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This condition is not met as evidenced by:

Based on observation, a review of hospital documentation, contracted service reports, hospital committee meeting minutes, e-mail communications, interviews and policies, it was determined that the hospital did not meet the Condition of Participation for Pharmaceutical Services by failing to:

1. Ensure the ISO-classified IV room was recertified following HEPA filter replacements at the bank of the HVAC unit and cleaning of the duct work. Please refer to A-492

2. Ensure that medications administered were not expired. Please refer to A-505

Based on observation, a review of hospital documentation, contracted service reports, hospital committee meeting minutes, e-mail communications, interviews and policies, the hospital failed to ensure that the IV room, where sterile products are compounded, was recertified following HEPA filter replacements at the bank of the HVAC unit and cleaning of the duct work. The finding includes:

A review of the monthly pharmacy surface and air sampling results was conducted on 12/1/17 with the Director of Pharmacy. Monthly surface samples dated 7/25/17 to 10/26/17 identified no growth in all sampled areas in the ante, non-hazardous and hazardous rooms within the main pharmacy.

The air samplings taken on 7/25/17 indicated no growth.

Air samplings taken on 8/9/17 indicated non-actionable bacterial growth within the ante and hazardous room (hazardous room not in use).

Air samplings taken on 9/8/17 indicated non-actionable bacterial growth within the ante room.

Air samplings taken on 9/28/17 identified one (1) colony of non-sporulating fungi in the ante room, one (1) colony of fungus in the hazardous room (not in use), and non-actionable levels of bacterial growth.

Air samples dated 10/26/17 noted 3 colonies of bacteria (non-actionable) in the ante room.

The Hospital remediation plan dated 11/14/17 identified, in part, that in an effort to address environmental results within the ISO-classified areas, the HVAC (air handling unit to ISO-classified areas) HEPA filter will be changed, duct work will be cleaned, and cleaning of the environment will be performed on 11/20/17.

Interview with the Director of Pharmacy Services on 12/1/17 at 10:10 AM noted that the decision to replace the HEPA filter was a proactive response to decreasing airflow velocity from 9/28/17 testing and the recent upward trend of air sampling results in the pharmacy as previously described. The Director further indicated that compounding of low and medium risk preparations resumed on 11/21/17 at 5:00 AM. The Director of Pharmacy identified that although he discussed a plan to be proactive with a representative from the Department of Consumer Protection (DCP), changing of the HEPA filters outside of the ISO classified areas was not discussed.

Review of hospital email correspondence to DCP dated 11/29/17 and interview with the Director of Pharmacy on 12/1/17 at 10:10 AM identified that once drug control was made aware that the HEPA filter was changed at the HVAC system and duct cleaning was performed, it was determined that the pharmacy failed to ensure that the ISO-classified areas were recertified following the remediation activities on 11/20/17, could not support medium-risk compounding and needed to initiate a 12 hour beyond use date (BUD) for all low-risk compounding products. The Director further indicated that compounded products made from 11/21/17 to 11/29/17 had to be destroyed and air and surface samples of the ISO-classified areas were performed on 11/22/17 at the direction of DCP. The Director further stated that the compounding areas needed to be recertified and the 12 hour BUD would continue for the low risk compounded products without compounding of medium risk products until the recertification scheduled for 12/9/17 and clearance by the DCP.

Review of facility data requested on 12/4/17 and submitted on 12/6/17 for the evaluation of products made and administered to patients from 11/21/17 to 11/29/17 identified that a total of 4 patients received medium risk compounded products (Total Parenteral Nutrition) and 9 patients received low risk compounded products that exceeded the 12 hour BUD. The Hospital is currently working with the DCP to ensure patient safety and compliance with the USP <797>.

Interview with MD #1 on 12/4/17 at 2:30 PM noted that compounding should have been performed in a certified room for assurance of sterility. MD #1 indicated that, although he believed the risk to be negligible, infection was possible for those patients who received the compounded product prepared from 11/21/17 to 11/29/17.

The Hospital policy for sterile preparations identified that air sampling shall be performed when a primary engineering controls are relocated or the physical structure of the buffer or ante areas have been altered in addition to quarterly and biannually. The policy did not direct air sampling when physical changes were made to the designated air handling system and did not direct surface sampling in the event of physical structure changes or changes to the designated air handling system as would be required per USP <797>. The hospital policy for sterile compounding identified that the pharmacy shall compound sterile preparations in a certified Primary Engineering Control ("hood") within a buffer area which meets the requirements of USP <797>.

Based on medical record reviews, review of hospital documentation, observation and interview for one (1) of three (3) patients' observed for medication administration (Patient #4), the hospital failed to ensure that the medication had not expired prior to administration.

A tour of the 8th floor was conducted with VP of Risk Management on 12/1/17. Observation on 12/1/17 at 12:12 PM identified an empty 100cc IV bag of Valproate (compounded medication) with the label that read "due to expire 12/1/17 at 10:00 AM" hanging on the IV pole in Patient #4's room. Review of Patient #4's electronic medication administration record identified that RN #1 hung and began to infuse the Valproate at 10:20 AM (20 minutes after the medication had expired). Interview with RN #1 on 12/1/17 at 12:16 PM noted that she did not see the expiration label on the outside of the IV bag. Although the Email from the DCP (Department of Consumer Protection) dated 11/29/17 requested, in part, that the Hospital provide documentation of communication notifying employees of the 12 hour BUD assigned to low risk compounded sterile products, nursing staff did not receive this communication until 12/1/17 following surveyor inquiry.
The facility policy for medication administration identified that outdated drugs must not be given.