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Based on interview and document review, the critical access hospital (CAH) failed to ensure a representative sample of active and closed inpatient and outpatient records were reviewed. This had the potential to affect all current and future inpatients and swing bed patients of the CAH.

The findings include:

A review of the CAH's periodic evaluation completed for 2019 fiscal year, lacked indication a representative sample of inpatient and outpatient records had been reviewed. The CAH lacked documentation of the review of the 10% minimum required active and closed records for all services provided by the CAH.

On 2/12/20, at 9:15 a.m. the chief executive officer (CEO) confirmed the CAH served over 500 inpatients and the prior year the CAH had over 400 inpatients. The CEO confirmed the 30 records were peer reviewed within the last year, which did not represent 10% of the CAH's patients served.

On 2/12/20, at 10:15 a.m. the director of nursing confirmed the CAH peer review only included closed records and open records were not reviewed.

Review of a the CAH's Medical Records Peer Review 2018, dated 3/8/19, revealed 30 records were peer reviewed.

A facility form titled Lake View, Medical Record Quality Assurance Review, dated 1/21/20, identified a physican would perform peer review on 30 inpatient/observation patients annually. However, the medical record quality review form lacked information regarding closed record review.

Based on interview and document review the Critical Access Hospital (CAH) failed to ensure quality assurance/performance improvement projects were developed and integrated into the CAH's quality improvement program for central processing and environment. This had the potential to affect all current and future patients of the CAH.

Findings include:

On 2/12/2020, at 10:35 a.m. the surgical services manager (SSM) was interviewed and stated the central process department did not have a quality assurance (QA) or process improvement (PI) project currently in place. The SSM confirmed there was no written QA action plans developed or implemented.


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During an interview on 2/11/20, at 9:30 a.m. the facility manager (FM) stated the quality assurance performance improvement (QAPI) focus for the environment was to improve response time of the fire location page overhead in the event of a fire. The goal was for the response time between the time fire alarms sound to the time of the location is paged overhead should be no longer than 30 seconds. The QAPI plan started in June 2019. FM was able to provide documentation only for the amount of time it took for the location page to be called overhead each month. On 1/12/20, at 9:55 a.m. the FM verified there was no other documentation of the environmental QAPI plan.


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On 2/13/20, at 9:15 a.m. the director of nursing (DON) confirmed the facility did not have any current quality assurance, performance improvement (QAPI) related to the facility's medications errors. The DON stated all facility medication errors were addressed by himself, the director of pharmacy and the staff involved in the medication error. He stated all medication errors were reviewed with Risk Management Committee which met monthly. The DON stated he felt if any patterns had been identified when reviewing the facility's medication errors, he would have initiated a QAPI project.

Review of a facility policy titled Lake View Quality Improvement Plan revised 1/15/19, identified the Quality and Performance Improvement process included an organization wide and involved departments and services of the hospital and medical staff, which included services under contract and arrangement. The policy revealed the CAH's quality and performance improvement plan included the following:

-ongoing monitoring and data collection
-problem prevention, identification and data analysis.
-identification of corrective actions
-implementation of corrective actions
-evaluation of corrective actions, and measures to improve quality and performance on a continuous basis.

The policy further identified medical staff quality and performance improvement process included medication errors and adverse drug events.

Based on observation, interview, and document review the critical access hospital (CAH) failed to ensure a planned maintenance program was able to track repairs for patient rooms. This had the potential to affect patients receiving cares in the CAH.

Findings include:

On 2/11/20, at 10:17 a.m. an environmental tour of the patient care area was completed with the facility manager (FM). The following patient rooms were found to be in need of repair:

Room 201: Had gauges in the paint on the walls, missing doorframe paint exposed to the metal, there was a gauge in the flooring between the patient room and bathroom. The FM verified the findings and stated the room had been partially remodeled.

Room 202: Had gauges in the paint on the walls, missing doorframe paint exposed to the metal, there was gauges and cracks in the flooring. The FM verified the findings and stated the room had been partially remodeled.

Room 204: Had gauges in the paint on the walls, missing doorframe paint exposed to the metal, there was gauges in the flooring. There was vinyl coming away from the wall in the bathroom sink area and vinyl coming away from the wall under the locker area. The FM verified the findings and stated the room had been partially remodeled.

Room 206: Had gauges in the flooring at the entrance to the room, pealing and tears in wallpaper in the patient room, missing doorframe paint exposed to the metal. The FM verified the findings and indicated this room was to be remodeled next.

Room 208: Had approximately 22 gauges in the paint in a four-foot area. The doorframe to the bathroom had a couple of areas of paint missing down to the metal. The FM verified the findings and stated this room had been remodeled. The FM verified there was no scheduled walk through of patient rooms to identify areas needed for repair.

Room 210: Had wallpaper seems ripping, the doorframes to the room and bathroom had paint exposed to the metal and there were cracks in the flooring. The FM verified the findings and stated the room had been not been remodeled.

Room 212: Had approximately 31 gauges in the paint in a six-foot area of the wall. The doorframe to the bathroom had a couple of areas of paint missing down to the metal. The FM verified the findings and stated the room had been remodeled.

Room 214: Had gauges in the doorframe to the room with missing paint down to the metal. There was an area of the wall that was approximately 4 feet long with several gauges in the paint/wall. The wall corner area had areas of missing paint down the metal. The FM verified the findings and stated the room had been remodeled. The FM verified the CAH did not have a system in place for upkeep of the patient rooms.

On 2/12/20, at 2:55 p.m. the chief executive officer (CEO) stated the CAH was unable to afford to remodel all of the rooms at once and they choose on room a year to remodel. The CEO stated we should be doing a daily walk through of the outside and inside of the building and making a priority list based on what was seen during the walk through for repairs.

On 2/13/20, at 10:08 a.m. the director of environmental services (DES) stated the CAH had been taking each room and trying to remodel as we could. The DES stated they were annually trying to get one room done (remodeled). The DES stated she was aware the rooms were not in good shape. The DES stated the CAH had daily walk through inspection sheets that were to be filled out by the maintenance staff daily and verified these forms were not being completed. The DES stated she created a policy today, for routine maintenance of the physical environment. The DES stated previously there was no policy or tracking to ensure the maintenance daily walk through logs were being completed.

Based on observation, interview, and record review the critical access hospital (CAH) failed to ensure an adequate system for monitoring, tracking, and maintaining the maintenance of appropriate humidity levels within acceptable standards within 2 of 2 operating rooms.

The findings include:

During a tour of the OR's on 2/11/20, at 10:40 a.m. with surgical technician (ST)-A and the surgical services manager (SSM). At 1:00 p.m. ST-A stated OR-2 was more frequently used as a staging area and most of the surgical procedures were done in OR-1. Each OR had a gage on the wall that measured temperature and humidity; the gages were not connected to an electronic monitoring system. February's temperature and humidity logs that hung outside of the ORs were reviewed with ST-A and SSM. ST-A verified the log sheets were not reflective of monitoring over the weekends or non-surgical days. ST-A stated when she worked she would always check the temperature and humidity daily before procedures, the humidity levels were supposed to be between 20-60%. ST-A stated if the temperature or humidity levels were not within range, the maintenance director was contacted for temperature/humidity adjustment. ST-A and SSM indicated since the building was older, they had problems with lower humidity levels. SSM stated that when humidity levels were low, it increased the risk for spark and fire in the OR's.

A surgical listing reports reviewed from 9/1/19, through 2/12/20, identified 20 patients with procedures that required the use of a cautery tool during surgery. The reports identified 10 procedures were completed in OR-1 and 10 were completed in OR-2.

The 20 patient records reviewed included a completed fire risk assessment that identified all 20 patients had a medium fire risk score.

Temperature and tracking logs were requested for the last year.

During an interview on 2/11/20, at 5:15 p.m. chief executive officer (CEO) provided OR temperature/humidity control logs. Director of nursing services (DNS), CEO, and SSM stated not all the logs could be found or recovered. Logs not obtained included; both OR logs for 3/19, 4/19, 5/19, OR-2 log for 7/19, both OR logs for 8/19, 9/19, 10/19, 11/19, and OR-2 log for 12/19. CEO indicated there had been a change in leadership of the surgical services; stated the logs should have been uploaded into a computer for quality assurance. SSM verified the lack of recorded monitoring on the logs even on surgical days since December, and the humidity levels when recorded were consistently under 30%. SSM also indicated that when the levels were outside of acceptable ranges staff were supposed to notify the maintenance director, record what was completed as a result of the level, and recheck the levels.

During an interview on 2/12/20, at 1:15 p.m. facilities manager (FM) indicated an unawareness of CMS requirements for humidity levels of 30-60% without a categorical waiver. FM indicated awareness of the Hospital policy it directed OR humidity levels of 20-60%, and indicated an unawareness of how the lower level was determined. FM stated an awareness of the concerns with the temperature and humidity control in the OR's. FM indicated a couple of years ago the hospital had 2 different HVAC companies come out to assess the problem; the results of the assessment indicated the system had not been installed correctly which would require extensive repair. FM stated after the hospital had identified the issue, gages were put into the OR's and the plan was to monitor the temperature and humidity. FM indicated surgical staff were responsible for monitoring and logging the levels daily. FM stated surgical staff did not notify him when the humidity levels were too low, staff were supposed to use the control panels for the Nortec canisters that were located on the wall of ORs to adjust the humidity up or down. FM stated he assumed that the staff were aware of how to adjust the humidity.

During an interview on 2/12/20, at 2:00 p.m. surgical registered nurse (RN)-A stated surgical technicians were supposed to check the temperature/humidity levels prior to the surgical procedures; SRN-A stated she was not aware of any humidity controls in the ORs.

During an interview on 2/12/20, at 2:05 p.m. SSM stated up until 5 minutes ago had not been aware of any humidity controls in the ORs.

The CAH lacked evidence of a categorical waiver to maintain humidity levels not lower than 20%.

CAH policy/procedure Climate Control In The OR with an effective date 11/13/17, and last reviewed date of 11/6/19, indicated that the standard of relative humidity in OR's was between 20-60% and did not address CMS humidity level requirements.

Based on the Life Safety Code (LSC) survey component. A Medicare-participating Critical Access Hospital (CAH), including all component parts or facilities of the CAH, must comply with the applicable LSC requirements.

Please refer to the life safety code deficiencies cited at: K341, K346, K351, K354, K712, K346, K761

Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure policies and procedures and competencies were developed and implemented related to non-pharmacy staff compounding low level sterile preparations (CSPs) not for emergent use. Additionally, the CAH failed to have documented training and competency testing of non-pharmacy staff who compounded medications, according to Untied States Pharmacopoeia Convention chapter (USP) <797>.

Based on observation, interview, and document review the Critical Access Hospital (CAH) failed to secure prescription pads and paper.

Findings include

COMPOUNDING

Hospital Policy Compounding For Immediate Use dated 3/2019, included Hospital pharmacy and nursing staff may compound non-hazardous sterile products for immediate use in accordance with USP <797>. Immediate use compounding: the preparation of sterile products in emergent situations outside a sterile environment when preparation of the compounded sterile product under low-risk level conditions by pharmacy staff would subject the patient to additional risk due to delays in therapy. The policy indicated the aseptic technique for the preparations and once mixed had to be started within one hour.

During an interview on 2/11/20, at 1:30 p.m. CAH pharmacist stated pharmacy hours were Monday through Friday 8:00 a.m. to 4:00 p.m.; after 4:30 p.m. an after-hours pharmacy was utilized for physician order verification. Pharmacist indicated hospital registered nurses (RNs) mixed low-level sterile compounds such as intravenous (IV) antibiotics for emergency use outside of pharmacy hours. Pharmacist indicated there was a potential that IV antibiotics that required mixing could be ordered for swing bed or inpatient patients after pharmacy hours. Pharmacist stated that there was an isolator in the nursing station medication room, however nurses had not been trained, and competency tested on the use.

During an interview on 2/12/20, at 8:25 a.m. registered nurse (RN)-A stated she rarely compounded medications outside the emergency room, stated she had been trained and competency tested on mixing medications aseptically, but had not received training and competency testing for preparations not for immediate use. RN-A stated she thought once the medications were mixed outside the isolator it was dependent upon the medication.

During an interview on 2/12/20, at 8:27 a.m. RN-B stated she occasionally mixed medications after pharmacy hours. RN-B the last time she was competency tested for mixing medications aseptically was 3 years ago however, education was periodically reviewed in meetings. RN-B stated she had not been trained or competency tested for mixing medication using the isolator for medications not for immediate use. RN-B stated she thought the mixture needed to be administered within 24 hours, however indicated an unawareness and would ask the director of nursing services.

During an interview on 2/13/20, at 11:15 a.m. director of nursing services (DNS) stated aseptic technique for sterile preparations for immediate use medications was reviewed during staff meetings however, nurses were not competency tested. DNS stated nursing staff have not been trained and competency tested on preparations that would not be considered emergent use that required the use an isolator. DNS indicated that medications that would not be considered an emergency have been mixed without using the isolator.

Record review of after-hours pharmacy log between 6/30/19, through 12/3/19, identified 17 low-level antibiotics were mixed outside of the emergency room for 13 different patients. IV Antibiotics that were mixed included; 10 doses of Vancomycin, 3 doses of Meropenem, 1 dose of Cefpime, and 3 doses of Azithromycin.

During an interview on 2/13/20, at 10:00 a.m. pharmacist referenced listing of antibiotics; indicated the antibiotics were mixed after pharmacy hours for inpatient or during the weekends when a pharmacist was not available. Pharmacist indicated that the mixtures should have been mixed using the isolator.

During an interview on 2/14/20, at 8:59 a.m. Minnesota Board of Pharmacy pharmacist stated it was the expectation the hospital followed USP <797> for mixing low-level medications. Pharmacist stated outside of emergency situations when the time it would take to mix the medication using an isolator would jeopardize the patient's health, the medication needed to be mixed in the isolator. Pharmacist stated the expectation that at least one nurse on each shift be trained and competency tested according to USP <797> to mix sterile compounds.

SECURITY OF Rx PADS/PAPER

On 2/10/20, at 3:40 p.m. a tour of the hospital's nursing unit was completed with the director of nursing services (DNS). Adjacent to the nursing station desk was a short walk way that lead to an area with the Omnicell and storage cabinets and drawers. When asked to open the cabinets the DNS opened an unlocked drawer and obtained a key for the two locked cabinets located above the counter which contained a box of physician pads, 2 prescription pads on top of the box, and a stack of prescription paper. DNS indicated that the key to the cabinet could potentially be accessed by all hospital staff and visitors and verified there was cameras in this area. DNS also indicated that the prescription pads and paper were not secured appropriately.

During an interview on 2/11/20, at 1:30 p.m. hospital pharmacist confirmed the prescription pads and paper were not appropriately secured. Pharmacist stated the 29 prescription pads had since been removed from the nursing cabinet, 2 pads were placed in the Omnicell and the rest were secured in the pharmacy. Pharmacist indicated the pads were previously stored in the Omnicell however, had been removed and stored in the nursing cabinets for easier accessibility for staff. Pharmacist stated an unawareness of how long the pads had been moved and stated there was not a system in place to account for the pads or paper. Pharmacist provided an email communicated that was received on 11/8/19, from their network hospital (St. Luke's) pertaining to the security of prescription pads and the potential high risk of diversion without appropriate security, further indicating an upcoming plan to outline a consistent process to control storage of the pads and paper.

During an interview on 2/14/20, at 8:59 a.m. Minnesota Board of Pharmacy pharmacist stated it was an expectation prescription pads and paper be appropriately secured, controlled, and there be a system in place so that the pads/paper be accounted for in order to prevent or reduce the risk of medication diversion.

CAH policy pertaining to security of prescription pads/paper was not provided.

Based on observation, interview, and document review, the Critical Access Hospital (CAH) failed to maintain the confidentiality of record information and provide safeguards against loss, destruction, or unauthorized use in 1 of 1 medical record storage areas used for CAH medical records storage.

Findings include:

On 2/11/20, at 11:58 a.m. the storage area where medical records are kept was toured with the medical records director (MRD). The CAH medical records were stored in an open room on six shelves. There were other items stored in the storage room from other departments including decorations, paint and equipment. The MRD verified the CAH medical records were not secured from unauthorized use and unauthorized personnel would have access to the CAH records kept in this location. The MRD verified the CAH was not following the facility policy to secure the medical records from unauthorized personal.

On 2/11/20, at 3:54 p.m. the MRD stated the storage area could be accessed by the CEO, director of primary care and specialty services, director of nursing, director of imaging, manager of facilities, manager of nutrition services, manager of rehab services, the administrator secretary and maintenance.

The Security-Information policy dated 8/16, included physical security: Lake View will make every attempt to safeguard medical records, documents and electronic storage medium in structurally safe, fire resistant and water resistant storage environments which are located in restricted areas. Lake View requires that physical access to areas containing electronic information systems (including diagnostic equipment that maintains electronic PHI) to those properly authorized.

Based on observation, interview, and record review, the critical access hospital failed to ensure hand hygiene practices were performed according to the facility policy, failed to ensure location of endoscopes were reprocessed in an appropriate location in conjunction with a procedure room, and failed to appropriately store sterile endoscopic supplies.

Findings include

Endoscopic reprocessing room and storage of sterile supplies

On 2/11/20, at 11:00 a.m. the CAH's procedure room was toured with surgical technician (ST)-A and surgical services manager (SSM). ST-A stated the procedure room was used for endoscopic procedures including EGD's (Esophagogastroduodenoscopy) and colonoscopies. Inside the procedure room was a smaller room located at the back of the room with the door open; ST-A stated the endoscopes were reprocessed in that room. A two compartment sink with an automatic endoscopic reprocessor was observed. In addition, there was hose that connected to the wall in the procedure room that ran across the door to the reprocessing room; not allowing for a barrier between the rooms. At the back of the room was a counter with cupboards above and below. On top of the counter were 4-5 bins that contained packages of sterile reprocessed endoscope buttons/components as well as packages of endoscope tubing. The bins were not covered.

During an observation of a colonoscopy procedure on 2/12/20, from 8:46 a.m. to 10:00 a.m. the sterile packages in bins remained on the counter at the back of the room without a cover. ST-A indicated that the scopes from the previous procedure were in the reprocessor. The door to the reprocessing room remained open throughout the procedure. At 9:24 a.m. ST-B completed the initial rinse of the scope and carried the scope in her hands from the procedure room to the adjacent repossessing room.

Hand Hygiene

At 9:23 a.m. the colonoscopy procedure ended, MD-A walked over to the hand sink, removed gloves, through gloves in small waste canister next to hand sink, answered his phone, placed the phone in left pants pocket, and walked out of the procedure room without washing hands or using hand sanitizer.

At 9:27 a.m. ST-B used Super Sani-Cloth Germicidal Disposable wipes to wipe down surfaces in the procedure room. After ST-B completed wiping down the surfaces, ST-B removed gloves and donned new gloves without performing hand hygiene. ST-B then obtained a clean scope from the scope storage cabinet hung the piece of equipment, opened sterile packages of scope buttons and tubing, and affixed the components to the scope.

During at interview at 9:35 a.m. ST-B stated she had thought she had sanitized her hands after she had removed the gloves and it was an oversight that she had not. Surgical services manager (SSM), stated ST-B should have completed hand hygiene prior to donning new gloves.

During an interview at 9:40 a.m. MD-A verified he did not perform hand hygiene after he removed his gloves and prior to leaving the procedure room. MD-A stated he didn't need to perform hand hygiene after glove removal because his hands were clean because he had performed hand-hygiene prior to the procedure.

During an interview at 10:35 a.m. SSM stated the procedural supplies should not be stored on the counter, they need to be covered and closed. SSM indicated the location of the processing room is not ideal and the door should at least be kept closed.

On 2/13/20, SSM indicated the CAH followed CDC guidelines for reprocessing room physical location and provided a CDC reference dated 1/25/2017: Essential Elements of Reprocessing Program for Flexible Endoscopes-Recommendations of the Health Care Infection Control Practices Advisory Committee. The guidelines included: Physical Setting 1) The processing area should be in a space that is separate from the patient procedural area. 2) Review the physical setting to ensure a "one way" work flow that separates contaminated work spaces from clean work spaces. 3) If a separate room is used for manual cleaning of endoscopes ensure a directional airflow that maintains negative pressure within that room relative to adjoining spaces.

CAH policy Infection Control Practices dated 1/7/20, included: 1) Good handwashing before and after caring for each patient and handling of all equipment is of utmost importance. Hands are to washed even when gloves have been used.

CAH provided Infection Prevention and Control Guideline education provided to staff, the education included: Wash (sanitize) hands "UPON ENTERING AND EXITING PATIENT OR EXAM ROOM", before and after patient contact, and after removing exam or surgical gloves.

CAH's policies did not address storage of procedural or surgical supplies