucose level. Patient #24's interdisciplinary care plan did not include interventions or goals related to DM.

During an interview on 5/17/18 at 9:55 AM, a DNS reviewed Patient #24's interdisciplinary care plan and confirmed it did not include interventions or goals related to his DM.

Patient #24's care plan was not comprehensive to include interventions or goals related to his DM.

3. Patient #18 was an 87 year old female admitted to a swing bed at the CAH on 1/04/18, with a diagnosis of pneumonia. Additional diagnoses included atrial fibrillation and chronic pain. She was discharged on 1/08/18.

Patient #18's record included a swing bed admission history and physical dated 1/04/18, signed by an MD. The document stated she was taking Eliquis, an anticoagulant, to prevent blood clots related to her atrial fibrillation. Her interdisciplinary care plan did not include interventions or goals related to her anticoagulant or bleeding precautions.

During an interview on 5/17/18 at 9:55 AM, a DNS reviewed Patient #24's interdisciplinary care plan and confirmed it did not include interventions or goals related to her anticoagulant therapy.

Patient #18's care plan was not comprehensive to include interventions or goals related to her anticoagulant therapy.

The CAH failed to ensure swing bed patients' care plans were comprehensive to address all relevant problems.