Health, Administration

Rule R380-210

Health Care Facility Patient Safety Program

Notice of Proposed Rule

(Amendment)

DAR File No.: 33425
Filed: 03/02/2010 10:24:15 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this amendment is to improve and streamline the current rule. A requirement for an independent audit of hospitals and ambulatory surgical centers of their medication safety program has been determined to be a cost burden with limited results. Only one facility (rural) each three year period has had difficulty with their audit findings at a cost of approximately $1,500 - $2,000 per non-Joint Commission on the Accreditation of Healthcare Organization (JCAHO) facility. The problem areas are due to lack of resources in the rural community and this additional cost burden is not positively contributing to improved care.

Summary of the rule or change:

The changes delete Subsections R380-210-3(4) and R380-210-4(2) both of which read: Each facility shall have the implementation and accuracy of the internal patient safety identification processes required in R380-210-3(1) audited every three years by an independent auditor approved by the Department's Facility Licensing Committee.

State statutory or constitutional authorization for this rule:

• Subsection 26-1-30(2)(d)
• Subsection 26-1-30(2)(a)
• Subsection 26-1-30(2)(g)
• Subsection 26-1-30(2)(b)
• Section 26-3-8
• Subsection 26-1-30(2)(e)

Anticipated cost or savings to:

the state budget:

None--This is currently a third party requirement and does not involve state government.

local governments:

None--No local government involvement.

small businesses:

There is an anticipated $1,500 - $2,000 cost savings every three years to non-Joint Commission Accredited hospitals and Ambulatory Surgical Centers in Utah. Any consulting business which provides this audit function to the hospitals would no longer be able to provide this service or to gain this revenue.

persons other than small businesses, businesses, or local governmental entities:

There is an anticipated $1,500 - $2,000 cost savings every three years to non-Joint Commission Accredited hospitals and Ambulatory Surgical Centers in Utah. Any consulting individual who provides this audit function to the hospitals would no longer be able to provide this service or to gain this revenue.

Compliance costs for affected persons:

The current audit requirement in this rule costs between $1,500 - $3,000 every 3 years for an independent audit of non-Joint Commission Accredited hospitals and Ambulatory Surgical Centers Medication Safety Programs. This rule has been in effect since 2001 with three rounds of implementation. Only one facility each audit cycle has not passed the initial audit. The facility was then placed on corrective action and has resolved its problems in 90 days. Some of the issues identified are related to lack of rural resources, training and expertise. The Medication Safety Work Group consisting of pharmacy experts from various hospital systems have determined that the audit section of this rule is not truly effective and should be eliminated. Facilities are still required to report medication-related deaths and permanent loss or harm to the Utah Department of Health through Rule R380-200.

Comments by the department head on the fiscal impact the rule may have on businesses:

This rule change is positive for business by eliminating a regulatory requirement that has not proven effective.

David Sundwall, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Health
Administration
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Iona Thraen at the above address, by phone at 801-273-6643, by FAX at 801-273-4150, or by Internet E-mail at ithraen@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

05/03/2010

This rule may become effective on:

05/10/2010

Authorized by:

David Sundwall, Executive Director

R380. Health, Administration.

R380-210. Health Care Facility Patient Safety Program.

R380-210-3. Patient Injury Identification.

(1) Each facility shall implement processes to effectively identify and report to the Department the incidence of all:

(a) adverse drug events.

(2) Reporting to the Department may occur through established, statewide, electronic health care facility reporting systems managed by the Department.

(3) The report shall include codes applicable to the event from the current International Classification of Diseases Clinical Modification (ICD-CM) diagnosis coding, including codes for external cause of injury (E-codes) and codes for place of occurrence.[

(4) Each facility shall have the implementation and accuracy of the internal patient safety identification processes required in R380-210-3(1) audited every three years by an independent auditor approved by the Department's Facility Licensing Committee.]

 

R380-210-4. Patient Injury Reduction.

(1) Each facility shall implement processes that are effective in reducing the incidence of:

(a) adverse drug events.[

(2) Each facility shall have the implementation and effectiveness of the internal patient injury reduction processes required in R380-210-4(1) audited every three years by an independent auditor approved by the Department's Facility Licensing Committee.]

 

KEY: hospital, injury prevention, quality improvement, patient safety

Date of Enactment or Last Substantive Amendment: [October 15, 2001] 2010

Notice of Continuation: October 10, 2006

Authorizing, and Implemented or Interpreted Law: 26-1-30(2)(a); 26-1-30(2)(b); 26-1-30(2)(d); 26-1-30(2)(e); 26-1-30(2)(g); 26-3-8