HospitalInspections.org

Due to a system error, the regulatory language failed to include the regulation found at C-0229

485.623(c)(3) Providing for an emergency fuel and water supply: and

This STANDARD is not met as evidenced by:

Based on policy review, document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to secure an emergency water agreement for potable and non-potable water, with an outside entity, to ensure the availability of adequate water in the event of an interruption in the water supply. The administrative staff identified a census of 7 inpatients at the time of the survey, and reported an average daily census of 8 inpatients. The CAH identified 262 employees at the time of the survey.

Failure to ensure emergency water is available to meet the facility's critical functions during an emergency/crisis situation inhibits the facility's ability to ensure patient safety and quality of care while responding to and recovering from a situation that resulted in disruption of water.

Findings include:

1. During an interview on 5/29/19, at 8:45 AM, the Director of Plant Operations reported he thought the CAH had an agreement for potable water with a distribution service and an agreement for non-potable water with the city. He explained the city manager verbalized the CAH would have priority access to the water in the water tower, which could be diverted from other customers. The Director of Plant Operations was not sure if the CAH had a current written agreement for emergency water and the Director of Plant Operations would look for the current written agreement.

2. Review of a maintenance Memorandum of Understanding (MOU) Burgess Health Center, signed by both parties on 5/29/19, revealed in part "... [Distribution Service Company - Vendor A] agrees to provide needed medical supplies, potable water and IV sets and solution on an emergency basis delivered to the Facility as soon as possible ..." The document lacked details identifying the quantity of water Vendor A could provide the CAH, the time-frame in which Vendor A could deliver the water. Additionally, Vendor A and the CAH administrative staff signed the contract after the beginning of the re-certification survey.

During an interview on 5/30/19, at 7:50 AM, the Director of Compliance/Risk Management confirmed the CAH staff could not locate a MOU with Vendor A. The CAH staff created a new MOU with Vendor A on 5/30/19. Additionally, the document lacked specific details regarding the quantity of water that Vendor A could provide and the time-frame in which Vendor A could deliver the water.

3. Review of a Plant Operations policy "Emergency Water Plan," with an effective date 5/14/04, revealed in part "... Purpose - to provide potable drinking water for the hospital upon contamination of city water supply ... Upon water contamination in the hospital, the hospital will notify [Vendor B's Name] ... to order bottled potable water in gallon jugs to be delivered to Burgess Health Center ... Need for water for sanitation purposes - the city of Onawa, Iowa will be notified of this need and water will be provided from the City by trucking water from a surrounding town."

During an interview on 5/30/19, at 10:15 AM, the Director of Compliance/Risk Management, confirmed the Emergency Water Plan contained incorrect information indicating the CAH staff would utilize Vendor B to provide emergency potable water in the event the city could not provide the CAH with potable water. Additionally, the CAH lacked a written agreement with the Vendor C to supply the CAH with non-potable water. The CAH did not know the quantity of non-potable water Vendor C could supply or the time-frame in which Vendor C could supply the non-potable water.

Based on personnel file review, document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure new employees with a criminal background, received an Iowa Department of Human Services (DHS) clearance to work, according to State law, for 2 of 4 new employee personnel files selected for review (Occupational Therapist A and Supervisor of Nutrition Services B).

Iowa Administrative Code 481 - 51.41(3) A person who has committed a crime or has a record of founded child or dependent adult abuse shall not be employed in a hospital unless an evaluation has been performed by the department of human services.

Failure to ensure the Department of Human Services reviewed and cleared new employees with a history of criminal convictions could potentially result in the CAH staff placing patients at risk for becoming victims of criminal activity from the new employee.

Findings include:

1. Review of Occupational Therapist A's personnel file revealed the CAH staff hired Occupational Therapist A on 11/28/18. A document "Single Contact License and Background Check (SING)," dated 11/20/18, revealed revealed the Iowa Division of Criminal Investigation needed to perform additional investigation on Occupational Therapist A's criminal background check. A document "Iowa Record Check Request" revealed the DCI identified a criminal record for Occupational Therapist A on 11/20/18 and provided a report which provided further details on the criminal conviction. The personnel file lacked evidence of a DHS clearance to work at the CAH.

2. Review of Supervisor of Nutrition Services B's personnel file revealed the CAH staff hired Supervisor of Nutrition Services B on 2/14/19. The "Single Contact License and Background Check (SING)," dated 2/5/19, revealed the Iowa Division of Criminal Investigation needed to perform additional investigation on Supervisor of Nutrition Services B's criminal background check. The "Iowa Record Check Request" revealed the DCI identified a criminal record for Supervisor of Nutrition Services B on 2/8/19 and provided a report which provided further details on the criminal conviction. The personnel file lacked evidence the DHS staff evaluated and cleared Supervisor of Nutrition Services B to work at the CAH. The personnel file lacked evidence of a DHS clearance to work at the CAH.

During an interview on 5/29/19, at 4:10 PM, Human Resources Assistance C acknowledged Occupational Therapist A's and Supervisor of Nutrition Services B's personnel files lacked evidence the DHS staff performed an evaluation and determined if Occupational Therapist A and Supervisor of Nutrition Services B could work at the CAH. Instead, if the candidate for employment at the CAH had a criminal conviction, the Director of Human Resources would review the information provided by the DCI and determine if the CAH would hire the candidate.

During an interview on 5/20/19, at 8:40 AM, the Director of Human Resources confirmed the CAH did not obtain a DHS clearance to work when the background check for Occupational Therapist A and Supervisor of Nutrition Services B revealed a criminal history.

Review of the policy "Background/Sanction Screening," effective 11/16/14, revealed in part " ... criminal offenses in an individual's background will be considered on a case by case basis and dependent on numerous factors including, but not limited to, the nature of the the offense, evidence of rehabilitation and the amount of time passed since the conviction...The following language shall appear on all applications: Have you ever been convicted of any criminal violation of law ... Verification of the responses will be accomplished by conducting a sanction screening/criminal background check on all individuals to whom an offer of employment has been proffered prior to employment ..." The policy failed to identify the need for a DHS evaluation of a criminal record and a clearance to work in the CAH.

Based on observation, document review and staff interview, the Critical Access Hospital (CAH) staff failed to check and document the temperature of the refrigerator storing medications used for anesthesia in Room 329, Anesthesia Storage. Failure to ensure CAH staff checked and documented the temperature in the refrigerator could potentially result in patients receiving anesthetic medications that do not work in the body as expected resulting in unintended consequences or side effects of anesthesia. The CAH performs approximately 450 surgical procedures/year.

Findings included:

1. Observations on 5/29/19, at approximately 9:00 AM, during a tour of the Operating Room, revealed a refrigerator located in Room 329, Anesthesia Storage, that contained 5 vials of Rocuronium 100mg/10 ml (medication used during anesthesia to relax muscles) and 1 vial of Succincycholine 200mg/20 ml (medication used during anesthesia to relax muscles).

2. Review of the refrigerator temperature log for May 2019, during the time of the tour, revealed CAH staff failed to document refrigerator temperatures 9 out of 30 days on week-ends or holidays, when the OR staff did not utilize the operating rooms.

3. Review of the policy, "Quality Assurance of Compounded Sterile Product (CSP) Preparation," effective 4/7/18, revealed in part, "Temperatures in refrigerated....and controlled room temperature...storage areas will be monitored once daily."

4. During an interview at the time of the tour, the Director of Anesthesia acknowledged the staff failed to monitor the temperature of the refrigerator every day. The Director of Anesthesia confirmed that the medication refrigerator had a temperature alarm to indicate if the temperature went outside the required temperature range, but the staff would not know if the refrigerator's temperature had gone outside the required range if the staff did not monitor the area or if the refrigerator returned to the required temperature before staff returned on the next business day.

5. During an interview on 5/29/19 at 1:30 PM, Pharmacy Director verified the pharmacy did not provide any remote monitoring or oversight of the medication refrigerator in Room 329, Anesthesia Storage.

Based on document review and staff interview, the Critical Access Hospital (CAH) failed to document evidence of physician chart review in conjunction with midlevel practitioners for 3 of 3 Physician Assistants (PA E, PA F, and PA G) and 1 of 1 Advanced Registered Nurse Practitioners (ARNP). Failure to ensure a physician periodically reviewed, in conjunction with the midlevel practitioners, the care provided by the mid-level practitioners, affected the CAH's ability to assure the mid-level practitioners consistently provided quality care to patients of the CAH. The CAH administrative staff identified the PAs and ARNP saw approximately 985 patients per year in the Emergency Room.

Findings include:

1. Review of two "Record Review Sheet" for Patient #6 and Patient #7, both signed on 3/4/19 by the Chief of Medicine, revealed Patient #6 and Patient #7 received care from Physician Assistant E (PA E). The documentation lacked evidence that PA E participated in the review of Patient #6 and Patient #7's medical records with the Chief of Medicine.

2. During an interview on 5/29/19 at approximately 3:30 PM, the Vice President of Nursing revealed that the CAH lacked a policy directing the medical staff to include the mid-level provider in the physician review of medical records of patients who received care from the mid-level providers.

I. Based on review of policies/procedures, meeting minutes, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the required group of professionals, including a physician and a mid-level provider, reviewed all patient care policies annually for 20 of 20 patient care departments (Ambulance/Emergency Room, Environmental Services, Mental Health, Surgery, Health Information, Materials Management/Nutrition Services, Pharmacy, Physical Therapy/Occupational Therapy/Speech Therapy, Skilled Care, Anesthesia, Laboratory, Cardiac/Pulmonary Rehabilitation, Family Beginnings, Medical/Surgical/Special Care Unit, Radiology, Respiratory, Infection Control, Infusion Center, Plant Operations, and Specialty Clinic). The CAH administrative staff identified a census of 7 patients at the beginning of the survey. Failure to ensure the required group of professionals reviewed all patient care policies annually could potentially result in failure to identify patient care needs not addressed in the CAH policies/procedures.

Findings include:

1. Review of the CAH policy "Critical Access Hospital Policy Committee," dated 12-24-2014, revealed in part, "The Critical Access Hospital Policy Committee serves an an oversight committee for Critical Access Hospital (CAH) coordination. Policies are developed with the advice and approval of this group of professionals...The CAH Committee shall: Approve annual policy and procedure revisions for all patient services departments...The committee will be composed of the following:...A physician (MD or DO), usually the Chief of Staff, A mid-level provider...."

2. Review of "CAH Committee Meeting Minutes" dated 9/26/18, revealed in part, "...The annual CAH program and annual policy review is attached to the minutes including the recommendations of the committee. All policy changes and additions were approved by the committee...."

The minutes for the CAH Committee Meeting Minutes lacked annual approval of all patient care policies for Ambulance/Emergency Room, Environmental Services, Mental Health, Surgery, Health Information, Materials Management/Nutrition Services, Pharmacy, Physical Therapy/Occupational Therapy/Speech Therapy, Skilled Care, Anesthesia, Laboratory, Cardiac/Pulmonary Rehabilitation, Family Beginnings, Medical/Surgical/Special Care Unit, Radiology, Respiratory, Infection Control, Infusion Center, Plant Operations, and Specialty Clinic.

3. During an interview on 5/30/19 at 9:50 AM, the Director of Compliance/Risk Management verified the CAH Committee only reviewed and approved new policies and policies that had revisions. The Director of Compliance/Risk Management further acknowledged the required group of professionals, including a physician and mid-level provider, failed to review or revised the CAH's existing policies.


II. Based on review of policies/procedures, meeting minutes, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the required group of professionals, including a mid-level provider that was a member of the medical staff, reviewed all patient care policies annually for 20 of 20 patient care departments (Ambulance/Emergency Room, Environmental Services, Mental Health, Surgery, Health Information, Materials Management/Nutrition Services, Pharmacy, Physical Therapy/Occupational Therapy/Speech Therapy, Skilled Care, Anesthesia, Laboratory, Cardiac/Pulmonary Rehabilitation, Family Beginnings, Medical/Surgical/Special Care Unit, Radiology, Respiratory, Infection Control, Infusion Center, Plant Operations, and Specialty Clinic). The CAH administrative staff identified a census of 7 patients at the beginning of the survey. Failure to ensure a mid-level provider that was a member of the medical staff reviewed all patient care policies annually could potentially result in failure to identify patient care needs not addressed in the CAH policies/procedures.

Findings include:

1. Review of the CAH policy "Critical Access Hospital Policy Committee," dated 12-24-2014, revealed in part, "The Critical Access Hospital Policy Committee serves an an oversight committee for Critical Access Hospital (CAH) coordination. Policies are developed with the advice and approval of this group of professionals...The CAH Committee shall: Approve annual policy and procedure revisions for all patient services departments...The committee will be composed of the following:...A mid-level provider...."

2. Review of "CAH Committee Meeting Minutes" dated 9/26/18, revealed Advanced Registered Nurse Practitioner (ARNP) I attended the meeting to approve all patient care policies for Ambulance/Emergency Room, Environmental Services, Mental Health, Surgery, Health Information, Materials Management/Nutrition Services, Pharmacy, Physical Therapy/Occupational Therapy/Speech Therapy, Skilled Care, Anesthesia, Laboratory, Cardiac/Pulmonary Rehabilitation, Family Beginnings, Medical/Surgical/Special Care Unit, Radiology, Respiratory, Infection Control, Infusion Center, Plant Operations, and Specialty Clinic.

3. Review of the Medical Staff Roster, dated 5/2019, revealed the Medical Staff Roster lacked evidence ARNP I was a member of the CAH's medical staff.

4. During an interview on 5/30/19 at 11:30 AM, the Executive Assistant verified ARNP I was not a member of the CAH's medical staff and had not been a member of the CAH's medical staff since November 2017.

During an interview on 5/30/19 at 11:35 AM, the Director of Compliance/Risk Management verified ARNP I attended the CAH Committee meeting on 9/26/18 as the mid-level representative for the annual review of CAH policies.

During an interview on 5/30/19 at 11:40 AM, the Chief Executive Officer verified ARNP I was not a member of the CAH's medical staff at the time of the CAH Committee meeting on September 26, 2018 as the mid-level representative for the annual review of CAH policies.

I. Based on observation, document review and staff interview, the Critical Access Hospital (CAH) staff failed to ensure the anesthesia staff discarded 1 of 1 observed syringes of succinylcholine after drawing it up in an active operating room and not using the succinycholine for the patient. Failure to ensure the anesthesia staff discarded the succinycholine after drawing it up could potentially result in the anesthesia staff using the succinycholine which contained contaminants from the first patient and sat longer than the hospital's policy allowed, which potentially could result in bacterial contamination of the succinylcholine. The hospital's administrative staff identified the surgical services staff performed an average of 450 surgical procedures and 474 endoscopies per year.

Findings include:

1. Observations on 5/29/19, at approximately 9:00 AM during a tour of the Operating Rooms, revealed a 5 milliliter (mL) syringe labeled succinycholine (a medication to relax patient's muscles for surgery), dated 5/29/19, untimed, on the anesthesia cart located in the Room 329, Anesthesia Storage.

2. During an interview at the time of the tour, the Director of Anesthesia revealed he drew up the succinylcholine in OR 2, during the night before, when the Director of Anesthesia assisted with a C-Section. The Director of Anesthesia normally drew up the medication during a surgical procedure, to have available if needed. The Director of Anesthesia would store the unused medication in Room 329, Anesthesia Storage, for use on a patient the next day.

3. Review of policy, "Quality Assurance of Compounded Sterile Product (CSP) Preparation," effective 4/7/18, revealed in part, "(s)ingle dose containers must be used within 1 hour..."

4. During an interview at the time of the tour, the Director of Anesthesia acknowledged the succinylcholine was not used within 1 hour of drawing up the medication, as required by CAH's policy.

II. Based on observation, document review and staff interviews, the Critical Access Hospital (CAH) failed to ensure proper water temperature for 2 of 2 products used to disinfect surgical instruments and endoscopes. Failure to ensure proper water temperature could potentially result in the enzymatic detergents not functioning adequately and failing to remove all bacteria or other infectious agents from the surgical instruments or endoscopes, potentially allowing the bacteria or other infectious agents to pass to the next patient, potentially resulting in the next patient developing a life-threatening infection. The hospital's administrative staff identified the surgical services staff performed an average of 450 surgical procedures and 474 endoscopies per year.

Findings include:

1. Observation on 5/29/19, at approximately 9:00 AM, during a tour of Room 325, Instrument Cleaning, revealed the CAH surgical staff used EmPower Dual Enzymatic Detergent to pre-clean surgical instruments.

2. Review of the manufacturer's recommendations for EmPower Dual Enzymatic Detergent revealed the surgical staff should use water with a temperature between 68 - 104 Fahrenheit (F) when using the product to pre-clean surgical instruments.

3. Observation on 5/30/19 at 8:30 AM revealed the water temperature in the sink used to pre-clean the surgical instruments was 111 degrees F (7 degrees above the manufacturer's recommendations for EmPower Dual Enzymatic Detergent).

4. During an interview at the time of the observation, Director of Surgery disclosed that the surgical services staff do not routinely check or document water temperatures when they use EmPower Dual Enzymatic Detergent to pre-clean surgical instruments. The Director of Surgery acknowledged the water temperature was higher than the manufacturer's recommendations for use with the EmPower Dual Enzymatic Detergent.

5. Observation on 5/30/19, at approximately 8:20 AM, during endoscope reprocessing after Patient #1 underwent an esophagogastroduodenoscopy (endoscopic procedure to examine stomach areas) revealed the surgical staff placed the endoscope into a water bath containing Medivator Intercept Detergent (an enzymatic cleaner used to start the cleaning and disinfection process).

6. Review of manufacturer's recommendations for Medivator Intercept Detergent revealed the surgical staff should use water with a temperature between 68 - 95 degrees Fahrenheit (F).

7. During an interview at the time of the observation, Staff D stated the surgical services staff do not test the water temperatures during the endoscope reprocessing while using Medivator Intercept Detergent. The surgical services staff let the water run until it is warm, fill the sink with appropriate amount of water, and then let the water sit until the surgical services staff begin cleaning and processing the endoscope.

8. Observations on 5/30/19, at approximately 9:30 AM, revealed the surgical services staff used an endoscope to perform a colonoscopy on Patient #5. Following the procedure, the surgical services staff filled the sink with water. Measurements of the temperature, just prior to the surgical services staff adding the Medivator Intercept Detergent, was 98.6 degrees F (3.6 degrees higher than the manufacturer recommended), and shortly prior to the surgical services staff placing the endoscope in the water.

9. During an interview at the time of the observation, the Director of Surgery disclosed the surgical services staff do not routinely check the water temperature when using the Medivator Intercept Detergent, to ensure the water temperature falls within the range specified by the manufacturer. The Director of Surgery acknowledged the water temperature exceeded the range specified by the manufacturer.

Based on document review and staff interview, the Critical Access Hospital (CAH) failed to ensure 1 of 5 physicians (Surgeon H ) had the quality and appropriateness of the diagnosis and treatment furnished to patients evaluated by a peer physician outside the CAH. Failure to ensure all physicians underwent external peer review could potentially result in Surgeon H providing substandard or inappropriate care to patients at the CAH, and the CAH staff failing to detect that Surgeon H provided substandard or inappropriate care. The CAH administrative staff identified Surgeon H performed an average of 28 surgical procedures per year.

1. Review of Surgeon H's credentialing file, for the 2 year period ending 1/30/18, revealed the credential file lacked evidence that Surgeon H's medical care to patients at the CAH underwent external peer review prior to the Medical Staff approving Surgeon H's application to the medical staff on 1/16/18 and the Governing Board appointing Surgeon H to the medical staff on 1/30/18.

2. A review of the "Critical Access Hospital Program, Medicare Rural Hospital Flexibility Program, Network Agreement", signed 2/9/04 by the CAH's President, revealed in part, "The parties agree that [Network Hospital], through participating members of its medical staff or other personnel designated by [Network Hospital], shall meet with the CAH's QA representatives no less than on a semi-annual basis to provide objective oversight and assistance to the CAH in reviewing the quality and appropriateness of the diagnosis and treatment furnished by CAH's doctors of medicine or osteopathy..."

3. Review of policy, "Peer Review External", dated 8/7/18, revealed the CAH failed to include requirements and timeframes for external peer review.

4. During an interview on 5/29/19 at approximately 3:15 PM, the Vice President of Nursing verified the CAH staff failed to ensure the CAH staff arranged for an external peer review to evaluate Surgeon H's medical care during the 2 year period prior to Surgeon H's reappointment to the Medical Staff on 1/30/18. Instead, the last time the CAH staff requested an external peer review to evaluate Surgeon H's care was 5/21/14 (4 years prior, and 2 recredentialing cycles prior).

Based on policy and patient medical record review, and staff interviews, the Critical Access Hospital (CAH) staff failed to perform a comprehensive activities assessment for 3 of patients (Patients #2, #3, and #4) closed swing bed patients which resulted in failure to ensure activity personnel developed and implemented an ongoing activity program that included an activities care plan for 3 of 5 closed swing bed patients (Patients #2, #3, and #4). Failure to provide a comprehensive activity assessment and an activity program that meets the physical and psychosocial needs of the individual patients could potentially impede the patient's progression toward attaining goals and achieving the highest level of well being and independence possible. The CAH administrative staff identified a census of 1 swing patient at the time of the survey and an average of 10 swing bed patients per month.

Findings include:

1. Review of the policy, "Activities Program, Swingbed," effective 9/26/16, revealed in part, "Performs initial activities assessment on each patient admitted to [Swing Bed Status]...Establishes a program that provides for ongoing program of meaningful activities appropriate to needs and interests of the patients.....Activities are assigned to promote physical, social and mental well being..."

2. Review of 5 of 5 closed swing bed patient medical records revealed the following information:

a. A physician ordered swing bed services for Patient #2 on 2/28/19 and the CAH discharged Patient #2 on 3/4/19. The Activity Coordinator failed to complete a comprehensive activity assessment for Patient #2.

Patient #2's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.

b. A physician ordered swing bed services for Patient #3 on 3/7/19 and the CAH discharged Patient #3 on 3/11/19. The Activity Coordinator failed to completed a comprehensive activity assessment for Patient #3..

Patient #3's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.

c. A physician ordered swing bed services for Patient #4 on 3/9//19 and the CAH discharged Patient #4 on 3/13/19. The Activity Coordinator failed to complete a comprehensive activity assessment for Patient #4.

Patient #4's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.

3. During an interview on 5/30/19 at 10:04 AM, the Activities Coordinator acknowledged she was responsible for completing a comprehensive activity assessment and providing an activity program for swing bed patients. The Activity Coordinator said in addition to activity calendars swing bed patients had a variety of activities available to them at the hospital. The Activity Coordinator verified she failed to complete a comprehensive activity assessment and to develop and implement an ongoing activities program that included an activities care plan for swing bed Patients #2, #3, and #4.

4. During an interview on 5/30/19 at 9:20 AM, the Utilization Review Manager acknowledged she had the responsibility to ensure the activity program functioned in compliance with the hospital's policy. The Utilization Review Manager verified the lack of documentation of a comprehensive activities assessment, activities, and activity care plans for Patients #2, #3, and #4.