HospitalInspections.org

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ITEM #1 - MULTI-DOSE MEDICATION VIALS

Based on observation, interview, and review of hospital policies and procedures, the Critical Access Hospital failed to develop and implement policies and procedures for labeling and storing multi-dose vials of medication in accordance with USP 797.

Failure to date and discard multi-dose vials after 28 days of opening risks contamination of the contents of the vials and transmission of infectious diseases to patients during medication administration.

Resource: United States Pharmacopoeia (USP) - General Chapter 797 - "Sterile Compounding - Sterile Preparation" (Revised 04/16).

Findings included:

1. On 01/09/18 at 1:20 PM, Surveyor #2 and the Director of Pharmacy (Staff #1) inspected two anesthesia carts in the hospital's surgery department. The anesthesia cart for operating room (OR) #1 contained one open undated multi-dose vial of neostigmine and one open undated multi-dose vial of succinylcholine.

2. During an interview at the time of the observation, the pharmacy director confirmed the vials were open and undated and removed them from the cart.

3. The hospital's policy and procedure titled "Multi-dose Vials" (Policy ID 3593776; Revised 01/17) showed that all multi-dose vials saved for future use would be dated and initialed at the time of the first use. The policy stated if multi-dose medication vials were unrefrigerated, they could be used for up to 30 days. If the multi-dose medication vials were refrigerated, they could be used for up to 90 days. The policy and procedure had not been written in accordance with USP 797.


ITEM #2 - MEDICATION EXPIRATION DATES

Based on observation, interview, and review of hospital policies and procedures, the Critical Access Hospital failed to ensure that all drug storage areas were inspected monthly to prevent administration of outdated medications, as directed by hospital policy.

Failure to inspect medication storage areas and to remove and discard medications that have exceeded their manufacture's expiration date risks administration of medications that are no longer effective, which can result in patient harm.

Findings included:

1. The hospital's policy and procedure titled "Inventory Inspection for Expiration Dating" (Revised 11/12; Review Due Date 08/17) stated that all medication storage areas throughout the hospital would be inspected monthly. All expired medication would be removed from the storage areas and destroyed.

2. On 01/09/18 at 1:20 PM, Surveyor #2 and the Director of Pharmacy (Staff #1) inspected two anesthesia carts in the hospital's surgery department. The anesthesia cart for operating room (OR) #2 contained one 5-ml syringe of ephedrine 25 mg. with a manufacturer's expiration date of 12/17/17; one 10-ml syringe of succinylcholine 200 mg. with a manufacturer's expiration date of 12/25/17; and one 10-ml syringe of phenylephrine 100 mcg. with a manufacturer's expiration date of 12/25/17.

3. During an interview at the time of the observation above, the pharmacy director confirmed the vials were open and undated and removed them from the cart.

4. On 01/09/18 at 2:30 PM, Surveyor #2 and the nurse lead for the emergency department (ED) (Staff #2) inspected medication storage areas in the hospital's ED. A medication storage box labeled "Stroke Box #1" contained one 10-ml syringe of saline flush with a manufacturer's expiration date of 01/01/17; and one 200-ml bag of 5% dextrose intravenous solution with a manufacturer's expiration date of 12/01/17. A medication storage box labeled "Cardiac Box #1" contained a vial of liquid labeled "Donnatal" with a hand-written expiration date of 12/19/17.

5. During an interview at the time of the observation above, the nurse confirmed the medications had exceeded their expiration dates and removed them from the cart.


ITEM #3 - MEDICATION STORAGE

Based on observation and interview, and review of hospital policies and procedures, the Critical Access Hospital failed to ensure that medications were stored in accordance with the manufacturer's directions for use.

Failure to store medications in accordance with the manufacturer's directions for use risks administration of medications that are ineffective and harmful to patients.

References:

Rocuronium - "Store in a refrigerator 2°C - 8°C (36-46 Fahrenheit)... Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use rocuronium bromide within 60 days..." (Teva Pharmaceutical Ind. Ltd - Manufacturer's directions for use).

Anectine (Succinylcholine Chloride Injection, USP) - "Store in refrigerator at 2°C to 8°C (36 to 46 Fahrenheit). Multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency". (Sandoz Inc. - Manufacturer's directions for use).

Findings included:

1. On 01/09/18 at 1:20 PM, Surveyor #2 and the Director of Pharmacy (Staff #1) inspected two anesthesia carts in the hospital's surgery department. The anesthesia cart for operating room (OR) #1 contained two undated unrefrigerated vials of succinylcholine and two undated unrefrigerated vials of rocuronium. The anesthesia cart for OR #2 contained one unrefrigerated 10-ml syringe of fluid labeled "Anectine" with no date, time prepared, concentration, or initials of the preparer.

2. During an interview at the time of the observation, the pharmacy director confirmed the vials had not been stored in accordance with the manufacturer's directions for use and removed them from the cart. The pharmacy director stated the syringe was not labeled according to hospital policy and removed it from the cart.


ITEM #4 - MEDICATION SECURITY

Based on observation, interview, and review of hospital policies and procedures, the hospital failed to ensure that medications were secured and not accessible to unauthorized individuals.

Failure to secure medications risks drug diversion, tampering, and /or unauthorized use which can endanger staff and patients.

Findings included:

1. The hospital's policy and procedure titled "Departmental Security" (Policy #3245133; Approved 10/17) showed that all medication storage areas would be locked after normal working hours.

2. On 01/10/18 at 9:20 AM, Surveyor #2 inspected the emergency equipment and supplies located in the hospital's surgery department. Operating Room (OR) #1 contained a cart of supplies for treatment of malignant hyperthermia (a life-threatening reaction to anesthesia medications). The cart contained 36 vials of dantrolene medication. The cart was unlocked.

3. At the time of the inspection, Surveyor #2 interviewed a nurse (Staff #3) who was working in the post anesthesia recovery unit that day. The nurse confirmed that the cart was not locked. The nurse stated that hospital environmental services staff members had access to OR #1 when not in use.
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ITEM #1 WATER MANAGEMENT PLAN

Based on interview and document review, the critical access hospital failed to develop and implement a water management plan designed to reduce the risk of Legionella and other water-borne diseases in the patient population.

Failure to develop and implement a hospital-wide water management plan puts patients, staff and visitors at risk of infection from water-borne pathogens.

Reference: Centers for Medicare and Medicaid Services (CMS) Survey & Certification Letter S&C 17-30, subject line, "Requirement to Reduce Legionella Risk in Healthcare Facility Water Systems to Prevent Cases and Outbreaks of Legionnaires' Disease (LD)"- Facilities must develop and adhere to policies and procedures that inhibit microbial growth in building water systems that reduce the risk of growth and spread of Legionella and other opportunistic pathogens in water.

Findings included:

On 01/10/18 at 10:00 AM, Surveyor #1 interviewed the facility's plant manager (Staff #5) regarding the hospital's water management program. The manager indicated that the hospital established a committee to work on the water management plan and is in the process of completing a schematic to identify areas in the utility system where pathogens have a potential to grow. The water management plan did not include control measures such as:

a) Implement a water management program that considers the ASHRAE industry standard and the CDC toolkit, and includes control measures such as physical controls, temperature management, disinfection level control, visual inspections, and environmental testing for pathogens.

b) Specify testing protocols and acceptable ranges for control measures, and document the results of testing and corrective actions taken when control limits are not maintained

ITEM #2 DIETARY

Based on observation, and interview, hospital staff failed to assure compliance with the Washington State Retail Food Code (246-215 WAC).

Failure to maintain equipment places patients and staff at risk for foodborne illness

Finding included:

On 01/09/18, between the hours of 10:00 AM and 11:30AM, Surveyor #1 observed food debris on the meat slicer. This was confirmed by the dietary cook (Staff #6). To prevent contamination of foods, equipment should be washed, rinsed and sanitized after use.

Reference: Washington State Retail Food Code, WAC 246-215-04206(1)
Reference: Washington State Retail Food Code, WAC 246-215-04600(1)
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Based on interview and review of patient rights information, the hospital failed to inform patients of all of their rights as long-term ("swing bed") patients in accordance with 42 CFR 483 Subpart B Requirements for Long Term Care Facilities.

Failure to notify patients of their healthcare rights risks violation of those rights, which may result in undesired and/or sub-optimal health outcomes.

Reference: §483.10(b) Notice of Rights and Services. (1) The facility must inform the resident both orally and in writing in a language that the resident understands of his or her rights and all rules and regulations governing resident conduct and responsibilities during the stay in the facility. The facility must also provide the resident with the notice (if any) of the State developed under section 1919(e)(6) of the Act. Such notification must be made prior to or upon admission and during the resident's stay. Receipt of such information, and any amendments to it, must be acknowledged in writing;

Findings included:

1. On 01/09/18 at 3:40 PM during an interview with Surveyor #2, the hospital's Chief Nursing Officer (Staff #4) stated that a written list of patient rights was given to all swing bed patients.

2. Review of the hospital's written list of swing bed patient rights revealed the list did not include all of the patient's rights identified in the Medicare long term care patient regulations. The list did not include the patient's right to formulate an advance directive for health care; the right to be informed of Medicaid benefits; and the right to choose a personal physician.
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Based on interview and review of hospital policies and procedures, the Critical Access Hospital failed to develop a process for notifying long-term care ("swing bed") patients in writing of an impending transfer or discharge in accordance with 42 CFR 483 Subpart B Requirements for Long Term Care Facilities.

Failure to notify swing bed patients of the reason for transfer or discharge, the effective date, the location to which the resident is being transferred or discharged, and information regarding the appeal process risks violation of the patient's rights as long-term care residents.

Reference: 483.12(a)(6) Contents of the notice. The written notice specified in paragraph (a)(4) of this section must include the following:
(i) The reason for transfer or discharge;
(ii) The effective date of transfer or discharge;
(iii) The location to which the resident is transferred or discharged;
(iv) A statement that the resident has the right to appeal the action to the State;
(v) The name, address and telephone number of the State long term care ombudsman;

Findings:

1. The hospital's policy and procedure titled "Swing Bed" (Policy #2998830; Revised 01/17) showed that the hospital would provide written notification to swing bed patients and a family member or legal representative when the patient was transferred or discharged.

2. On 01/09/18 at 3:40 PM, Surveyor #2 interviewed the hospital's Chief Nursing Officer (CNO) (Staff #4) regarding how swing bed patients were notified of an impending transfer or discharge. The CNO stated that the patients did not receive a written notice prior to transfer or discharge.
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Based on interview, record review, and review of hospital policies and procedures, the Critical Access Hospital failed to ensure that staff members developed a care plan for each long-term care ("swing bed") patient that included measurable objectives, interventions, and timetables for meeting treatment goals.

Failure to develop and implement a comprehensive plan for care that includes measurable objectives, interventions, and timetables for meeting treatment goals risks deterioration of the patient's condition and health status.

Findings included:

1. The hospital's policy and procedure titled "Care Plan for Swing Bed Patient" (Policy #2989639; Revised 01/17) showed that a care plan would be developed for each swing bed patient that addressed the patient's physical, psychological, and spiritual problems. The care plan would include interventions to address these problems and specific time frames for meeting goals for care.

2. The hospital's policy and procedure titled "Swing Bed" (Policy #2998830; Revised 01/17) showed that the patient's care plan would include the patient's activity plan in accordance with an assessment of the patient's interests and physical, mental, and psychosocial well-being.

3. On 01/10/18 at 3:55 PM, Surveyor #2 reviewed the medical records of three swing bed patients who had been treated at the hospital between 10/12/17 and 12/26/17 (Patients #1, #2, #3). Review of these records showed that the comprehensive patient care plans did not include interventions or time frames to address problems found during the patients' assessments and time frames to meet goals for care. The plans also did not include plans for activities based on the patients' activities assessments.

4. During an interview with Surveyor #2 at the time of the record review, the hospital's Chief Nursing Officer (CNO) (Staff #4) confirmed the findings above.
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Based on document review and interviews with maintenance staff, the facility has failed to provide a written policy for alternate power sources.

Failure to develop and implement polices for alternate power sources places patients and staff safety at risk during an emergency event.

Findings included:

Fire marshal document review on 01/09/2018 between the hours of 9am and 1:00pm revealed that the hospital did not have a procedure to have the generator maintain the following:

1. Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions.
2. Emergency lighting.
3. Fire detection, extinguishing, and alarm systems.
4. Sewage and waste disposal.

Interview with staff indicated they were not aware of the requirement for this policy.

This finding was observed and discussed with the maintenance director.

Based on interview and record review, the facility had not developed initial emergency preparedness training to all new and existing staff.

Failure to train staff on how to respond during emergencies places patients and staff at risk of injury and/or death in the event of a man-made and/or natural disaster.

Findings included:

1. Surveyor #1 reviewed the hospital's emergency preparedness plan on 01/10/18. The plan did not address training requirements of all staff.

2. On 01/10/18, at 9:00 AM Surveyor #1 interviewed the facility's plant manager (Staff #5) to identify the process for training staff. The manager provided documentation for key staff training but did not have a process in place to ensure all staff were trained.

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Based upon record review and staff interviews on 01/09/18 between 9:00 AM and 1:00 PM, the facility failed to meet the generator requirements for Emergency Preparedness. The facility failed to maintain and test the emergency generator in accordance with NFPA 110.

Failure to maintain and test the emergency generator could result in a failure of the emergency power system which would leave the facility without egress and task lighting during a power failure. This would endanger hospital patients, staff, and visitors within the facility.

Findings included:

Fire marshal reviewed the generator servicing records which revealed the following deficiencies:

1. The generator has not had a 4 continuous hour load test within the last 3 years.
2. Documentation was not provided that the diesel has been tested annually.

The above was discussed and acknowledged by the facility staff.