HospitalInspections.org

Chapter 51: 51.24(3) Health Examinations. Health examinations for all personnel shall be required at the commencement of employment and there after at least every four years. The examination shall include at a minimum, the health and tuberculosis status of the employee ...

Based on personnel record reviews, staff interview and hospital policy/ procedure review the Critical Access Hospital (CAH) failed to provide health exam and/or tuberculosis (TB) skin tests every 4 years for 4 of 5 volunteer (Volunteer F,G,H,I, and J) and 1 of 19 Staff (Staff P). The Administrator identified an average of 10 inpatients per day.

Failure to provide TB skin testing for staff and volunteers every 4 years could potentially place patients at risk for contacting an infectious disease.

Findings include:

1. Review of the CAH volunteer records on 4/27/2011 revealed 4 of 5 volunteers lacked documentation of health exam and a TB skin test completed every 4 years and 1 of 5 volunteers prior to their start date.

a. Volunteer F's personnel record revealed a start date of June 2004 included a health exam dated 6/27/2005 and lacked a completed TB skin test.

b. Volunteer G's personnel record revealed a start date of April 2003 included a health exam dated 4/24/2007 and lacked TB skin test.

c. Volunteer I's personnel record revealed a start date of June 2003 included a TB skin test dated 6/21/2005 and lacked a health exam.

d. Volunteer J's personnel record revealed a start date of January 2006 included a TB skin test and a health exam dated 1/26/2006.

e. Volunteer H's personnel record revealed a start date of January 2011 and lacked a completed TB skin test and health exam prior to their start date.

f. Staff P's personnel record revealed a hire date of August 1990 included a TB skin test dated 6/25/2004 and a health exam dated 2/8/2002.

2. During an interview on 4/2711 at 9:00 AM Staff D, Infection Control Nurse, confirmed the volunteers (F, G, I, and J) did not have an updated health exam and/or TB test. Staff D confirmed volunteer (H) did not have a completed health exam and/or TB test prior to their start date.

During an interview on 4/27/11 at 1:50 PM Staff E, Marketing Communications Specialist said volunteers use to have a health exam and a TB skin test upon hire. Staff E stated, as of 2/2/2010, the volunteers up for renewals and new volunteers did not have health exams and TB test completed.

During an interview on 4/27/11 at 1:45 PM Staff C, Employee Health Manager, confirmed the volunteers lacked an updated TB skin test and/or a health exam. Staff C confirmed the volunteers worked the gift shop and at times delivered mail to the patients.

During an interview on 4/27/11 at 9:20 AM, Staff E stated the CAH did not have any policies for volunteers.

Based on review of the blood bank agreement, Medical Staff Meeting minutes, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH's Medical Staff approved the updated blood bank agreement. The Laboratory administrative staff reported the laboratory had 21 units of blood products available to CAH patients daily.

Failure to ensure a current, approved blood bank agreement was in place could potentially interrupt the availability of blood products needed for emergencies resulting in patient harm and/or death.

Findings include:

1. Review of the "Amendment to the Blood Services Agreement between the American Red Cross . . . and Regional Medical Center. . . .", signed by the CAH's Chief Executive Officer on 10/26/2010 revealed amendments to the contract commencing on October 26, 2010.

The blood agreement lacked approval by the CAH's Medical Staff.

2. Review of the CAH's Medical Staff Meeting minutes from October 2010 through April 2011 revealed the Blood Bank Agreement Amendment lacked approval by the CAH's Medical Staff.

3. During an interview on 4/28/11 at 9:35 AM, Staff O, Chief Nursing Officer, acknowledged the Blood Bank Agreement Amendment dated October 26, 2010 lacked approval by the CAH's Medical Staff.

Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) Radiology administrative staff failed to ensure ultrasound staff tested the disinfecting solution in 1 of 1 disinfecting bottle prior to each use per manufacturer's recommendations. (Ultrasound) The Radiology Director identified an average of 26 ultrasound procedures using the transvaginal probe per month.

Failure to test the disinfecting solutions prior to each use could potentially result in the disinfecting solution lacking sufficient strength of the active ingredient to kill all microorganisms, resulting in the spread of infectious microorganisms between patients.

Findings include:

1. Observations, during a tour of the Radiology Department (Ultrasound), on 4/26/11 at 10:30 AM, revealed 1 of 1 disinfecting bottle contained MetriCide OPA Plus Solution.

2. Review of the MetriCide OPA Plus Solution Test Log, revealed Staff K, Sonographer, failed to test the MetriCide OPA Plus Solution prior to each use in accordance with the manufacturer's recommendations.

3. During an interview, at the time of the tour on 4/26/11 at 10:30 AM, Staff K reported only testing the MetriCide OPA Plus Solution daily.

4. Review of the manufacturer's directions for Metricide OPA Plus Solution revealed in part, "Always use Metricide OPA Plus Test Strips to monitor the concentration of [active ingredient] before each use. . . ."

5. Review of CAH policy/procedure on 4/26/11 titled, "Endovaginal Transducer Disinfection", dated February 2008, revealed in part, "Policy: To adequately disinfect the endovaginal transducer after patient use to ensure sterility and cleanliness for all patients. Procedure: . . . Daily litmus test of the Cidex is performed. The results of the litmus test are documented on the Cidex Solution Log Sheet. . . ."

The policy/procedure failed to address testing the MetriCide OPA Plus disinfecting solution prior to each use in accordance with the manufacturer's recommendations.

Based on review of documents and staff interview, the Critical Access Hospital (CAH) Dietary Staff failed to ensure the Medical Staff approved the Diet Manual updates.

The CAH Dietitian stated the dietary staff provided approximately 30 meals per day.

Failure to ensure the Medical Staff approve the updates to the Dietary Manual could potentially result in diet adjustments without Physician knowledge.

Findings included:

1. Review of dietary policies showed the CAH lacked a current policy that required Medical Staff approval of the Simplified Diet manual and/or updates adopted by the registered dietitian.

The Medical Staff meeting notes lacked documented evidence the Medical Staff approved the Dietary Manual.

2. During an interview on 4/26/11 at 4:30 PM, the Chief Nursing Officer (CNO) confirmed they could not find evidence that showed the Medical Staff had approved the Simplified Diet Manual.

Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) Radiology administrative staff failed to provide a dosimeter badge (radiation-detecting device) to all staff exposed to radiation in the operating room during surgical procedures utilizing the C-Arm fluoroscope. The CAH surgical staff performed 4 surgical procedures utilizing the C-Arm fluoroscope from 8/1/10 - 4/27/11, with 1 of 1 Orthopedic Physician in the operating room without a dosimeter badge during the procedures that utilized the C-Arm fluoroscope. (Physician A)

Failure to provide dosimetry badges could potentially result in staffs ' exposure to unintentional and unknown amounts of ionizing radiation, potentially causing cancer or death.

Findings include:

1. Observations, during a tour of the Surgery Department, on 4/26/11 at 1:35 PM showed the facility had 1 C-Arm Fluoroscope machine.

2. During an interview on 4/26/11 at 9:15 AM, Staff L, Radiology Manager, stated all surgery staff present in the operating room during surgical procedures utilizing the C-Arm Fluoroscope had dosimeter badges except for the Orthopedic Surgeons including Physician A.

3. During an interview on 4/26/11 at 1:35 PM, Staff M, Manager OR, stated during use of the C-Arm Fluoroscope, all surgical services staff leaves the room, except for the surgeon, anesthesia provider, and radiation technologist and the surgeon could receive an undetected amount of unintentional exposure to radiation since the orthopedic surgeons do not wear dosimeter badges.

4. Review of CAH policy/procedure on 4/26/11 titled, "Radiation Protection - OR Nursing Personnel", dated March 2008, revealed in part, "Policy: The Iowa Radiation Emitting Equipment rules require all facilities who have radiation emitting equipment to establish diagnostic x-ray safety procedures. The purpose of these safety procedures is to minimize radiation exposure to the patients and personnel and produce the best radiographic image possible with the least amount of human radiation. . . Procedure: Personnel film dosimeters are recommended for use by personnel who may routinely be exposed to radiation such as radiographer and surgeon. Dosimeter film badges are available for these individuals. . . ."

Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to protect all confidential patient information from unauthorized access in 1 of 1 Radiology department, 1 of 1 Therapy department, and 2 of 3 Basement Storage rooms. The Physical Therapy administrative staff identified an average of 16 in-patients/out-patients per day in the Therapy department. The Administrator identified an average of 10 inpatients per day.

Failure to secure medical records against unauthorized access could result in identity theft and/or unauthorized disclosure of personal medical information.

Findings include:

1. Observations on 4/26/11 at 9:15 AM, during the tour of the Radiology department, with Staff L, Radiology Manager, revealed 14 unsecured film jackets that contained patient identifying information, x-rays, and reports in an open area, called the Mammography workspace.

2. During an interview on 4/26/11 at 9:15 AM, Staff L, Radiology Manager stated the housekeeping staff cleaned the Radiology department, including the Mammography workspace, between 5:30 AM and 6:30 AM. Staff L further acknowledged Radiology staff was not present when the housekeeping staff cleaned the department. According to Staff L, Radiology staff left the film jackets that contained patient identifying information, x-rays, and reports in the unsecured Mammography workspace overnight.

3. During an interview on 4/27/11 at 9:45 AM, Staff P, Housekeeping Supervisor, stated the housekeeping staff had access to the Radiology department and entered the department at 5:30 AM to clean the department when no Radiology Staff were present.

4. Observations on 4/26/11 at 10:00 AM, during the tour of the Therapy department, with Staff Q, Physical Therapy, revealed an unlocked 6 shelf bookcase that contained patient medical records.

5. During an interview on 4/26/11 at 10:00 AM, Staff Q stated housekeeping staff had a key to the Therapy department and cleaned the department, without supervision of therapy staff, after the Therapy Department had closed and staff left for the day.

6. Observations on 4/27/11 beginning at 8:45 AM, during the initial tour of the physical environment, with Staff R, Maintenance Coordinator and Staff S, Chief Financial Officer, revealed 2 of 3-basement storage rooms (Rooms A and C) used for medical record storage.

Observation revealed the following confidential patient information in Room C.
- approximately 2400 Radiology film jackets that contained patient films and patient reports
- 4 boxes of Respiratory Therapy patient records
- 18 boxes of Laboratory patient records
- 21 boxes of X-Ray patient records
- Health Information Records - 52 boxes of patient records
- 17 boxes labeled Pharmacy including patient physician orders and patient prescriptions
- 1 box of Emergency Room patient records
- 50 boxes of Therapy patient records
- 1 box of Stress Test patient records
- 72 boxes Community Health and Public Health patient records
- 1 box of Ambulance patient records
- 1 of 1 unlocked file cabinet that contained approximately 260 patient records from another hospital.

Observation revealed the following confidential patient information in Room A.
- 1 unlocked 5 drawer file cabinet that contained Emergency Room and Operating Room log books
- 1 unlocked 4 drawer file cabinet that contained Critical Care Unit Register, Medical/Surgical Discharge Register, Clinic Log.
- 1 unlocked 4 drawer file cabinet that contained x-ray logs and personnel wage and tax information.
- 24 Radiology film jackets on a cart that contained Radiology logs including patient names and examinations ordered.

7. During an interview on 4/27/11 at 10:00 AM, Staff R, Maintenance Coordinator, stated Maintenance staff had keys for Basement Storage Rooms A, B, C. Other staff including Maintenance, Home Care, Radiology, and Community Health could check out the keys from the Maintenance department. Staff from these areas would log out the key and enter the storage room unsupervised.

8. During an interview on 4/28/11 at 8:02 AM, Staff S, Chief Financial Officer, reported that Maintenance had keys and made them available to staff including Maintenance, Home Care, Radiology, and Community Health. Information Technology staff had keys and made them available to staff including Lab. Administration staff also had keys and made them available to other staff including Health Information and Public Health. Staff from these other areas would log out a key and enter the storage room unsupervised.

9. Review of the Key log charts from Maintenance and Administration showed staff from Maintenance, Home Care, Radiology, and Community Health had signed out keys to Basement Storage Rooms A and C then entered the rooms without supervision.

10. Review of CAH policy/procedure on 4/26/11 titled, "Storage and Security of Medical Records" dated August 2008, stated in part "Policy: All medical records shall be housed in physically secure areas under the immediate control of the Health Information Department. Areas housing health information shall be restricted to authorized personnel. . . "

11. During an interview on 4/12/11 at 10:20 AM, Staff T, Medical Services Coordinator stated he/she was not aware maintenance staff had a set of keys to the Basement Storage room or that staff from other departments could check out the key and enter the storage rooms without supervision.

I. Based on document review and staff interview, the Critical Access Hospital (CAH) Administrative staff failed to ensure 10 of 15 medical staff members, selected for review, received external peer review from an equivalent peer prior to reappointment to the Medical Staff (Physicians A, C, D, E, F, G, I, J, K, and L). The 4/22/11 Medical Staff Roster identified 130 members of the medical staff.

Failure to ensure all medical staff members received an external peer review from a physician reviewer with enough knowledge of the respective areas of practice to evaluate the medical records presented to him/her appropriately, prior to reappointment to the Medical Staff, could potentially result in the Board approving a physician's reappointment to the Medical Staff without assurance that the physician had the necessary knowledge and skills to provide safe care to patients of the CAH. Additionally, failure to ensure an equivalent external peer reviewed medical records for all medical staff members could inhibit the CAHs ability to identify when patients may have received inappropriate medical care.

Findings include:

1. Physicians A, C, D, E, F, G, I, J, K, and L's credential files lacked documented evidence that showed their external peer reviews were conducted by an equivalent peer. The documentation showed that Physician B, a Neuro Surgeon, performed the external peer reviews for the following physicians.

Physician A, Orthopedic Physician
Physician C, Family Physician
Physician D, Optometrist
Physician E, Dentist
Physician F, Orthopedic Physician
Physician G, Family Physician
Physician I, Radiologist
Physician J, Radiologist
Physician K, radiologist
Physician L, Family Physician

2. Review of the Quality Improvement Network Agreement dated 5/07, revealed in part, "...[Network Hospital], through participating members of its medical staff and other designated personnel shall assist RMC [Regional Medical Center] in evaluating the total quality assurance program annually at minimum. The evaluation shall include reviews of utilization of services at RMC (including at least the number of patients served, and the volume of service); a representative sample of both active and closed records to assure the appropriateness of the diagnosis and quality of treatment furnished by RMC; Regional Medical Center Quality Management, Utilization Review and Credentialing Policies and procedures...."

3. Review of "Credentials Committee Meeting" notes dated July 13, 2011, showed Physician B met bi-monthly with RN T and reviewed all applications for appointment and reappointment to the Medical Staff. During these meetings, Physician B conducted the external peer reviews for physicians applying for reappointment to the Medical Staff.

4. During an interview on 4/27/11 at 7:25 AM, RN T reported that Physician B worked for their Network Hospital as a Neuro Surgeon. Physician B conducted the external peer reviews for all of Regional Medical Center's physicians applying for reappointment. RN T confirmed that Physician B reviewed medical records for all departments of the medical staff including, for example, obstetrical, radiology, and surgery. RN T explained, for radiology medical records, Physician B did not view the films for accuracy of diagnosis but only reviewed the report written by the radiologist. Based solely on the radiologist's written report, Physician B would determine whether the diagnosis was accurate or not then make a check mark next to the radiologists name indicating he had reviewed the radiologist's diagnosis and determined that the diagnosis was accurate. RN T further reported that Physician B had performed the external peer reviews for Physicians A, C, D, E, F, G, I, J, K, and L prior to their reappointment to the Medical Staff and that these physicians had treated patients of the CAH prior to their reappointment in 2010.

5. During an interview on 4/28/11 at 10:30 AM, the CNO also confirmed Physicians A, C, D, E, F, G, I, J, K and L had provided treatment to patients at the CAH prior to their reappointment in 2010 and that Physician B had performed their external peer reviews. According to the CNO, Physician B performed all the external peer reviews at the Regional Medical Center, except for the Pathologist and Emergency Department physicians.

II. Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure that an appropriate external entity evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors of the CAH for 3 of 21 contracted Emergency Department (ED) physicians (Physicians M, N, and O). The 4/22/11 Medical Staff Roster identified 21 members of the contracted Emergency Department medical staff.

Failure to ensure all medical staff members received an external peer review from an appropriate external entity could potentially result in the Board approving a physician's reappointment to the Medical Staff without assurance the physician had the necessary knowledge and skills to provide safe care to patients of the CAH. Additionally, failure to ensure an external entity evaluated the quality and appropriateness of the diagnosis and treatment furnished by all medical staff members could potentially result in misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of Physician credential files showed that Physician P, Director of the Emergency Physician Association (EPA) performed the external peer reviews for EPA physicians M, N, and O.

2. EPA is a contracted service that provides weekend Emergency Department physician services to the CAH. Documentation showed that Physician P was the Medical Director for EPA and currently credentialed at the CAH.

3. During an interview on 4/28/11 10:30 AM, the Chief Nursing Officer (CNO) confirmed Physician P conducted the external peer reviews for Physicians M, N, and O. The CNO further stated the CAHs Medical Staff used these reviews when recommending the respective physician's reappointment to the Board and agreed the peer reviews conducted by Physician P would not constitute an external peer review.