South Carolina              
Administrative Law Court
Edgar A. Brown building 1205 Pendleton St., Suite 224 Columbia, SC 29201 Voice: (803) 734-0550

SC Administrative Law Court Decisions

CAPTION:
DHEC vs. Piedmont Medical Center

AGENCY:
South Carolina Department of Health and Environmental Control

PARTIES:
Petitioner:
South Carolina Department of Health and Environmental Control

Respondent:
Piedmont Medical Center
 
DOCKET NUMBER:
03-ALJ-07-0279-CC

APPEARANCES:
Dennis L. Gibbs, Director
DIVISION OF HEALTH LICENSING

Nancy L. Roberts
Attorney for Health Regulation
SOUTH CAROLINA DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL

Daniel J. Westbrook
NELSON MULLINS RILEY & SCARBOROUGH, LLP

Charles F. Miller
Chief Executive Officer
PIEDMONT MEDICAL CENTER
 

ORDERS:

SETTLEMENT AGREEMENT & ORDER

This final Settlement Agreement (“Agreement”) is entered into on the dates herein subscribed to, by and between the South Carolina Department of Health and Environmental Control (the “Department”) and Amisub of South Carolina d/b/a Piedmont Medical Center (“Piedmont”).

PREAMBLE

As preamble to this Agreement, the parties agree as follows:

1.On April 8, 2003, a representative of the Department visited Piedmont Medical Center, Rock Hill, South Carolina, to conduct a complaint investigation regarding an alleged medication error.

2.During the course of this investigation, the inspector noted that the medication Lidocaine bolus had been administered to a patient in error instead of Hespan. There was no order for Lidocaine bolus for the patient. The administration of medication in the absence of a physician’s order is a violation of Section 404.3.A of 24A S.C. Code Ann. Reg. 61-16.

3.The inspector further note that Hospital records did not indicate the patient’s physician was immediately notified of the error at the time it occurred. The failure to inform a physician of a medication error is a violation of 404.3.E of 24A S.C. Code Ann. Reg. 61-16.

4.After careful review, the Department sent a letter to Charles Miller, CEO Piedmont Medical Center, on May 30, 2003, advising that is was imposing a one thousand five hundred dollar ($1,500.00) monetary penalty in accordance with 24A S.C. Code Ann. Reg. 61-16, Standards for Licensing Hospitals and Institutional General Infirmaries. In that letter the Department also informed Mr. Miller of his right to appeal the Department’s decision within 30 days pursuant to S.C. Code Ann. Section 44-7-320(B)(2002) and the Rules of Procedure for the Administrative Law Judge Division.

5.Piedmont denies liability for any errors and submitted a timely request for a contested case hearing by letter dated June 30, 2003.

6.Prior to proceeding to a hearing on the merits, the parties met and Piedmont provided the following information regarding the circumstances of the medication error that contributed to the patient’s death and formed the basis for the Department’s citations and monetary penalty.

a.) The patient at issue was admitted to Piedmont on October 30, 2002, for an aorta bi-femoral bypass graft. Several days later, on November 3, 2002, the patient underwent an exploratory laparotomy.

b.) The anesthesiologist assigned to the laparotomy was not employed by the Hospital, but was a member of an anesthesiology group that provides services to the Hospital. Prior to the laparotomy, the anesthesiologist walked to the operating room pharmacy to retrieve two IV bags of medication called Hespan. When she reached the pharmacy, she picked up a bag of medication and confirmed it was Hespan. She picked up a second bag, but did not verify that it was Hespan. The anesthesiologist then walked to the operating room and placed both bags on the anesthesia table.

c.) A Certified Registered Nurse Anesthetist (“CRNA”) employed by the anesthesiologist’s practice assisted the anesthesiologist. The anesthesiologist ordered the CRNA to administer Hespan to the patient. The CRNA picked up one of the IV bags the anesthesiologist had placed on the anesthesia table and administered it to the patient without first confirming that it was Hespan. Shortly afterwards, the patient’s condition deteriorated. While still in the operating room, the anesthesiologist examined the IV and saw that the medication being administered was not Hespan, but Lidocaine. Without informing anyone else of the error, the anesthesiologist removed the bag of Lidocaine from the IV pole and put it aside. Soon afterwards, the patient died.

d.) The anesthesiologist, without informing anyone of the medication error, removed the bag of Lidocaine from the operating room. She then met with the admitting physician and informed him of the mistake. The admitting physician informed the patient’s family of the patient’s death, but not of the medication error. Neither the admitting physician nor the anesthesiologist recorded the error in the patient’s chart. No one else knew of the error.

7.Piedmont denies liability for these errors.

8.Piedmont first learned of the medication error on March 13, 2003 - over four months after the event occurred. In accordance with Departmental regulations, the Hospital reported this matter to the Department on March 20, 2003.

9.In view of Piedmont’s timely reporting of this event and of Piedmont’s action to ensure that a similar situation does not recur, the Department and Piedmont were able to reach the following settlement in this matter.

TERMS AND CONDITIONS

10.The Department and Piedmont wish to resolve this matter and to compromise and settle the disputes and allegations that have been pled or that could have been pled in the above-captioned case.

11.In view of the foregoing, the mutual promises and covenants set forth herein, and for such other good and valuable consideration as set forth herein, the receipt and sufficiency of which is hereby acknowledged, the Department and Piedmont agree as follows:

a.) The Licensee has taken and will continue to take action to ensure that this type of circumstance does not recur.

b.) The Licensee will withdraw its request for a contested case hearing pending before the Administrative Law Judge Division.

c.) In consideration of the remedial action taken by the facility, the Department agrees to accept $1,000 in settlement of the $1500.00 total monetary penalty assessed against Piedmont Medical Center, for violations of 61-16.

12.Piedmont agrees to submit payment of a $1,000 settlement amount by check or money order made payable to the S.C. Department of Health and Environmental Control prior to or at the time of the signing of this Agreement. Payment may be mailed to the following address:

Attention: Earl Bleakley

Division of Health Licensing

S.C. Department of Health and Environmental Control

2600 Bull Street

Columbia, SC 29201

13.It is understood by the Licensee that S.C. Code Ann. Section 44-7-320(D)(2002) provides that “[f]ailure to pay a penalty within thirty days is grounds for suspension, revocation, or denial of a renewal of a license. No license may be issued, reissued, or renewed until all penalties finally assessed against a person or facility has been paid.” It is further understood that the failure to pay the settlement amount may also result in suspension, revocation, or denial of a license and that no license may be issued, reissued, or renewed until a settlement amount has been paid.

14.The Department in no way waives its authority to enforce, by imposing penalties or otherwise, any statutory and regulatory requirements for the licensure of Piedmont Medical Center.

15.It is further agreed that, pursuant to S.C. Code Ann. Section 44-7-320(2002), future violations or repeat violations of the regulations, or applicable licensing statutes, may result in the imposition of penalties or the revocation of the license to operate Piedmont Medical Center, and the facility administrator has been informed of these potential actions.

16.Piedmont agrees to withdraw its request for a contested case hearing in Docket No. 03-ALJ-07-0279-CC that is currently pending in the South Carolina Administrative Law Judge Division.

17.This Agreement does not constitute an admission of liability by Piedmont or a withdrawal of the citations by the Department, but is entered into by the parties solely for purposes of compromising, settling, and resolving this disputed matter without incurring the time and expense that would be involved in proceeding further with this legal action.

18.This Agreement constitutes the entire agreement between the parties with respect to the resolution and settlement of the matters discussed herein and supercedes all prior or contemporaneous agreements, promises, or understandings between the parties. The parties are not relying upon any representations, promises, understandings, or agreements except as expressly set forth within this Agreement.

19.The undersigned individuals signing this Agreement on behalf of the parties represent and warrant that they are duly authorized to execute this Agreement and lawfully bind their principals.

20.In the event of the invalidity of any term or provision of this Agreement, all terms and provision shall be considered severable and the balance of this Agreement shall remain in effect.


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