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Based on document review and staff interviews, the facility administrative staff failed to consider their potential need for water and fuel during an interruption in service, as part of the planning for emergency fuel and water agreements. The administrative staff identified a census of 2 patients, an average daily census of 2 patients, and 89 employees.

Failure to ensure emergency water and fuel is available to meet the facility's critical functions during an emergency/crisis situation could potentially cause a lack of necessary resources to provide adequate patient care including electricity, heating, cooling, and potable water.

Findings include:

Review of a Memorandum of Understanding dated 8/28/09 revealed in part, "Northeast Iowa Co-op, Sumner branch agrees to provide: Diesel fuel for the hospital generator in case it runs low in an emergency. Also, if city water becomes unavailable, a water tank-truck could be provided on-site for the hospital's use...." The agreement lacked details of the potential needs of the facility or a timeframe for delivery of either water or fuel.

Review of a Memorandum of Understanding dated 9/23/09 revealed in part, "Schemmel's Family Foods agrees to provide: Bottled drinking water and grocery items for Community Memorial Hospital (CMH) in the event of an emergency...." The agreement lacked details of the potential needs of the facility or a timeframe for delivery.

Review of a Memorandum of Understanding dated 8/20/09 revealed in part, "Sumner Volunteer Fire Department agrees to provide: Water to fill the large tank in the CMH Ambulance garage and if available, a water-tank truck for use on-site, when city water is not available...." The agreement lacked details of the potential needs of the facility or a timeframe for delivery.

During an interview on 5/21/13, as part of the facility environment tour beginning at 8:30 AM, Staff F, Plant Services Manager, reported the facility's large non-potable storage tank was now in the biohazard storage room. He was not aware of any emergency supply of drinking water except for 2 cases of bottled water stored in the hazmat room, inside the ambulance garage. Observation of the hazmat room revealed 1 case of bottled water. During a follow-up interview on 5/21/13 at 1:45 PM, Staff F and Staff I, Health Information Management staff and Hospital Preparedness Planner, confirmed the facility failed to include an assessment of their needs during potential service interruptions as part of their emergency planning process.

Based on observation, review of documents, and staff interview, the facility failed to develop an active Infection Prevention Program that provided appropriate monitoring to ensure all surgical instruments were sterile and that an effective system was in place to identify, track, and monitor surgical site infections.
The facility failed to:
1. ensure Surgery Staff performed the sterile process correctly and used the Biological Indicator and Chemical Integrator according to the manufacturer's directions. (Refer to C-0278)

2. ensure the Infection Control Nurse developed and implemented an effective system to detect, track, and monitor surgical site infections. (Refer to C-0278)

The cumulative effect of these systemic failures and deficient practices resulted in the facility's inability to guarantee sterility of the surgical instruments and determine if surgical site infections had resulted.

I. Based on observation, review of documents, and staff interviews, the facility failed to ensure Surgical Staff employees followed the manufacturer's directions when using biological indicators and chemical integrators in 1 of 1 terminal sterilization autoclaves. The facility identified an average of 40-45 surgical procedures performed at the facility per month that required sterile surgical instruments.

Failure to follow the manufacturer's directions for challenging the biological indicators and chemical integrators resulted in the facility's inability to ensure items processed in the autoclave had sufficiently killed all microorganisms. Inadequate sterilization could potentially result in surgical instruments/tools passing microorganisms from one patient to the next and the patient acquiring an infection from the surgical instrument or tool.

Findings include:

1. Observation during the tour of the surgical department, on 05/21/13 at 9:50 AM, revealed the facility's sterilizing process used 1 sterilization autoclave (a device that uses steam pressure, heat, and time to kill all bacteria, viruses, and fungi on surgical instruments/tools) located in the sterilization room. Additional observations revealed 1 partial empty box of individual 3M Attest 1292 Rapid Readout Biological Indicator (BI - a tube approximately 1 inch by 1/8th inch in diameter that contained bacterial spores from the most difficult to kill bacteria. At the conclusion of an autoclave cycle the BI and chemical integrator should indicate all bacteria, viruses, and fungi were killed.).

During an interview on 05/21/13 at 1:00 PM, Staff K, Surgery/Infection Control Manager, stated surgical sterilization (autoclave) loads are not run daily, but only as needed; approximately 3-4 loads a week are run that include approximately 46 peel packs and 27 packages of surgical instruments/tools. A BI is placed in a load 1 time per week. The BI is always placed close to the door and in the fold of a paper wrap. Staff L, Purchasing Manager/Surgical Technician, and Staff K only run loads in the autoclave.

An interview with Staff L on 05/22/13 at 1:42 PM, revealed Staff L ran loads in the surgical sterilizer and placed a BI in 1 load a week in the same manner as Staff K. Staff K and L stated that they had received training on the use of the BI many, many years in the past. Both staff verified they had not received any additional or new training related to sterilization using the BI.

A phone interview on 05/21/13 at 1:55 PM with a 3M Customer Services Representative revealed staff need to process the BI in the same manner as the other items in the load, and place the BI near the drain and door, at the bottom, the most difficult area for the steam to reach. Staff K explained the process the facility was using to run the BI indictor. The representative stated placing the BI close to the door and in the fold of the paper wrap would not sufficiently challenge the BI to ensure killing all microorganisms and guaranteeing sterility. The representative recommended that staff run a BI in each sterilization load to ensure killing of all microorganisms and guarantee sterility.

Review of the Sterilization Log dated 2-3/13 revealed weekly loads included the BI with positive steam sterilization completion (meaning the BI indicated all microorganisms were killed).

Review of the manufacturer's directions titled "3M Attest 1292 Rapid Readout Biological Indicator (RRBI)", dated 2005, stated in part, "Monitoring Frequency: Monitor every load that contains critical medical devices and implants with an Attest 1292 RRBI placed in the appropriate test tray or package, now referred to as process control device, to improve the outcome of the sterilization process and patient safety."

Review of a policy titled "Biological Indicators", dated 06/09/1992, revealed in part, "Purpose, to monitor steam sterilization cycles to ensure that sterilization is maintained. Testing shall be performed weekly unless a positive growth results." However, the policy lacked instructions regarding where to place the BI during the sterilization process.

Review of a policy titled "Steam Sterilization", dated 06/08/2000, revealed in part, "Purpose, to provide guidelines for steam sterilization techniques. A biological monitor shall be used weekly to test the sterilizer by using a live spore test to verify sterilization process." However, the policy lacked instructions regarding where to place the BI during the sterilization process.

2. Observation during the tour of the surgical department, on 05/21/13 at 9:50 AM, revealed 1 partially empty box of 3M Comply Integrator Extender (a chemical integrator is a paper wick 9 inches long and 3/8 inch wide with a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked REJECT or ACCEPT. The extent of migration depends on steam, time, and temperature at the conclusion of an autoclave cycle.).

Upon request, on 05/22/13 at 1:30 PM, staff opened 3 sterilized surgical instrument/tool packages for inspection. Observation of the open packs revealed staff failed to place a chemical integrator in a peel pack, single layer instrument pack, and 1 chemical integrator on the top shelf of a 2-layer pack.

During an interview while opening the surgical packs, Staff K reported a chemical integrator is placed in each load they run, but not in each package they run. Chemical integrators are used only if there is more than 1 layer of instruments/tools. Peel packs have no chemical integrators and single layer packs have no chemical integrator.

An interview on 05/22/13 at 1:42 PM with Staff L revealed staff do not place chemical integrators in each package sterilized. Staff K and L stated they had received training on the use of chemical integrator many, many years in the past. Both verified they had not received additional or new training related to sterilization using the chemical integrator.

Review of manufacturer's directions for the 3M Comply (SteriGage) Steam Chemical Integrator, dated 09/08, sated in part, "The dynamics of steam prove the need for accurate monitoring of internal sterilization conditions. Pack control is the use of chemical indicators for the internal monitoring of packs, trays, containers, and peel pouches. Internal chemical indicators should be used inside each type of packaging to address the potential for interference with proper steam sterilization conditions in all of these types of packaging. Place a Comply SteriGage 1243A or 1243B Steam Chemical Integrator in each pack, peel pouch, container system or tray to be steam sterilized in the area determined to be the least accessible to steam penetration."

A policy titled "Steam Sterilization", dated 06/08/2000, stated in part, "Purpose, to provide guidelines for steam sterilization techniques. Chemical indicator strips shall be included with every load. A recorder chart provides a permanent record of the chamber temperature and exposure time during cycles."


II. Based on review of documents and surgery staff interview, the facility failed to develop and implement an effective system to detect, track, and monitor surgical site infections. The facility identified and average of 20-25 surgical procedures performed per month.

Failure to have an effective system to detect, track, and monitor surgical site infections prevents the facility from identifying and treating patients with surgically-related infections (also known as a nosocomial infection - an infection acquired in the hospital). This also inhibits the facility's ability to identify patterns and trends in surgically-related infection rates, which would enable the hospital to identify the source of the problem and change their practice to prevent or minimize future infections.

Findings include:

1. During an interview on 05/21/13 at 1:30 PM, Staff K, Surgery/Infection Control Manger, stated the facility completes approximately 20-25 surgical procedures a month. The surgery department only performs minor surgical procedures and discharges the patients the same day of the procedure. Within 24-48 hours following surgery, surgery staff contacts the patient by telephone and ask questions related to their surgery experience and if they had any associated problems. If staff identified a surgical problem, they would follow up with that patient through additional phone calls.

Review of the facility's Post Op Questionnaire, dated 05/09/13, revealed it lacked specific questions regarding the surgical site and signs and symptoms of surgical site infections.

Staff K verified that 24-48 hours was not a sufficient amount of time for a surgical site infection to develop. Staff K relies on the physician's office to notify the facility if surgical site infections develop after 48 hours, but lacked documentation of this taking place.

Staff K stated they generate a monthly CQI (Constant Quality Improvement) report if there was a post-operative infection. Review of the CQI reports for 2013 showed 1 surgical site infection reported in 04/13: a surgical patient developed a sinus infection on post-surgical day 4.

Staff K verified the facility followed the CDC (Centers for Disease Control) Definitions of Nosocomial Infections, dated 1996, for surgical site infections. The definition states, in part, "Infection that occurs within 30 days after the operative procedure if no implant is left in place or within one year if implant is in place and the infection appears to be related to the operative procedure and infection involves any part of the body, excluding the skin incision, fascia, or muscle layers, that is opened or manipulated during the operative procedure."

Staff K stated the facility lacked an implant log and, again, would rely on the physician's office and other associated personal (i.e., nursing home staff or clinic staff) to notify the facility if a surgical site infection developed within 1 year following the surgical implant.


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III. Based on document review and staff interview, the facility failed to establish a system to identify and prevent transmission of infections and communicable diseases for the facility's volunteers. Administrative staff reported an average daily census of 2 patients and identified 28 volunteers.

Failure to identify infections and communicable diseases among volunteers could potentially result in transmission to patients.

Findings include:

1. During an interview on 5/22/13 at 11:10 AM, Staff I, Health Information Management, reported the facility did not have any personnel files on the facility volunteers as there was no formal process in place for screening and training. She said the volunteer program was brand new following the facility relocation in January 2013. Staff I said the volunteer program was initiated as a result of a request from the hospital auxiliary program to greet patients at the entrance and help them find their way to the greeters desk. Staff I reported now that the facility had been open awhile, there has been discussion about continuing the volunteer program and expanding their responsibilities, so they developed volunteer screening and orientation requirements that are ready for approval at the next Critical Access Hospital (CAH) committee meeting. Staff I said the process would include, among other requirements, a healthcare provider approval form, a tuberculosis (TB) symptom screen form and a TB test, which would be the same health screening procedures required of employees. Staff I confirmed the current volunteers have not received any health screening.

2. Review of an Employee Health policy titled "Tuberculosis", reviewed and approved in 3/13, revealed in part, "Purpose: To provide protection for associates and patients against transmission of mycobacterium tuberculosis... 4. New employees shall receive a baseline TB screening at their pre-employment physical by the Employee Health Provider or their designee. 5. Annually, employees shall receive their serial TB screening from the Employee Health Nurse...7. An HCW (healthcare worker) may be working with patients after a negative TB symptom screen and a negative TST (tuberculin skin test)...."

Review of an Employee Health policy titled "Employee Health Examinations", reviewed and approved in 3/13, revealed in part, "Policy: Health examinations shall be required for all Community Memorial Hospital (CMH) personnel and contracted personnel at the commencement of employment and every four years thereafter. 1. The health exam will include a physical and a health statement ... 2. TB status of all CMH employees and of those contracted personnel having direct patient contact shall be tested at commencement of service and at least every four years thereafter...."

Based on observations, policy/procedure review and staff interviews, the facility failed to maintain x-ray emitting equipment in 1 of 1 onsite x-ray rooms in the Radiology Department to ensure the safety of staff using this machine. The radiology staff reported an average of 300 x-ray exams completed every month.

Failure to maintain x-ray emitting equipment could potentially cause harm if over exposure occurs during a radiology procedure with staff present in the room.

Findings include:

1. Observation during tour of the Radiology Department on 5/21/13 at 1:10 PM, with Staff A, Radiology Manager, revealed the x-ray emitting equipment control cord in the Radiography Room could extend outside the safety barrier for the personnel operating the equipment. The x-ray emitting control cord extended approximately 6 feet into the x-ray room.

During an interview on 5/21/13 at 1:30 PM, Staff A confirmed the x-ray emitting equipment control cord in the Radiography Room could extend into the room where the radiology procedure was performed, a room outside the safety barrier for the personnel operating the equipment.

Staff A acknowledged the x-ray emitting control cord did extend approximately 6 feet into the x-ray room and would allow staff to be present in the x-ray room during a procedure.

2. Review of the facility policy titled, Guidelines For Diagnostic Radiation Safety Procedures, reviewed 2/21/2012, revealed in part "...During the
x-ray procedures, the technologists and other staff will remain behind the lead shield if at all possible."

Based on observations, document review, policy review, and staff interviews, the facility failed to secure all medical records (including paper, film, and electronic records) from unauthorized access in 1 of 1 storage rooms and from 6 of 6 Dietary Services cooks. The facility had an average daily census of 2 patients.

Failure to secure medical records from access by unauthorized individuals could potentially result in unauthorized use of a patient's personal information found in his/her medical record.

Findings include:

1. Review of a Health Information Management (HIM) policy titled "Secure Filing of Medical Records", reviewed and approved on 3/26/13, revealed in part, "Policy: It is the policy of Community Memorial Hospital that the medical records are maintained in a secure and confidential manner. Areas housing health information shall be restricted to authorized personnel. Procedure: Medical records housed within the hospital shall be kept in secure areas at all times. Medical records shall not be left unattended in areas accessible to unauthorized individuals...."

-Review of a HIM policy titled "Security of Safeguarding of Health Information Management", reviewed and approved on 3/26/13, revealed in part, "Policy: It is the policy of Community Memorial Hospital to provide guidelines for the security and safeguarding of health and hospital information against... unauthorized access and use... will strive to ensure that medical records and other information medium will be maintained in secure and restricted areas with access limited to those staff members who have a 'need to access' based on either patient care needs and/or position responsibilities...."

2. Observation during the facility environment tour on 5/21/13, beginning at 8:30 AM, accompanied by Staff F, Plant Services Manager, revealed a locked storage room in the radiology area. The room contained a variety of items including radiology film jackets and several cardboard file storage boxes, some of which were labeled "deaths" and "physician encounter records". Staff F reported 3 maintenance personnel, 3 housekeeping personnel and administration were able to access the area. Staff F said the hospital did not have enough storage space and used the room as a multi-purpose storage area.

During an interview on 5/21/13 at 10:30 AM, Staff E, HIM Manager, reported there were approximately 673 medical records of deceased patients in the storage room. Staff D, HIM staff and Privacy Officer, reported there were approximately 10 to 15 file boxes of patient physician encounter forms in the storage room.

During a follow-up interview on 5/22/13 at 1:00, Staff D reported the physician encounter forms were a single sheet of paper documenting a patient's clinic visit and would include information such as the patient name, address, phone number, date of visit, reason for the visit and care/procedures provided. Staff E and D both confirmed maintenance and housekeeping personnel would not have the need to access to the information in these records.

During an interview on 5/21/13 at 10:50 AM, Staff A, Radiology Manger, reported there were approximately 1,000 patient file jackets in the storage room, containing patients' X-ray information.

During an interview on 5/20/13 at 2:30 PM and a follow-up interview at 3:10 PM, Staff G, cook, demonstrated her access to the electronic medical record (EMR) and the portions she utilizes to verify patient diet and/or supplement orders, any nutrition referrals triggered through the admission screening process or any nutrition consults ordered. Staff G said she pulls a diet report which includes each patient and the pertinent nutrition information she needs to perform her job duties. Staff G selected a patient to demonstrate where she could view additional information, such as a diet order history, nutrition screening information, etc. Observation of this screen revealed multiple tabs available for selection including, but not limited to, patient summary, chart review, results, order review, flowsheet data and rehab. Upon surveyor request, Staff G selected the results tab and selected the "30 days" option, which led to the view of a patient's lab results in that time period. Upon surveyor request, Staff G selected the patient summary tab which led to a history of the patient's medical visits to the facility, aside of the current admission. Staff G reported she had never selected any of the available tabs, except nutrition screen and nutrition profile, and did not believe she needed to view any of the other information in order to perform her job duties as a cook.

During an interview on 5/21/13 at 12:30 PM, Staff H, cook, demonstrated her access to the EMR and the portions she utilizes to verify patient diet and/or supplement orders, any nutrition referrals triggered through the admission screening process or any nutrition consults ordered. Staff H's access to view the EMR was identical to Staff G's. Staff H reported she had never selected any of the tabs, other than nutrition screen and nutrition profile, and did not believe she needed to view any of the other information in order to perform her job duties as a cook.

Review of a Dietary policy titled "Job Description - Cook", reviewed and approved on 3/26/13, lacked any reference to job duties which required access to a patient's medical record.

Review of a Dietary policy titled "Nutrition Screening and Assessment", reviewed and approved on 3/26/13, revealed in part, "Policy: All...patients will be screened by qualified hospital staff...2. Authorized personnel (certified dietary manager, registered nurse, and/or registered dietitian)...
4. Dietary staff checks for nutrition consults and notifies the registered/licensed dietitian of the referral...6. If the dietitian is not on campus...the dietitian will retrieve the necessary information by calling the dietary manager or nurse...."

During an interview on 5/21/13 at 10:30 AM Staff D, HIM staff and Privacy Officer, reported the current EMR, EPIC, was put into use in December 2012. She said previous to going live with the program, employees were assigned a user template, which defined the ability to view/access portions of a patient's medical record, depending on the specific job duties, in order to limit a user's access to only the portions needed to perform their job. During a follow-up interview at 2:45 PM, along with with Staff E, Staff D reported she performed monthly audits of the previous EMR, which included 10% of all encounters, in addition to any employees, employee family members and any high profile community cases, to check for potential unauthorized access to the patient's medical record. She said if inappropriate access was identified, a disciplinary process was initiated. Staff D reported she had not conducted any audits on the current EMR, but had recently received the required security access and would begin audits this month. Both Staff D and Staff E confirmed cooks would not have the need to access a patient's medical record beyond basic nutrition and diet information and were not aware that they were able to view portions of the record beyond this scope.

Review of an undated document titled "EPIC templates information", revealed in part "... dietary aide-group of users, view only access to the inpatient chart ... able to do chart review, result review and review demographics ..."

Review of an undated, untitled document, reported by Staff D, HIM staff and Privacy Officer, to include the EPIC template assigned to employees, revealed 6 of 6 cooks assigned the dietary aide template.

-During an interview on 5/21/13 at 1:15 PM, Staff C, Chief Nursing Officer, reported she played a role in setting EMR access for the current system previous to it's implementation. Staff C was unaware the cooks were able to view portions of the EMR beyond the basic nutrition and diet information. Upon surveyor request, Staff H demonstrated to Staff C her access to the record and was able to view the information previously viewed with this surveyor, in addition to a section that contained a history of surgical procedures, including the operative reports. Staff B, Dietary Manager, whom was also present at the time, was unaware of the extent of the cooks abilities to view a patient's medical record.

-During an interview on 5/22/13 at 2:00 PM, Staff B, Dietary Manager, reported, with the previous EMR, she had a planned extended medical absence so the cooks were trained to perform a nutrition chart screen on all patients, in order to gather information and determine if the consultant dietitian should be notified. Staff B confirmed the cooks were not trained, nor required to perform this function, with the current EMR.