Fannie Fang
Executive Editor
Loyola University Chicago School of Law, JD 2017

 

On September 15, 2016, Michigan state regulators cited the Detroit Medical Center (“DMC”) for violating the State’s Public Health Code for failing to properly sterilizing surgical instruments. Although DMC promised to address the issue with correction actions, the violation has left an alarming impression in many patients’ minds.

Timeline of the Complaint

It all started when the Bureau of Community and Health Systems (“The Bureau”) filed a health facility complaint against the Detroit Receiving Hospital (“DRH”), an affiliate of DMC. In the complaint, The Bureau claims DMC used unsanitary instruments and practiced unhygienic procedures throughout the hospital and thus increased great risks to its patients. The complaint was the result of an investigation that was conducted on DRH in August of 2016, when an allegation claimed that DRH was violating the Michigan’s Public Code.

Under Michigan’s Public Health Code and Administrative Rules Minimum Standards for Hospitals (“Rules”), a licensed hospital must meet both of the Code’s and Rules’ laws. These rules include:

1. The department must establish a comprehensive system of licensure and certification for health facilities to protect the health, safety, and welfare of individuals receiving care and services in or from a health facility or agency.
2. The department must include policies for protection of individuals receiving care and services.
3. The owner, operator, and governing body of a hospital are responsible for all phases of operation of the hospital, selection of the medical staff, and quality of care rendered in the hospital.
4. Read all the Rules here.

The investigation applied the Rules accordingly and focused on the operational and procedural processes of Central Sterile Processing Department (“CSP”), which is responsible for services of the four licensed hospitals on the DMC central campus, including DRH. The investigation included a tour of DRH, an on-site walk through the CSP Department, interviews with DMC staff, thorough review of CSP staff records, DMC and CSP training records, and lastly, a review of DMC and CSP policies and procedures.

Correction Action to the Violation

Through the investigation, there were many red flags that raised concerns of the sanitization policies and procedures at DRH. For example, The Bureau looked over all the training materials for DRH’s employees in the recent years, however, the majority of the records were either unavailable or misplaced. Moreover, CSP staff allegedly received training 18 times in 2016 on subjects related to instrument inspection, cleaning, and processing. However, CSP was only able to provide two physical records of those 18 trainings. Furthermore, The Bureau discovered that employees of both DRH and CSP frequently missed training sessions. Lastly, the investigation also found a lack of collaborative sharing, communication and process consistency between the DRH and the CSP Department.

At the end of the complaint, The Bureau warned DMC that correction actions were needed immediately and continued noncompliance could result in a series of penalties, from monetary fines to license suspensions. Soon after the news, DMC released a statement in response to the violation stating that they promised to take all the necessary steps to provide proper and efficient remedial actions based on the results of the investigation. The correction action starts by submitting a correction plan to the State Licensing Section of the Michigan Department of Licensing and Regulatory Affairs and the Bureau of Community and Health Systems within 60 days. DMC plans to implement policies that will make the proper arrangements for the sterilization of surgical instruments and maintain a consistent monitoring on the performance of all sterilizing equipment.

The Growing Need for a Robust Compliance System

Incidents like the DMC violation is a direct result of the lack of the standing policies and procedures some health systems have in existence. While many still view the need of a robust compliance system as minimal, they cannot deny that with a heavily regulated industry, running a large health care system without a robust compliance system is now almost implausible.