http://www.healthplusnj.com/

Sterile Processing University, LLC
Training, Education and Consulting for Sterile Processing and GI/Endo
59 Allerton Road, Lebanon, New Jersey 08833
Office: 908-735-8944 FAX: 908-730-6025
Email: nancy@spdceus.com webpage: www.sterileprocessing.org

December 28, 2018
Health Plus Surgery Center contracted with my company to provide consultation services for their sterile processing practices. As such the following improvements were made based on our recommendations and in compliance with all national and recognized standards of practice including the Association for the Advancement of Medical Instrumentation (AAMI), the Centers for Disease Control (CDC) and Occupational Safety & Health Administration. A consultant was on site during the entire process of implementation of the changes.

1. Obtaining all current manufacturers’ instructions for use (IFUs) for cleaning and sterilization of all devices being used at the facility. These IFUs can change so a process was put in place where the IFUs are updated every 2 years.

2. A Cleaning Reference Chart was developed for the staff for easy reference as to the manufacturer’s recommended cleaning protocols. A separate reference chart was made for the staff to refer to for the sterilization instructions. This is a difficult task for sterile processing since there can be hundreds of surgical instruments and devices in use of which all can have different cleaning and/or sterilization instructions.

3. All of the surgical instruments and sets were refurbished by an outside repair company. The instruments were then completely reprocessed according to the IFUs. The reprocessing activities were monitored by the consultant during the entire process.

4. A new Sterilization Policy Manual to comply with all federal and state regulations as well as national standards, was developed and inserviced to the staff.

5. New SPD technicians were hired and were trained by staff and the consultant. Competency assessments were made on all processing staff members based on the new processes.

6. Implemented the new protocols (recently published) to test the equipment used for cleaning instruments.

7. Provided extensive inservicing to the new staff on the new AAMI standards for processing.

8. Developed Process Improvement Plan for the Sterile Processing area where work practices will be audited on a monthly basis.

9. Based on our most recent visit, we will now monitor the practices monthly until March, 2019.

SUMMARY:

Health Plus’s administration cooperated 100% in terms of complying with all recommendations made, purchasing all the products and services recommended and ensuring that the facility not only met but exceeded standards. Few facilities can make this statement today. This was accomplished within a 3-week period of time which is remarkable and is a testament to their commitment to correct any and all deficiencies.

Respectfully submitted,

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Nancy Chobin, RN, AAS, ACSP, CSPM, CFER,
President
Sterile Processing University, LLC
Consulting and Training Division

NJ Health Hotline:

1-800-962-1253

Sterile Processing experience for 39 years
Member of AAMI 1990 - present, serve on 15 Committees and co-chaired two committees; member of AORN, SGNA and IAHCSMM
Founder and past Executive Director of the Certification Board for Sterile Processing & Distribution, Inc., Lebanon, NJ. (1998-2014)
2018 recipient of the AAMI Standards Developer Award
2017 Certificate of Appreciation from AAMI Board for Contributions and Service to the AAMI Standards Committee 2002-2018.
Acknowledged as “One of the 30 Most Important People in Sterile Processing” selected by Healthcare Purchasing News, October, 2007.
Acknowledged as “Who’s Who in Infection Control” December 2006; Infection Control Today Magazine.
Contributor to Infection Control Today and Endo Pro magazines
Author of the Basics of Sterile Processing Textbook and Workbook, The Basics of Flexible Endoscope Reprocessing Textbook and Workbook and Management Basics for Sterile Processing
Developed Sterile Processing Management Course; have been provided continuously since 1997
Principal author for “Infection Prevention in Dental Offices” DVD set for United States Navy
Instructor for US Army for Sterile Processing Management
Have consulted in over 250 hospitals and surgery centers in the US, Thailand, Malaysia, Canada, Latin and South America.

Background:

Statement by Mark Manigan on behalf of HealthPlus Surgery Center at December 29, 2018 Press Conference

December 29, 2018 (Saddle Brook, NJ) – I want to start with background of how we arrived at where we are today.
The facts surrounding the report of our closure on September 7^th have been reported. Upon being surveyed by the Department of Health, we were engaged by HealthPlus to oversee the response. I am a partner specializing in healthcare at the law firm of Brach Eichler. Mr. Yan Moshe, who owns the facility and who we have represented on a number of healthcare matters, recognized that in order to assure that the DOH and the public trusted the transparency and comprehensiveness of the response to this incident, it should be overseen by external parties.

Mr. Moshe delegated the responsibility to Brach Eichler to investigate the situation; coordinate the hiring of appropriate and respected consultants to correct procedures; and guide the process with the Department of Health. This team of professionals involved in this matter are experts in their field who take their reputation, both publicly and before the Department of Health, very seriously.

Compliance is at the heart of this issue and so it is appropriate for counsel, working collaboratively with medical experts and the facility’s management team, to vet the methodology being used to reach a compliant status.

In all matters related to compliance issues, it is important to understand that the Department of Health is the ultimate authority in terms of establishing standards to be met and processes to be followed. HealthPlus has responded as expediently as possible to all DOH requests. As a result, the closure was relatively brief. However, some issues, especially related to the testing methodology, required more time to develop and implement despite the fact that they were being worked on urgently by HealthPlus from the beginning and DOH.

Upon the September 7 inspection, non-medical management learned that sterilization and medication dispensing were not operating consistent with standard procedure. The day before the inspection, as has been widely reported, the facility’s Director of Nursing resigned and was subsequently replaced; and on September 17^th HealthPlus terminated and replaced two additional employees. Leading consultants to provide a procedural overhaul and to train staff were immediately engaged, and we are confident that the issues raised by the Department have been addressed.

The public now has access to the final report from the DOH indicating that multi-dose medicines were improperly dispensed and lapses in sterilization procedures occurred, primarily concerning orthopedic instruments and surgical trays. The report goes into great detail regarding DOH’s findings, which you can find online if you have not already. We will be maintaining a website at www.healthplusnj.com where the report, as well as the facility’s comprehensive plan of correction, have been posted and where information will be updated from time to time.

HealthPlus now conducts weekly inspections and has been found to be compliant by DOH since September 27th. In addition, routine audits by our outside consultants will occur in order to ensure compliance.

There were several factors in determining the methodology for the testing program which was announced by letter to the patient group DOH identified for testing – those who had procedures from January 1 through September 7. DOH determined patients HealthPlus treated prior to January 1 or after September 27 were not at risk and has affirmed that our procedures since September 27 are compliant with standards. Again, we cannot speak for DOH beyond what is in the report and we would defer all questions regarding DOH policy and regulatory activity to DOH.

As expected, so far from the partial review of the patient population, we are aware of many patients with pre-existing conditions such as HIV, Hepatitis B and C. We expect to find more as the process continues. The DOH also recognizes that within this population there could be undiagnosed cases of pre-existing conditions, and on the basis of what we know and don’t know, the appropriate response is to test. The DOH has indicated that the risk of infection as a result of conditions at HealthPlus is low, but even the slimmest prospect of exposure creates a first priority, which is testing.

The DOH set the testing parameters, which include testing by an independent third party -- Labcorp -- and a requirement that patients and the DOH are notified of results. We have preliminary results from the first 186 patients tested that show no acute infection in any of the patients. One preliminary result indicates a case of chronic hepatitis. Typically, this would indicate a pre-existing condition that was active prior to the patient being treated here, but the ultimate determination on that is for DOH to make, and the Department will perform a comprehensive analysis.

The unlikelihood of exposure does not mean that previously undiagnosed infections will not be discovered. For example, patients vaccinated against a particular condition could show as up as positive. When previously undiagnosed infections, if any, are found, DOH will determine whether the condition was pre-existing or whether other exposure factors might need to be researched. Those results will indicate whether an infection could have occurred at HealthPlus, and that may be weeks or months off.

The important consideration is that each of these patients will know their status a week or two after they have been tested. Upon reporting their results to them, if necessary, and depending on a variety of factors beginning with the nature of the ailment, we will refer them to the appropriate medical resources for additional consultation.

In closing, we would urge that social media posts be considered dubious in nature if they contain information that has not been released by the Department of Health. If there is a public health issue, DOH will be the first to report it.

Medicine is a highly regulated industry with tried and true standard procedures that are closely monitored. One question that has been asked is why HealthPlus let people with pre-existing conditions into the surgical center. HealthPlus does not discriminate against patients with these conditions. Medical facilities expect to encounter and manage illness and when things are working properly potential exposure events will not occur. HealthPlus deeply regrets this incident, but is proud of how we responded to it and is committed to continuing to perform admirably.

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About HealthPlus Surgery Center

Established in 2016, HealthPlus Surgery Center is an ambulatory surgery center located in Saddle Brook, NJ. With approximately 30 employees, the Center offers the following procedures: Manipulation under Anesthesia, Orthopedics, Podiatry, Pain Management and Plastic Surgery.

Statement by Mark Manigan on behalf of HealthPlus Surgery Center at December 29, 2018 Press Conference