HospitalInspections.org

Based on the manner and degree of deficiencies cited, the hospital failed to be in compliance with the Condition of Governing Body. The hospital's governing body, which was legally responsible for the conduct of the hospital as an institution, failed to ensure that the persons (Chief Executive Officers, current interim CEO and previous CEO) delegated the responsible for the conduct of the hospital, carried out the functions specified in the part that pertain to the governing body.

The facility failed to meet the following standards under the Condition of Participation of Governing Body:

A 046 Medical Staff - Appointments
The hospital failed to ensure that credential files for all medical staff and allied health staff contained delineation of privileges documentation, current proof of malpractice insurance coverage and current professional license verification, including information about any actions against a license and the nature of the action.

A 048 Medical Staff - Bylaws
The governing body and medical staff failed to review the medical staff bylaws and rules and regulations annually, as prescribed in the bylaws.

A 084 Contracted Services - Safe and Effective
The governing body and it's representative Chief Executive Officers (current interim CEO and previous CEO), failed to institute a process to review all contracted services on a regular basis to ensure the services were provided in a safe and effective manner.

A 085 Contracted Services - List of Contracts
The hospital failed to maintain a complete and accurate list of all contracted services, which included a description of the scope and nature of the services provided.

Based on the manner and degree of deficiencies cited, the hospital failed to be in compliance with the Condition of Nursing.

The facility failed to meet the following standards under the Condition of Nursing Services:

A 393 Nursing Services - RN/LPN Staffing
The hospital failed to ensure that a registered nurse was immediately available for bedside care in each patient care unit.

A 394 Nursing Services - Licensure of Nursing Staff
The hospital failed to ensure that hospital nursing personnel had a valid and current license or certification, with no adverse action against the license.

A 405 Nursing Services - Administration of Drugs -
The hospital failed to ensure that opened multiple dose vials of medication were labeled with an opening date and were discarded after 28 days, as required by hospital policy.

Based on staff interviews and review of facility documents, the hospital failed to ensure that credential files for all medical staff and allied health staff contained delineation of privileges documentation, current proof of malpractice insurance coverage and current professional license verification, including information about any actions against a license and the nature of the action.

Findings:

1. On 08/21/12, the credential files for 4 physicians and 2 allied health practitioners (AHP) were reviewed. The review revealed that none of the 6 files reviewed contained a current request for privileges, with specific delineation of privileges, in the application or a delineation of the privileges granted in the appointment documents. In addition, the file of one AHP had an expired proof of malpractice insurance coverage, with an expiration date of 02/03/12. The physician was a locum tenens physician that was still working at the facility and was on the current call schedule. In addition, the credential files only contained photocopies of the wallet-sized license cards issued by the professional licensing agency, rather than the professional license verification report, available on-line from the issuing professional board, which would have provide information about any current or prior adverse actions against the professional's license. One credential file for an allied health professional contained a wallet-sized photocopy of the AHP's registered nursing license, but not the advanced practice license under which the AHP was practicing as a nurse anesthetist.


2. On 08/23/12 at approximately 9:00 a.m. the staff member in charge of the credential files was interviewed and confirmed the findings in the files. The CFO, who was also present with the DON, stated that the delineations of privileges had previously been a part of the appointment/reappointment process and had been contained in the files. They were unclear how the written documentation regarding delineation of privileges had fallen out of the process and was no longer a part of the credential files. They stated that the lapse would be corrected going forward. The CFO, who managed contracts, stated that the proof of malpractice coverage for the locum tenens physician was in his/her work to be filed, but had not been forwarded to the staff member maintaining the credential files. They had no explanation regarding the advanced practice nurse that did not have the current specialized license in his/her file. The person maintaining the files stated that s/he did not realize that the professional would have a separate licensed beyond the basic nursing license for the advanced practice nursing s/he was providing at the hospital, as a nurse anesthetist.

3. Review on 8/22/12 of the Medical Staff Bylaws revealed the following, in part:
"ARTICLE VII - DETERMINATION OF CLINICAL PRIVILEGES
7.1 EXERCISE OF PRIVILEGES
Every practitioner or other professional providing direct clinical services at this hospital by virtue of medical staff appointment or otherwise shall, in connection with such practice and except as other wise provided, in Sections 7.4 and 7.6, be entitled to exercise only those clinical privileges or specified services specifically granted to him by the Board.
7.2 DELINEATION OF PRIVILEGES IN GENERAL
7.2.1 REQUESTS
Each application for appointment and reappointment to the medical staff must contain a request for the specific clinical privileges desired by the applicant. Privileges granted to Doctors of Osteopathy may include musculoskeletal manipulation if requested by the practitioner and approved by the Medical Staff and the Board of Trustees. A request by staff appointee pursuant to Section 6.6 for a modification of privileges must be supported by documentation of additional training and/or experience supportive of the request.
7.2.2 BASIS FOR PRIVILEGES DETERMINATION
Requests for clinical privileges shall be evaluated on the basis of the practitioner's education, training, experience and demonstrated ability and judgement and confirmed health status. The bases for privileges determination to be made in connection with periodic reappointment or otherwise shall include observed clinical performance and the documented results of the patient care audit and other quality review and evaluation activities required by these and the hospital by-laws to be conducted by the hospital. Privileges determination may also be based on pertinent information concerning clinical performance obtained from other sources, especially other institutions and health care settings where a practitioner exercises clinical privileges. This information shall be added to and maintained in the medical staff file established for a staff appointee.
7.2.3 PROCEDURE
All requests for clinical privileges shall be processed pursuant to the procedures outlined in Article VI.

ARTICLE VI - PROCEDURES FOR APPOINTMENT AND REAPPOINTMENT
6.1 GENERAL PROCEDURES (Physicians and Dentists)
The medical staff shall investigate and consider each application for appointment and reappointment to the staff and each request for modification of staff appointment status or privileges and shall adopt and transmit recommendations thereon the the Board of Trustees. The medical staff shall perform these same investigations, evaluation and recommendation functions in connection with any AHP (Allied Health Professional) or other individual who seeks to exercise clinical privileges or provide specified services in any service of the hospital, whether or not such individual is eligible for medical staff appointment.
6.2 APPLICATION FOR INITIAL APPOINTMENT
6.2.1 APPLICATION FORM
6.2.2 CONTENT
The application form shall include:
c. Requests - Requests stating the staff category, clinical privileges for which the applicant wishes to be considered.
e. Professional sanctions - Information as to whether any of the following have ever been or are in the process of being denied, revoked, suspended, reduced, not renewed or voluntarily relinquished:
1. Staff membership status or clinical privileges at any other hospital or health care institution.
4. License to practice any profession in any jurisdiction.
6.4.3 MEDICAL STAFF ACTION
Upon receipt, the MEC (Medical Executive Committee) shall review the application and supporting documentation, conduct personal interviews, as deemed necessary with the applicant and transmit a written report and recommendations as to staff category, clinical privileges to be granted and any special conditions to be attached to the appointment.
6.4.5 BOARD ACTION
6.4.8 NOTICE OF FINAL DECISION
a. Notice of the Board's proposed decision will be given, through the Administrator, to the MEC, and to the applicant by means of notice, special or other.
b. A decision and notice to appoint shall include:
1. the staff category to which the applicant is appointed;
2. the clinical privileges he may exercise;
3. any special conditions attached to the appointment.
6.5 REAPPOINTMENT PROCESS
6.5.2 CONTENT OF REAPPOINTMENT APPLICATION
a. Continuing training, education and experience that qualified that staff appointee for the privileges sought on reappointment.
e. Sanctions of any kind imposed or pending by any other health care institution, professional health care organization or licensing authority.
f. Professional Liability Insurance - A statement that the applicant carries at least the minimum amount of $1,000,000.00 professional liability insurance coverage required by Section 15.2 and information on his malpractice claims history and experience during the past five (5) years, including a consent for the release of information by his present and past malpractice insurance carrier(s).
6.5.4 MEDICAL EXECUTIVE COMMITTEE ACTION
The MEC shall review each reappointment form and all other relevant information available to it and shall, on the prescribed form to the Administrator for transmittal to the Board its report and recommendations that appointment be either renewed, renewed with modified staff category, and/or clinical privileges, or terminated.
6.6 REQUEST FOR MODIFICATION OF APPOINTMENT STATUS OR PRIVILEGES
A staff appointee may, either in connection with reappointment or at any other time, request modifications of his staff category, or clinical privileges by submitting a written application to the Administrator on the prescribed form. Such application shall be processed in substantially the same manner as provided in Section 6.5 for reappointment."




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Based on review of facility documents and staff interviews, the governing body and medical staff failed to review the medical staff bylaws and rules and regulations annually, as prescribed in the bylaws.

Findings:

1. Review on 8/21/12 of the "Medical Staff Bylaws, Rules and Regulations," requested at the entrance conference, revealed that the document was last reviewed by the medical staff on 10/22/10 and last reviewed by the board on 10/29/10, based on the signature review page on the front of the documents. The title page of document stated that the document was last revised 12/96.

Further review of the bylaws revealed the following, in part:
"12.4.10 BYLAWS REVIEW AND REVISION FUNCTION
The duties in maintaining the appropriate by-laws, rules and regulations and other organization documents pertaining to the staff are to:
a. Conduct an annual review of the bylaws and the rules and regulations, procedures and forms promulgated in connection therewith.
b. Submit recommendations to the MEC (Medical Executive Committee), unless other wise documented and to the Board for changes in these documents.
c. Act upon all matters specified in (a) above as may be referred by the Board, the Joint Conference Committee, the MEC, the Chief of Staff, Administration and committees of the staff."

2. Review of the hospital bylaws on 08/21/12 revealed the following in part:
"ARTICLE IX
MEDICAL STAFF
9.4 Medical Staff Bylaws - There shall be Bylaws, Rules and Regulations for the Medical Staff, setting forth its organization and government. Periodic review of these Bylaws, Rules and Regulations shall be accomplished by the Medical Staff to assure consistency with Hospital policy, legal requirements, and applicable standards. The proposed Bylaws, Rules and Regulations may be recommended by the Medical and Dental staff, subject to approval by the Board. The power of the Board to adopt or to amend Medical and Dental Staff Bylaws, Rules and Regulations shall not be dependent upon ratification by the Medical and Dental Staff."

Based staff interviews and review of facility documents. the governing body and its representative Chief Executive Officers (current interim CEO and previous CEO), failed to institute a process to review all contracted services on a regular basis to ensure the services were provided in a safe and effective manner.

Findings:

1. The hospital failed to institute a process for regular evaluation of performance for contracted services, to ensure the were being provided in a safe and effective manner that ensured the safety of patients, staff and visitors.

a. On 08/22/12 at 10:15 a.m., the Chief Financial Officer (CFO), who was in charge of managing the hospitals contracts, was interviewed, along with the interim CEO and the Director of Nursing (CNO). The CFO acknowledged that the hospital did not have a current system in place to evaluate the quality of contracts, except from a financial perspective. The CFO and CEO confirmed that the contracts did not currently include specific performance standards that ensured safety and effectiveness. The CEO also acknowledged that evaluation of all contracts from a clinical safety/effectiveness point-of-view would be a standard management tool in a health care setting. S/he stated that such a process would be a "Management 101" activity. All three managers recognized that there were multiple file cabinets full of contracts, some of which might be old and no longer in effect. The CEO acknowledged the problem, but expressed concerns about the manpower hours that would be needed to go through all of the contracts to bring everything up to date. The CNO, who will be assuming the interim CEO position at the first of the next month (September), expressed confidence that the current contracts could be identified and a system put in place to evaluate active contracts for safety and effectiveness, rather than that being delayed by the daunting task of reviewing and archiving all of the old contracts simultaneously. S/he and the CFO agreed that the organizing of old contracts could happen after current contracts were addressed with a new review process.

2. The hospital failed to ensure that the contracted radiation physicist provided consistent oversight of the radiology department and provided accurate and complete reports of equipment inspections and review of radiation safety processes, including staff/patient protective devices, such as lead aprons and dosimetry badges.

a. On 08/22/12, a physicist report that appeared to have been prepared in February, 2012, was reviewed. The report was provided by the Director of Radiology and Imaging. Initial review was conducted to determine if there was documentation in the prepared report that the physicist had inspected the protective equipment and reports of the dosimetry badges, to ensure the continued safety of patients and staff. Further review on 08/29/12 revealed that the report contained information on the credentials of a radiologist related to another hospital, with the letterhead of the other hospital. It also included reports of radiology rooms in a third hospital. The report, which also contained a page related to some of the inspection activities entitled " Administrative Controls," did not have any information identifying the administrative controls as having been assessed at the hospital being surveyed. Because of the information found in the report that did not relate to the hospital and appeared to have been included in the report accidentally by the physicist, it was not possible to rely on parts of the report that did not specifically refer to the hospital being surveyed.

3. The hospital failed to ensure that a personnel file was maintained for the radiology technician that was provided by the contract nuclear medicine entity, to ensure the skills and qualifications of the technician.

a. During the tour/observation of the radiology department on 08/22/12 at 9:15 a.m., it was determined that the nuclear medicine was provided under contract, that the hospital physician was present during the nuclear medicine cardiac testing, and that the nuclear material was injected by a technician that was an employee of contract nuclear medicine entity. Subsequently, a personnel file of the technician was requested, to assess compliance with a state licensure requirement that the hospital maintain a personnel file, including qualifications, education, training and background check. After the tour, the director of radiology and imaging was asked to provide the personnel file for the nuclear medicine technician. S/he stated that they did not have/maintain a file, because the technician was not an employee of the hospital. S/he stated that there was a way to go to a website to get that information. On 08/23/12 at 9:30 a.m., the director of radiology and imaging provided a file s/he had compiled after going to the website to access the information about the technician's qualifications, after the surveyor request was made.

Based on staff interviews and review of facility documents, the hospital failed to maintain a complete and accurate list of all contracted services, which included a description of the scope and nature of the services provided.

Findings:

1. On 08/22/12 the list of contracted services provided by the facility was reviewed. The list of services was a hand-written list titled "Service Agreements," that was provided by the Chief Financial Officer (CFO). The list was compared against a list of contracted services that the surveyors had compiled, based on tours and interviews. The surveyor compiled list included the following:
- contracted nuclear medicine
- transfer agreements
- organ procurement organization
- donor eye bank
- locum tenens physicians
- contracted laundry
- contracted preventive medical equipment inspections
- food
- contract dietician/dietary consultant
- inspection of fire suppression hood in kitchen
- pest control
- biomedical waste removal
- trash removal
- fire inspections
- oxygen/medical gases
- consultant physicist
The facility list did not include any of the goods/services that the surveyors had determined were being provided under contractual agreements in the hospital. The CFO was interviewed on 08/22/12 at 10:15 a.m., and acknowledged that the list was not complete and that such a list did not currently exist in the facility. S/he acknowledged that s/he was unaware of a requirement to maintain such a list. The findings were also confirmed by the Chief Executive Officer (CEO) and the Director of Nursing (DON), who were also present. The CEO, who had been at the facility since 01/12 in an interim position, stated that/she was familiar with the requirement and had no explanation for the fact that such a list was not being maintained. The CFO stated that s/he was working with a new software product that would create a complete and accurate list of contracted services for future compliance.

Based on observations and interviews the hospital failed to ensure that a registered nurse was immediately available for bedside care in each patient care unit.


On 08/22/2012 at 10:15 a.m., an interview was conducted with the Registered Nurse (RN) that was working the medical/surgical unit. S/he stated that they staffed the facility with one RN and one Certified Nursing Assistant (CNA). The RN staffed the inpatient area. When a patient came to the Emergency Department the RN would then go to the ED to do patient care. At that time they would call the backup RN to come in to work. S/he stated that the Licensed Practical Nurse (LPN) or the CNA would cover the floor until the backup RN arrived. They did not have any LPN's on staff, so the person left to cover the unit was always the CNA.

On 08/22/2012 at 10:25 a.m., a review of the facility's staffing schedule for the month of August 2012 revealed that there was only one RN scheduled daily. They also had a schedule for the month of August 2012 with the name of the back-up RN listed for each day of the month.

On 08/22/2012 at 1:15 p.m., an interview was conducted with the Director of Nursing (DON). S/he confirmed that they staffed one RN for the facility per shift. When a patient came into the ED the RN would then go to that department. S/he stated that if s/he were in the facility s/he would staff the ED. If s/he were not there, then they would call the back up RN. They required the back up RN to report to work within 15 minutes.

Based on interviews, human resource file reviews the hospital failed to ensure that hospital nursing personnel had a valid and current license or certification.

1. On 08/22/2012 at 2:00 p.m., a review of 10 human resource files was conducted. It was revealed that there was no evidence of an inquiry to verify whether the licenses or certifications had any actions against them, and the nature of the actions.

2. On 08/22/2012 at 1:15 p.m. an interview with the Director of Nursing (DON) and the Human Resource Manager was conducted. They both stated that they were under the impression that they were not supposed to look into individual licenses and certifications, because of personal privacy issues.

Based on tours/observations, staff interviews and review of facility policy, the hospital failed to ensure that opened multiple dose vials of medication were labeled with an opening date and were discarded after 28 days, as required by hospital policy.

Findings:

1. On 08/21/12 at approximately 3 p.m., a tour of the medication room, pharmacy and emergency department was conducted. During the tour of the medication room on the patient care unit, an open multi-use vial of pneumovax with a hand-written date of 04/26/12 was found in the medication refrigerator. In addition, a multi-dose vial of tuberculin skin testing solution, with a date of 6/19/12 was found in the same medication refrigerator. In the emergency department, in the main trauma room, an opened multi-dose vial of Xylocaine was found on the shelf with no open or discard date hand-written on the vial, as required. The findings were confirmed with the Director of Nursing (DON), who accompanied the surveyor on the tour. The DON confirmed that the medications should have been properly labeled and/or discarded after 28 days. All three vials were removed during the tour and discarded.

2. Review on 08/23/12 of the hospital pharmacy policy/procedure entitled "Multi-Dose Vials" revealed the following, in part:

"POLICY: Proper use of multi-dose vials.
PROCEDURE:
Multi-Dose Vials
A multi-dose vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that contains more than one dose of medication. Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.

Use of Multi-Dose Vials
Multi-Dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If (a) multi-dose vial enters the immediate patient treatment area, it should be dedicated to that patient only and discarded after use.

Examples of the "Immediate Patient Treatment Area"
Examples of the immediate patient treatment area include patient rooms or bays and operating rooms.

Discarding Multi-Dose Vials
Medication vials should always be discarded whenever sterility is compromised or questionable. In addition, the United States Pharmacopoeia (USP) General Chapter 797 recommends the following for multi-dose vials of sterile pharmaceuticals:
- If a multi-dose has been opened or accessed (e.g., needle-punctured), the vial should be dated and discarded within 28 days unless the manufacturer specifies a different date for that opened vial."

Based on tours, staff interviews and review of facility documents, the hospital failed to ensure that the contracted radiation physicist provided consistent oversight of the radiology department and provided accurate and complete reports of equipment inspections and review of radiation safety processes, including staff/patient protective devices, such as lead aprons and dosimetry badges.

Findings

1. On 08/22/12, the radiology policy/procedure entitled "Regulatory Agency Inspections" was reviewed and revealed the following, in part:

"PURPOSE: TO ASSURE EQUIPMENT PERFORMS PROPERLY AND MEETS THE SPECIFICATIONS AND GUIDELINES SET FORTH BY REGULATORY AGENCY.

POLICY:
1. Annual inspection will be done on all radiation producing equipment and protective devices.
2. Inspections will be done by a qualified physician or qualified medical radiation physicist.
3. Standards of compliance will be based on recommendations set forth by the National Council on Radiation Protection and Measurements or equivalent agency.
4. Policy and procedure manuals will be inspected also.
5. Radiation dosages to personnel will be checked and monitored.
6. Radiation dosages to patients per type of examination will be checked and monitored.
7. A report of the inspection will be made listing compliance and deficiencies.
8. If any deficiencies are listed or calibration are needed, these will be corrected and performed by qualified service personnel.
9. All inspections and corrections will be reported to the State Department of Health.
10. Licensing of each approved piece of equipment will be done by the State Health Department with certification stickers to be affixed to each piece of equipment."

2. On 08/22/12, a physicist report that appeared to have been prepared in February, 2012, was reviewed. The report was provided by the Director of Radiology and Imaging. Initial review was conducted to determine if there was documentation in the prepared report that the physicist had inspected the protective equipment and reports of the dosimetry badges, to ensure the continued safety of patients and staff. Further review on 08/29/12 revealed that the report contained information on the credentials of a radiologist related to another hospital, with the letterhead of the other hospital. It also included reports of radiology rooms in a third hospital. The report, which also contained a page related to some of the inspection activities entitled " Administrative Controls," did not have any information identifying the administrative controls as having been assessed at the hospital being surveyed. Because of the information found in the report that did not relate to the hospital, and appeared to have been included in the report accidentally by the physicist, it was not possible to rely on parts of the report that did not specifically refer to the hospital being surveyed.

Based on observations and interviews the facility failed to ensure that clean linens were protected against contamination.

Findings:

1. On 08/22/2012, 10:30 a.m., a tour of the medical/surgical unit was conducted with the Director of Nursing (DON). The entrance to the clean utility room had a door that was closed. Once inside the room it was noted that there were many open shelves with stacks of clean linen on them. The shelves did not have anything covering them to protect the linens. The DON stated "they don't need a cover because they are in a room with the door shut." The door to the clean linen room was frequently opened by staff to retrieve linens for patients, exposing the clean linens to contaminates.

Based on interview and human resource file review, the facility failed to ensure that the nursing staff had the specialized training and certifications needed in emergency care.

Findings:

On 08/22/2012 at 11:00 a.m., a review of personnel files revealed that neither the Director of Nursing (DON) nor any of the Registered Nurses held a Pediatric Advanced Life Support (PALS) certificate.

On 08/22/2012 at 1:15 p.m., an interview with the DON was conducted. S/he verified that none of the nursing staff at the hospital had PALS training, but they were all signed up to take the course. All Registered Nurses worked the inpatient care unit and the Emergency Department and were certified in Advanced Care Life Support (ACLS). The DON stated that the hospital did provide medical care to patients of all ages, including infants and children.

Based on observations and interviews the facility failed to ensure that patient records were secured from unauthorized individuals.

On 08/21/2012 at 2:45 p.m., a tour of medical records was conducted with the Director of Medical Records. S/he stated that all medical records were kept on the premises. The most current records were kept in a closed area next to the office of the Chief Executive Officer (CEO) and the Chief Financial Officer (CFO). The door to that room did not have a lock. The Director of Medical Records stated that the two doors leading out of that area could be locked, but were left open during business hours. S/he stated nursing staff had access to the records during off-hours.

On 08/23/2012 at 9:20 a.m. the CFO stated that the doorknob on the door to the medical records storage area next to the CEO and CFO's office had been replaced, with a door knob that has a lock. S/he also stated that there would be limited access to the storage area.

Based on tours/observations and staff interviews, the hospital failed to maintain a personnel file for the contract nuclear medicine technician, and to review the technician's qualifications, including job title, education, experience, special training and any required licensure/certification.

Findings:

1. The hospital failed to maintain a personnel file that contained evidence of education, training, qualifications and background check, for a contracted nuclear medicine technician whose role was to inject nuclear material intravenously into patients having nuclear medicine diagnostic testing.

a. During the tour/observation of the radiology department on 08/22/12 at 9:15 a.m., it was determined that the nuclear medicine was provided under contract, that the hospital physician was present during the nuclear medicine cardiac testing, and that the nuclear material was injected by a technician that was an employee of contract nuclear medicine entity. Subsequently, a personnel file of the technician was requested, to assess compliance with a state licensure requirement that the hospital maintain a personnel file, including qualifications, education, training and background check. After the tour, the director of radiology and imaging was asked to provide the personnel file for the nuclear medicine technician. S/he stated that they did not have/maintain a file, because the technician was not an employee of the hospital. S/he stated that there was a way to go to a website to get that information. On 08/23/12 at 9:30 a.m., the director of radiology and imaging provided a file that s/he had compiled after going to the website to access the information about the technician's qualifications, after the surveyor request was made.