Updated State Operations Manual (SOM) Reflects the Requirements of Participation (RoP)

CMS recently posted an advance copy of the State Operations Manual which includes all the updates and changes secondary to the revised Requirements of Participation. There will be a series of articles exploring those requirements with a Phase 2 deadline for implementation of November 28, 2017.

First, CMS has delayed the imposition of remedies for certain Phase 2 requirements, which be identified at a later date. However, you will still be surveyed on them and it is expected that your facility will be working toward compliance.

The requirements for Antibiotic Stewardship is not only in the infection prevention area, but is a key part of the old F-Tag 315 which is now F-690. In this interpretative guidance for Urinary Tract Infection, there is reference to following current standards of practice for obtaining urine cultures and administering antibiotics inappropriately.

F-Tag 881 is a new tag mandating that an infection prevention and control program be established. Within this tag is a full description of the Antibiotic Stewardship program, including the intent, definitions, and guidance, all of which is basically verbatim from the Requirements of Participation. There are five and one-half pages of new guidelines with several referrals to the CDC and its antibiotic stewardship program requirements.

In summary, this program must include protocols for the treatment of infections ensuring that the resident receives the right medication, at the right dose, for the right reason, and the right amount of time. Other requirements are the monitoring of antibiotic use, reduction of the risk for adverse events with regard to antibiotic use, and use of the CDC core elements to develop the program.

To determine compliance, the surveyor will use an Infection Control Facility Task worksheet. Though the actual form is not available at this time, it will include:

• Whether a program is in place.
• If there are antibiotic protocols that indicate the dose, duration, and lab support when appropriate.
• Whether a tool is used when discussing medication with the prescribing physician or non-physician practitioner.
• If there is a system for monitoring the efficacy of the antibiotic used.

Should the surveyor believe there is a problem, further investigation would include:

• Record reviews.
• Interviews with various facility staff and medical staff.
• QAA involvement will be reviewed.

It is interesting to note what is considered non-compliance. It includes a lack of developing and implementing an antibiotic stewardship program. However, additional items to be aware of include:

• Not notifying the physician or non-physician practitioner of lab results, in particular if the antibiotic ordered was resistant to the organism.
• No system to monitor antibiotic use, including administration of antibiotic when there is no appropriate indication to do so.
• Not monitoring start and stop dates of the antibiotic.
• Not following the facility’s own protocols.

If you have any questions regarding the new requirements of participation or the guidance, please contact your Marcum advisor.