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Based on observation, policy review, document review, and staff interview, it was determined the CAH failed to ensure all drugs and biologicals used in life-saving procedures were not expired and readily available for all patients receiving care in the CAH. This resulted in the potential for patients' health and safety to be compromised in the event of a medical emergency. Findings include:

A policy "Crash Cart Check, Monthly/Daily," dated 1/27/14, was reviewed. The policy included the following information:
- "All carts will be opened and checked for contents once monthly and following each use."
- "These medications may also be removed, replaced or audited by the licensed pharmacist for the facility."

The CAH failed to ensure all emergency medications were not expired and readily available for use in emergency situations as follows:

An observation was conducted of Treatment Room #1 on 9/01/16, beginning at 1:30 PM, in the presence of the Director of Nursing. During the observation, Treatment Room #1's emergency crash cart was opened and contents inspected. A bag of Dopamine, a medication used in emergency situations to increase a patient's low blood pressure, was noted to have an expiration date of 5/2016, which was confirmed by the Director of Nursing at the time of the observation.

The Director of Nursing stated the contents of crash carts were to be audited monthly to ensure no equipment or medications were outdated. She stated nursing staff were assigned monthly by the Emergency Department Coordinator to audit each crash cart's contents and medications.

The Emergency Department Coordinator was interviewed on 9/01/16, beginning at 3:00 PM. He stated he assigned nursing staff, on a monthly rotational basis, to open and inspect each crash cart for equipment and medication content as well as check for expired items. The Emergency Department Coordinator stated he used a CAH document, "Monthly Crash Cart 2016 Check List Schedule," to track the assignment and completion of crash cart checks. The CAH document was reviewed in the Emergency Department Coordinator's presence and noted to be blank. He confirmed the CAH document had not been filled out since the beginning of 2016.

Four additional CAH documents were reviewed in the presence of the Emergency Department Coordinator:

- "Main ER Crash Cart." The last date of entry on this form was 12/02/15.
- "Treatment Room Crash Cart." The last date of entry on this form was 8/29/14.
- "Floor Crash Cart." The last date of entry on this form was 1/05/16.
- "Braslow Crash Cart." The last date of entry on this form was 11/25/15.

The Emergency Department Coordinator confirmed the CAH documents did not have updated entries.

The CAH failed to ensure all drugs and biologicals used in life-saving procedures were not expired and readily available for all patients receiving care in the CAH.

Based on observations, document review, policy review, and staff interviews, it was determined the CAH failed to ensure emergency medical equipment was maintained. This resulted in the potential for patients' health and safety to be compromised in the event of a medical emergency. Findings include:

A policy "Crash Cart Check, Monthly/Daily," dated 1/27/14, was reviewed. The policy included the following information:
- "A Licensed Staff member as designated by the head of the department is responsible for checking the crash cart and documenting compliance on crash cart checklist."
- "Crash cart/defibrillators daily checks will be performed every shift and recorded. This will document that all external supplies and equipment are present and in working order on a daily basis."
- "All carts will be opened and checked for contents once monthly and following each use."
- "Oxygen cylinders are replaced when the tank has emptied. This will be done with the daily cart checks."

Additionally, a policy "Equipment and Supplies; Location, Storage, and Procurement," dated 11/04/13, was reviewed. The policy stated "Emergency equipment is checked every 8 - 12 hours and at the time of used [sic] to ensure functioning of the equipment."

The CAH failed to follow their policies and ensure all emergency medical equipment was maintained for all patients. Examples include:

1. The Treatment Room #1 crash cart was observed in the presence of the Director of Nursing on 9/01/16, beginning at 1:30 PM. The following items inside the crash cart were expired:
- Two ABG needles, expired on 8/2016 and 10/2014.
- Nasopharyngeal airway, expired on 5/2015.
- NS 10 ml flush, expired on 8/2015.
- Six 18 GA IV needles, each expired on 3/2016.
- IV start kit, expired on 1/2014.

During the observation the Director of Nursing stated the contents of crash carts were to be audited monthly to ensure no equipment or medications were outdated. She stated nursing staff were assigned monthly by the Emergency Department Coordinator to audit each crash cart's contents and medications. She confirmed the above items were expired.

2. The floor crash cart was observed in the presence of the Emergency Department Coordinator on 9/01/16, beginning at 11:25 AM. The following items inside the crash cart were expired:
- Fluid transfer set with female luer lock, expired 3/2012.
- A 25 mm 15 GA IO needle set, expired 4/2016.
- Colormetric, expired 2/2016.
- CO2 detector, expired 4/2016.
- Three nasopharyngeal airways, expired on 4/2016, 2/20/16, and 7/2011.

The Emergency Department Coordinator confirmed the crash cart did not have an oxygen tank as part of its equipment and confirmed the above items were expired.

3. Four additional CAH documents were reviewed in the presence of the Emergency Department Coordinator:
- "Main ER Crash Cart." The last entry on this form was 12/02/15.
- "Treatment Room Crash Cart." The last entry on this form was 8/29/14.
- "Floor Crash Cart." The last entry on this form was 1/05/16.
- "Braslow Crash Cart." The last entry on this form was 11/25/15.

the Emergency Department Coordinator confirmed the 4 CAH documents did not have updated entries.

4. The CAH document "Daily Crash Cart Checklist" was reviewed for 3 crash carts. The documents were incomplete. Examples included:
- "Main ER Crash Cart" checklist had missing entries on 6/29/16, 7/10/16, 7/13/16, 7/14/16, 7/24/16, 7/30/16, 8/06/16, 8/16/16, and 8/22/16.
- "Treatment Room 1 Crash Cart" checklist had missing entries on 6/29/16, 7/01/16, 7/06/16, 7/09/16, 7/10/16, 7/14/16, 7/20/16, 7/22/16, 7/26/16, 7/30/16, 7/31/16, 8/01/16, 8/05/16, 8/06/16, 8/08/16, 8/16/16, 8/18/16, 8/22/16, 8/24/16, and 8/29/16-c. "Floor Crash Cart" checklist had missing entries on 6/29/16, 7/01/16, 7/04/16, 7/09/16, 7/10/16, 7/11/16, 7/12/16, 7/13/16, 7/16/16, 7/30/16, 8/01/16, 8/02/16, 8/08/16, 8/16/16, 8/18/16, and 8/28/16.

The Emergency Department Coordinator was interviewed again on 9/01/16, beginning at 3:00 PM. He stated he assigned nursing staff to open and inspect each crash cart for equipment and medication content as well as check for expired items. The Emergency Department Coordinator confirmed the missing daily crash cart checklist entries.

The CAH failed to follow their policies and ensure all emergency medical equipment was maintained for all patients receiving care at the facility.

Based on observations, review of pharmaceutical security requirements referenced in IDAPA rules, and staff interviews, it was determined the CAH failed to develop a policy related to medication storage and security and failed to ensure all medications were properly stored and locked for all patients receiving care at the facility. This resulted in the potential for unsecured medications being accessible to the public and staff without accountability. Findings include:

A policy was requested related to medication storage and security. None was provided.

IDAPA 16.03.14.330.08 references pharmaceutical security requirements. It stated "All prescribed medications shall be under lock and schedule II drugs shall be double-locked."

The CAH failed to ensure all medications were properly stored and locked. Examples include:

1. An observation was conducted of the Emergency Department, in the presence of the CAO, on 8/29/16, beginning at 2:00 PM. During the observation, it was noted the medication cabinets located on the south wall were unlocked. Inside these cabinets were numerous intradermal anesthetics.

The CAO confirmed, at the time of observation, the medications in the ED cabinets were not properly secured.

2. An observation was conducted of the CAH on-site, attached clinic, in the presence of the Clinic Manager and Clinic RN Supervisor, on 9/01/16, beginning at 10:01 AM. During the observation, the following unsecured medication locations were noted:

a. Procedure Room - unlocked cabinets containing multiple intradermal anesthetics.

b. Supply Closet - unlocked closet containing multiple, non-narcotic "sample" medications. The categories of medications, labeled on shelves, included the following:
- Respiratory
- Antihypertensive
- Antidepressant
- Anti-inflammatory
- Diabetic
- Cholesterol medications
- Antibiotics

The Clinic Manager and Clinic RN Supervisor confirmed the medications in these clinic areas were not properly secured.

3. An observation was conducted of the Nursery, in the presence of the Emergency Department Coordinator, on 9/01/16, beginning at 11:30 AM. During the observation, it was noted the neonatal cart was unlocked. Inside the unsecured cart were:
- IV Epinephrine
- IV Benadryl
- IV Narcan

The Emergency Department Coordinator confirmed the medications in the neonatal cart were not properly secured.

4. A second observation was conducted of the Nursery, in the presence of the DON, on 9/02/16, beginning at 10:00 AM. During the observation, it was noted the OB delivery cart was unlocked. Inside the unsecured cart, in the top drawer, was an unlocked lock-box with the corresponding key inserted into the lock. Inside the lock-box were:
- IV Epinephrine
- IV Benadryl

Additionally, during the same observation, several cabinets on the south wall of the Nursery Workroom were unlocked. The unsecured cabinets contained multiple, non-narcotic medications used for infant circumcision procedures.

The DON confirmed, at the time of observation, the medications in the Nursery and Nursery Workroom were not properly secured.

The CAH failed to ensure all medications were properly stored and locked.

Based on review of policies and bylaws, staff interview, and observation, CAH leadership failed to ensure sufficient oversight to the functioning of the organization. This resulted in policies that were not developed, maintained, followed, or enforced related to surgical services, infection control, pharmaceutical services, and nursing services. This had the potential to interfere with quality and safety of patient care. Findings include:

1. Refer to C 203 as it relates to the failure of CAH leadership to ensure all drugs and biologicals used in life-saving procedures were not expired and readily available for all patients receiving care in the CAH in accordance with CAH policy.

2. Refer to C 204 as it relates to the failure of CAH leadership to ensure emergency medical equipment was maintained in accordance with CAH policy.

3. Refer to C 224 as it relates to the failure of CAH leadership to ensure a policy was developed for appropriate storage and security of medications and that medications were appropriately stored and secured.

4. Refer to C 271 as it relates to the failure of CAH leadership to ensure healthcare services were being provided in accordance with appropriately written policies.

5. Refer to C 272 as it relates to the failure of CAH leadership to ensure the policy development procedure addressed the requirement for NP/PA involvement and the failure to ensure policies were updated annually.

6. Refer to C 276 as it relates to the failure of CAH leadership to ensure pharmaceutical services were provided within standards of practice required by federal, state, and local laws.

7. Refer to C 278 as it relates to the failure of CAH leadership to ensure establishment of a current and reliable infection control system.

8. Refer to C 320 as it relates to the failure of CAH leadership to ensure surgical services were provided in a safe manner.

The cumulative affect of these negative systemic practices resulted in the failure of CAH leadership to provide oversight to ensure care was provided in a safe and effective manner.

Based on observation, policy review, and staff interview, it was determined the CAH failed to ensure healthcare services were provided in accordance with appropriately written policies. This resulted in services not being furnished in a consistent manner, and had the potential to result in avoidable, adverse patient outcomes. Findings include:

The CAH failed to follow their policies. Examples include:

1. A policy "Terminal Cleaning," dated 4/15/09, was reviewed. The policy included "The disinfectant detergent solution used during terminal cleaning shall be freshly prepared, and shall be discarded immediately upon completion of the terminal cleaning."

The following pre-mixed, terminal cleaning chemicals were noted during observations:

a. An observation of Treatment Room #2 was conducted on 8/29/16, beginning at 2:30 PM, in the presence of the CAO. An unlabeled spray bottle of Virex was noted with the word "Virex" handwritten on it. The spray bottle did not have the date and time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. The CAO confirmed, at the time of observation, the spray bottle was not properly labeled, dated, timed, or discarded according to CAH policy.

b. An observation of Radiology was conducted on 8/29/16, beginning at 2:00 PM, in the presence of the CAO. An unlabeled spray bottle of Virex was noted with the word "Virex" handwritten on it. The spray bottle did not have a date or time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. Additionally, an unlabeled spray bottle of bleach was noted with the word "Bleach" handwritten on it. The spray bottle did not have a date or time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. The CAO confirmed, at the time of observation, the spray bottles were not properly labeled, dated, timed, or discarded according to CAH policy.

c. An observation of Ultrasound was conducted on 8/31/16, beginning at 9:36 AM, in the presence of the Radiology Manager. An unlabeled spray bottle of Virex was noted with the word "Virex" handwritten on it. The spray bottle did not have a date or time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. The Radiology Manager confirmed, at the time of observation, the spray bottle was not properly labeled, dated, timed, or discarded according to CAH policy.

d. An observation of room 147, in the ED, was conducted on 8/31/16, beginning at 2:00 PM, in the presence of the CAO. An unlabeled spray bottle of Virex was noted with the word "Virex" handwritten on it. The spray bottle did not have a date or time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. Additionally, an unlabeled spray bottle of Bleach was noted with the word "Bleach" handwritten on it. The spray bottle did not have a date or time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. The CAO confirmed the spray bottles were not properly labeled, dated, timed, or discarded according to CAH policy.

2. A policy "Expiration Dates For Sterile Items," dated 12/11/14, was reviewed. The policy included "Items purchased as sterile should be used according to the manufacturer's directions. This may be either a designated expiration date, or a day-to-day expiration date such as 'sterile unless the integrity of the package is compromised.'"

The following expired items were noted during observations:

a. An observation of room 147, in the ED, was conducted on 8/29/16, beginning at 2:00 PM, in the presence of the CAO. The following items were expired:

- Two EZ Scrub 107, expired 3/2016
- Clorox Wipes for Healthcare, expired 6/22/16

The CAO confirmed the expired dates.

b. An observation of room 147, in the ED, was conducted on 8/31/16, beginning at 2:00 PM, in the presence of the CAO. The following items were expired:

- All Sexual Assault Kits, expired 5/2015

The CAO confirmed the items were expired.

c. An observation of the CAH's attached clinic was conducted on 9/01/16, beginning at 10:01 AM, in the presence of the Clinic Manager. The following items were expired:

- Two IV caps, expired 3/2015
- A bottle of 70% isopropyl alcohol, expired 2/12/15
- Three containers of Clorox Wipes for Healthcare, expired 6/22/16

The Clinic Manager confirmed the items' expiration dates.

d. An observation of the emergency equipment in the Nursery was conducted on 9/02/16, beginning at 10:00 AM, in the presence of the ED Coordinator. The following items were noted to be expired:

- Needle Aspiration Kit, expired 7/2016
- Pneumothorax Needle, expired 8/2016
- Two Stylets, expired 3/24/16

The ED Coordinator confirmed the items were expired.

e. An observation of the Chemical Closet was conducted on 9/01/16, beginning at 11:45 AM, in the presence of the EVS Manager. The following items were expired:

- One bottle of 70% isopropyl alcohol, expired 10/2010
- Five bottles of Activate Bleach Hospital Cleaner and Disinfectant, expired 5/22/16
- Three containers of Clorox Wipes for Healthcare, expired 2/2015, 3/2016, and 11/05/15
- Two containers of Purel Gel, expired 2/2015 and 6/2015

The EVS Manager confirmed, at the time of the observation, the items' expiration dates.

f. An observation of Treatment Room #1 was conducted on 9/01/16, beginning at 1:30 PM, in the presence of the DON. The following items were expired:

- Clorox Wipes for Healthcare, expired 6/22/16

The DON confirmed the items were expired.

g. An observation of the Nursery was conducted on 9/01/16, beginning at 1:30 PM, in the presence of the DON. The following items were expired:

- Four 3.0 Chromic Gut, expired 1/2016
- Two 8.5 Sterile Gloves, expired 5/2016
- Two 8.5 Sterile Gloves, expired 3/2015
- Sterile Gown, expired 3/2014

The DON confirmed the items were expired.

The CAH failed to follow their policies.

Based on policy review and staff interview, the CAH failed to ensure the policy "Policy Development" addressed the requirement for NP/PA involvement. It also failed to ensure policies were updated annually. This had the potential for staff to operate on outdated information which could impact the quality and safety of patient care. Findings include:

1. The policy "Policy Development," dated 5/11/16, was reviewed. It stated the following:

- "All clinical policies and procedures are reviewed a minimum [sic] every 12 months unless otherwise required by regulation."
- The CAH's "Director of Nurses will approve clinical nursing policies."
- The CAH's "Medical Staff, upon recommendation of the Hospital's respective Clinical Coordinators and Director of Nursing, will approve nursing policies with direct clinical care implications for patients, including nursing policies for IV medication administration, standing protocols and orders."

The CAH's list of employees included one PA and 4 NPs.

The policy did not address the requirement to have policies developed with the advice of members of the CAH's professional healthcare staff, including one or more physician assistants, nurse practitioners, or clinical nurse specialists, if they are on staff.

The President and CAO were interviewed together on 9/01/16 beginning at 4:12 PM. They stated that the PA and NPs were not involved in policy development but they did have an opportunity to comment on policies prior to finalization.

The policy did not address the requirement for policies to be developed with the advice of members of the CAH's professional healthcare staff, including one or more physician assistants or nurse practitioners who are on staff.

2. A 10 page list of policies was provided by the CAO for surveyor review. The list included the titles of the policies, the document owners, the dates submitted, and the dates approved. The date of last review was not specifically listed. The list did not separate clinical policies from operational policies.

The CAO was interviewed on 8/29/16 at 3:50 PM. He stated that the "date approved" was also the last revised or reviewed date. He stated the plan was to review the policies annually, he was aware some policies were outdated, and they were in the process of updating policies.

The following is a sample of clinical policies and their last review/revision dates, showing they had not been reviewed within the prior year:

- ACLS, 6/16/14
- Administration and Ordering of TPN, 10/06/14
- Adverse Drug Reaction, 11/20/08
- Alcohol Withdrawal, 6/16/14
- Aminoglycosides (Collaborative Drug Therapy Management Protocol), 09/24/13
- Aspiration Precautions, 3/04/14
- Assessment - Postpartum patient, 12/03/13
- Assessment, Surgical Patient in the OR, 10/22/13
- Blood Transfusion, 3/18/14
- Bloodborne Pathogens, 3/05/14
- Cardiac Rehab - Emergency Response, 3/10/14
- Code Blue - Cardiac Arrest, 6/04/14
- Colostomy and Ileostomy, Care of, 6/16/14
- Crash Cart Check, 1/27/14
- Dental Emergencies and Consults, 12/27/13
- Dietary Menus, 10/17/14
- Dopamine Infusion, 2/12/09
- Electronic Fetal monitoring, 12/03/13
- Emergency Surgery, 10/04/11
- Fall Prevention, 9/25/13
- Group B Strep - OB Patient, 10/31/13
- Hand Hygiene, 2/06/14
- Heparin, Continuous Infusion, 6/11/09
- Infection Control Program, 3/06/14
- Isolation Precautions, 10/31/13
- Labor Analgesia, 3/05/09
- Management of Patient with Malignant Hyperthermia, 4/30/09
- Mannitol, Dosage and Administration, 8/12/13
- MRSA (Methicillin-Resistant Staphylococcus Aureus), 8/07/13
- Newborn Daily Care, 10/22/13
- Nutritional Assessment, 4/23/12
- Oxytocin Usage, 5/30/14
- PICC Line Insertion, 6/29/11
- Postoperative Care, 11/18/13
- Precipitous Delivery - ER, 10/22/13
- Pulmonary Function Test Procedure, 3/18/14
- Referral and Transfer of Patients, 10/09/13
- Respiratory Therapy - Incentive Spirometry, 12/31/13
- Sexual Assault Victim, 11/18/13
- Shortness of Breath Standing Orders Protocol, 11/26/13
- Standard Precautions, 9/06/11
- Suicide Precautions, 10/15/14
- Surgical Hand Scrub, 10/23/13
- Surgical Patient Preparation, 11/18/13
- Terminal Cleaning, 4/15/09
- Topical EMLA Cream, 10/21/14
- Tracheal Suctioning, 12/13/13
- Transporting Surgery Patient to OR, 1/08/14
- Vasopressin Infusion for Refractory Hypotension, 3/21/11

Policies were not reviewed at least annually.

Based on policy review, staff interview, review of IDAPA rules, review of the telepharmacy contract, and observation, it was determined that the CAH failed to ensure pharmaceutical services were provided in accordance with IDAPA rules which define standards of practice for pharmacies in CAHs, including storage of medications. This resulted in a lack of pharmaceutical oversight, unsecured and expired medications, and a lack of training to RN staff related to the mixing of medications. Findings include:

1. There were inadequate pharmacy services to meet the needs of the CAH.

Idaho State Hospital Rules define standards of practice for pharmacies in CAHs. IDAPA 16.03.14.330 stated the following, "Pharmacy Service: Pharmacy Services shall be under the overall direction of a pharmacist who is licensed in Idaho and is responsible for developing, coordinating and supervising all pharmaceutical services in the CAH ..." The regulations discuss such areas as supervision of staff, management of medications in all departments, involvement in the Pharmacy and Therapeutics Committee, providing the medical staff and nursing staff with education, pharmaceutical policy management, review of adverse drug reactions and medication errors, ordering, storing and dispensing medications according to state rules.

The CAH contracted with a telepharmacy company to provide services 24 hours a day 7 days a week. The telepharmacy contract was dated 5/16/16, and stated they will "provide information and clinical support to Customer's staff with respect to Orders." It did not state the other requirements of pharmacy services as listed in the Idaho State Hospital Rules, as referenced above. The CAH policy "Pharmacy and Support Staff, responsibilities of Telepharmacy Protocol," version 1, reviewed 2/06/15, was written with the name of a previous telepharmacy company. The policy was not updated to reflect agreements with the current telepharmacy company.

The in-house pharmacy staff was comprised of the Director of Pharmacy and the PRN Pharmacist. During an interview on 8/30/16 at 1:30 PM, the PRN Pharmacist stated she helped out by working about one day a month. She stated sometimes she worked for 2 hours, sometimes 5 hours, depending on how busy the CAH was. She stated the nurses never called her, rather they called the Director of Pharmacy. She stated the telepharmacy took care of the nursing questions and patient orders.

During an interview on 9/01/16, at 1:30 PM, the Director of Pharmacy stated he worked 2 - 3 days a week. When questioned regarding his availability to the CAH, he stated he was always available by phone. He stated if he could not get to the CAH, he called the PRN Pharmacist. However, he stated there was no set schedule or call schedule. The Director of Pharmacy stated there was no policy related to pharmacy staffing.

The Director of Pharmacy stated the telepharmacy company reviewed direct copies of medication orders, checked for interactions and allergies, maintained the MAR, and programmed the Pyxis machine, an automated medication dispensing system, to deliver medications to nurses. The policy "Pharmacy and Support Staff, responsibilities of Telepharmacy Protocol" did not define the Director of Pharmacy's duties related to supervision and oversight of pharmacy services and personnel, or how he was to evaluate and provide oversight of the telepharmacy company.

On 9/09/16, at 3:00 PM, the CAO was interviewed. He confirmed there were no job descriptions for the Director of Pharmacy or for the PRN Pharmacist.

The CAH failed to provide pharmacy services to meet the needs of the patients.

2. The CAH had multiple areas with unsecured medications, potentially causing negative patient outcomes and harm to patient visitors.

IDAPA 16.03.14.330.08 stated "All medications shall be under lock and schedule II medication shall be double locked."

The "Pharmacy Services" policy, approved 4/01/16, stated "The door to the pharmacy shall remain locked at all times." The policy made no reference to securing medications stored outside the pharmacy including IV solutions, IV solutions mixed with medications, and medications stored in the CAH based clinics.

Unsecured medications were observed in the following areas:

a. The Central supply room, off the main CAH hallway; the medication supply included IV solutions, IV potassium mixtures, various antibiotics and IV Tylenol.

During an interview with a Central Supply Employee on 8/31/16, at 2:05 PM, she stated the door was never locked and always kept wide open. She stated "The nurses can come in at any time to get what they need." This was confirmed by observations on 8/30/16 at 11:00 AM, 8/31/16 at 8:00 AM, and 9/01/16 at 4:45 PM. The door was open and no staff was present.

b. An observation was conducted of the ED, in the presence of the CAO, on 8/29/16, beginning at 2:00 PM. During the observation, it was noted the medication cabinets located on the south wall were unlocked. Inside these cabinets were numerous, non-narcotic medications, including forms of lidocaine and ethyl chloride spray.

c. In the Mother Baby room 103, an antibiotic eye ointment and Vitamin K injectable were in an unlocked drawer lowest to the floor at a level potentially accessible to children in the CAH room.

d. On 8/31/16 at 1:50 PM the PRN Pharmacist was observed with bags of medications for delivery to the CAH clinics. Inside the CAH clinics, the procedure room contained unlocked cabinets with multiple, non-narcotic medications. There was an unlocked supply closet containing multiple, non-narcotic "sample" medications.

During an interview with the Director of Pharmacy on 9/01/16 at 1:30 PM, he stated he does not check on medications stored in areas outside of the pharmacy or Pyxis machines. He also stated neither he nor the PRN Pharmacist had any involvement with medications once they were delivered to the clinics.

The CAH failed to ensure all medications stored in the CAH were securely stored.

3. There was no written procedure to direct nurses in the mixing of parental medications.

IDAPA 16.03.14.330.06 stated "The pharmacist shall develop a procedure for the safe mixture of parental products."

There was no procedure or policy developed by the pharmacy for mixing parental products.

The PRN Pharmacist was interviewed on 8/31/16 at 1:30 PM. She stated the RNs did all of the mixing of IV medications.

There was no documentation of RN competencies related to the mixing of IV medications.

The Director of Pharmacy was interviewed on 9/01/16 at 1:30 PM. He stated that he had not provided any guidelines or education to the RNs regarding the safe mixing of IV medications. He confirmed that there was no documentation of RN competencies.

The CAH failed to ensure staff were competent to mix IVs.



37262

Based on observation, review of policy and infection control standards of practice, and staff interview, it was determined the CAH failed to ensure a current and reliable infection control system was established to reduce the risk of infections. This impacted 1 of 1 surgical patient (#31) whose care was observed. It had the potential to impact all patients provided care in the CAH. Findings include:

1. The Infection Control RN was interviewed on 9/01/16 beginning at 9:30 AM.

During the interview, she stated when she was hired into the position she had no prior experience in infection control and she became an RN within the prior 2 years, and there was not anyone in the position to train her. She stated she was given an infection control binder, dated 2004, as a resource that had been used by the prior Infection Control Officer. The CAH also sent her to an APIC conference during 2016 to learn infection control. She stated she was working to get updated resources, researching online for current resources, such as CDC guidelines and CMS regulations, and it was taking time to learn the position and get current resources.

When asked how much time she had been given to focus on infection control, she stated she had been delegated 8 hours per week for CAH infection control issues and she worked in the clinic for the other 32 hours. She stated there was not enough time allocated to deal with all of the needed infection control activities. She stated the DON was dealing with some of the infection control issues, such as employee health.

When asked about the infection control committee, she stated it was the intention to meet quarterly but they were behind schedule. She stated they met last on 4/25/16.

When asked about her involvement with housekeeping and laundry, she stated she had not been involved but she wanted to have time to review the cleaning products that had already been established to make sure standards were met.

When asked who was responsible for infection control in the clinics that were a part of the CAH, she said she thought the Clinic Manager was in charge.

The Clinic Manager was interviewed on 9/01/16 beginning at 10:45 AM. When asked who was in charge of infection control for the clinics, she stated the Infection Control Officer was in charge. The Infection Control RN, who was present during the interview, replied "Oh" and stated she had not been aware of this responsibility. She also stated she not been provided a job description that described her responsibilities.

The CAH failed to ensure adequate time, resources, structure, and support to adequately oversee an infection control program.

2. The CAH failed to ensure policies and practices related to hand hygiene were effective. Examples include:

a. The policy, "Standard Precautions," dated 9/06/11, was reviewed. It stated "handwashing is the most important factor in reducing the risk of transmission of bacteria or virus from one person to another or from one site to another on the same patient."

The policy, "Hand Hygiene," dated 2/06/14, was reviewed. The policy included the following information:

- "All members of the healthcare team will comply with current Center for Disease Control and Prevention (CDC) hand hygiene guidelines."
- "Handwashing may be used for routinely decontaminating hands in the following clinical situations:"
- "Before having direct contact with patients"
- "Before inserting indwelling urinary catheters, IV catheters or other invasive procedures"
- "After contact with body fluids or excretions, mucous membranes, non-intact skin, and wound dressings, even if hands are not visibly soiled"
- "When moving from a contaminated body site to a clean body site during patient care."
- "After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient."
- "After removing gloves."

The policy "Policy Development," dated 5/11/16, was reviewed. It included the following information:

- "The terms 'shall', 'must', 'are', 'is', or 'will' are used to indicate a mandatory statement (i.e., the only acceptable method under the current standards)."
- "The term 'should' reflects the commonly accepted method, yet allows for use of effective alternatives."
- "'May' is a term used in the interpretation of a standard to reflect an acceptable method that is recognized but not necessarily preferred."

The term "may" used in the policy, "Hand Hygiene," dated 2/06/14, was not consistent with the CDC recommendation (https://www.cdc.gov/handhygiene, accessed 9/07/16), which did not consider hand hygiene, in the circumstances listed in policy, as optional.

The Infection Control RN was interviewed on 9/01/16 beginning at 9:30 AM. She stated the term, may, in the handwashing policy was not accurate and it should say have said must. When asked if there were any CAH activities related to handwashing, she stated new employees were educated on handwashing but there was no review of handwashing with existing employees and there was no monitoring of handwashing related to employees. She expressed an interest and desire to have time to do training and monitoring with existing employees.

b. Patient #31 was a 57 year old male admitted to the facility on 8/31/16, for surgical repair of an inguinal hernia. The care of Patient #31 was observed on 8/31/16, from 7:30 AM when he was in pre-op, until approximately 10:50 AM while Patient #31 was still in PACU. There were no episodes of handwashing observed by the RN OR Coordinator who provided care during this time. Examples include:

- Prior to inserting an IV catheter in pre-op
- Before clipping hair from the surgical site (pubic area) in pre-op
- After removing gloves after clipping surgical site in pre-op
- After working on the computer in pre-op or handling the camera in the surgical suite
- Before inserting a urinary catheter in the surgical suite
- Before direct contact with the patient, such as when applying blood pressure cuff and finger monitor, applying socks, before putting together the incentive spirometer, or before cleansing the surgical site in the surgical suite, or before physical assessment with a stethoscope in PACU

There was no sink or hand cleanser observed in the surgical suite, except a portable hand cleanser kept on the anesthesia cart for use by the CRNA.

The RN OR Coordinator, who provided care to Patient #31, was interviewed on 8/31/16 at 1:45 AM. He stated he washed his hands before coming into pre-op and after he left the room. He stated there was no hand dispenser available in the surgical suite.

Hand washing policy and practice did not meet CDC standards.



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3. A policy "Expiration Dates For Sterile Items," dated 12/11/14, was reviewed. The policy stated:

- "Items purchased as sterile should be used according to the manufacturer's directions. This may be either a designated expiration date, or a day-to-day expiration date such as 'sterile unless the integrity of the package is compromised.'"

An observation of the Chemical Closet was conducted on 9/01/16, beginning at 11:45 AM, in the presence of the EVS Manager. The following items were noted to be expired:

- One bottle of 70% isopropyl alcohol, expired 10/2010
- Five bottles of Activate Bleach Hospital Cleaner and Disinfectant, expired 5/22/16
- Three containers of Clorox Wipes for Healthcare, expired 2/2015, 3/22/16, and 11/05/15
- Two containers of Purel Gel, expired 2/2015 and 6/2015

The EVS Manager confirmed, at the time of the observation, the items' expiration dates.

The CAH failed to ensure all healthcare cleaning agents used in patient care areas were not expired.

4. A policy "Terminal Cleaning," dated 4/15/09, was reviewed. The policy stated "The disinfectant detergent solution used during terminal cleaning shall be freshly prepared, and shall be discarded immediately upon completion of the terminal cleaning."

a. An observation of Treatment Room #2 was conducted on 8/29/16, beginning at 2:30 PM, in the presence of the CAO. A spray bottle was observed with the word "Virex" handwritten on it. The spray bottle did not have a date or time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. The CAO confirmed the spray bottle was not properly labeled, dated, timed, or discarded according to CAH policy.

b. An observation of Radiology was conducted on 8/29/16, beginning at 2:00 PM, in the presence of the CAO. A spray bottle was observed with the word "Virex" handwritten on it. The spray bottle did not have a date or time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. Additionally, a spray bottle was observed with the word "Bleach" handwritten on it. The spray bottle did not have a date or time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. The CAO confirmed the spray bottles were not properly labeled, dated, timed, or discarded according to CAH policy.

c. An observation of Ultrasound was conducted on 8/31/16, beginning at 9:36 AM, in the presence of the Radiology Manager. An unlabeled spray bottle of Virex was noted with the word "Virex" handwritten on it. The spray bottle did not have a date or time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. The Radiology Manager confirmed the spray bottle was not properly labeled, dated, timed, or discarded according to CAH policy.

d. An observation of Emergency Room 147 was conducted on 8/31/16, beginning at 2:00 PM, in the presence of the CAO. A spray bottle was observed with the word "Virex" handwritten on it. The spray bottle did not have a date or time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. Additionally, a spray bottle was observed with the word "Bleach" handwritten on it. The spray bottle did not have a date or time it was mixed. The spray bottle contents were not immediately discarded upon completion of terminal cleaning. The CAO confirmed the spray bottles were not properly labeled, dated, timed, or discarded according to CAH policy.

The CAH failed to ensure healthcare cleaning agents were prepared and used as outlined in CAH policy and per manufacturer's instructions for use.

5. A policy "Ambulance Maintenance," dated 6/29/16, was reviewed. The policy stated "The ambulance interior will be cleaned at the completion of each run. This may include, but is not limited to, sweeping/mopping the pt. [sic] care area, wiping down surfaces with a disinfectant, and vacuuming the cab and module component."

The "Guidelines for Environmental Infection Control in Health-Care Facilities (https://www.cdc.gov)," website accessed on 9/08/16, at 3:45 PM, stated "Use a one-step process and an EPA-registered hospital detergent/disinfectant designed for general housekeeping purposes in patient-care areas..."

An observation of the Lab EVS Closet was conducted on 9/01/16, beginning at 11:45 AM, in the presence of the EVS Manager. Multiple containers of "Swiffer WetJet" cleaning solution and a "Swiffer WetJet" mop were noted alongside other healthcare cleaning agents. When asked what the "Swiffer WetJet" cleaning solution was used for, the EVS Manager stated it was for mopping and cleaning the Ambulances. She stated EVS and Infection Control followed CDC guidelines and confirmed "Swiffer WetJet" was not an EPA-registered hospital detergent/disinfectant designed for use in patient care areas.

The CAH failed to ensure only EPA-registered cleaning agents were used in patient care areas.

6. An observation of the nursing unit was conducted on 9/01/16, beginning at 9:30 AM. Several containers of open green top "Clorox Disinfectant Wipes" were noted in this patient care area. These Clorox wipes were labeled for household use only and were not listed as an EPA-registered healthcare cleaning agent.

The "Guidelines for Environmental Infection Control in Health-Care Facilities (https://www.cdc.gov)," website accessed on 9/08/16, at 3:45 PM, stated "1. Use a one-step process and an EPA-registered hospital detergent/disinfectant designed for general housekeeping purposes in patient-care areas..."

A charge nurse was interviewed on 9/01/16, beginning at 9:30 AM, regarding these "Clorox Disinfectant Wipes." When asked what they were used for, the charge nurse stated for cleaning keyboards, stethoscopes, blood pressure cuffs, Emergency Department oxygen saturation probes, and electronic cords. When asked if the "Clorox Disinfectant Wipes" were approved for cleaning these items, the charge nurse stated she did not know.

An observation of the CAH was conducted on 9/01/16, beginning at 11:45 AM, in the presence of the EVS Manager. During this observation, multiple EVS chemical storage closets, patient care areas, and non-patient care areas were observed. Numerous containers of open green top "Clorox Disinfectant Wipes" were noted throughout these areas. These Clorox wipes were labeled for household use only and were not listed as an EPA-registered healthcare cleaning agent.

The EVS Manager was interviewed on 9/01/16, beginning at 11:45 AM, regarding these "Clorox Disinfectant Wipes." When asked what they were used for, the EVS Manager stated for business office use only. She stated EVS and Infection Control followed CDC guidelines and confirmed "Clorox Disinfectant Wipes" was not an EPA-registered hospital detergent/disinfectant designed for use in patient care areas.

The CAH failed to ensure only EPA-registered cleaning agents were used in patient care areas.

7. CAH employees from several departments were unable to provide consistent answers when questioned about cleaning agents being used in CAH patient care areas. Examples include the following:

a. CAH employees were unable to provide consistent answers when questioned about the cleaning agent "Virex." Examples include:

i. The EVS Manager was interviewed on 9/01/16, beginning at 8:30 AM, regarding the cleaning agent, "Virex." When asked what "Virex" was used for, she stated RN staff were to use it for cleaning surfaces. When asked how long surfaces must remain wet for "Virex" to be effective, the EVS Manager stated 10 minutes. When asked what PPE was used in preparation of "Virex," she stated staff must wear a mask and gloves.

ii. An EVS housekeeper was interviewed on 9/01/16, beginning at 9:05 AM, regarding the cleaning agent, "Virex." When asked what "Virex" was used for, she stated EVS staff were to use it for cleaning surfaces. When asked how long surfaces must remain wet for "Virex" to be effective, the EVS housekeeper stated 7 minutes. When asked what PPE was used in preparation of "Virex," the EVS housekeeper stated gloves and "sometimes glasses."

iii. A charge nurse was interviewed on 9/01/16, beginning at 9:30 AM, regarding the cleaning agent, "Virex." When asked what "Virex" was used for, she stated staff were to use it for cleaning the Emergency Department and ambulances only. The charge nurse stated "Virex" was not used on the nursing unit. When asked how long surfaces must remain wet for "Virex" to be effective, she stated she was unsure.

"Virex" manufacturer's instructions for use stated staff are to wear chemical splash-proof goggles or face shield, rubber gloves, and protective clothing when preparing. The instructions for use also stated all surfaces must remain wet for 10 minutes for "Virex" to be effective.

CAH staff were inconsistent in their interpretation of preparing and using "Virex" and failed to follow manufacturer's instructions for use.

b. CAH employees were unable to provide consistent answers when questioned about the cleaning agent "Clorox Disinfectant Wipes." Examples include:

i. The EVS Manager was interviewed on 9/01/16, beginning at 8:30 AM, regarding the cleaning agent, "Clorox Disinfectant Wipes." When asked what "Clorox Disinfectant Wipes" were used for, she stated for business office use only.

ii. An EVS housekeeper was interviewed on 9/01/16, beginning at 9:05 AM, regarding the cleaning agent, "Clorox Disinfectant Wipes." When asked what "Clorox Disinfectant Wipes" were used for, she stated "quick wipe-ups" in patient care areas.

iii. A charge nurse was interviewed on 9/01/16, beginning at 9:30 AM, regarding the cleaning agent, "Clorox Disinfectant Wipes." When asked what "Clorox Disinfectant Wipes" were used for, she stated for cleaning keyboards, stethoscopes, blood pressure cuffs, Emergency Department oxygen saturation probes, and electronic cords.

"Clorox Disinfectant Wipes" manufacturer's instructions for use stated the cleaning agent was for home use only.

CAH staff were inconsistent in their interpretation of where "Clorox Disinfectant Wipes" were to be used and failed to follow manufacturer's instructions for use.

Based on review of the list of contracted services, email communication, and staff interview, it was determined the CAH failed to ensure maintenance of a current and complete list of contracted services and resulted in outdated information. This had the potential to interfere with full utilization of contracted services. Findings include:

A list of contracted services was requested for review. A one page document, "List of Contracted Services - July 2014," was provided. The list included contracted services that were no longer being utilized by the CAH, for example vendors related to anesthesia call, EKG overreads, radiology services, transcription services, and disposal of pharmaceutical waste. The list did not include contracted services that were currently being utilized by the CAH, for example, services related to medical coding, lab courier, pharmacy, laundry, radiology, information technology, and billing.

The CAH President and CAO were interviewed on 9/01/16 at 4:12 PM. The CAH President confirmed the list was outdated and she would update it.

The CAH did not maintain a current list of all contracted services.

Based on observation, record review, policy review, and staff interview, it was determined the CAH failed to ensure nursing needs were met for 2 of 6 surgical patients (#3 and #31) whose records were reviewed. This resulted in the potential for an increased risk of infection in one surgical patient and for inadequate discharge planning in another surgical patient. Findings include:

1. Patient #31 was a 57 year old male admitted to the facility on 8/31/16 for surgical repair of an inguinal hernia. The care of Patient #31 was observed on 8/31/16 from 7:30 AM while he was in pre-op, until approximately 10:50 AM while Patient #31 was still in PACU, prior to transferring to the medical/surgical floor. The RN OR Coordinator provided care to Patient #31. Patient needs for nursing care were not met. Examples include:

a. A CAH nursing policy, "Surgical Patient Preparation," dated 11/18/13, was reviewed. It included the expectation that vital signs be assessed immediately before going to OR, including temperature, blood pressure, pulse, and respiratory rate. It also included the expectation nursing staff would perform a physical examination, including assessment of heart and lungs.

The RN did not take Patient #31's temperature or listen to Patient #31's heart and lungs in pre-op. The "Preop Physical Assessment," dated 8/31/16 at 7:51 AM, documented "breath sounds clear all lobes." The information that was documented did not match the observation.

b. A CAH policy "Intravenous Therapy - Initiation," dated 6/16/14, was reviewed. The policy stated:

- "Perform hand hygiene before patient contact."
- "Verify the correct patient using two patient identifiers per institution policy."
- "Apply label to IV tubing that indicates either when tubing was hung or when tubing should be changed."
- "...don clean gloves."
- "Swab injection cap with antiseptic swab."
- "Label dressing. Include date and time of IV insertion, VAD gauge size and length, and nurse's initials."

The RN did not follow the CAH policy related to intravenous therapy. Examples include:

- The RN did not perform hand hygiene or don new gloves prior to IV therapy initiation.
- The RN did not use 2 patient identifiers prior to IV therapy initiation.
- The RN did not apply a label to the IV tubing indicating when it was hung or should be changed.
- The RN did not swab the IV tubing injection cap with antiseptic swab prior to attaching secondary IV tubing which contained pre-operative antibiotics.
- The RN did not label date and time of IV insertion, VAD gauge size, or nurse's initials on Patient #31's IV dressing.

c. A CAH policy "Patient Identification," dated 12/16/13, was reviewed. The policy included the following information:

- "Purpose: To provide accurate identification of patients prior to any surgical or invasive procedure, when drawing blood, and when administering medications and/or blood products..."
- "To identify a patient, staff will ask the patient to state his or her name and date of birth and the staff will verify that it matches the identification band."

The RN was observed to scan Patient #31's identification band, but was not observed to ask Patient #31 for his name and date of birth or compare that information against his armband prior to medication administration, including IV medication.

d. The RN did not wash his hands (and/or use alcohol based hand gel) while in pre-op, the surgical suite, or in PACU. Examples include:

- Prior to inserting an IV catheter in pre-op
- Before clipping hair from surgical site (pubic area) in pre-op
- After removing gloves after clipping surgical site in pre-op
- After working on the computer in pre-op or handling the camera in the surgical suite
- Before inserting a urinary catheter in the surgical suite
- Before direct contact with the patient, such as when applying blood pressure cuff and finger monitor, applying socks, before putting together the incentive spirometer, or before cleansing the surgical site in the surgical suite, or before physical assessment with a stethoscope in PACU

e. The RN listened to Patient #31's lungs in PACU and stated Patient #31 had crackles in his left lung. The "RECOVERY ROOM FLOWSHEET," dated 8/31/16 at 10:25 AM, documented Patient #31's lungs were "clear." The documentation did not match the observation.

Patient #31's RN was interviewed on 8/31/16 at 11:45 AM. He stated he generally did use a stethoscope to listen to lungs prior to surgery. He stated he did not have a stethoscope with him while in pre-op caring for Patient #31. He confirmed he did not take Patient #31's temperature during pre-op. He stated the CRNA generally took the patient's temperature in the surgical suite. He stated he confirmed the patient's identity by checking date of birth prior to the surveyors entering pre-op. He confirmed he did not use a second patient identifier at the time of administration of the IV medication. He stated he washed his hands prior to entering pre-op and after leaving the room, prior to entering the surgical suite.

Nursing care did not meet the needs of Patient #31 to ensure a thorough assessment, accurate documentation, appropriate identification of the patient, appropriate labeling of medications, and appropriate handwashing in accordance with CAH policy.

2. Patient #3 was a 56 year old female admitted to the CAH on 7/13/16 for a laparoscopic cholecystectomy.

Patient #3's care plan stated nursing staff should call the physician for oxygen saturation levels that fell below 90%.

An RN visit note, dated 7/14/16, stated "PT'S 02 SATS WILL DESAT TO MID 80'S WHEN SHE FALLS ASLEEP BUT COMES RIGHT BACK UP TO THE HIGH 90'S. NO COMPLAINTS OF PAIN. PT IS BEING DISCHARGED HOME NOW."

There was no documentation to indicate Patient #3's physician had been contacted regarding saturation levels that fell below 90%.

The Informatics RN was interviewed on 8/31/16 at 2:43 PM. She reviewed Patient #3's record and stated she could not find any documentation to indicate the physician had been notified of the low oxygen saturation levels prior to discharge from the CAH. She stated she would have expected physician notification for oxygen saturation levels in the 80s and could have impacted discharge plans.

Nursing staff did not alert physician to Patient #3's abnormal oxygen saturation levels in accordance with her plan of care.

Based on staff interview and a review of policies and medical records, it was determined the CAH failed to ensure a nursing care plan was developed and kept current for 23 of 23 inpatients (#2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #31, #32, #33, #34, #35, #36, #37, #38, and #39) whose records were reviewed. This resulted in a lack of direction to nursing staff and an inability to involve patients in their care planning. It had the potential to result in uncoordinated nursing care that did not meet the needs of patients. Findings include:

The policy "Nursing Care Plan, Interdisciplinary Rounds," dated 4/13/15, defined NCP as "Utilization of the nursing process (assess, diagnose, plan, implement, evaluate) to provide a framework by which the professional nurse can connect clinical events and data obtained from a variety of sources with the appropriate interventions to safely manage and evaluate nursing care." The policy stated the RN would collaborate with the patient to individualize the NCP to the unique needs of the patient. The policy further stated an NCP with strategies, alternatives, and goals would be developed. The policy stated there were 15 available care plans in the EMR including a standard adult plan, a standard newborn plan, a standard postpartum plan, a standard adult outpatient observation plan, and others.

The policy was not followed. Instead, the CAH's EMR took items from diagnoses and initial nursing assessments and automatically populated fields to remind nurses to enter information and perform tasks. The policy did not address how NCPs would be individualized. The policy did not address how patients would participate in the development of care plans when those care plans were not identified.

Finally, the policy did not address how NCPs would be documented.

Excluding ED patients and 1 baby, NCPs were not present in the medical records of acute inpatients #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #31, #32, #33, #34, #35, #36, #37, #38, and #39.

The EMR was confusing. For example, Patient #3 was a 56 year old female admitted to the CAH on 7/13/16 for a laparoscopic cholecystectomy. She was discharged on 7/14/16.

Some of Patient #3's nursing notes referred to "CP" (care plan). These were items inserted by the computer. With 1 exception they did not direct care. For example, a nursing note, dated 7/13/16 at 6:53 AM, stated "IV peripheral site #1." The note did not state where the IV was or what gauge needle was used or whether any solutions were infused. It did not provide any direction to staff. However, it was labeled "CP."

A nursing note, dated 7/13/16 at 2:28 PM, stated "Pain Assessment/Management." Prepopulated fields stated pain score 0-10, acceptable pain level, location, level of sedation, and others. None of these fields was filled in except "Medicated" which was marked "no." While being labeled "CP," the note did not provide any information about the patient or any direction to nursing staff.

A nursing note, dated 7/13/16 at 3:00 PM, stated "Dietary Intake...Meal + Snack Diet+ Nothing by Mouth." While being labeled "CP," the note did not provide any information about the patient or any direction to nursing staff. There was one exception, labeled "CP" that provided direction to staff in Patient #3's record. It gave direction to nursing staff to call a physician if vital signs fell outside of specified parameters. Other than this one example, an identifiable NCP was not documented for any patient.

The Informatics RN was interviewed on 9/02/16 beginning at 10:45 AM. She stated no NCP documents were present for the above patients. She stated elements of NCPs were incorporated in other parts of the record but documents that included patients' problem lists, direction to nursing staff, and goals of care were not generated.

The CAH failed to develop NCPs for patients.

Based on record review, observation, and staff interview, it was determined the facility failed to ensure records were complete and accurate for 4 of 6 surgical inpatients (#5, #11, #14, and #31) and 1 of 17 non-surgical inpatients (Patient #7) whose records were reviewed. Incomplete and inaccurate documentation interfered with the clarity of the course of patient care and had the potential to impact the quality and safety of patient care. Findings include:

The CAH did not have a policy that addressed the requirement that clinical records be legible, complete, accurately documented, readily accessible, and systematically organized.

1. Patient #31 was a 57 year old male who was admitted to the CAH on 8/31/16 for a right inguinal hernia repair, whose record was reviewed.

a. Patient #31's record included a CAH document "ANESTHESIA RECORD," dated 8/31/16, which was reviewed. The document included a section "IV" where multiple anesthetic medications used during the procedure were documented. Number values were used next to medications administered instead of the number value and unit of measurement for the medication (i.e. milliliters, milligrams, micrograms, etc.). The documentation was incomplete.

b. Patient #31's record included a CAH document "Preop Physical Assessment," dated 8/31/16 at 7:51 AM, which was reviewed. The document included the following:

- "Cardio: ...Pulse regular and strong."
- "Resp: ...Breath sounds clear to all lobes."

Patient #31's pre-surgical period was observed on 8/31/16, beginning at 7:30 AM. During this period, the OR RN Coordinator did not listen to Patient #31's heart and lungs and did not palpate Patient #31's pulse. The documentation did not match the observation that occurred during the pre-op period.

The OR RN Coordinator was interviewed on 8/31/16, beginning at 11:45 AM. He confirmed he did not use a stethoscope when doing Patient #31's pre-operative physical assessment. When asked about pre-surgical physical assessments, the OR RN Coordinator stated "I usually do." Additionally, he stated he did not take Patient #31's pre-surgical temperature as it was usually done by the CRNA in the operating room.

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and Patient #31's record was reviewed in her presence. She confirmed the nursing documentation in pre-op for Patient #31 did not accurately reflect care.

The record documentation for Patient #31 was not complete and accurate.

2. Patient #14 was a 19 year old female who was admitted to the CAH on 7/30/16 for pregnancy, failure to progress, and caesarian section, whose record was reviewed.

a. Patient #14's record included a CAH document used for "time-out" (verification pause immediately prior to surgical procedure) purposes which was unnamed, undated, which was reviewed. The document included a section "Before induction of anesthesia." Under this section, the following "Yes" and "No" checkboxes were left blank:

- "Does patient have a known allergy"
- "Does the patient have a difficult airway/aspiration risk?"
- "Does the patient have a risk of >500ML blood loss (7ML/KG in children)"

The CAH document also included a section "Before skin incision." Under this section, all checkboxes were left blank. Additionally, the document was undated and untimed, making it difficult to ascertain if the "time out" procedure was performed prior to the surgical procedure.

c. Patient #14's record included a CAH document "ANESTHESIA RECORD," dated 7/31/16, which was reviewed. The document included a section "IV" where multiple anesthetic medications used during the procedure were documented. Number values were used next to medications administered instead of the number value and unit of measurement for the medication (i.e. milliliters, milligrams, micrograms, etc.).

d. Patient #14's record included a CAH document "RECOVERY ROOM FLOWSHEET," dated 7/31/16, which was reviewed. The document included a section "I/O." This section was left blank. The document also included a section "OUTCOMES." This section was left blank.

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and Patient #14's record was reviewed in her presence. She confirmed the missing documentation.

The record documentation for Patient #14 was not complete and accurate.

3. Patient #11 was a 78 year old female who was admitted to the CAH on 4/11/16 for hyponatremia, heart failure, and bilateral pneumonia whose record was reviewed.

a. Patient #11's record included a CAH document "Swing Bed Orders," dated 4/11/16, which was reviewed. The document included "Allergies" next to a blank line. This line was left blank; however Patient #11's record included an allergy to Macrobid (an antibiotic).

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and the patients' records were reviewed in her presence. She confirmed the inaccurate and missing documentation.

The record documentation for Patient #11 was not complete and accurate.



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4. Patient #5 was a 7 year old male who was admitted to the facility on 7/20/16 to have has tonsils removed. The pre-anesthesia assessment, dated 7/26/16, was reviewed. The time of the assessment was not documented.

The Informatics RN was interviewed on 8/03/16 at 3:05 PM. She reviewed Patient #5's record. She confirmed the missing documentation.

The timing of the pre-anesthesia assessment for Patient #5 was not included. The documentation was incomplete

5. Patient #7 was a 66 year old male who was admitted to the facility on 4/18/16 for care related to pancreatic cancer. The discharge summary, dated 4/22/16, was not signed.

The Informatics RN was interviewed on 8/03/16 at 3:05 PM. She reviewed Patient #7's record. She confirmed the discharge summary was not signed.

The discharge summary for Patient #7 was not signed. The documentation was incomplete.

Based on record review, policy review, and staff interview, it was determined the facility failed to ensure properly executed informed consent forms were completed for 8 of 23 inpatients (#1, #5, #6, #7, #11, #14, #22, and #28) whose records were reviewed. This resulted in a lack of clarity as to whether patients or their representatives were fully informed prior to signing documents and prior to treatment. Findings include:

A policy, "Surgery - Rules and Regulations," dated 10/07/13, was reviewed. It stated "Except in emergencies, surgical procedures shall not be performed until an informed consent of the patient or patient's legal representative has been obtained and documented."

A policy "General Consent and Authorization," dated 11/19/13, was reviewed. The policy stated:

"VI. When a patient is not able to consent due to age, mental status or other legitimate reason, the following may sign the GCA on the patient's behalf:

a. In the case of a minor, the parent or legal guardian.

b. A court-appointed guardian.

c. A person designated in writing by the patient (i.e. advanced directive).

d. In the event of an unplanned event rendering the patient unable to make medical decisions, the family member who has legal authority to make medical decisions on the patient's behalf."

Patient consent forms were not appropriately completed. Examples include:

1. Patient #6 was a 92 year old male who was admitted to the facility on 7/22/16 for surgery on an incarcerated inguinal hernia.

The surgical consent form was signed by the patient on 7/22/16 at 5:12 PM. However, the anesthesia consent form was not signed by the patient or a patient representative. A handwritten note on the form documented the following: "UNABLE TO HAVE PT. SIGN DUE TO HARD OF HEARING (SEVERE) & NEED TO PROCEED QUICKLY. PT. APPEARS TO UNDERSTAND THAT HE IS HAVING SURGERY & APPEARS TO AGREE."

Patient #6's record included "ANESTHESIA PROGRESS NOTES," dated 7/22/16 and untimed. The notes included checked boxes for the following: "POSSIBLE COMPLICATIONS EXPLAINED, QUESTIONS ANSWERED YES, and "RISKS, BENEFITS & ALTERNATIVES EXPLAINED."

There was no documentation that explained how the surgical consent form could be signed by Patient #6, there was a discussion related to anesthesia risk, and the anesthesia consent form could not be signed.

The CRNA who cared for Patient #6 was interviewed on 9/29/16 at 9:48 AM. When asked to clarify how he was able to answer Patient #6's questions and explain risks and benefits to Patient #6 but was unable to get written consent, he stated he was not able to explain complication or risks because Patient #6 was hard of hearing and he checked the boxes as a matter of routine and should not have done so. He could not explain how surgical consent was able to be given.

Consent for Patient #6 was not properly obtained.

2. Patient #5 was a 7 year old male who was admitted to the facility on 7/20/16 to have his tonsils removed.

a. The "GENERAL CONSENT AND AUTHORIZATION," was signed on 7/20/16 by an individual other than the patient. The relationship to Patient #5 was not indicated on the form.

b. The "Surgical-Procedural Informed Consent," dated 7/20/16, was signed by an individual other than the patient. The relationship of the individual to Patient #5 was not indicated on the form. The time consent was given was not documented.

c. The "CONSENT FOR ANESTHESIA SERVICES," was signed by an individual identified as Patient #5's grandmother. The date and time consent was given was not documented.

The Informatics RN was interviewed on 8/03/16 at 3:05 PM. She reviewed Patient #5's record. She confirmed the missing documentation on the consent forms.

Consent for Patient #5 was not properly executed.

3. Patient #7 was a 66 year old male who was admitted to the facility on 4/18/16 for care related to pancreatic cancer.

The "GENERAL CONSENT AND AUTHORIZATION," was signed on 4/22/16 by an individual other than the patient. The relationship to Patient #7 was not indicated on the form. The form was incomplete.

The Informatics RN was interviewed on 8/03/16 at 3:05 PM. She reviewed Patient #7's record. She confirmed the missing documentation on the consent forms.

Consent for Patient #7 was not properly executed.



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4. Patient #1 was a 40 year old female who was admitted to the CAH on 8/25/16 for acute alcohol intoxication and anemia, whose record was reviewed.

Patient #1's record included a CAH document "History & Physical," dated 8/25/16, which was reviewed. The CAH document included "GENERAL: The patient is an intoxicated 40-year-old [ethnicity] female who appears her stated age. Difficult to carry on a conversation with the patient because she is so intoxicated."

Patient #1's record included a CAH document "Discharge Summary," dated 8/29/16, which was reviewed. The CAH document included "HOSPITAL COURSE: Patient admitted to [Hospital] on 08/25/16, with acute alcohol intoxication. Patient's blood alcohol level at the time was noted to be 304."

Patient #1's record included a CAH document "GENERAL CONSENT AND AUTHORIZATION," dated 08/25/16 at 1:45 AM, which was reviewed. The CAH document included the line "Signature Patient or Authorized Representative." Although she was described as "highly intoxicated," Patient #1's signature appeared on this line.

Patient #1's record included a CAH document "GENERAL CONSENT AND AUTHORIZATION," dated 08/25/16 at 3:10 AM, which was reviewed. The CAH document included the line "Signature (Patient or Authorized Representative)." Although she was described as "highly intoxicated," Patient #1's signature appeared on this line.

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and Patient #1's record was reviewed in her presence. She confirmed the conflicting consent and record documentation.

Consent for Patient #1 was not properly executed.

4. Patient #11 was a 78 year old female who was admitted to the CAH on 4/11/16 for hyponatremia, heart failure, and bilateral pneumonia whose record was reviewed.

a. Patient #11's record included a CAH document "GENERAL CONSENT AND AUTHORIZATION," dated 04/26/16 at 2:00 PM, and signed by Patient #11. The consent was signed on the date she was discharged on 4/26/16 rather than the date she was admitted on, 4/11/16.

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and Patient #11's record was reviewed in her presence. She confirmed the conflicting consent and record documentation.

Consent for Patient #11 was not properly executed.

5. Patient #14 was a 19 year old female who was admitted to the CAH on 7/30/16 for pregnancy, failure to progress and caesarian section, whose record was reviewed.

Consents related to blood administration were inconsistent. Examples include:

a. Patient #14's record included a CAH document "CONSENT FOR ANESTHESIA SERVICES," dated 7/30/16, which was reviewed. The CAH document stated, "I give consent to receive blood or blood products only as an emergency life-saving measure" with a checked checkbox next to it and Patient #14's handwritten initials.

b. Patient #14's record included a document "Surgical-Procedural Informed Consent," dated 7/30/16. The CAH document stated:

"I have been told how likely it is that I may need a blood transfusion (initial one box) [sic]
Yes, you may give me blood (blood products). I have received and read the pre-transfusion information sheet.
No, I ask that no blood or blood products be given to me. I do not hold SMH, its staff and/or its doctors responsible in any way for any bad results, or even death, which may occur as the result of my choice not to receive blood. The possible problems that can result from not receiving blood have been explained to me."

Next to the "Yes" statement was a checked checkbox and Patient #14's handwritten initials. However, the "Yes" statement in this CAH document was not consistent with the previous document "CONSENT FOR ANESTHESIA SERVICES."

c. Patient #14's record included a CAH document "CLEARWATER VALLEY/ST. MARY'S HOSPITALS Consent/Refusal for Blood Transfusion," dated 7/31/16 and signed by Patient #14, which was reviewed. The CAH document included risks and benefits of receiving a blood transfusion, but did not include an option to receive blood or blood products only in the event to save the patient's life, as previously indicated by Patient #14 in the "CONSENT FOR ANESTHESIA SERVICES" CAH document.

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and Patient #14's record was reviewed in her presence. She confirmed the conflicting consent and record documentation.

Consent for Patient #14 was not properly executed.

5. Patient #22 was a 41 year old female who was admitted to the CAH on 7/05/16 for altered mental status, whose record was reviewed.

a. Patient #22's record included a CAH document "History of Present Illness," dated 7/05/16, signed by the physician. The document stated "Again, history was very difficult to obtain from patient. She was confused, and crying out for her cat..."

b. Patient #22's record included a CAH document "GENERAL CONSENT AND AUTHORIZATION," dated 7/05/16, at 10:00 AM. The CAH document included the line "Signature (Patient or Authorized Representative." Although Patient #22 was described as "confused," her signature appeared on this line.

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and Patient #22's record was reviewed in her presence. She confirmed the conflicting consent and record documentation.

Consent for Patient #22 was not properly executed.

6. Patient #28 was a 79 year old female who was admitted to the CAH on 7/18/16, for care related to hip surgery, whose record was reviewed.

a. Patient #28's record included a CAH document "List Patient Notes," dated 7/18/16 at 10:09 AM, signed by an RN. The document included "PATIENT CONFUSED IN BED, WONDERING WHERE [sic] IS AT."

b. Patient #28's record included a CAH document "GENERAL CONSENT AND AUTHORIZATION," dated 7/18/16 at 3:30 PM, which was reviewed. The CAH document included the line "Signature (Patient or Authorized Representative." Although Patient #28 was described as "confused," her signature appeared on this line.

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and Patient #28's record was reviewed in her presence. She confirmed the conflicting consent and record documentation.

Consent for Patient #28 was not properly executed.

Based on review of medical records and medical staff rules, and staff interview, it was determined the facility failed to ensure physician and CRNA entries in the medical record were timed, dated, and authenticated for 5 of 23 inpatients (#4, #5, #11, #14, and #18) whose records were reviewed. This resulted in a lack of clarity as to whether H&Ps were reviewed immediately prior to surgery. It also resulted in invalid physician orders, incomplete consents and progress notes. Findings include:

The "MEDICAL STAFF RULES," dated 2/07/05, were reviewed. They stated "Signature requirements 7.4.1. Physician shall sign and date entries the physician makes, or directs to be made."

Dated physician and CRNA signatures were missing. Examples follow:

1. Patient #5 was a 7 year old male who was admitted to the facility on 7/20/16 to have his tonsils removed. His H&P, dated 5/26/16, had a handwritten note, signed by the surgeon, indicating Patient #5 did not have any new signs and symptoms. The note was not dated. It could not be determined the timing of the physician's findings and whether the H&P was reviewed immediately prior to surgery.

The Informatics RN was interviewed on 8/03/16 at 3:05 PM. She confirmed the physician's note on the H&P was not dated.

A physician entry on Patient #5's H&P was signed but not dated.

2. Patient #4 was a 54 year old male admitted to the facility on 6/07/16 for surgical repair of an inguinal hernia. The H&P, dated 4/07/16, had a handwritten note, signed by the surgeon, indicating Patient #4 did not have any new signs and symptoms. The note was not dated. It could not be determined the timing of the physician's findings and whether the H&P was reviewed immediately prior to surgery.

The Informatics RN was interviewed on 8/03/16 at 3:10 PM. She confirmed the physician's note on the H&P was not dated.

A physician entry on Patient #4's H&P was signed but not dated.



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3. Patient #18 was a 66 year old female who was admitted to the CAH on 8/05/16 for depression with history of suicidal thoughts and hypoxia.

a. Patient #18's record included a CAH document "LINCARE," dated 8/05/16, which was reviewed. The document was an order form for home oxygen DME. The document was not signed, dated, or timed by the ordering physician.

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and Patient #11's record was reviewed in her presence. She confirmed the missing physician signature, date, and time.

Physician orders for Patient #18 did not include date, time, or signature.

4. Patient #11 was a 78 year old female who was admitted to the CAH on 4/11/16 for hyponatremia, heart failure, and bilateral pneumonia.

a. Patient #11's record included a CAH document "Swing Bed Orders," dated 4/11/16. The document was not dated or timed by the ordering physician.

b. Patient #11's record included a CAH document "Physician Medication Order Sheet," dated 4/11/16. The document was not signed, dated, or timed by the ordering physician.

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and Patient #11's record was reviewed. She confirmed the missing physician information.

Physician orders for Patient #11 did not include dated signatures.

5. Patient #14 was a 19 year old female who was admitted to the CAH on 7/30/16 for pregnancy, failure to progress and caesarian section.

a. Patient #14's record included a CAH document "ANESTHESIA PROGRESS NOTES," dated 7/30/16. The document was not signed, dated, or timed by the CRNA.

b. Patient #14's record included a CAH document "Surgical-Procedural Consent," dated 7/30/16. The document was not signed, dated, or timed by the ordering physician.

c. Patient #14's record included a CAH document "Surgical-Procedural Consent," dated 7/31/16. The document was not signed, dated, or timed by the ordering physician.

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and Patient #14's record was reviewed in her presence. She confirmed the missing physician and CRNA information.

Anesthesia progress notes and Surgical Consents for Patient #14 did not include dated signatures.

Based on observation, staff interview, and review of policies, surgical standards of practice, medical staff bylaws, and medical records, it was determined the CAH failed to ensure surgical services were provided in a safe manner. This impacted 4 of 6 surgical patients (#4, #5, #14, and #31) whose records were reviewed which had the potential to interfere with the quality and safety of patient care in the surgical setting. Findings include:

1. The "Surgical Services Policy," dated 6/16/14, was reviewed. It stated the "H&P is to be performed and recorded within the previous seven (7) days prior to the surgery or procedure. An addendum to the H&P can be done by the surgeon if the H&P is more than seven (7) days out."

The "MEDICAL STAFF BYLAWS," dated 2/07/05, were reviewed. They stated it was the basic responsibility of medical staff to "ensure that a physical examination and medical history (or updated note for a physical examination and medical history done within the prior 30 days) is done no more than 7 days before or 48 hours after an admission for each patient by a physician in accordance with state law."

The H&P pre-surgical requirements were not met. Examples include:

a. Patient #5 was a 7 year old male who was admitted to the facility on 7/20/16 to have his tonsils removed. The H&P, dated 5/26/16, was performed 55 days prior to surgery. The H&P had a handwritten note, signed by the surgeon, at the end of the document, indicating Patient #5 did not have any new signs and symptoms. The note was not dated and did not indicate a physical examination was performed.

The Informatics RN was interviewed on 8/03/16 at 3:05 PM. She confirmed the outdated H&P and the undated physician's note handwritten on the H&P.

b. Patient #4 was a 54 year old male admitted to the facility on 6/07/16 for surgical repair of an inguinal hernia. The H&P, dated 4/07/16, was performed 61 days prior to surgery. The H&P had a handwritten note, signed by the surgeon, indicating Patient #4 did not have any new signs and symptoms. The note was not dated and there was no documentation of a physical examination.

The Informatics RN was interviewed on 8/03/16 at 3:10 PM. She confirmed the outdated H&P and the undated physician's note handwritten on the H&P.

2. Nursing care observed in the surgical setting did not meet patient needs and/or CAH policy requirements.

Patient #31 was a 57 year old male admitted to the facility on 8/31/16 for surgical repair of an inguinal hernia. The care of Patient #31 was observed on 8/31/16 from 7:30 AM while he was in pre-op, until approximately 10:50 AM while Patient #31 was still in PACU, prior to transferring to the medical/surgical floor. The RN (OR Coordinator) provided care to Patient #31. Patient needs for nursing care were not met. Examples include:

a. A CAH nursing policy, "Surgical Patient Preparation," dated 11/18/13, was reviewed. It included the expectation that vital signs be assessed immediately before going to OR, including temperature, blood pressure, pulse, and respiratory rate. It also included the expectation nursing staff would perform a physical examination, including assessment of heart and lungs.

The RN did not take Patient #31's temperature or listen to Patient #31's heart and lungs in pre-op. The "Preop Physical Assessment," dated 8/31/16 at 7:51 AM, documented "breath sounds clear all lobes." The information that was documented did not match the observation.

b. A CAH policy "Intravenous Therapy - Initiation," dated 6/16/14, was reviewed. The policy stated:

- "Perform hand hygiene before patient contact."
- "Verify the correct patient using two patient identifiers per institution policy."
- "Apply label to IV tubing that indicates either when tubing was hung or when tubing should be changed."
- "...don clean gloves."
- "Swab injection cap with antiseptic swab."
- "Label dressing. Include date and time of IV insertion, VAD gauge size and length, and nurse's initials."

The RN did not follow the CAH policy related to intravenous therapy. Examples include:

- The RN did not perform hand hygiene or don new gloves prior to IV therapy initiation.
- The RN did not use 2 patient identifiers prior to IV therapy initiation.
- The RN did not apply a label to the IV tubing indicating when it was hung or should be changed.
- The RN did not swab the IV tubing injection cap with antiseptic swab prior to attaching secondary IV tubing which contained pre-operative antibiotics.
- The RN did not label date and time of IV insertion, VAD gauge size, or nurse's initials on Patient #31's IV dressing.

c. A CAH policy "Patient Identification," dated 12/16/13, was reviewed. The policy included the following information:

- "Purpose: To provide accurate identification of patients prior to any surgical or invasive procedure, when drawing blood, and when administering medications and/or blood products..."
- "To identify a patient, staff will ask the patient to state his or her name and date of birth and the staff will verify that it matches the identification band."

The RN was observed to scan Patient #31's identification band, but was not observed to ask Patient #31 for his name and date of birth or compare that information against his armband prior to medication administration, including IV medication.

d. The RN did not wash his hands (and/or use alcohol based hand gel) while in pre-op, the surgical suite, or in PACU. Examples included:

- Prior to inserting an IV catheter in pre-op
- Before clipping hair from surgical site (pubic area) in pre-op
- After removing gloves after clipping surgical site in pre-op
- After working on the computer in pre-op or handling the camera in the surgical suite
- Before inserting a urinary catheter in the surgical suite
- Before direct contact with the patient, such as when applying blood pressure cuff and finger monitor, applying socks, before putting together the incentive spirometer, or before cleansing the surgical site in the surgical suite, or before physical assessment with a stethoscope in PACU

e. The RN listened to Patient #31's lungs in PACU and stated Patient #31 had crackles in his left lung. The RN visit, "RECOVERY ROOM FLOWSHEET," dated 8/31/16 at 10:25 AM, indicated Patient #31's lungs were "clear." The documentation did not match the observation.

Patient #31's RN was interviewed on 8/31/16 at 11:45 AM. He stated he generally did use a stethoscope to listen to lungs prior to surgery. He stated he did not have a stethoscope with him while in pre-op caring for Patient #31. He confirmed he did not take Patient #31's temperature during pre-op. He stated the CRNA generally took the patient's temperature in the surgical suite. He stated he confirmed the patient's identity by checking date of birth prior to the surveyors entering pre-op. He confirmed he did not use a second patient identifier at the time of administration of the IV medication. He stated he washed his hands prior to entering pre-op and after leaving the room, prior to entering the surgical suite.

Nursing care did not meet the needs of Patient #31 to ensure a thorough assessment, accurate documentation, appropriate identification of the patient, appropriate labeling of medications, and appropriate handwashing in accordance with CAH policy.

3. Environmental cleaning issues were identified as they related to storage and handling of supplies.

A policy "Storage and handling of sterile equipment and supplies," dated 12/17/14, was reviewed. The policy included "The temperature shall be controlled between 65 and 72 degrees F. [sic] and the relative humidity between 40% and 70% at all times."

An observation of the OR sterile supply area was conducted on 8/31/16, beginning at 10:20 AM, in the presence of the OR Tech. A humidity log was noted, however, a temperature log could not be located. When asked if temperature was being recorded for this area, the OR Tech stated no. She stated temperature was being visually monitored and pointed out the display device for temperature in the area. However, the OR Tech stated, during the time of the observation, the temperature information was not being recorded for reference and/or maintenance control.

Temperature was not monitored in accordance with CAH policy.

4. Environmental issues were identified as they related to cleaning procedures to maintain a sanitary environment.

A policy "Operating Room Sanitation," dated 12/17/14, was reviewed. The policy included "All horizontal surfaces on moveable and mounted equipment and overhead lights will be damp dusted with bacterial, tuberculocidal, pseudomonacidal and fungicidal disinfectant."

An observation of the OR was conducted on 8/31/16, beginning at 8:35 AM, and ending at approximately 10:45 AM. During the observation, a bottle of 70% isopropyl alcohol was noted next to the cleaning supplies.

The OR Tech was interviewed on 8/31/16, beginning at 10:20 AM. When asked what the 70% isopropyl alcohol was used for, she stated it was used to clean the OR surgical lights. When asked what guidelines the CAH used for surgical services, the OR Tech stated they used AORN standards. When asked if the 70% isopropyl alcohol was approved for use in the OR as a disinfectant, she stated she did not know.

The EVS Manager was interviewed on 9/01/16, beginning at 8:30 AM. When asked what the 70% isopropyl alcohol was used for in the OR, she stated she did not know. The EVS Manager stated she was unsure what cleaning agents were used in the OR due to the fact EVS staff did not clean the OR. When asked if the 70% isopropyl alcohol was approved for use in the OR as a disinfectant, she stated she did not know.

The Infection Control RN was interviewed on 9/01/16, beginning at 9:37 AM. When asked if she had reviewed OR cleaning procedures, cleaning agents used, and EVS policies, she stated she had not done so. The Infection Control RN stated she was planning on reviewing those items in the future, but had not gotten to it yet. When asked if the 70% isopropyl alcohol was approved for use in the OR as a disinfectant, she stated she did not know.

The website "AORN (https://www.aorn.org)," accessed on 9/06/16, included the following:

"Alcohol should not be used for cleaning and disinfecting surfaces in the operating room because alcohol is not an adequate cleaning and disinfecting agent."

Cleaning procedures were not conducted in accordance with CAH policy and standards of practice.

5. Refer to C 322 as it relates to the failure of the CAH to ensure each patient was examined immediately prior to surgery by an MD/DO to determine the risk of the procedure and by a qualified anesthesia provider to determine the risk of anesthesia.

The cumulative affect of these negative systemic practices resulted in the failure of surgical services being provided in a safe and effective manner.



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Based on observation, staff interview, policy review, and medical record review, it was determined the CAH failed to ensure each patient was examined immediately prior to surgery by an MD/DO to determine the risk of the procedure and by a qualified anesthesia provider to determine the risk of anesthesia for 4 of 6 surgical patients (#5, #6, #14, and #31) whose records were reviewed. This had the potential to interfere with patient safety. Findings include:

The "Surgical Services Policy," dated 6/16/14, was reviewed. It included the following information:

- It is the CAH's policy "to assure that each patient undergoing operative and/or invasive procedures requiring anesthesia is appropriately assessed for clinical stability prior to the procedure."
- "Anesthetist will complete a pre-anesthesia evaluation and document the evaluation on the appropriate form. The pre-anesthesia evaluation will include notation of anesthesia risk; anesthesia, drug and allergy history; and potential anesthesia problems identified; and the patient's condition prior to induction of anesthesia."
- "Upon arrival to PACU the CRNA and Circulating and/or PACU nurse will immediately assess patient's cardiopulmonary status, level of consciousness, and provide any needed care (e.g. Oxygen, Pain Control)."

A policy "Surgery - Rules and Regulations," dated 10/07/13, was reviewed. It stated "The Anesthesia Department shall record a complete anesthesia record, which includes pre-anesthetic evaluation and a post-operative follow-up."

Pre-surgical, pre-anesthesia, and post-anesthesia assessment requirements were not met. Examples include:

1. Patient #31 was a 57 year old male admitted to the facility on 8/31/16 for surgical repair of an inguinal hernia.

The care of Patient #31 was observed on 8/31/16 from 7:30 AM while he was in pre-op until approximately 10:50 AM while Patient #31 was in PACU, prior to being moved to a medical/surgical floor. The surgeon and CRNA did not use a stethoscope to auscultate Patient #31's heart and lungs prior to surgery or in PACU following surgery.

Patient #31's record included a CAH document "ANESTHESIA PROGRESS NOTES," dated 8/31/16. Consistent with the observation, the anesthesia notes did not document a pre-anesthesia physical assessment by the CRNA, or indicate if there were any post-procedure anesthesia complications, as the "Yes" and "No" checkboxes were blank.

Consistent with the observation, there was no documentation of a physician's physical assessment of Patient #31 immediately prior to surgery to determine the risk of the procedure.

2. Patient #6 was a 92 year old male who was admitted to the facility on 7/22/16 for surgery related to an incarcerated inguinal hernia.

The surgical consent form was signed by the patient on 7/22/16 at 5:12 PM. The pre-anesthesia assessment, dated 7/22/16, was reviewed. There was no documentation of a pre-anesthesia physical assessment of Patient #6, such as, auscultation of heart and lungs with a stethoscope.

3. Patient #5 was a 7 year old male who was admitted to the facility on 7/20/16 to have his tonsils removed.

There was no documentation of a physician's physical assessment of Patient #5 immediately prior to surgery to determine the risk of the procedure.

The pre-anesthesia assessment, dated 7/26/16, was reviewed. There was no documentation of a pre-anesthesia physical examination, such as auscultating heart and lungs, to determine the risk of anesthesia.



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4. Patient #14 was a 19 year old female who was admitted to the CAH on 7/30/16 for pregnancy, failure to progress and caesarian section.

Patient #14's record included a CAH document "ANESTHESIA PROGRESS NOTES," dated 7/30/16, which was reviewed. The document did not include documentation of a pre-anesthesia physical assessment by the CRNA, or indicate if there were any post-procedure anesthesia complications, as the "Yes" and "No" checkboxes were blank. Additionally, there was no documentation in Patient #31's record of physical assessment by the physician immediately prior to surgery to determine the risk of the procedure.

The surgeon was interviewed on 9/01/16 at 10:55 AM. He stated he did not typically do a physical assessment in pre-op. He stated he typically did a physical assessment in the clinic, days before surgery.

A CRNA was interviewed on 9/02/16 at 9:40 AM. He stated he did not routinely listen to heart and lungs in pre-op. Instead, he stated he auscultated for breath sounds after intubation in the OR. He explained he was hard of hearing and the equipment in the pre-op area (which is also the PACU area) was not sufficient to allow him to hear breath sounds. He stated he had a "300 dollar stethoscope" that he used in the OR that allowed him to hear breath sounds.

The DON was interviewed on 9/01/16, beginning at 1:40 PM. She confirmed the missing documentation in patient records.

Pre-surgical, pre-anesthesia, and post-anesthesia assessments were incomplete as patients were not physically examined immediately prior to surgery by the MD/DO and prior to anesthesia by a qualified anesthesia provider and in the post-operative setting by qualified anesthesia provider.

Based on record reviews, staff interview, patient interview, and policy review, it was determined the CAH failed to provide an ongoing program of activities for 4 of 4 swing bed patients (Patient #11, #28, #29, and #30) whose records were reviewed. This resulted in the lack of recreational activities for swing bed patients, and had the potential to result in unmet patient needs. Findings include:

A policy "Swing bed - Policies and Procedures," dated 4/29/09, was reviewed. The policy included the following information:

- "An Activities Program will be available to all residents."
- "An assessment will be done and an individualized activities plan will be developed for each Resident."
- "The resident is encouraged to participate in activities at their discretion unless medically contraindicated."

The CAH failed to follow their policy and ensure swing bed patients' activity program needs were individualized and met. Examples include:

a. Patient #11 was a 78 year old female who was admitted to the CAH on 4/11/16 for hyponatremia, heart failure, and bilateral pneumonia whose record was reviewed.

Patient #11's record included a CAH document "Discharge Summary," multiple dates, which was reviewed. The document included the questions "Visited with Patient About [sic] +" and "Response [sic] +." Examples include:

- "4/12/16 5:48 AM
Visited with Patient About [sic] + Personalized to Patient
Response [sic] + Smiled"

- "4/21/16 2:07 AM
Visited with Patient About [sic] + Personalized to Patient
Response [sic] + Smiled"

The same, predetermined drop-down options were used for both of these questions for the duration of Patient #11's admission.

Patient #11's record did not include an activities assessment or a plan to provide activities.

b. Patient #28 was a 79 year old female who was admitted to the CAH on 7/18/16 for status post hip surgery rehab, whose record was reviewed.

Patient #28's record included a CAH document "Discharge Summary," multiple dates, which was reviewed. The document included the questions "Visited with Patient About [sic] +" and "Response [sic] +." Examples include:

- "7/19/16 5:08 AM
Visited with Patient About [sic] + Personalized to Patient
Response [sic] + Smiled"

- "7/24/16 2:29 AM
Visited with Patient About [sic] + Personalized to Patient
Response [sic] + Smiled"

The same, predetermined drop-down options were used for both of these questions for the duration of Patient #28's admission.

Patient #28's record did not include an activities assessment or a plan to provide activities.



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c. Patient #29 was a 95 year old male who was admitted to swing bed services on 6/16/16 for continued care of a pelvic fracture. He was discharged on 7/05/16.

Patient #29's record did not include an activities assessment or a plan to provide activities.

Patient #29's record included a CAH document "Discharge Summary," multiple dates, which was reviewed. On 6/17/16 at 7:29 AM, the document by the RN stated "One to One Program for Swing Bed...Visited with Patient About +...PT SLEEPING AT THIS TIME."

On 6/17/16 at 10:00 AM, the document by the RN stated "One to One Program for Swing Bed...Visited with Patient About +newspaper Response+ laughing." The same, predetermined drop-down options were used for these questions for the duration of Patient #29's admission.

d. Patient #30 was a 65 year old female who was admitted to swing bed services on 8/25/16 for continued care of kidney pain. She was currently a patient as of 9/02/16.

Patient #30's record did not include an activities assessment or a plan to provide activities.

Patient #30's record included a CAH document "Discharge Summary," multiple dates, which was reviewed. On 8/25/16 at 9:07 PM, the document by the RN stated "One to One Program for Swing Bed...Visited with Patient About +...Personalized to patient...Angry" The note did not explain why Patient #30 was angry.

On 8/26/16 at 6:30 AM, the document by the RN stated "One to One Program for Swing Bed...Visited with Patient About +...Personalized to patient...Frowned" The note did not explain why Patient #30 frowned. The same, predetermined drop-down options were used for these questions for the duration of Patient #30's admission.

The Informatics RN was interviewed on 8/30/16, beginning at 10:50 AM. When asked how swing bed patients' ongoing activities program was individualized, she stated RNs would utilize the predetermined EMR drop-down options for the activities section. The Informatics RN confirmed the predetermined activity options were not individualized and the free-form section for "comments" was not utilized.

The DON was interviewed on 9/01/16, beginning at 1:40 PM, and the patients' records were reviewed in her presence. She stated a patient specific activities assessment was not conducted for swing bed residents. She stated a patient specific activities POC was not developed for swing bed residents. She confirmed the swing bed patients' ongoing activities program were not individualized to meet patients' specific needs.

The CAH failed to follow their policy and ensure swing bed patients' activity program needs were individualized and met.

Based on staff interview, review of policies, and review of medical records, it was determined the CAH failed to ensure comprehensive care plans including measurable objectives and timetables were developed for 4 of 4 swing bed residents (#11, #28, #29 and #30), whose medical records were reviewed. This resulted in a lack of direction to staff and an inability to involve residents in their care planning. Findings include:

A policy addressing care plans for swing bed residents had not been developed and was not present at the CAH.

Care plans were not present in the medical records of swing bed residents #11, #28, #29 and #30.

The Informatics RN was interviewed on 9/02/16 beginning at 10:45 AM. She stated no care plan documents were present for the above patients.

The DON was interviewed on 9/02/16 beginning at 10:20 AM. She stated no specific care plans were present for swing bed residents. She stated swing bed policies did not address care plans.

The CAH failed to develop care plans for swing bed residents.