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Based on observation, interview, and record review, the hospital failed to ensure documents belonging to an unknown number of patients were protected. This failure had the potential to result in a breach of patients protected health information (PHI).

Findings:

During an observation and concurrent interview with the Risk Manager (RM), on 11/6/15, at 2:20 PM, an unknown number of intravenous piggyback (IVPB - a method of infusion used for intravenous medication administration) dated 1/2015, with information labels that included patient name, medical record number, date of birth, name of the medication and date medication provided, were found in the bio-hazardous waste storage. The RM stated, "The labels should be removed before disposal."

The patient information was able to be accessed by anyone entering the bio-hazard storage unit. This group of people would include maintenance staff, bio-hazard waste transport company personnel, or other non-patient care staff.

The Health and Humans Services, Office of Civil Rights document titled "THE HIPAA PRIVACY AND SECURITY RULES ", dated 1996, indicated "Covered entities must implement reasonable safeguards to limit incidental, and avoid prohibited, uses and disclosures of PHI, including in connection with the disposal of such information. Failing to implement reasonable safeguards to protect PHI in connection with disposal could result in impermissible disclosures of PHI. Covered entities are not permitted to simply abandon PHI or dispose of it in dumpsters or other containers that are accessible by unauthorized persons. A covered entity may not dispose of PHI in paper records, labeled prescription bottles.. in dumpsters, recycling bins, garbage cans, or other trash receptacles accessible by unauthorized persons."

Based on observation, interview, and record review, the hospital failed to:

1. Monitor temperatures for intravenous (IV) solutions stored in the hospital warehouse. This had the potential for all patients to receive IV solutions that may have reduced stability, strength, and purity. (refer to A 491, Item 1)

2. Provide pharmaceutical oversight of the storage of IV solutions in the hospital's warehouse. This had the potential to administer deteriorated IV solutions to its patients. (refer to A 491, Item 2)

3. Ensure IV solutions and IV medications were properly labeled per the hospital policy and procedure. This failure had the potential to cause patients to receive the wrong medication, out dated medications, and receive medications that were incomparable and compromised. (refer to A 505)

The cumulative effects of these systematic problems resulted in the failure of the pharmacy services at the hospital to ensure safe practice of medication administration to all patients.

The hospital policy and procedure titled "IV labeling" dated 4/23/14, indicated, "1. All Intravenous (IV) admixture (a product of combining two or more substances) labels will contain the following details: a. Name, location and ID number of patient b. Medication, dosage with frequency, C. diluent (diluting agent) and volume d. Infusion time and/or rate e. special instructions, f. Initials of technician making product an/d pharmacist validating, g. Barcode for product. 2. Stickers are affixed to the IV admixture: a. Beyond use date and time b. warning or caution stickers."

Based on observation and interview, the hospital failed to ensure:

1. Outdated intravenous intravenous (IV) solutions; and,

2. One IV medication for one of 18 sampled patients (10) were not available for patient use.

This failure had the potential to administer compromised medications to its patients.

Findings:

1. A cart with six boxes of IV fluids (some partial boxes) all had an expiration date of 2/2015 stamped in black ink. The Material Management Director (MM) stated "They (IV Fluids) were to be disposed of." The MM did not comment when asked why they had not been disposed of for nine months.

2. During a concurrent observation and interview with Registered Nurse 1 and the Director of Pharmacy on 11/3/15, at 10:35 AM, on the Medical Surgical unit, Patient 10 had IV fluid infusing continuously into an IV site into his right arm. A second bag of fluid, covered with a black plastic bag, was hanging with the end of the tubing piggybacked into a side port of the main IV line. The second bag was a 250 milliliters of IV fluids contained Amphotericin B (a medication used to treat fungal infection and needed to be kept from lights). It was noted there was approximately 100 milliliters of fluids left in it. On the bag, there was a label read, "DO NOT USE BEYOND 1530 (3:30 PM) 110115 (11/01/15)." The IV solution contained Amphotericin B was not to be used after 3:30 PM the day before the observation. RN 1 was asked why the Amphotericin B was still hanging, RN 1 stated she was not sure.