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Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure the staff removed outdated medication and supplies from Cardiac Rehabilitations emergency crash cart, Malignant Hyperthermia cart, and Operating Room (OR) #1. Failure to remove outdated medications and supplies from the CAH's supplies, available for patient use, could potentially result in the staff using expired medications and/or supplies for patient use after the manufacturer's expiration date, potentially resulting in the staff using medication on a patient after the date which the manufacturer guaranteed the sterility and efficacy of the medication and supplies. The CAH administrative staff identified an average of approximately 105 inpatients and 579 outpatients per month from October 1, 2020 until September 30, 2021.

Findings included:

1. Review of the policy, "Supplies Expiration Process," approved on 7/2021, revealed in part, "... all medical supplied throughout the hospital must be checked for expiration dates." "... each department must ... regularly check their supplies ... on a monthly basis."

2. Observations during a tour on 9/28/21 at 10:20 AM of the Cardiac Rehab Department and inspection of the crash cart with the Infection Control and Cardiac Rehab Supervisor, revealed the following:

One of one 3.0 millimeter (mm) endotracheal tube (used to keep the airway open in order to give oxygen, medicine, or anesthesia) expired on 2/8/21.

One of one 4.5 mm endotracheal tube expired on 6/2020.

One of one 5.0 mm endotracheal tube expired on 9/2018.

Two of two 6.5 mm endotracheal tube expired on 4/6/21.

One of one 7.5 mm endotracheal tube expired on 8/2020.

One of one 8.0 mm endotracheal tube expired on 6/2019.

Curaplex Nasopharygeal (NPA) (used to keep the airway open and can be used with patients who are conscious or semi-conscious) Kit containing 20 French (F)-36 F, expired on 7/31/21.

Shiley Tracheostomy tube (a tube that is placed through a hole in the neck and directly into your windpipe to help patients breathe), cuffed with disposable inner cannula expired on 9/2019.

One of one Tegderm Film (2 in. x 2.75 in.), expired on 02/2020.

One of two Primary Intravenous Tube with secure lock (107 in.), expired on 10/10/20.

Two of two ConMed 6 ft. long suction connector tubing, expired on 12/14/20.



3. During an interview on 9/28/21 at 10:20 AM with the Infection Control and Cardiac Rehab Supervisor they acknowledged the outdated supplies.



4. Observations during a tour on 9/28/21 at 9:00 AM of the Operating Room Suite, with the Outpatient Specialty Coordinator, revealed the following:

In the Operating Room supply cupboard, 2 of 2 McMurray Enhanced Airway (adult), expired 1/14/21.

2 of 2 LoPro S4 Glidescope spectrum blades (are designed to enable fast intubation in routine and difficult airways), expired on 2/14/21.

2 of 2 LoPro S3 Glidescope spectrum blades, expired on 2/20/21.

5 of 5 LoPro S2 Glidescope spectrum blades, expired on 3/8/21.

b. Operating Room Malignant Hyperthermia cart, 3 of 3 12 ml syringes, expired 11/20/20.

1 of 1 22 gauge (g) 1 (0.7 mm x 25 mm) BD Eclipse Needle, expired 6/2020.

1 of 1 5 ml bottle of 2% Xylocaine MPF (100 g/5 ml), expired 8/2021.


6. Review of the policy, "Expired Medications," approved on 7/2021, revealed in part, "... inspections of all medication storage areas are performed on a monthly basis .... and medications that outdate in the upcoming month will be pulled ..."

7. During an interview on 9/29/21 at 10:30 AM, the Outpatient Specialty Coordinator reported the Malignant Hyperthermia cart did not have a log to track outdates and acknowledged the outdated supplies and the staff need to track these outdate per the CAH's policy.

I. Based on document review and staff interviews, the Critical Access Administrative (CAH) staff failed to ensure the Cardiac Rehab staff had a system in place to ensure the Cardiac Rehab Medical Director ordered Cardiac Rehabilitation (cardiac rehab) prior to initiating exercise for 1 of 4 sampled open cardiac rehab patients (Patient #4). Failure to have an order for cardiac rehabilitation prior to the start of an exercise program could potentially result in a patient beginning exercise before the doctor determined a patient was medically stable and may have a direct effect on the quality, effectiveness, and safety to patients ultimately impacting the outcome for patients participating in the Phase II cardiac rehab. The CAH Administrative staff identified approximately 30 patients received Phase II cardiac rehabilitation from October 1, 2020 to September 30, 2021.


Findings include:

1. Review of the facility's policy, "Rules and Regulations of the Medical Staff", last approved 2/2019, revealed in part, "All orders for treatment ... must be written clearly, legibly and completely, and signed by the practitioner responsible for them."

Review of the Cardiac Rehabilitation policy "Physician Referral", last approved 7/2021, revealed in part, "... referral for cardiac rehab can be ordered from an MD, DO and/or mid-level [provider]..."

Review of the Cardiac Rehabilitation policy "Initial Patient Assessment/Evaluation", last approved 7/2021, revealed in part, "Initial patient assessment and evaluation for benefits of Cardiac Rehab Program will be performed on all patients referred to Cardiac Rehabilitation by an ordering physician ..."


2. Review of Patient # 4's medical record revealed Patient #4 was admitted to the cardiac rehab program on 7/19/2021 at 10:30 AM with a medical diagnosis of Mitral valve replacement with coronary artery bypass surgery, CABG X 2 ( a surgical procedure used to divert blood around narrowed or clogged parts of major arteries to improve blood flow and oxygen supply to the heart) on 6-26-2021 Patient #4's post operative recovery was complicated by an episode of atrial fibrillation (an irregular, often rapid heart rate, in which the heart's upper chambers beat out of coordination with the lower chambers) after surgery. A cardiac rehab Phase II interview and assessment, which included a 6 minute walk test and exercise on a recumbent bike for 10 minutes, was completed at this first visit. Patient #4 returned on 7/23/21 at 10:14 AM for Cardiac Rehab Session 2. Patient # 4 exercised on a treadmill for 20 minutes, on a recumbent bike for 10 minutes, and on a treadmill again for 20 minutes. Patient #4 completed 13 exercise sessions prior to receiving the order from the Cardiac Rehab Medical Director on 8/18/21 for Patient #4 to participate in the Cardiac Rehabilitation Program.

3. During an interview on 9/28/21 at approximately 10:20 AM, the Cardiac Rehab Supervisor reported she sometimes started patients in the cardiac rehab program before obtaining the Cardiac Rehab Medical Director's order and acknowledged Patient #4 started their cardiac rehab program a month prior to receipt of the doctor's order.

4. During an interview on 9/29/21 at 3:29 PM, the Director of Nursing acknowledged that Patient #4 had started the cardiac rehabilitation program without a doctor's order for cardiac rehabilitation as required.




II. Based on document review and staff interviews, the Critical Access Administrative (CAH) staff failed to ensure the Cardiac Rehab staff had a system in place to ensure the Cardiac Rehab Medical Director reviewed and signed Phase II exercise prescriptions and individual treatment plans (ITP) completed by the Cardiac Rehab Registered Nurse Supervisor at the start of cardiac rehab and failed to submit an ITP every 30 days to the Cardiac Rehab Medical Director and the patient's primary physician for review and signature, for 4 of 4 sampled open cardiac rehab patients (Patient #1, Patient #2, Patient #3, and Patient #4). Failure to review and sign the Phase II exercise prescription and every 30 day ITP's could potentially have a direct effect on the quality, effectiveness, and safety to patients ultimately impacting the outcome for patients participating in the Phase II cardiac rehab. The CAH Administrative staff identified approximately 30 patients received Phase II cardiac rehabilitation from October 1, 2020 to September 30, 2021.


Findings include:

1. Review of the Cardiac Rehabilitation policy "Patient Progress Report", last approved 7/2021 revealed in part, "To update and inform primary physician on the patient's progress ... individual treatment plan will be signed by the patient's primary physician every 30 days ..." The policy lacked direction for the cardiac rehab staff to update and inform the doctor who ordered and is medically responsible for the patient (Cardiac Rehab Medical Director), on the patient's progress and lacked the requirement for the physician to sign the ITP every 30 days.

Review of the Cardiac Rehabilitation policy "Exercise Prescription - Outpatient", last approved 7/2021, and "Treatment Plan" last approved 7/2021, lacked direction for the Cardiac Rehab Medical Director or other provider medically responsible for the patient to review and sign the Phase II exercise prescription and the individualized treatment plan developed by the cardiac rehab nurse prior to implementing the exercise prescription and treatment plan.


2. Review of Patient's medical record revealed the following information.

a. Patient #1's medical record revealed Patient #1 was admitted to the cardiac rehab program on 7/7/21 at 8:35 AM with medical diagnoses including percutaneous transluminal coronary angioplasty (PTCA) (a minimally invasive procedure that opens blocked coronary arteries to improve blood flow to the heart) on 6/29/21. A Cardiac Phase II session report and individualized treatment plan lacked the Cardiac Rehab Medical Director's signature for Patient #1's Phase II Cardiac Rehab Therapy. Patient #1 received cardiac rehab without a physicians order/prescription for exercises. Patient #1 had participated in 12 exercise sessions from 7/7/21 to 8/2/21. The ITP, developed to update and inform the physician on the patient's progress, dated August 2, 2021, lacked evidence of physician review and signature. Patient #1 participated in 12 exercise sessions from August 2, 2021 to September 1, 2021. The ITP, dated September 1, 2021, lacked evidence of physician review and signature.

b. Patient #2's medical record revealed Patient #2 was admitted to the cardiac rehab program on 8/30/21 at 10:40 with medical diagnoses including percutaneous coronary artery disease (CAD) with diabetes. A Cardiac Phase II session report and individualized treatment plan lacked the Cardiac Rehab Medical Director's signature for Patient #2's Phase II Cardiac Rehab Therapy. Patient #2 received cardiac rehab without a physicians order/prescription for exercises.

c. Patient #3's medical record revealed Patient #3 was admitted to the cardiac rehab program on 8/20/21 at 1:00 PM with medical diagnoses of CAD and congestive heart failure (a chronic condition in which the heart doesn't pump blood as well as it should.) A Cardiac Phase II session report and individualized treatment plan lacked the Cardiac Rehab Medical Director's signature for Patient #3's Phase II Cardiac Rehab Therapy. Patient #3 received cardiac rehab without a physicians order/prescription for exercises. Patient #3 had participated in 5 exercise sessions from 8/20/21 to 9/1/21. The ITP, developed to update and inform the physician on the patient's progress, dated September 1, 2021, lacked evidence of physician review and signature.

d. Patient #4's medical record revealed Patient #4 was admitted to the cardiac rehab program on 7/19/2021 at 10:30 AM with a medical diagnosis of mitral valve replacement with coronary artery bypass surgery, (CABG) X 2 ( a surgical procedure used to divert blood around narrowed or clogged parts of major arteries to improve blood flow and oxygen supply to the heart) on 6/26/2021. Patient #4's post operative recovery was complicated by an episode of atrial fibrillation (an irregular, often rapid heart rate, in which the heart's upper chambers beat out of coordination with the lower chambers) after surgery. The monitored Cardiac Phase II session report and Individualized Treatment Plan lacked the Cardiac Rehab Medical Director's signature for Patient #4's Phase II Cardiac Rehab Therapy. Patient #4 received cardiac rehab without a physicians order/prescription for exercises. Patient #4 participated in 5 exercise sessions from 7/19/21 to 8/2/21. The ITP, dated August 2, 2021, lacked evidence of physician review and signature. Patient #4 participated in 13 exercise sessions from 8/2/21 to 9/1/21. The ITP, dated September 1, 2021, lacked evidence of physician review and signature,


3. During an interview on 9/28/21 at 10:20 AM, the Cardiac Rehab Supervisor reported she has at times started a patient in the cardiac rehab program prior to receiving the order for cardiac rehab form the cardiac rehab medical director.

During an interview on 9/29/21 at 9:45 AM, the Cardiac Rehab Supervisor reported she was responsible for all aspects of the cardiac rehab program such as patient intake, assessment, developed the exercise plan, implemented the plan and created the individual treatment plans/summary outcomes report. The Cardiac Rehab Supervisor verbalized that she did not send the exercise plan, which she created during the patient's second session, to the physician to be reviewed for approval and signed. The Cardiac Rehab Supervisor reported at one time it had been required that the physician reviewed and sighed the ITP every 30 days, but that she stopped requiring signatures about 3 years ago as she had so much trouble getting the ITP signed and returned timely. The ITP's are now created every 30 days and sent to the physician but the Cardiac Rehab Supervisor reported she can not confirm if the ITP's are reviewed. The Cardiac Rehab Supervisor acknowledged that once the order for a patient to begin Phase II cardiac rehab has been given, there is no evidence in the patient's medical record of physician involvement or oversight of the patient's cardiac rehabilitation. The Cardiac Rehab Supervisor acknowledged she was not aware of any specific cardiac rehab program requirements outside of the diagnoses required to qualify for Phase II rehab.

4. During an interview on 9/27/21 at 3:29 PM, the Director of Nursing (DON) acknowledged that the exercise prescriptions and individual treatment plans created for patients in the CAH's cardiac rehab Phase II program did not show evidence of physician review, approval, and signature. The DON acknowledged she was not aware of the requirements for a Cardiac Rehab Phase II program.

Based on observation, document review, and interviews, the Critical Access Hospital (CAH) Administrative staff failed to ensure the surgery staff changed the sterile water flush bottles after endoscope procedures for each patient, in accordance with the manufacturer's directions. Failure to change the flush bottle of sterile water after each patient could potentially result in bacteria growing in the sterile water and potentially causing an infection in the next patient. The Administrative staff identified that the surgery staff performed an average of 7.5 endoscope procedures per month from 9/1/2020 to 9/28/2021.

Findings include:

1. Observations during a tour of the surgery department on 9/28/2021 at approximately 10:33 AM in Operating Room (OR) #2 revealed 1 of 1 ICUmedical 1000 ml (milliter) bottle of sterile water for irrigation connected to the endoscope equipment (a nonsurgical procedure where a physician inserts a flexible camera into a patient's body to examine the digestive tract).

2. Review of the manufacturer's instructions indicated in part, "... intended for use only as a single-dose or short procedure irrigation." "Unused portions should be discarded and a fresh container of appropriate size used for the startup of each cycle or repeat procedure." (The hospital staff must discard any unused portions of the sterile water for irrigation after use on a single patient. The sterile water for irrigation did not contain any chemicals to prevent bacteria from growing in the sterile water once the hospital staff opened the bottles of sterile water for irrigation.)

3. During an interview on 9/28/21 at 10:30 AM, at the time of the tour, the Outpatient Specialty Coordinator of Surgery, indicated that the surgery staff opened the bottles of sterile water for irrigation each day for endoscope procedures that are scheduled and connected it to the equipment. The equipment contained a one-way valve to prevent backflow between patients to prevent contamination of the source bottle. The surgery staff changed the flush tubing between the patient and the one-way valve after each endoscope procedure, but did not change the tubing between the one-way valve and the bottle of sterile water for irrigation or replace the bottle of sterile water for irrigation between endoscope procedures. The surgery staff would only discard the bottles of sterile water for irrigation once they completed all of the endoscope procedures for the day or if the bottle ran empty.

4. During an interview on 09/28/2021 at approximately 10:30 AM, the Outpatient Specialty Coordinator of Surgery reviewed and confirmed the manufacturer's directions for ICU Medical 1000 ml of sterile water for irrigation. The Outpatient Specialty Coordinator of Surgery acknowledged the manufacturer's product information did not support using the bottles of sterile water for irrigation for more than one patient.

Based on observation, document review and staff interviews, Critical Access Hospital (CAH) administration failed to ensure 3 of 3 reviewed laboratory staff members (Laboratory Supervisor, Medical Technologist A, and Medical Technologist B) and 4 of 4 Registered Nurses (RN) reviewed (Director of Nursing, Registered Nurse (RN) C, RN D, and RN E) had color vision proficiency prior to interpreting the results of fecal occult blood (blood in stool) tests for all laboratory and nursing staff who read the results of the test. Failure to test all laboratory and nursing staff for color blindness before performing this test may result in staff misreading the results of the fecal occult blood test which could potentially adversely affect the diagnosis and treatment plan for patients. The CAH laboratory and nursing staff performed 53 fecal occult blood tests from 9/28/20 to 9/28/21.

Findings include:

1. Observation on 9/28/21 at 10:55 PM, during a tour of the Laboratory revealed the laboratory staff utilized Beckman Coulter Hemoccult slides to check stool for occult blood.

2. During an interview at the time of the tour of the laboratory,the Laboratory Supervisor reported the laboratory and nursing staff identified a positive occult blood test result by identifying the slide turned the color blue. The Laboratory Supervisor acknowledged the laboratory and nursing staff interpreting the test would require the ability to identify the color blue.

3. Review of the manufacturer's recommendations for Beckman Coulter Hemoccult slides, dated March 2015 revealed, in part: "Because this test is visually read and requires color differentiation, it should not be interpreted by individuals with blue color deficiency (blindness) ...."

4. Review of the CAH policy "Hemoccult Waived - Procedure," dated 11/2019, revealed in part, "Any trace of blue on or at the edge of the smear is positive for occult blood ...."


5. Review of personnel files revealed the following:

a. Laboratory Supervisor started working at the CAH on 1/18/02. The Laboratory Supervisor's personnel file lacked documentation the CAH staff tested the Laboratory Supervisor for blue color vision proficiency upon hire or at any time after hire.

b. Medical Technologist A started working at the CAH on 10/14/1991. Medical Technologist B's personnel file lacked documentation the CAH staff tested Medical Technologist B for blue color vision proficiency upon hire or at any time after hire.

c. Medical Technologist B started working at the CAH on 06/18/18. Medical Technologist B's personnel file lacked documentation the CAH staff tested Medical Technologist B for blue color vision proficiency upon hire or at any time after hire.

d. Director of Nursing (DON) started working at the CAH on 7/14/1997. The DON's personnel file lacked documentation the CAH staff tested the DON for blue color vision proficiency upon hire or at any time after hire.

e. RN C started working at the CAH on 10/15/20. RN C's personnel file lacked documentation the CAH staff tested RN C for blue color vision proficiency upon hire or at any time after hire.

f. RN D started working at the CAH on 2/26/20. RN D's personnel file lacked documentation the CAH staff tested RN D for blue color vision proficiency upon hire or at any time after hire.

g. RN E started working at the CAH on 7/14/20. RN E's personnel file lacked documentation the CAH staff tested RN E for blue color vision proficiency upon hire or at any time after hire.


5. During an interview on 9/28/21 at 10:55 AM, the Laboratory Supervisor confirmed the CAH administrative staff did not currently require color blind testing of laboratory or nursing staff and the CAH's administrative staff had not performed testing for color blindness on any of the CAH laboratory or nursing staff.

During an interview on 9/27/21 at 1:40 PM, the Assistant Director of Nursing confirmed the CAH administrative staff did not currently require color blind testing of nursing staff and the CAH's administrative staff had not performed testing for color blindness on any of the CAH nursing staff.

Based on review of documentation and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to focus on measures related to improved health outcomes that are shown to be predictive of desired patient outcomes for all services, including contracted services for 23 of 28 departments (Anesthesia, Anesthesia Pain Clinic, Surgical Services, Emergency Room [ER], Laboratory, Respiratory Therapy [RT], Speech Therapy, Occupational Therapy, Physical Therapy, Radiology, Nuclear Medicine, Dexa Scan, Magnetic Resonance Imaging [MRI], Dietary, Nursing, Outpatient Treatment Center, Cardiac Rehab, Sleep Study, Nebraska PICC, Health Information Management, Social Services/Discharge Planning, Chemotherapy, and Environmental Services) by failing to change indicators after 6 consecutive months of attaining goals at or above threshold in accordance with facility policy. The CAH administrative staff identified a census of 3 patients at the beginning of the survey. Failure to focus on measures related to improved health outcomes that are shown to be predictive of desired patient outcomes to include involvement of all of the CAH's departments on a continuous basis could potentially result in the CAH quality staff failing to identify potentially significant patient care concerns while monitoring items not related to patient care, thus missing potentially life-threatening patient care concerns.

Findings include:

1. Review of the CAH "Quality Improvement Plan," revised 11/2020, revealed in part, "All departments and all staff are responsible for implementing quality improvement activities ..."

Review of CAH policy "Quality Improvement Monitor Development," last approved 11/2020, revealed in part, "The Quality Improvement Department will routinely contact the individual departments to assist with any monitors which have maintained at or above goal for 6 consecutive months which might be changed to address other problem areas ...."

2. Review of the CAH's quality documentation revealed the following:

a. No quality indicators were identified for Anesthesia, Respiratory Therapy, Dexa Scan, or Chemotherapy for the year 2021.

b. Review of the Anesthesia Pain Clinic, Surgery, ER, Laboratory, Speech Therapy, Occupational Therapy, Physical Therapy, Radiology, Dietary, Nursing, Outpatient Treatment Center, Cardiac Rehab, Sleep Study, Nebraska PICC, Health Information Management, Social Services/Discharge Planning, and Environmental Services documentation for year 2021 revealed the indicator was maintained above goal for 8 consecutive months and no further indicators were identified.

The documentation lacked evidence that the CAH's quality staff focused on measures related to improved health outcomes for patients.

3. During an interview on 9/29/21 at 8:35 AM, the Quality Improvement Coordinator verified the CAH staff failed to ensure monitors which have maintained at or above the goal for 6 consecutive months were changed to address other problems to focus on measures related to improved health outcomes.

Based on review of policy/procedure and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure 1 of 1 abuse policy contained the required language in the regulations that all alleged violations involving abuse, neglect, exploitation or mistreatment, including injuries of unknown source and misappropriation of resident property, are reported immediately, but not later than 2 hours after the allegation is made, if the events that cause the allegation involve abuse or result in serious bodily injury, or not later than 24 hours if the events that cause the allegation do not involve abuse and do not result in serious bodily injury, to the administrator of the facility and to other officials (including to the State Survey Agency) for swing bed patients. The CAH administrative staff identified a monthly average of 3.25 skilled patients from October 1, 2020 until September 30, 2021. Failure to include the required language in the abuse policy could potentially prevent CAH staff from reporting alleged violations involving abuse to the CAH administrator and to other officials (including to the State Survey Agency) in a timely manner.

Findings include:

1. Review of the CAH's policy "Dependent Adult Abuse Prevention and Reporting," approved date, 7/2021, failed to include the required language in the regulations that all alleged violations involving abuse, neglect, exploitation or mistreatment, including injuries of unknown source and misappropriation of resident property, are reported immediately, but not later than 2 hours after the allegation is made, if the events that cause the allegation involve abuse or result in serious bodily injury, or not later than 24 hours if the events that cause the allegation do not involve abuse and do not result in serious bodily injury, to the administrator of the facility and to other officials (including to the State Survey Agency).

2. During an interview on 9/29/21 at 2:55 PM, the Director of Nursing (DON) acknowledged the abuse policy failed to include the required language in the regulations that all alleged violations involving abuse, neglect, exploitation or mistreatment, including injuries of unknown source and misappropriation of resident property, are reported immediately, but not later than 2 hours after the allegation is made, if the events that cause the allegation involve abuse or result in serious bodily injury, or not later than 24 hours if the events that cause the allegation do not involve abuse and do not result in serious bodily injury, to the administrator of the facility and to other officials (including to the State Survey Agency).