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Based on interview and record review, the hospital failed to ensure that one patient was administered their insulin medication according to the order of their practitioner. This failure increased the risk for the patient to have elevated blood sugar levels which could lead to patient harm.

Findings:

During a review of the clinical record for Patient 1 on September 1, 2015, at 9:45 AM, the patient was noted to have an order for insulin (Lispro - a medication used to reduce sugar level in the blood), per sliding scale (a dosing scale used to determine the dose of insulin medication to be given based on the patient's blood sugar level), every 6 hours subcutaneously (beneath the skin). Order details included "Administer within 15 minutes before a meal." The blood sugar result on September 1, 2015, at 6:15 AM, was recorded to be 181. The sliding scale indicated 1 unit of insulin should be given for a blood sugar result between 151-200. The Medication Administration Record (MAR) for September 1, 2015, was reviewed, and it was found the 5th Floor night shift Regisitered Nurse (RN 1) documented at 6:22 AM, the insulin Lispro as "Not given - Not appropriate".

During a concurrent interview with the 5th Floor day shift Registered Nurse (RN 2 - who relieved RN 1 from duty), and the Director of Medical/Surgical/Telemetry (Med/Surg/Tele) Units, when RN 2 was asked whether she had given any insulin. She responded by stating, "No, it wasn't scheduled during my shift." When asked whether the patient had received a meal, she stated, "Yes." The Director of the Med/Surg/Tele Units stated, "Because the patient did not have a meal, the nurse wanted to hold the insulin to avoid a low blood sugar." When she was asked what her expectation would be to ensure the patient received their medication, she stated, "I would expect RN 2 to repeat the fingerstick (blood sugar check)."

Further review of the clinical record revealed a follow-up blood sugar check was not done, and documentation indicated the patient ate 100% of the breakfast meal.

A review of the hospital's policy & procedure, titled "Medications - Standardized Time Schedule - policy number 8720.0293, effective date 3/91, revised date 3/12, Definitions 2.0" indicated the following:

"Time-critical scheduled medications: are those where early or delayed administration of maintenance doses of greater than 30 minutes before or after the scheduled dose may cause harm or result in substantial suboptimal therapy or pharmacologic effect...It is the responsibility of all clinical staff authorized to administer medications to administer scheduled medications in the time frames set forth in this policy...Oral/Topical/Subcutaneous medication standard administration times are as follows: before (AC) meals - 0730, 1130, and 1630".

Further review of the MAR confirms that no insulin doses were given from 6:00 AM to 10:00 AM, on September 1, 2015, despite a meal having been provided and eaten by the patient.

Based on observation, interview, and document review, the hospital failed to store three different medications in accordance with manufacturer's directions. This failure had the potential to expose patients that require antibiotics (medications to treat infections), anesthesia (reduction in pain), or have chest pain due to heart disease, to medications that may not have the same potency, or integrity intended by the manufacturer, if stored under proper conditions. Medications not stored under proper conditions may not provide the desired effect which can lead to patient harm.

Findings:

During a tour of the Pharmacy Department on August 31, 2015, at 9:30 AM, the following medications were observed to be stored on shelves in the pharmacy medication storage area, immediately available for patient use:

-Four (4) vials of Lidocaine (a medication used to numb an area of the body from pain) 1% Epinephrine (a medication used to constrict blood vessels) 1:100,000, 30 milliliter (mL) were observed to be stored on the pharmacy shelf, exposed to light.

-One (1) clear plastic container of Trimethoprim sulfate (an antibiotic) and Polymyxin B sulfate (an antibiotic) 10mL ophthalmic (eye) solution, were observed stored on the pharmacy shelf, exposed to light.


During a tour on August 31, 2015, at 2:55 PM, in the Intensive Care Unit (ICU), the following medication was observed to be stored in the Omnicell dispensing cabinet (an automated pharmacy storage machine) available for patient use:


-Three (3) clear glass bottles, 250 milliliters (mL) of Nitroglycerin (a medication used for abnormal heart rhythm) 50 milligram (mg) in a 5% Dextrose solution (a sugar solution used for mixing other medications to give through the vein) were observed on the Omnicell storage shelf, exposed to light.


During a review of the manufacturer's (Hospira Inc.) 2015 package insert (a document providing detailed information about the medication), the storage requirements for Lidocaine/Epinephrine indicate to "...Protect from light."

During a review of the manufacturer's (Akom Inc.) 2015 package insert, the storage requirements for the eye ointment Trimethoprim sulfate/Polymyxin B sulfate, indicate to "...Protect from light."

During a review of the manufacturer's (Baxter Pharmaceuticals), 2015 package insert, the storage requirements for Nitroglycerin, indicate to "Protect from light until time of use."

During a concurrent interview in the pharmacy storage area, the Director of Pharmacy acknowledged that the Lidocaine/Epinephrine and Trimethoprim/Polymyxin B medications were exposed to light and should have been placed in their respective boxes or light protective containers.

During a concurrent interview in ICU 1, the ICU/Emergency Department (ED) Manager was asked whether the Nitroglycerin was exposed to light while in the Omnicell machine. She responded, "Yes." The Director of Pharmacy also acknowledged the medication was exposed to light and should have been kept in light protective plastic pouches.

A review of the hospital policy & procedure titled, "Safe Storage of Medications" - Policy No. 8390.222 with an effective date of "6/74", and a revised date of "1/15" indicated "... Medications will be stored under appropriate conditions to maintain medication integrity... All medications will be stored in accordance with all applicable laws and regulations and manufacturer's guidelines."

Based on observation, interview, and document review, the facility failed to ensure that two, unusable medications, were not available for patient use, by removing them from the active, and available medication storage area shelves. This failure had the potential to expose patients who may require hydration (need more water in their body) and cardiovascular (human body system involving the heart and lungs) treatment to medications that may not have the same potency, integrity, or sterility intended by the manufacturer. Due to medications being used past their expiration date they may not provide the desired effect and the used injectable medications may have been exposed to microbial (organisms such as bacteria) growth, which can lead to patient harm.

Findings:

1. During a tour on August 31, 2015, at 2:18 PM, on the 5th floor nursing unit, in the medication room, the following medication was identified to have been unusable, on the pharmacy storage shelves:

-One 1000 milliliter (mL) injectable bag (to have the ability to inject medication through a portal with a syringe), manufactured by B. Braun Medical Inc., containing Lactated Ringer's (a fluid used for improving hydration in a patient) without the manufacturer's protective outer plastic wrap.

Upon removal from the protective outer wrap, the medication degrades and must be used during a period of time determined by the manufacturer. In a letter dated February 28, 2014, provided by the hospital and addressed to hospital management, B. Braun states, "The EXCEL 250 mL, 500 mL and 1000 mL size containers, without any additions, can be stored at 25°C (degree centigrade) for one month without its plastic overwrap...".

During a concurrent interview, the Pharmacy Manager acknowledged the injectable bag did not have the date indicating when the protective outer wrap was removed, and it could not be determined if the medication was within the manufacturer's expiration date.

The facility's policy and procedure titled "Outdated Drug Control" undated, indicated:

"The Department of Pharmacy will ensure that no outdated medications are dispensed for patient use or allowed to remain in the dispensing area of the pharmacy, or in a patient care area of the hospital."

2. During an observation on August 31, 2015, at 2:55 PM, in the Intensive Care (ICU) nursing unit, the medication storage refrigerator was inspected, and a vial of Diltiazem (a medication used to reduce blood pressure) 25 milligram (mg) in 5 milliliters (mL) solution for injection, labeled as "Single dose flip-top vial", was found opened and used. There was no patient specific labeling, or dating to indicate when the vial was opened. The Director of Pharmacy confirmed the single dose vial had been opened, partially used, and that there was no date indicated when the vial had been opened.

Review of the hospital's policy and procedure, titled "Multiple Dose Vials", policy number 8390.208, with an effective date of "2/88" and revised "1/15" indicated " ... SDV (single dose vial) is discarded after single use and should never be returned to stock...Open SDVs will not be stored for later use."

Review of the manufacturer's package insert (detailed information from the manufacturer regarding the medication), indicated "... Discard unused portion."

The Centers for Disease Control and Prevention (CDC - a federal agency with a main goal to protect public health and safety through the control and prevention of disease, injury, and disability) under it's "Injection Safety Statement" titled "Protect Patients Against Preventable Harm from Improper Use of Single-Dose/Single-Use Vials" indicates, "A large single-dose/single-use vial may appear to contain adequate drug to treat more than one patient. However, single-dose/single-use vials typically lack antimicrobial preservative and can become contaminated and serve as a source of infection when they are used inappropriately. Therefore, they should only be used for a single patient and a single procedure."