HospitalInspections.org

Based on observations, interviews and document reviews the hospital failed to administer medications in accordance with accepted standards of practice as evidence by:

1. Licensed Nurse (LN) 7, subcutaneously (under the skin) injected Enoxaparin without cleaning the injection site with an antiseptic pad for 1 of 1 patients, (Patient 18).

2. LN 7, did not wait for the antiseptic (disinfectant that slows down or prevents the growth of germs) to dry prior to administering subcutaneous Enoxaparin for 1 of 1 patients, (Patient 18).

These failures potentially exposed patients to adverse drug reactions.

Findings:

1. During an observation on 07/06/16 at 9:09 a.m., LN 7 administered a subcutaneous injection of Enoxaparin to Patient 18. She wiped with an antiseptic pad on the left lower abdomen and wiped in a straight line right to left. She then injected the Enoxaparin outside of the area that was wiped with the antiseptic pad. She injected in an area that had not been cleaned by the antiseptic pad.

During an interview on 07/06/16 at 11:00 a.m., Pharmacist 2 stated that the nurses at the hospital utilized the online version of Lippincott Procedures as a standard of practice when the hospital policy did not address a nursing practice.

A review on 07/05/16 of the online Lippincott Procedures for subcutaneous injections indicated "Subcutaneous injections...For subcutaneous injections...Clean the injection site with an antiseptic pad, beginning at the center of the site and moving outward in a circular motion..."

2. During an observation on 07/06/16 at 9:09 a.m. to Patient 18, LN 7 administered a subcutaneous injection of Enoxaparin. She wiped with an antiseptic pad and then immediately administered the subcutaneous Enoxaparin. She did not wait for the antiseptic to dry.

During an interview on 07/06/16 at 11:00 a.m., LN 7 stated that she did not wait for the antiseptic to dry prior to administering the Enoxaparin. She did not follow the Lippincott standard of practice for administering a subcutaneous injection.

A review on 07/05/16 of the online Lippincott Procedures for subcutaneous injections indicated "Subcutaneous injections...For subcutaneous injections...Clean the injection site with an antiseptic pad...Allow the skin to dry before injecting the drug to avoid a stinging sensation caused by introducing antiseptic into the subcutaneous tissue..."

Based on observation, interview and document review the hospital failed to maintain their emergency medication supply in accordance with standards of practice when the hospital's malignant hyperthermia (MH) cart (portable vehicle used to transport emergency supplies used when patients have a potentially fatal reaction to an anesthetic drug, [a medication used to abolish the sensation of pain]) did not have insulin readily available in case of an emergency. This failure had the potential to delay the response to administer insulin for patients during an MH emergency.

Findings:

During an observation on 07/05/16 at 3:02 p.m. in the Birthing Center (BC) operating room (OR), the MH cart indicated the regular insulin was located in the refrigerator. When checking the BC OR refrigerator, there was no regular insulin inside the refrigerator.

During an observation on 07/05/16 at 3:33 p.m. in the main OR, the MH cart indicated the regular insulin was located in the refrigerator. When checking the OR refrigerator there was no regular insulin inside of it.

During an interview on 07/05/16 at 3:23 p.m., Pharmacist 1 stated the regular insulin should be in the refrigerator. He also said he did not know why there was no regular insulin readily available in case of an emergency.

A review on 07/05/16 of the un-dated hospital policy entitled Protocol for Management of Malignant Hyperthermia indicated "Malignant Hyperthermia (MH): Is an uncommon, life-threatening hypermetabolic [heat production by the body above normal] disorder of skeletal muscles, triggered in susceptible individuals by inhalation [breathing in] anesthetics or the muscle relaxant succinylcholine...A MH cart shall be readily available for use by departments where inhalation anesthesia is administered...Hyperkalemia [abnormally high levels of potassium in the blood] is common and should be treated with...insulin...[contents of MH cart] Regular Insulin 100 units/ml."

Based on observation, interview, and document review the hospital failed to keep compromised medications (drugs that are no longer effective) unavailable for patient use as evidenced by:

1. The hospital staff did not store medications that should be protected from light appropriately when nitroglycerin injection (medication used for blood pressure and heart problems) was stored on shelves in direct light.

2. The hospital pharmacy staff did not have a documented expiration date and preparation date on a medication label for a 1 liter intravenous fluid bag of multivitamins.

These failures had the potential for the use of compromised and expired medications for patient use.

Findings:

1. During an observation on 07/05/16 at 9:39 a.m. in the pharmacy, multiple bottles of nitroglycerin injection were found under direct light. The nitroglycerin bottles were not covered and were found on the open shelf under direct light. The label indicated, "Protect from light."

During an interview on 07/05/16 at 9:39 a.m., Pharmacist 1 stated, "That's how we usually store our nitroglycerin."

During an interview on 07/05/16 at 10 a.m., Pharmacist 1 stated he called the manufacturer and the manufacturer recommended that nitroglycerin should be protected from light. He acknowledged that the nitroglycerin was compromised.

A review on 07/05/16 of the manufacturer inserts (guidelines from drug manufacturers on how to safely use their products) for nitroglycerin indicated "protect from light".

A review on 07/05/16 of the un-dated hospital policy titled, "Medication Management-Storage of Medications" indicated "Medications that are light sensitive will be stored in a protective wrapping cover or otherwise protected from light. These medications will also be labeled with an alert to staff to protect the medication from light."


2. During an observation on 07/05/16 at 10:23 a.m., in the medical unit medication room refrigerator, there was a 1 liter intravenous fluid bag of multivitamins that was available for patient use. The label on the bag did not have an expiration date or a preparation date.

During an interview on 07/05/16 at 10:23 a.m., Pharmacist 1 stated the expiration and preparation date should be on the label. He also stated he did not know why it was not on the label.

The hospital's undated policy titled, "Intraveneous Admixture Service, Pharmaceutical Services," indicated, "D. A label will be prepared for each I.V. admixture/parenteral pharmaceutical with the following information: i. Expiration date and time (beyond use). j. Preparation date and time..."

Based on observation, interview, and document review the hospital failed to ensure effective food and nutrition service systems to prevent foodborne illness. Failure to ensure implementation of effective food handling procedures may result in unsafe food handling practices, placing all inpatients at risk for foodborne illness, further compromising their medical and nutritional status.

Findings:

1. On 7/5/16 at 10:50 a.m. during kitchen observations with Dietary Manager (DM):
a. In the dry storage area, a plastic tub of rice was not labeled with either its contents or a received date. The DM stated it was parboiled (partially boiled in the husk) rice.

b. In the reach-in freezer located in the dry storage area, five sealed brown bags with no label of contents or received dates. The DM stated the bags contained hash brown potatoes.

c. In the reach-in freezer located in the dry storage area, three rolls of ground meat with no label of contents or received dates. The DM stated the meat was beef.

d. In the reach-in freezer located in the kitchen, a container of a green substance dated 5/26/16. The DM stated the substance was pesto (a sauce made with basil, garlic, and olive oil).

e. In a bulk plastic storage bin located in the food preparation area, a white powdery substance was found with no label or date. The DM stated the item was flour.

f. In the cafe/grill, five individually packaged "Rice Krispie Treats" and six individually packaged "Real Medley's" cereal bars were found with no expiration date.

During a concurrent interview, the DM stated these items should have been labeled with contents, date of receipt and expiration or use by date.

A review of the hospital policy (undated) titled, "Nutritional Services Competency Labeling and Dating indicated, "3. Label all food that has arrived to the facility with the arrival date. 4. Label all product that has been removed from the master container, ensuring that the date is transferred from the master container to individual products. 8. If the manufacturer's use by date is not visible on the product container, place a label with an appropriate use by date on the product. 9. Label all bulk food storage containers."

A review of the hospital policy dated 11/17/15 titled, "Materials Handling, Food Storage," indicated "F.7. Food being removed from original container shall be labeled with the product name on the container into which the food is transferred."

According to the Food and Drug Administration (FDA) Federal Food Code 2013 (Food Code), the standard of food safety practice for the food service industry:
"Section 3-602.11 Food Labels.
(A) FOOD PACKAGED in a FOOD ESTABLISHMENT, shall be labeled as specified in LAW, including 21 CFR 101 - Food labeling, and 9 CFR 317 Labeling, marking devices, and containers.
(B) Label information shall include:
(1) The common name of the FOOD, or absent a common name, an adequately descriptive identity statement; and
Section 3-302.12 Food Storage Containers, Identified with Common Name of Food. Certain foods may be difficult to identify after they are removed from their original packaging. Consumers may be allergic to certain foods or ingredients. The mistaken use of an ingredient, when the consumer has specifically requested that it not be used, may result in severe medical consequences."

2. On 7/5/16 at 10:50 a.m. during kitchen observations with the DM, the coffee dispenser contained two bags of concentrated coffee. The bags did not have a label indicating when they were opened. The DM stated they should have been labeled when they were removed from the freezer and again when placed in the dispenser.

A review of hospital policy (undated) titled, "Nutritional Services Competency Labeling and Dating," indicated "7. Use the manufacturer's use by date placed on an unopened container of food until the container is opened and then label the container appropriately. 8. Place a label on any item removed from the freezer that is to be thawed."

According to the manufacturer, the frozen product should be thawed in the refrigerator for 48-hours and once placed in the dispenser, the product is good for six days.

3. On 7/5/16 at 10:50 a.m. during kitchen observations with the DM, three bulk storage containers were lined with plastic bags. The DM stated they were "trash liners" and he obtained them from the housekeeping department. He stated he did not know if they were approved for food contact use.

Upon request, the hospital did not show the surveyor the box the liners came in. In addition, a copy of an invoice indicating the liner specifications was not provided.

According to Sectopm 4-102.11 of the Food Code, items that come into direct contact with food must be made of acceptable materials and used for their intended purpose. The intended purpose of the trash liners was for garbage and refuse storage, not food storage. Because it touches the food, packaging is considered an indirect additive. Chemicals in packaging can migrate into the food.

According to the FDA, the regulatory authority that approves food packaging materials (materials that come into direct contact with food), "Any material intended for use in food packaging (food storage) must be formulated in compliance with FDA requirements for its intended use under the Federal Food, Drug and Cosmetic Act."

4. On 7/5/16 at 10:50 a.m. during kitchen observations with the DM, 1 bag of hoagie rolls (bread) dated 6/22/16 was co-mingled with bread dated 6/30/16. The DM stated bread was good for seven days, and the rolls should have been discarded.

A review of the hospital document dated 4/2016 entitled "Nutritional Services Guidelines for Food Storage" indicated, "Bagels [bread] from freezer good for 7 days from the freezer."

A review of the undated hospital document titled, "Nutritional Services Competency Labeling and Dating," indicated, "2. At the beginning of the shift, check your area and remove/discard all food from storage that is held beyond the use by date."

5. On 7/5/16 at 10:50 a.m. during cafe/grill observations with the DM, a beverage refrigerator labeled "Aquafina" did not contain a thermometer. The DM stated all the refrigerators should have a thermometer in them.

A review of the hospital policy dated 11/17/15 titled, "Materials Handling, Food Storage," indicated "8. Refrigerated foods shall be maintained at 40 degrees Fahrenheit (F, a measure of temperature) or below, frozen foods at 0 degrees Fahrenheit or below."

According to the Food Code Section 4-204.112, all refrigeration units must be equipped with at least one temperature measuring device.

6. On 7/5/16 at 11:55 a.m. during kitchen observations, Dietary Aide 1 was asked to demonstrate how to make and test the chemical used to sanitize (make free from dirt and germs) work surfaces. Dietary Aide 1 used a red bucket to obtain a quaternary ammonium solution (product used to sanitize surfaces) from a pre-mixing dispenser located in the mop/chemical storage room. The temperature of the solution was 97 degrees F. She stated that was the correct temperature to use, since it was dispensed directly from the dispensing unit and was set-up by the chemical supplier. She further stated that she never took the temperature of the solution.

Review of the quaternary ammonium label for the chemical test strips indicated, "Testing solution should be between 65-75 degrees F. Follow Manufacturer's dilution instructions carefully."

A review of the hospital document dated 5/26/16 titled "Nutritional Services Competency Utensil Cleaning and Sanitizing," indicated "1. All equipment and utensils shall be cleaned and sanitized according to the manufacturer's recommendations." The document further indicated Dietary Aide 1 and DM confirmed she was competent in the policy and procedure.

A review of hospital policy dated 3/24/16 titled, "Sanitation of Work Areas and Equipment," indicated "A. Sanitation 1. All kitchens and food contact areas shall be kept clean and sanitized using food-contact safe facility-approved sanitizing solutions. The use of quaternary or chlorine sanitizer shall be per manufacturer guidelines with documentation for assurance of sufficient concentration."

7. On 7/5/16 at 2:05 p.m. during observation of the Med-Surg (Medical-Surgical) Unit Nourishment room (pantry) with Nutrition Services Manager (NSM):
a. Juices stored in the back of the refrigerator had older dates than items stored in the front. NSM stated the older items should be stored in the front, to make sure they were used first and stock was rotated.

b. Two storage bags of individually wrapped crackers, one bag of individually wrapped graham crackers and two storage bags of individually packaged peanut butter had no dates (either when they were placed in the room or when they should be used by). NSM stated the bags should have been date labeled.

c. Two containers of coffee concentrate in a coffee dispensing machine were labeled, "Use by 7/1/16". NSM stated the room was checked and restocked twice a day by assigned dietary staff. Once in the morning and again in the afternoon. She stated the coffee concentrate should have been replaced. She stated she had not verified the assigned staff were completing their assignments according to policy.

d. Two individually portioned boxes of cornflakes cereal with a manufacturer's expiration date of 4/17/16. NSM stated the hospital didn't use this product any more, and they should have been discarded.

A subsequent observation of the Birthing Center pantry later that same day at 2:35 p.m., revealed the same concerns noted in the Med-Surg pantry.

Review of the hospital policy dated 4/15/16 titled "Unit Supplies at Nursing Station," indicated "B. Procedure: 3. It is the responsibility of Nutritional Services to keep unit food supplies properly rotated and in a clean, sanitary condition."

Review of the hospital policy dated 11/17/15 entitled "Materials Handling, Food Storage" indicated, "F. 14. Food items from Nutrition Services that are stored in refrigerators located in nursing units will be labeled with an expiration date." The policy did not indicate what should be done with food items not stored in the refrigerator.