Compliance Mentor - September 2015

Hospital Access Management - Hospital Case Management - Hospital Employee Health
Hospital Infection Control - Hospital Peer Review - Healthcare Risk Management
Case Management Advisor - IRB Advisor - Medical Ethics Advisor - Same-Day Surgery

ISMP Updates Safe Injection Practices for IV Push Medication

The Institute for Safe Medication Practice (ISMP) recently published the 26-page “ISMP Safe Practice Guidelines for Adult IV Push Medications.” CMS, under tag 405 in the hospital conditions of participation, says hospitals must follow these standards of practice, ensuring their policies and procedures are consistent with these national recognized organizations with expertise in medication preparation and administration. Under the section on accepted standards of practice, ISMP is specifically referenced.

All hospitals should be familiar with this document and implement its recommendations. CMS has a standard on IV medication that was placed in the hospital manual effective June 6, 2014, and April 7, 2015, for Critical Access Hospitals (CAH).

The document is organized into factors that increase the risk of IV push medications in adults, current practices with IV injectable medications, developing consensus guidelines for adult IV push medication, and safe practice guidelines. There is also a conclusion, references, definitions, and a section on future inquiry.

About 90% of all hospitalized patients have some form of infusion therapy. IV medications were associated with 56% of preventable adverse drug events over a 5-year study. The publication lists many other studies that indicate IV medication errors are frequent. There is a lack of established safe practices associated with IV push medication. The ISMP put together an Adult IV Push Medication Safety Summit to identify and gain consensus on the most common risks associated with IV push medications and to standardize the safe administration of parenteral medication though the IV push route. This comes at a time where accreditation organizations like The Joint Commission and CMS are assessing safe injection practices. In fact, CMS issued a survey memo on safe injection practices and has a section on it in the infection control worksheet.

Recommendations included providing IV push medications in a ready-to-administer form. Healthcare facilities should use only commercially available or pharmacy prepared prefilled syringes of IV solutions to flush and lock vascular access devices. If the medication is available in a single-dose vial, then the facility should buy single-dose vials. This is also one of the 10 CDC safe injection practices. Aseptic technique should be used when preparing and administering IV medication, including hand hygiene before and after administration. The diaphragm on the vial should be disinfected even if newly opened. This is also contained in the CMS infection control worksheet section on safe injection practices. The top should be cleaned using friction and a sterile, 70% isopropyl alcohol, ethyl alcohol, iodophor, or other approved antiseptic swab for at least 10 seconds. Medication from a glass vial should be with a filter needle unless the specific drug precludes it. Medication should only be diluted when recommended by the manufacturer or in accordance with evidence-based practice or approved hospital policies. If IV push medication needs to be diluted or reconstituted, do it in a clean, uncluttered, and separate location. This is also a CMS pharmacy standard. Medication should not be withdrawn from a commercially available, cartridge-type syringe into another syringe for administration. It is also important that medication not be drawn up into the commercially prepared and prefilled 0.9% saline flushes.

Hospitals and other healthcare facilities should have a copy of this document, which is available here. The recommendations should be incorporated into policies and procedures. Staff should be trained on these policies in orientation and periodically down the road. IV injection safety is not only a nursing issue since others in the hospital may have responsibility for preparing and administering IV medication. Phlebitis and other complications from IVs have resulted in hospitals being penalized for readmissions.

The CDC 10 safe injection practices are in the CMS infection control worksheet issued Nov. 26, 2014, and the safe injection practices memo, dated June 15, 2012, can be accessed here.

Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, Section on Safe Injection Practices III.A.1.b., is here.

To learn more about the upcoming webinar covering this topic, you can go to the following link: [Live Webinar] The Latest and Greatest CMS Nursing CoPs or contact us at [email protected] or 800.688.2421 for additional information.

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There’s a New ASC Infection Control Worksheet

The first worksheet on infection control for ambulatory surgery centers was created in 2009. It lead to the implementation of the final infection control worksheet for hospitals published in November 2014. Now the ASC infection control worksheet, exhibit 351, has been revised again.

CMS says the changes were made to bring the infection control worksheet into alignment with current standards of practice. In fact, the worksheet emphasizes that ASCs must follow nationally recognized infection control guidelines. It is also amended to reflect some of the recently issued survey memos and guidance. This worksheet will continue to be used by state and federal surveyors on all survey activity for ASCs when assessing compliance with infection control standards in the conditions for coverage. Therefore, all ASCs should have a copy of this document and should review closely the changes, which are highlighted in yellow.

CMS recommends that all ASCs use this as a self-assessment tool.

The updates focus on many issues including safe injection practices, including disinfecting the rubber septum with alcohol before piercing.

Many ASCs in the past have been cited for unsafe injection practices. If the manufacturer makes it as a single-dose vial then the ASC needs to buy it. If it only made as a multi-dose vial, then try to use it only one patient and never take it into the patient’s room. This includes taking the vial into an immediate care unit such as the operating room, unless it will be used on that patient and discarded afterward.

The worksheet includes a recommendation for the ASC to voluntarily adopt a policy that multi-dose vials will be used for only one patient.

CMS had issued an infection control breach memo May 30, 2014, and if four specific breaches were noted another knock at the door could occur from the state epidemiologist. Here are four of the 10 CDC unsafe injection practices:

• Using the same (pre-filled/manufactured/insulin or any other) syringe, pen or injection device for more than one individual.
• Re-using a needle or syringe that has already been used to administer medication to an individual to subsequently enter a medication container (e.g., vial, bag), and then using the contents from that medication container for another individual.
• Using the same lancing or fingerstick device for more than one individual, even if the lancet is changed.
• Using the same needle for more than one individual.

The ASC must ensure that its infection preventionist has infection control training. The ASC must have a system to identify infections related to procedures performed; surveyors will look for it. If staph infection-control training is absent, the worksheet instructs surveyors to give the ASC a condition level deficiency. Training should be provided in orientation for new staff and practitioners and periodically afterward.

Other new categories require soap and water or hand sanitizer to be readily accessible. Staff providing direct care cannot wear artificial fingernails or extenders, which is also a CDC hand-hygiene guideline.

There are many additions related to processing and sterilizing equipment. Items should be pre-cleaned according to the manufacturer or, if is none provided, then according to evidenced-based standards. It also covers the use of chemical and biological indicators.

ASCs should carefully review this section to ensure compliance. Staff should be trained and be familiar with all of the sections contained in the ASC revised infection control worksheet.

The ASC revised infection control surveyor worksheet, Exhibit 351, dated June 17, can be found here.

The upcoming webinar covering this topic can be found here:
[Live Webinar] Ambulatory Surgery Centers: Infection Control Standards & Safe Injection Practices from CMS or contact us at [email protected] or 800.688.2421 for additional information.

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The Rules of the 60-Day Overpayment Rule

A federal court issued its first court opinion on Aug. 3 that interprets the False Claims Act’s requirement that overpayments be made within 60 days. This provision was enacted in 2010 by the Affordable Care Act. Previously, no court had made any rulings on this and CMS had not issued a memo or final regulations that could help hospitals or healthcare facilities interpret the rule.

The rule requires an overpayment by Medicare or Medicaid be returned within 60 days on which payment is identified. But what did “identified” mean? It wasn’t not defined in the statute. That changed with the Kane v. Healthfirst Inc. case, a U.S. District Court decision in the Southern District of New York.

In the case at bar, three hospitals billed Medicaid incorrectly because of a software problem. In 2011, a hospital employee, Robert Kane, prepared a spreadsheet showing more than 900 incorrectly filed claims of more than $1 million. Kane informed hospital administrators of the potential liability and was subsequently terminated. The hospital did not pay this incorrectly billed amount back until two years later. The hospital said this was a list of potential errors and overpayment was not “identified,” which would start the 60-day payment rule into motion.

The court sided with the Department of Justice and the New York State Attorney General. It argued that failure to pay this back in a timely way violated the False Claims Act and requested a penalty of $11,000 for each improperly retained overpayment.

Hospitals and other healthcare facilities should review internal compliance processes to reflect the court’s holding. Overpayments should be paid back when identified within 60 days.

Following this was the first false claims settlement for alleged violations of the 60 day rule was made in the amount of $6.88 million. It was made by a company that specializes in pediatric healthcare. The settlement was made with the U.S. Attorney’s Office for the northern and southern districts of Georgia. (Pediatric Services of America Healthcare, Pediatric Services of America, Inc., Pediatric Healthcare, Inc., Pediatric Home Nursing Services (collectively known as PSA) and Portfolio Logic)

See Kane v. Healthfirst Inc. et al, No. 1:2011cv02325 - Document 63 (S.D.N.Y. 2015) here.

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CMS Updates the CAH Manual

CMS updated the Critical Access Hospitals (CAH) on July 31, making the manual now 270 pages long. CMS had just rewritten a third of it on April 7. This included sections on pharmacy, nursing, dietary, infection control, contracted services, and rehab. This was the biggest revisions since the inception of the CAH program. These changes can be reviewed by clicking on the manual under Appendix W.

CMS issued a 24-page transmittal on July 31 discussing the changes. It revises four tag numbers: 160, 162, 165, and 168, all concerning the loss of rural status for some CAHs because of the adoption of the latest Office of Management and Budget metropolitan statistical area delineations.

Now CMS makes some additional revisions to clarify existing guidance related to requirements concerning CAH location requirements relative to other CAHs or hospitals. Changes were also made to the State Operations Manual under chapter two on the certification process. For example, any new hospital that wants to be certified as a CAH will be assessed first to make sure they meet the CAH criteria. This includes determining compliance with the location and distance requirements. All CAHs, including necessary provider CAHs, must be located in a rural area which is outside a Metropolitan Statistical Area.

The revised CAH manual can be accessed here, under Appendix W.

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Prepare for the Healthcare-Specific Federal OSHA National Emphasis Program

Join Lori A. Severson, CSP as she prepares hospitals and other healthcare facilities for OSHA’s expanded inspection process, announced on June 25^th of this year. Earn 1 nursing contact hour by attending. Click here to order.

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