HospitalInspections.org

Based on observation, document review, and staff interview conducted on 9/10/15, it was determined that the facility failed to ensure that pharmaceutical services are provided in a safe manner.

Findings include:

1. The facility failed to ensure that single-dose vials are discarded after use. Refer to Tag 0491.

2. The facility failed to ensure that multi-dose vials accessed in an immediate patient care area are discarded after use. Refer to Tag 0491.

3. The facility failed to ensure that syringes prepared from single-dose vials are discarded after 1 hour. Refer to Tag 0491.

4. The facility failed to ensure that sterile products are prepared in a suitable environment. Refer to Tag 0500.

5. The facility failed to ensure that compounding is conducted by a registered pharmacist or under the supervision of a registered pharmacist, in a suitable environment. Refer to Tag 0501.

A. Based on observation, document review, and staff interview conducted on 9/10/15, it was determined that the facility failed to ensure implementation of policies and procedures addressing the use of single-dose and multi-dose vials.

Findings include:

Reference: Facility policy MU301, titled "Multidose and Single Dose Containers," states, "Procedure:..2. Any unused portion of sterile medication in ampules, vials, bags, or irrigation containers labeled for one-time use shall be discarded promptly after single use...5. Multidose vials should be dedicated to a single patient whenever possible. If multidose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area. If a multidose vial enters the immediate patient treatment area it should be dedicated to that patient only and discarded after use. Examples of the immediate patient treatment area include..operating rooms."

1. At 12:00 Noon, an opened single-dose vial of Atropine was found in the Anesthesia Pyxis located in Operating Room (OR) #7.

2. At 12:00 Noon, opened multi-dose vials of Xylocaine 2% and Neostigmine were found in the Anesthesia Pyxis located in OR #7.

3. At 11:50 AM, an opened multi-dose vial of Neostigmine was found in the Anesthesia Pyxis in OR #4.

a. Upon interview, Staff #5 stated that he/she would used the vial again, but wipe the top with alcohol before entering it with a new needle and syringe.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 9/10/15, the day of survey, upon receipt of an acceptable plan of correction.

B. Based on observation, document review, and staff interview conducted on 9/10/15, it was determined that the facility failed to ensure that medications accessed from a single-dose container are used within 1 hour of preparation.

Findings include:

Reference #1: United States Pharmacopoeia Chapter 797 (USP 797) states, "opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CPSs [compounded sterile products] shall be used within 1 hour if opened in worse that ISO (International Organization for Standardization) Class 5 air quality and any remaining contents must be discarded."

Reference #2: Facility policy MU181, titled "Medication Labeling," states, "Procedure: At a minimum, all medications prepared in the hospital by all personnel are labeled with the following when not used immediately:..Drug name, strength, and amount (if not apparent from the container. Expiration date (use by) of (1) day when not used immediately. Container should be labeled with day of preparation."

1. Facility policy MU181 allows for an expiration of 24 hours for syringes prepared from a single-dose vial. This is not in compliance with USP 797 referenced above.

2. Staff #5 was observed preparing syringes of medications in OR #4 at approximately 12:30 PM. He/she stated that all medications, including medications from single-dose vials, were given a 24 hour expiration, with the exception of propofol, which was given a 6 hour expiration.

a. This finding was confirmed by Staff #4 and #6.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 9/10/15, the day of survey, upon receipt of an acceptable plan of correction.

Based on observation and staff interview conducted on 9/10/15, it was determined that the facility failed to ensure that sterile products are prepared in a suitable environment.

Findings include:

Reference: Centers for Disease Control (CDC) website http://www.cdc.gov/injection safety/providers/provider_faqs_med-prep.html, Medication Preparation Questions, states, "Where should I draw up medications? Medications should be drawn up in a designated clean medication area that is not adjacent to areas where potentially contaminated items are placed. Examples of contaminated items that should not be placed in or near the medication preparation area include: used equipment such as syringes, needles, IV tubing, blood collection tubes, needle holders (e.g., Vacutainer® holder), or other soiled equipment or materials that have been used in a procedure. In general, any item that could have come in contact with blood or body fluids should not be in the medication preparation area."

1. At 11:50 AM, Staff #5 was observed preparing syringes of medication in OR #4 while the room was being cleaned. Upon interview he/she stated that he/she was preparing medication for the next case. Upon interview, he/she stated that he/she would sometimes prepare medications for the next case while a patient was still in the OR and place the syringes back in the Anesthesia Pyxis.

a. An operating room that is being cleaned is not a suitable area for the preparation of medication, as there is potential for contamination from the dirty environment.

b. Medications for one patient cannot be prepared while another patient is in the operating room, as this is an immediate patient care area and there is potential for contamination.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 9/10/15, the day of survey, upon receipt of an acceptable plan of correction.

Based on observation, document review, and staff interview conducted on 9/10/15, it was determined that the facility failed to ensure that all compounding is conducted by a registered pharmacist or under the supervision of a registered pharmacist.

Findings include:

Reference #1: Facility policy MU 185, titled "Intravenous Admixture Distribution," states, "Policy: Sterile parenteral IV medications (except for base solutions) will be prepared, labeled and distributed by the Department of Pharmacy Services except in urgent situations where a delay could harm the patient or when the product's stability is short."

Reference #2: Facility policy MU 181, titled "Medication Labeling," states, "Procedure: At a minimum, all medications prepared in the hospital by all personnel are labeled with the following when not used immediately:..Drug name, strength, and amount (if not apparent from the container. Expiration date (use by) of (1) day when not used immediately. Container should be labeled with day of preparation."

Reference #3: USP 797 (United States Pharmacopoeia Chapter 797) states, "The Immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP (Compounded Sterile Product)... Immediate-use CSPs are except from the requirements described for Low-Risk Level CSPs only when all of the following criteria are met:...4. Administration begins not later than 1 hour following the start of the preparation of the CSP...6. If administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly and safely discarded." Compounding in worse than ISO Class 5 conditions increases the likelihood of microbial contamination, and administration durations of microbially contaminated CSPs exceeding a few hours increase the potential for clinically significant microbial colonization and thus for patient harm..."

1. During a tour of the Operating Room (OR) Suite, a 250ml bag of 0.9% Sodium Chloride for Injection, labeled "Phenylephrine 9/11/15 time 7, [Staff initials]" was found in the anesthesia cart in OR #7 and a 250ml bag of 0.9% Sodium Chloride for Injection, labeled "Phenylephrine 9/10/15 time 7 [Staff initials]" was found in the anesthesia cart in OR #11.

a. Upon interview, Staff #4 stated that this medication is prepared at the beginning of the surgical day by a member of the anesthesia department and given a 24 hour expiration. He/she stated that it is prepared "in case" it is needed in an emergent situation.

2. This practice is not in compliance with Facility Policy MU185 and USP 797, referenced above.

3. Facility Policy MU 181 is not in compliance with USP 797, referenced above. Products compounded outside of ISO Class 5 environment should not be stored for up to 24 hours prior to use.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 9/10/15, the day of survey, upon receipt of an acceptable plan of correction.