MCN Healthcare: Policy Management and Compliance Tools

The Joint Commission (TJC) has published an article about common myths surrounding the sentinel event reporting process.  A sentinel event is "...an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof."  These types of events are called "sentinel" because they signal a need for immediate response and investigation.

Every Joint Commission manual has a section with standards that outline requirements for the management of sentinel events.  For hospitals the requirements are, generally:

• Identify all sentinel events
• Appropriately respond to the event including timely investigation and root cause analysis
• Monitoring any changes put in place in response to the sentinel to ensure they are effective

Key points from TJC's new article include:

• The sentinel event reporting process is voluntary and non-punitive
• Unanticipated deaths are considered reviewable events
• Joint Commission and state reporting requirements are separate
• The need for a "for cause" survey following a sentinel event is determined by the severity if the incident and the systemic risk to patients
• Hospitals should have a sentinel event policy in place

Included with today's notice is an example sentinel event policy and procedure.

Sandoz US is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. Parenteral injection of drug from the affected lots can lead to microembolisation in areas where the particles lodge. Clinical symptoms are not to be expected from these microemboli and Sandoz is not aware of any reports of related adverse events.

Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. The lot numbers and expiration dates of the two recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). These lots were distributed nationally across the US and to a single foreign country (Poland).

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their healthcare professional as well as Sandoz to report the finding. The Sandoz Drug Information Direct Line is open at 800-525-2492, 24 hours/day, seven days a week, or reports can be made via email at qa.druginfo@sandoz.com.

Read the MedWatch alert, including a link to the Recall Notice, at the link below.

The Centers for Medicare & Medicaid Services (CMS) is issuing a categorical LSC waiver permitting new and existing ventilation systems supplying hospital and critical access hospital (CAH) anesthetizing locations to operate with a relative humidity (RH) of greater than or equal to 20 percent, instead of greater than or equal to 35 percent. CMS is also recommending that the RH not exceed 60 percent in these locations.

Hospitals and CAH should be aware that this waiver does not apply when more stringent RH control levels are required by State or local laws and regulations or where reduction in RH would negatively affect ventilation system performance.

Individual waiver applications are not required, but facilities are expected to have written documentation that they have elected to use the waiver. Further, at the entrance conference for any survey assessing LSC compliance, a facility that has elected to use this waiver must notify the survey team.

Facilities are required to monitor RH in anesthetizing locations and take corrective actions when needed to ensure RH remains at or above 20 percent.

Note that Ambulatory Surgical Centers (ASCs) are not subject to all of the same LSC requirements as hospitals, but are required, consistent with 42 CFR 416.44(a)(1), to maintain RH in operating rooms in accordance with nationally accepted guidelines.