The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

HOLMES REGIONAL MEDICAL CENTER 1350 S HICKORY ST MELBOURNE, FL 32901 July 26, 2011
VIOLATION: CRITERIA FOR MEDICAL STAFF PRIVILEGING Tag No: A0363
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review of patient #12, admitted on [DATE], received a Double Coronary Bypass on 10/1/10, and died 8 hours after the open heart surgery. The Nursing Intraoperative Record states that a perfusionist, was the "Heart Holder". The facility could not provide proof of credentialing for the contracted perfusionist to participant in the portion of the surgery. Based on review of medical staff bylaws, interview, and record review, the facility failed to specify and delineation privileges for 3 of 3 contracted perfusionist (staff F, V, & W).





Findings included:
Review of the Medical Staff Bylaws showed the facility did not classify a contracted perfusionist as an allied health professional.
Review of three of three credentialing files for perfusionist (staff F, V & W) showed no documentation of delineation of specific privileges related to patient related responsibilities for cardiovascular surgeries.
Review of the CVI (the contract company) personnel job description dated 10/05/2011 did not include any reference to "scrubbing and holding the heart" as part of the duties and responsibilities for staff cardiovascular perfusionist for staff F, V & W).
During an interview with the Vice President of Medical Affairs on 07/26/2011 at 2:10 p.m., he said that perfusionist do not touch patients but just run the perfusion machine. During an interview on 07/26/2011 at 2:15 p.m., the perfusion supervisor said, "yes" perfusion staff do scrub and hold the heart when the anesthesia technicians are not available. This has been the practice for the last fourteen years. He said he occasionally assists the surgeon with holding the heart if the other technicians are too busy. He said the only training he has received is informal on-the-job training. He said there would not be any documentation in his personnel file to document any formal training. He said he would not hold the heart if he was operating the bypass machine. He said, usually the anesthesia technicians assist with holding the heart if needed.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observations, interviews, review of facility Medical Staff Bylaws, and record reviews, the facility failed to:
- failed to ensure practitioners providing care to patients are working within the scope of privileges granted by the hospital medical staff (refer to A-0943 & A-0363).
- failed to ensure practitioners assisting in surgical procedures are appropriately credentialed by the medical staff (refer to A-0945);
- failed to ensure sanitary conditions in the operating rooms (refer to A-0951);
- failed to ensure opened medication are labeled (refer to A-0951); and
-failed to ensure expired medication are not available for immediate patient use (refer to A-0951);
The facility performs approximately 632 cardiac related surgeries per year. The severity and cumulative effect of these systemic practices resulted in the hospital's failure to have a consistent practice in the surgical services department and the facility is found to be out of compliance with 42 CFR 482.51 - Condition of Participation: Surgical Services.
VIOLATION: OPERATING ROOM SCRUB NURSES Tag No: A0943
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review of patient #12, admitted on [DATE], received a Double Coronary Bypass on 10/01/10, and died 8 hours after the open heart surgery. The Nursing Intraoperative Record stated that a perfusionist, was the "Heart Holder". The facility could not provide proof of credentialing for the contracted perfusionist to participant in the portion of the surgery. Based on interview and record review, the facility failed to ensure staff providing care to patients are working within the scope of practice as described in delegated responsibilities for 3 anesthesia technicians reviewed (staff U, DD & EE).





Findings included:
Medical record review showed patient #2, [AGE], admitted on [DATE] for a CABG (open heart surgery). Review of the Nursing intra-operative record showed staff U as the "heart holder" from 9:31 a.m. to 10:39 a.m.

Review of the Anesthesia technician personnel files showed:
Staff U, anesthesia technician, hired 09/12/2002. The job description and annual evaluation dated 09/16/2010 did not list scrubbing and holding heart as part of responsibilities.
Staff DD, anesthesia technician, hired 05/25/2001. The job description and annual evaluation dated 05/17/2011 did not list scrubbing and holding heart as part of responsibilities.
Staff EE, anesthesia technician, hired unknown date. The job description and annual evaluation dated 08/20/2010 did not list scrubbing and holding heart as part of responsibilities.

During an interview on 07/26/2011 at 2:20 p.m., Staff U, an anesthesia technician, said he would be in the cardiac rooms approximately 1/3 of the time when the patient is being operated on. He usually scrubs in and holds the heart about fifteen times per month and this is part of his responsibilities. He said most of his training is on-the-job- training, but he did complete some of the EMS (emergency medical service) training and did competencies on-line annually including infection control, HIPAA, etc.

During an interview on 07/26/2011 at 2:45 p.m., the registered nurse (RN) educator for surgical services said that in the past, scrubbing and holding the heart was part of the job description for the anesthesia technicians, but was removed at an unknown time. During the review of the three anesthesia technician personnel files, the RN educator confirmed the current job descriptions and competencies did not show scrubbing and holding the heart as part of the duties of the anesthesia technicians.
VIOLATION: SURGICAL PRIVILEGES Tag No: A0945
Based on review of medical staff bylaws, interview, and record review, the facility failed to specify and delineation privileges for 9 of 9 contracted registered nurse first assistants (RNFA).
Findings included:
Review of the Medical Staff Bylaws showed the facility did not classify RNFAs as an allied health professional. Review of two of nine credentialing files for RNFAs staff I and GG showed no documentation of delineation of specific privileges related to cardiovascular surgeries.

During an interview on 07/26/2011 at 1:15 p.m., the Medical Staff Office Coordinator said that all of the nine RNFAs with CVI (a contract company) have received administrative review and approval, however, none were credentialed through the hospital medical staff office.

During an interview on 07/26/2011 at 2:15 p.m., the perfusion supervisor said he supervises a total of nine RNFAs who function in an assisting capacity in the operating rooms.

Review of the Credential Committee meeting minutes dated 10/05/2010 showed "the committee agreed that we should follow our Medical Staff Bylaws and credential only those licensed practitioners as stated in Chapter 464. Human Resources may assume the credentialing for the other individuals currently credentialed through the Medical Staff office, i.e. MAs (medical assistants), RNFAs, etc."
Review of Florida Statutes 464.027 - Registered nurse first assistant states: "(4) INSTITUTIONAL POWERS - Each health care institution must establish specific procedures for the appointment and reappointment of registered nurse first assistant staff members and for granting, renewing, and revising their clinical privileges."
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on the observation of 7 operating rooms (ORs) and interviews with surgical staff and supervisors, the facility did not maintain equipment and housekeeping which assures adequate patient care, and unlicensed staff were observed to be performing portions of medication administration set up for surgical patients. Additionally, the facility failed to ensure expired and unlabeled medications are not available for immediate patient use in the operating rooms. These practices have the potential to compromise safety of surgical patients.

Findings include:

1. Observations of ORs was conducted on 7/25/11, at 11:15 a.m. with the Surgical Clinical Specialist. Bovie surgical carts were observed in ORs #15, 16,17,18 and 19. Paint was observed to be missing from lower shelves of the carts and metal wheel guards were rusty. Intravenous Poles in ORs 15, 17 and 18 had rust on lower portions of the base. Paper wrappers and tape were on the floors of ORs 15, and 17. Tape was observed to be stuck to arm rests of surgical patient OR tables in rooms 16, 17 and 18.

Interview of the of Clinical Specialist, and OR tech, was conducted as part of the tour. Neither were sure who would be responsible for the removing the rust or replacement of the equipment. All of the ORs observed were stated to have been cleaned after surgery by the Surgical Clinical Specialist.

2. Observations made in the surgical area on 7/25/11, at 12:10 p.m. with the Clinical Specialist and the Licensed Risk Manager. A Certified Nursing Assistant (CNA) was observed to be setting up Intravenous (IV) bags which included opening the bags and sterile tubing and spiking the tubing into the bag and running fluid through the tubing to free of air. The surveyor observed preparation of three of the IV bags and tubing. The CNA was not wearing gloves nor handwashing observed during procedure. Interview of the CNA was conducted as to specific training on this procedure. She responded that she had observed the nurse to perform task and that she had been setting up IVs for the past nine months. The licensed nurses will use these IVs and continue the steps of IV administration to surgical patients.





3. During a tour and observation of the phase I post anesthesia care unit on 07/25/2011 at 11:50 a.m., the anesthesia medication cart top drawer had one twenty milliliter vial of Lidocaine 1%, a local anesthetic medication, opened with an unknown amount remaining, unlabeled, undated, and not initialed with the date of opening. During an interview on 07/25/2011 at 11:50 a.m. the Registered Nurse Manager (RN) said the facility policy is to date, time, and initial all opened medication multi-dose vials when opened.
4. During a tour and observation of OR #4, the anesthesia medication cart top drawer had one twenty milliliter vial of Lidocaine 2%, a local anesthetic medication, opened with an unknown amount remaining, unlabeled, undated, and not initialed with the date of opening. During an interview on 07/25/2011 at 12:10 p.m., the OR RN Manager said this operating room was last used for a 7:30 a.m. surgical case today.
5. During a tour and observation of OR #2 the anesthesia medication cart top drawer had one ten milliliter vial of Neostigmine 1 milligram/milliliter, a medication used as an anesthesia reversal agent, opened with an unknown amount remaining, unlabeled, undated, and not initialed with the date of opening.
Also, the OR mattress had one hole, the size of a quarter, near the patient shoulder area, and one slit hole, dime size on the lower part of the mattress, exposing the foam inner core and inhibiting the antiseptic cleaning between patient use.
During an interview on 07/25/2011 at 12:10 p.m., the OR RN Manager said the facility policy is to date, time, and initial all opened medication multi-dose vials when opened and confirmed the presence of the mattress holes.
6. During a tour and observation of OR #17 the anesthesia medication cart top drawer had one twenty milliliter vial of Succinylcholine, a medication used to paralyze patients during surgery, opened with an unknown amount remaining, unlabeled, undated, and not initialed with the date of opening. Drawer #3 had one manufactured syringe of Labetalol 20 milligrams/4 milliliters with an expiration date of 06/27/2011. The Surgical Services RN Educator was present and confirmed the opened and expired medications.
Review of the facility policy "Dating of Sterile medication Containers", dated as revised 05/01/2010 read, "For opened and entered needle punctured closure sealed multiple-dose vials, do not use beyond 28 days, unless otherwise specified by the manufacturer or when suspect contamination occurs. Label vials with the date of expiration." In section related to paralytic medications, it specifies Succinylcholine expires in 14 days.