HospitalInspections.org

Based on interview and record review, the nursing staff failed to document the restraint safety checks and monitoring of patient every two hours for one (1) of 31 sampled patients (Patient 11).

This failure had the potential to result in injuries and distress due to restriction which could potentially cause harm to patient and increase the risk of prolonged hospitalization.

Finding:

During a review of Patient 11's "History and Physical" (H&P), dated May 31, 2022, the "H&P' showed, 44-year-old patient with a past medical history significant for developmental delay, hypertension (high blood pressure), hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development), hyperlipidemia (high concentration of fats in the blood), depression, bipolar (characterized by both manic and depressive episodes), and seizure disorder (uncontrolled body movements and changes in behavior), who was originally admitted to [Hospital Name] for altered mentation and hypothermia (abnormally low body temperature).

During a concurrent interview and record review, on September 2, 2022, at 9:50 AM, with Senior Director of Clinical Operation (SDCO), Patient 11's medical record titled "Safety checks and monitoring" was reviewed. There's no documented evidence that Restraint Safety checks and monitoring was done every two (2) hours on the following dates: June 30, 2022, and July 2, 2022. SDCO stated and confirmed, there was no documentation for Restraint Safety checks and monitoring on June 30, 2022, and July 2, 2022. SDCO further stated, restraint is checked every two (2) hours and restraint order is renewed every seven (7) days.

During a review of the facility's policy and procedure (P&P) titled "CORE: Physical Restraints (Violent and Non- Violent Behavior) and Seclusion," dated June 2022, the P&P showed,

"Purpose
This procedure establishes guidelines to utilize the Restraint Freedom Program to reinforce a culture that assesses patients at risk for restraint use, provides tools and strategies, including diversionary activities to prevent restraint use except as a last resort. When these strategies fail, this policy applies to ensure restraints are used safely, for the shortest possible time and discontinued at the earliest opportunity. Physicians, nurses and other members of the health care team are expected to work collaboratively to achieve the goal of making restraint use an uncommon event.

Policy
The policy of [Hospital Name] is to ensure the following:

1. Applying Restraint Procedures in Specific Clinical Situations: ...

2. Guidelines for Determining Which Restraint Procedures Apply to a particular situation - It can be difficult to determine how to apply the restraint standards with patients with cognitive or other impairment, such as Alzheimer's disease ...

3. Competency and Information Requirements ...

4. Physical Restraint Devices: ...

5. Timeframes for Restraint Orders and Use (PRN orders) ...

6. Clinical/Nursing Staff and Physician/Licensed Practitioner (LP)/Allied Health Practitioner (AHP) Responsibilities: ...

a. Physician/LP/AHP Responsibilities ...
b. Clinical/Nursing Staff Responsibilities - A Registered Nurse (RN) will perform assessment/reassessment at established intervals and as needed, obtain physician orders, facilitate communication and document assessments in the patient's medical record according to policy. Assessment and re-assessment of the patient occurs at appropriate interval(s): at admission, during the restraint episode, and after the restraint episode, including significant changes in the patient's condition that warranted restraint use. Direct care staff who have been educated regarding restraint use and have demonstrated competency may apply restraints under the supervision of an RN according to this policy ..."

Based on interview, and record review, the facility failed to ensure the formulary (approved list of medications the hospital stocks) drug rifaximin (antibiotic) 550 milligrams (mg - unit of measurement for dose) was readily available for dispensing from the pharmacy and/or administration resulting in two medication omissions (drug not administered because pharmacy did not obtain it to treat the patient) and the potential for inaccurate dosing for one of 31 sampled patients (Patient 13).

This failure had the potential to cause adverse health outcomes, incomplete treatment, longer drug course, and preventable medication errors which could negatively affect the patient's health and safety due to lack of safe and timely medication administration and lead to prolonged hospitalization and/or death.

Findings:

A review of Patient 13's "History and Physical (H&P)," dated June 22, 2022, showed, Patient 13 was admitted into the facility with diagnoses including respiratory failure (serious condition of difficulty breathing on one's own), tracheostomy on vent (tube inserted into the windpipe connected to a machine to help with breathing), hypertension (elevated blood pressure), renal failure (kidney failure), cirrhosis of the liver (liver damage), multiple wounds sites, dysphagia (difficulty swallowing), a generalized muscle wasting.

During a concurrent interview and record review, on September 1, 2022, at 10:16 AM, in the conference room, with the Staff Pharmacist (SP 1), Patient 13's medication order and "Medication Administration Record (MAR)," for rifaximin, dated June 22, 2022, through August 20, 2022, were reviewed. The rifaximin medication order and MAR showed as follows:

Rifaximin: per feeding tube tab, 550 mg, Start June 22, 2022, 10:00 AM, every 12 hours. Dose: Rifaximin 550 mg = 2.75 tablets. Order discontinued on July 13,2022 at 4:24 PM.

Rifaximin: per feeding tube tab, 200 mg, 600 mg = 3 tablets. Start July 13,2022, at 10:00 PM, every 12 hours. Order discontinued on July 19, 2022, at 10:12 PM.

Rifaximin: per feeding tube tab, 550 mg, Start July 20, 2022, at 10:00 AM, every 12 hours. Dose: Rifaximin 550 mg = 1 tablet. Order discontinued on July 20, 2022, at 8:04 PM.

Rifaximin: per nasogastric tube (feeding tube), tab, 600 mg. 3x 200 mg = 600 mg. Start on July 20, 2022, at 10:00 PM, every 12 hours. Dose: Rifaximin 600 mg = 3 tablets. Order discontinued on July 22, 2022, at 7:19 PM.

Rifaximin: per feeding tube tab, 550 mg, re-enter order started on July 20, 2022, to August 20, 2022, x 30-days treatment. Start July 22, 2022, at 10:00 PM, every 12 hours, stop August 20, 2022, at 11:00 PM, not renewable. Dose: rifaximin 550 mg = 1 tablet.

SP 1 verified and confirmed medication orders and MAR shown above. SP 1 stated, the pharmacy did not have rifaximin 550 mg in stock. The pharmacy only had rifaximin 200 mg in stock, so the order was changed multiple times. SP 1 further stated, 2.75 tablets indicates that the nurse would cut a 200 mg tablet into three fourths.

During a concurrent interview and record review, on September 1, 2022, at 10:16 AM, in the conference room, with the Staff Pharmacist (SP 1), Patient 13's "Medication Administration Record (MAR)," for rifaximin, dated July 19, 2022, through July 20, 2022, were reviewed. The MAR showed as follows:

July 19, 2022, at 10:46 PM, order not done, order to pharmacy.
July 20, 2022, at 3:57 PM, not done, ordered from pharmacy, not available.
SP 1 verified and confirmed that two doses were missed due to rifaximin 550 mg not in stock.

During a concurrent interview and record review, on September 1, 2022, at 10:16 AM, in the conference room, with the Staff Pharmacist (SP 1), the facility's, "Formulary," print date September 1, 2022, was reviewed. The Formulary showed as follows:

Rifaximin 550 mg tablet.

SP 1 verified and confirmed that rifaximin 550 mg tablet was on the facility formulary, meaning it should be in stock and available for administration.

During a concurrent observation and interview, on September 1, 2022, at 1:30 PM, in the pharmacy, with the Senior Director of Pharmacy Operations (SDPO), observations made were as follows:

Rifaximin 200 mg in stock.
Rifaximin 550 mg in stock.

SDPO stated, you cannot get an accurate dose when cutting a 200 mg tablet into three fourths. SDPO further stated, rifaximin 550 mg is on the formulary and should be in stock.

A review of the facility's policies and procedures (P&P) titled, "Core: Medication Formulary," release date June 2019, showed as follows:

"Purpose
This policy establishes processes for establishing and maintaining the hospital medication formulary and the corporate medication formulary ...
Policy
The policy of ... is to ensure the following:
1. Hospital Mediation Formulary
a. Development and Maintenance
i. Each facility, working via PNT (Pharmacy Nutrition and Therapeutics), will establish a hospital medication formulary. The hospital medication formulary will be approved, implemented, maintained and reviewed by PNT and approved by the Medical Staff of each ... hospital. The hospital medication formulary will be readily available to the professional staff. The corporate mediation formulary should be the basis for developing and maintaining the hospital medication formulary.
ii. The hospital medication formulary may be more restrictive than the corporate medication formulary ..."