Audit Case Study—
Shenandoah Medical Center

Case Study

Macro Helix Audit Services helps Shenandoah Medical Center pharmacies stay compliant with 340B Program requirements

When Amanda R. Mather, Director of Pharmacy at Shenandoah Medical Center, received notice of an upcoming 340B Health Resources and Services Administration (HRSA) audit, she knew she had to be prepared.

Audit Services eases the complexity of an HRSA audit

Mather contacted Macro Helix and their Audit Services team, signing up for pre-audit, on-site audit services, and post-audit support.

Shenandoah had not completed an HRSA audit before. They were not really sure what to expect, and Mather needed to make sure the organization was ready for the audit. Being prepared was paramount.

“There’s usually a one- to three-month long preparation period prior to an HRSA audit,” Mather says, “And there were many areas where we wanted to make sure we were compliant with all the regulatory and audit requirements.” The Shenandoah pharmacy staff is well-versed in the complexities of managing a 340B program. Mather and her staff have used Macro Helix’s 340B Architect for several years and they know the Macro Helix software comes with a high-touch customer relationship approach—so they knew the Audit Services would include the same level of expertise they were accustomed to.

“There are multiple pieces of information stored in your electronic health records, and your records don’t always store the same information in the same spot. Mikala, our specialist at Macro Helix, helped us find all those pieces of information and make sure they were in the right spots for the audit. She was fantastic! Always available for us, and always provided instant responses to our needs!”

“I didn’t realize Macro Helix would do all this for us. I was very pleasantly surprised! We felt very confident prior to the audit that we had things in place to prove we are compliant.”

Amanda Mather

PharmD, RPh, Director of Pharmacy, Shenandoah Medical Center (SMC), Shenandoah, Iowa

Advance preparation leads to smooth audit

Macro Helix provides several different types of audit services: virtual, telephone and on-site. Shenandoah elected to use all three types—a decision that proved extremely beneficial to them. Once SMC collected all the documentation requested by the auditor, HRSA performed a “desk audit” prior to the on-site visit. During the on-site visit, the auditors looked at a variety of prescriptions to ensure there were no compliance issues or diversions.

“The 340B Architect application comes with a multitude of reports, pre-programmed into the software. Mikala showed us which reports to use for the audit and explained how they would be useful during the audit. She showed us how to identify outliers, rectify issues, and spent a lot of time with us scrubbing the data; so that we were totally ready,” said Mather.

One extremely helpful component of the Macro Helix audit services program, according to Mather, was a “dry run” virtual meeting prior to the onsite visit. This process ensured Shenandoah felt comfortable and that the audit process ran smoothly and efficiently. “I didn’t realize Macro Helix would do all this for us. I was very pleasantly surprised! We felt very confident going in to the audit process that we had things in place to prove we were compliant,” she said.

“The results of the audit showed no issues and proved SMC to be fully compliant with all 340B regulations so we are thrilled that Macro Helix helped us prepare so well!” Amanda continued.

When asked for recommendations for other hospital pharmacies going through a 340B HRSA audit, Mather said, “Take advantage of the Macro Helix auditing services. Make sure you are utilizing all your resources. Practice using your electronic health records and your 340B Architect systems in conjunction prior to the audit. I would definitely recommend having the Macro Helix audit specialist onsite. Mikala really prepared us!”

  • Amanda Mather, PharmD, RPh, Director of Pharmacy, Shenandoah Medical Center (SMC), Shenandoah, Iowa
  • Hospital Pharmacy group with one in-patient pharmacy, one satellite clinic, and four contract retail pharmacies in the Shenandoah area
  • Prepare organization for upcoming 340B HRSA audit and measure compliance with all 340B regulations
  • Ensure all documentation is available, correct, and easily accessible
  • Coordinate support for pre-audit, on-site audit and post-audit processes
  • Macro Helix conducted virtual and telephone training in advance of onsite audit to fully prepare pharmacy staff to collect and submit necessary documentation.
  • SMC staff was briefed on the necessary compliance metrics and overall audit process.
  • Additional training was provided by Macro Helix for data extraction within 340B Architect and the availability of data feeds from electronic health records.
  • Post-audit findings proved SMC to be fully compliant.

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