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Based on CAH policy review, observation, and staff interview, it was determined the CAH failed to ensure a system to prevent potential transmission of infections and communicable diseases was fully implemented, and failed to ensure systems to identify and investigate infections was clearly defined and implemented. This had the potential to impact all staff and patients in the CAH. Failure to follow policies, nationally recognized guidelines, and standard precautions had the potential to allow for transmission of infections. Findings include:

1. A CAH policy "Infection Control Plan," reviewed 3/16/17, stated "It [infection control plan] requires cooperation between all departments." Additionally, the policy stated "For these reasons, [CAH]...has established an Infection Control Plan which requires the participation, support and cooperation of all personnel."

The CAH failed to fully implement, coordinate, and maintain oversight of its infection control plan to include all departments and staff. Examples include:

A contracted EVS housekeeper was interviewed on 9/19/17, beginning at 8:45 AM. She stated EVS did not participate in the CAH infection control plan or infection control training.

The contracted EVS Account Manager was interviewed on 9/19/17, beginning at 8:55 AM. She stated the CAH did not provide infection control training or CAH infection control policy and procedure review to EVS contracted employees.

The Infection Control Officer was interviewed on 9/19/17, beginning at 9:35 AM. She stated she performed annual infection control training for CAH staff, not contracted staff. The Infection Control officer stated, even though she was designated as having responsibility for the infection control plan, she did not provide infection control oversight to the entire hospital. She stated the OR Manager and Laboratory Manager had infection control oversight of their respective departments. The Infection Control Officer stated she only provided infection control oversight to the ED, inpatient floor, and for surgical site infections.

The Infection Control Officer stated the Infection Control Committee should involve all department managers, but acknowledged not all managers attended. She stated she does not partner with contracted EVS staff and provides no education, training, or CAH policy review with those contracted employees.

The CNO was interviewed on 9/19/17, beginning at 10:50 AM. She stated she was unaware of who had infection control oversight of the ED and inpatient floor. The CNO stated current infection control related data and education, collected by the DNS, was not reported to the Infection Control Officer. She stated she did not know who was responsible for contracted EVS infection control training and CAH policy review.

The DNS was interviewed on 9/19/17, beginning at 11:15 AM. She stated she was unsure if the Infection Control Officer or the EVS contract provided infection control training to contracted EVS staff.

The Laboratory Manager was interviewed on 9/19/17, beginning at 11:30 AM. He stated the Infection Control Officer was responsible for laboratory employee infection control education, not him. The Laboratory Manager stated he did not participate in the Infection Control Committee.

The OR Manager was interviewed on 9/20/17, beginning at 9:06 AM. She stated she was unaware the responsibility of infection control in the OR was delegated to her by the Infection Control Officer. The OR Manager stated she thought the Infection Control Officer oversaw that duty. She stated she did not present infection control related data or education to the Infection Control Officer. The OR Manager stated she did not participate in the Infection Control Committee.

The Director of Pharmacy was interviewed on 9/20/17, beginning at 10:35 AM. She stated she had "very little involvement" in the CAH's infection control plan.

The CEO and CNO were interviewed together on 9/21/17, beginning at 11:55 AM. They confirmed there was a lack of CAH infection control plan oversight by the Infection Control Officer and Governing Body. The CEO and CNO stated all departments should be involved with the Infection Control Committee and infection control plan. They confirmed the contradictory statements by department staff were confusing and could lead to poor implementation of the CAH's infection control plan and patient safety. The CEO and CNO stated contracted staff should be exposed to CAH infection control policy review related to their specific duties.

The CAH failed to fully implement, coordinate, and maintain oversight of its infection control plan to include all departments and staff.



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2. A CAH policy "Protective Equipment," approved 10/01/01, stated "Employees required to perform tasks that may involve the exposure to blood, body fluids, or other infectious materials will be provided with the appropriate protective clothing and/or equipment." This policy was not followed.

An observation was conducted of a knee arthroscopy (a surgical procedure which uses a small camera to view the knee joint) for Patient #20, beginning at 12:20 PM, on 9/20/17.

At the conclusion of the surgical procedure, at 1:01 PM, Scrub Technician A and Scrub Technician B were observed for proper cleaning and decontamination of the surgical instruments used during the procedure. The soiled surgical instruments were transported in a stainless-steel basin to the decontamination area.

In the decontamination area, Scrub Technician A began filling a stainless steel pan with the required amount of water and enzymatic cleaner. The pan was sitting on top of the sink at the upper abdomen level of Scrub Technician A. Once the pan was filled she began transferring the soiled instruments from the basin into the pan.

Scrub Technician A was wearing only gloves when she proceeded to soak/scrub the surgical instruments. Scrub Technician B was standing next to Scrub Technician A as she handed the cleaned instruments to him for drying. Scrub Technician B was wearing only gloves. Neither of the scrub technicians were wearing gowns or face/eye protection while cleaning the soiled surgical instruments.

The Guidelines for Perioperative Practice 2015, published by the AORN, included a chapter on cleaning of instruments with recommendations. Recommendation VI of this section stated "Personnel working in the decontamination area and handling contaminated instruments must wear PPE [personal protective equipment]." It further stated PPE consistent with exposure risks in the decontamination area included a fluid-resistant gown with sleeves, a mask, and eye protection.

During an interview at 1:30 PM on 9/20/17, both Scrub Technician A and Scrub Technician B stated they were not certified as scrub technicians. Both confirmed they did not wear gowns or face/eye protection when cleaning contaminated surgical instruments.

The scrub technicians failed to follow CAH policy and nationally recognized guidelines for personal protection when cleaning surgical instruments.

Based on contract review and staff interview, it was determined the CAH failed to ensure they maintained a list of all services provided by contract or agreement. This resulted in lack of oversight and monitoring of contracts, and had the potential to interfere with utilization of contracted services. Findings include:

A request was made for a list of services provided by contract or agreement to the CAH. Four large binders were provided. The binders contained all the contracts and agreements provided to the CAH. On the front of each binder was a list with the names of providers who had a contract for services. However, the lists did not include a description of the nature and scope of the services provided, or whether they were provided on or off site. Additionally, 1 of the binders included a contract with an eye bank which had expired in 2012.

The CEO was interviewed on 9/20/17, at 11:40 AM. He confirmed there was not a specific list for providers who had contracts with the CAH. He also confirmed the contract with the eye bank had expired.

The CAH failed to ensure there was a list of services provided by contract or agreement.

Based on medical record review and staff interview, it was determined the CAH failed to ensure nursing services met the needs of 1 of 3 patients (Patient #3) who were admitted for inpatient services and transferred to swing bed services, and whose records were reviewed. This resulted in orders not being followed and the patient's care needs not being met. Findings include:

Patient #3 was a 94 year old male admitted on 2/26/17, for new onset of CHF, atrial fibrillation, uncontrolled DM Type II, and generalized weakness. The nursing staff failed to identify and meet the care needs for Patient #3. Examples include:

1. Patient #3's record included an H&P, dated 2/26/17, signed by the NP. The H&P stated his DM was treated at the CAH with injections of insulin initially, and later would change to oral medications.

A medication order, signed by the NP on 2/26/17, was for Lantus (insulin) 10 units subcutaneously daily. This order was discontinued on 2/27/17, at 1:58 PM, by the NP. On 2/27/17, at 1:59 PM, an order for Lantus 15 units subcutaneously daily was signed by the NP. This order was discontinued on 3/02/17.

On 2/28/17 at 7:58 AM, the MAR documented Patient #3 received Lantus 10 units subcutaneously. At 9:00 AM on 2/28/17, he also received Lantus 15 units subcutaneously. Additionally, there was no documentation Patient #3 received the 15 units of Lantus ordered by the NP on 3/01/17.

2. Patient #3's record included nursing orders, dated and signed 2/26/17, for blood glucose checks before meals and at bedtime. This order was not followed.

A Diabetic Flow Sheet documented the dates, times, and results when Patient #3's blood glucose was checked. Patient #3's blood glucose was ordered to be checked 4 times a day from 2/26/17 until 3/02/17. On 2/27/17 and 3/01/17, his blood glucose was checked 3 times. On 2/28/17, Patient #3's blood sugar was checked 1 time.

3. Patient #3 was admitted for new onset of CHF. His initial complaint upon arrival to the ED was increased shortness of breath over the last several days and difficulty breathing when laying down.

The National Institutes for Health website, accessed 9/26/17, included a patient education guide for CHF. It stated "Heart failure is a condition in which the heart can't pump enough blood to meet the body's needs." Additionally, it stated weakening of the heart's pumping ability causes blood and fluid to back up into the lungs, fluid to buildup in the legs, ankles and feet (edema), and shortness of breath.

Patient #3's record included an H&P dated 2/26/17, signed by the NP, which stated he had 3+ edema in his left foot up to his left knee, and 2+ edema in his right foot up to his right knee. The nursing progress notes, dated 2/26/17, documented Patient #3 had no edema.

A provider progress note dated 2/27/17, signed by the NP, documented Patient #3 had 2+ edema to both of his lower extremities up to his knees. The nursing progress notes for Patient #3, dated 2/27/17, documented Patient #3 had no edema.

A provider progress note dated 2/28/17, signed by the NP, documented Patient #3 had 1+ edema to both of his lower extremities up to his mid-shin. The nursing progress notes for Patient #3, dated 2/28/17, documented Patient #3 had no edema.

A provider progress note dated 3/03/17, signed by the NP, documented Patient #3 had 2+ edema to both of his lower extremities up to his knees. The nursing progress notes for Patient #3, dated 3/03/17, documented Patient #3 had no edema.

4. A provider progress note dated 2/27/17, signed by a PA, documented he had gone to the CAH to assess Patient #3 because staff had called and reported "Pt sleeping and having apneic [absence of breathing] episodes for several seconds ..." The PA also documented Patient #3's oxygen levels had decreased into the 80s during these episodes. Normal oxygen levels are 90 or greater. The PA documented Patient #3 was to be observed and placed on oxygen at 2 LPM keep his oxygen levels between 90-99%.

A nursing progress note dated 2/27/17, at 9:30 PM, documented a PA was notified Patient #3 had difficulty breathing and the PA came to the CAH to assess him. There was no documentation of a reassessment by the RN, about whether Patient #3's status had improved, or if new orders were received. The next documented entry by the RN was at 1:30 AM, 3 hours after the PA was notified of Patient #3's respiratory distress.

During an interview at 2:10 PM on 9/21/17, the CNO reviewed Patient #3's record and confirmed his orders were not followed. She also confirmed there were discrepancies between the providers' assessments and the nursing assessments documented in the record. She stated the nurses failed to document a reassessment when there were changes to Patient #3's condition.

The CAH failed to provide nursing services for Patient #3 which met his care needs.

Based on medical record review and staff interview, it was determined the CAH failed to ensure an RN evaluated and provided supervision for 3 of 3 inpatients (#1, #2, and #3) who received LPN nursing care and whose records were reviewed. This lack of RN supervision had the potential for inpatients' conditions to deteriorate without appropriate intervention. Findings include:

1. Patient #1 was a 56 year old female who was admitted on 9/15/17, for recovery following a left hip replacement.

Patient #1's medical record included documented nursing care delivered by the LPN. Her medical record did not document RN supervision of care provided by the LPN.

The CNO was interviewed on 9/20/17, beginning at 11:16 AM, and Patient #1's medical record was reviewed in her presence. She confirmed Patient #1's medical record did not include documented RN supervision of care delivered by the LPN.

The CAH failed to ensure LPN care delivered to Patient #1 was supervised by an RN.

2. Patient #2 was a 90 year old male who was admitted on 9/06/17, with a diagnosis of pneumonia.

Patient #2's medical record documented nursing care delivered by the LPN. His medical record did not include RN supervision of care delivered by the LPN.

The CNO was interviewed on 9/20/17, beginning at 11:06 AM, and Patient #2's medical record was reviewed in her presence. She confirmed Patient #2's medical record did not include RN supervision of care delivered by the LPN.

The CAH failed to ensure LPN care delivered to Patient #2 was supervised by an RN.

3. Patient #3 was a 94 year old male who was admitted on 2/26/17, with a diagnosis of CHF exacerbation.

Patient #3's medical record documented nursing care delivered by the LPN. His medical record did not document RN supervision of care delivered by the LPN.

The CNO was interviewed on 9/20/17, beginning at 11:06 AM, and Patient #3's medical record was reviewed in her presence. She confirmed Patient #3's medical record did not include RN supervision of care delivered by the LPN.

The CAH failed to ensure LPN care delivered to Patient #3 was supervised by an RN.

Based on medical record review and staff interview, it was determined the CAH failed to ensure RN supervision of LPN medication administration for 3 of 3 inpatients (#1, #2, and #3) who received inpatient LPN nursing care and whose records were reviewed. This lack of RN supervision had the potential for unsafe medication delivery to patients. Findings include:

1. Patient #1 was a 56 year old female who was admitted on 9/15/17, for recovery following a left hip replacement.

Patient #1's medical record documented medication administration by the LPN. Her medical record did not document RN supervision of this LPN's medication administration.

The CNO was interviewed on 9/20/17, beginning at 11:16 AM, and Patient #1's medical record was reviewed in her presence. She confirmed Patient #1's medical record did not document RN supervision of LPN medication administration.

The CAH failed to ensure medications administered to Patient #1 by the LPN was supervised by an RN.

2. Patient #2 was a 90 year old male who was admitted on 9/06/17, with a diagnosis of pneumonia.

Patient #2's medical record documented medication administration by the LPN. His medical record did not document RN supervision of this LPN's medication administration.

The CNO was interviewed on 9/20/17, beginning at 11:06 AM, and Patient #2's medical record was reviewed in her presence. She confirmed Patient #2's medical record did not document RN supervision of LPN medication administration.

The CAH failed to ensure medications administered to Patient #2 by the LPN was supervised by an RN.

3. Patient #3 was a 94 year old male who was admitted on 2/26/17, with a diagnosis of CHF exacerbation.

Patient #3's medical record documented medication administration by the LPN. His medical record did not document RN supervision of this LPN's medication administration.

The CNO was interviewed on 9/20/17, beginning at 11:06 AM, and Patient #3's medical record was reviewed in her presence. She confirmed Patient #3's medical record did not document RN supervision of LPN medication administration.

The CAH failed to ensure medications administered to Patient #3 by the LPN was supervised by an RN.

Based on medical record review and staff interview, it was determined the CAH failed to ensure 3 of 20 medical records (#6, #9, and #20) included complete and accurate medical record entries. This had the potential to interfere with the coordination and provision of patient care. Findings include:

1. Patient #20 was a 48 year old male who was admitted on 9/20/17, with a diagnosis of right knee pain and surgical repair.

a. Patient #20's medical record included a "SURGERY SCHEDULING ORDERS," dated 9/20/17, signed by the physician. The form included a section titled "Indicate order with check mark:". Under this section were 2 options with a corresponding checkbox:

- "Place patient in OUTPATIENT status..."

- "Admit patient to INPATIENT status..."

Neither of these 2 options were checked.

b. Patient #20's medical record included a "History and Physical Exam" form, dated 9/20/17, signed by the physician. The form was not timed and it could not be determined if the exam took place before or after Patient #20's surgical procedure.

c. Patient #20's medical record included a "ANESTHESIOLOGY NOTES & PRE/POST-OP EVALUATION," dated 9/20/17, signed by the CRNA. The pre and post-anesthesia assessment times were not timed, and it could not be determined if the assessments were performed before or after Patient #20's surgical procedure.

The CNO was interviewed on 9/21/17, beginning at 11:30 AM, and Patient #20's medical record was reviewed in her presence. She confirmed Patient #20's medical record entries were not complete.

The CAH failed to ensure Patient #20's medical record was complete.

2. Patient #6 was a 21 year old female who was admitted on 4/13/17, with a diagnosis of endometritis.

Patient #6's medical record included an "Emergency Department Transfer Form," undated, signed by the physician. Three separate sections of the form did not include documentation as follows:

- "Provider to Provider report prior to patient being transferred at this time:"

- "Nurse to Nurse report prior to patient being transferred at this time:"

- "Name/ Title of accepting Facility Nurse:"

The CNO was interviewed on 9/20/17, beginning at 11:10 AM, and Patient #6's medical record was reviewed in her presence. She confirmed Patient #6's "Emergency Department Transfer Form" was incomplete.

The CAH failed to ensure Patient #6's medical record was complete.

3. Patient #9 was a 65 year old male who was admitted on 7/14/17, with a diagnosis of sepsis.

Patient #9's medical record included an "Emergency Department Transfer Form," dated 7/20/17, signed by the physician. Two separate sections of the form did not include documentation as follows:

- "Nurse to Nurse report prior to patient being transferred at this time:"

- "Name/ Title of accepting Facility Nurse:"

The CNO was interviewed on 9/20/17, beginning at 11:05 AM, and Patient #9's medical record was reviewed in her presence. She confirmed Patient #6's "Emergency Department Transfer Form" was incomplete.

The CAH failed to ensure Patient #9's medical record was complete.

Based on medical record review and staff interview, it was determined the CAH failed to ensure properly executed consents were obtained for 3 of 11 inpatients (#8, #9, and #19) whose records were reviewed. This resulted in a lack of clarity as to whether patients or their representatives were fully informed prior to signing documents and prior to treatment. Findings include:
1. Patient #8 was a 71 year old male who was admitted on 6/07/17, with a diagnosis of sepsis.

a. Patient #8's medical record included a "CONDITIONS OF ADMISSION TO [CAH]," dated 6/07/17, signed by Patient #8 and a witness. The witness signature on the consent form was not dated.

b. Patient #8's medical record included a "Consent for Radiographic Iodinated Contrast Administration," signed by Patient #8 and the radiological technician. Patient #8's signature was not dated.

The CNO was interviewed on 9/20/17, beginning at 11:00 AM, and Patient #8's chart was reviewed in her presence. She confirmed Patient #8's consents should have been dated appropriately.

The CAH failed to ensure Patient #8's consents were properly executed.

2. Patient #19 was a 64 year old female who was admitted on 5/18/17, with a diagnosis of hypoglycemia.

a. Patient #19's medical record included a "CONDITIONS OF ADMISSION TO [CAH]," signed by Patient #19 and a witness. Patient #19's signature was not dated.

b. Patient #19's medical record included a "Consent for Radiographic Iodinated Contrast Administration," dated 5/18/17, signed by the radiology technician. The consent was not signed or dated by Patient #19.

The CNO was interviewed on 9/20/17, beginning at 11:07 AM, and Patient #19's chart was reviewed in her presence. She confirmed Patient #19's consents should have been signed and dated appropriately.

The CAH failed to ensure Patient #19's consents were properly executed.

3. Patient #9 was a 65 year old male who was admitted on 7/14/17, with a diagnosis of sepsis.

Patient #9's medical record included a "CONDITIONS OF ADMISSION TO [CAH]," signed by Patient #9 and a witness. Patient #9's signature was not dated.

The CNO was interviewed on 9/20/17, beginning at 11:05 AM, and Patient #9's medical record was reviewed in her presence. She confirmed Patient #9's consent should have been dated appropriately.

The CAH failed to ensure Patient #9's consent was properly executed.

Based on medical record review and staff interview, it was determined the CAH failed to ensure medical record entries were dated by the physician for 1 of 6 patients (Patient #6) who were transferred to another facility and whose records were reviewed. This resulted in a lack of clarity regarding authentication of medical record entries. Findings include:

Patient #6 was a 21 year old female who was admitted on 4/13/17, with a diagnosis of endometritis.

Patient #6's medical record included an "Emergency Department Transfer Form," signed by the physician, but not dated.

The CNO was interviewed on 9/20/17, beginning at 11:10 AM, and Patient #6's medical record was reviewed in her presence. She confirmed the physician did not date the "Emergency Department Transfer Form."

The CAH failed to ensure the physician's signature for Patient #6's transfer form was dated.

Based on observation and staff interview, it was determined the CAH failed to ensure medical record information was safeguarded against destruction by fire and water damage. This impacted 2 of 2 medical record storage areas that were observed and had the potential to result in inaccessible medical records. Findings include:

1. A tour of the CAH was conducted on 9/18/17, beginning at 3:20 PM, in the presence of the CEO. A room located in the CAH basement was designated for storage of original, non-archived patient medical records. The medical records were uncovered and arranged in folders which sat on wooden shelving. Fire sprinklers were noted in the room to protect the medical records from fire damage, however there was no countermeasure in place to protect the medical records from water damage.

The CEO was interviewed on 9/18/17, beginning at 3:51 PM. When asked if the medical records in the CAH basement room were original, non-archived documents, the CEO stated yes. The CEO confirmed the medical records in this room were not safeguarded against destruction by water damage.

The CAH failed to ensure medical records were safeguarded against destruction by water damage.

2. A tour of the CAH CT suite was conducted on 9/19/17, beginning at 1:00 PM, in the presence of the Radiology Manager. An adjacent, attached room to the CT suite contained original, non-archived radiologic films arranged on an open shelf. This room did not have a fire suppression system to protect the radiologic films from fire damage.

The Radiology Manager was interviewed on 9/19/17, beginning at 1:28 PM. When asked if the radiologic films in the CT suite adjacent room were original, non-archived documents, the Radiology Manager stated yes. The Radiology Manager confirmed the radiologic films in this room were not safeguarded against destruction by fire damage.

The CAH failed to ensure radiologic films were safeguarded against destruction by fire damage.

Based on medical record review, observation, and staff interview, it was determined the CAH failed to ensure patients were discharged in the company of a responsible adult for 1 of 1 surgical outpatient (Patient #20) whose surgical procedure was observed and whose record was reviewed. This had the potential for poor patient safety outcomes. Findings include:

Patient #20 was a 48 year old male who was admitted on 9/20/17, with a diagnosis of right knee pain and surgical repair, whose right knee arthroscopy was observed.

Patient #20's medical record included documentation he received general anesthesia during his procedure and several doses of narcotic pain medication in the post-operative period. His medical record did not include documentation he was discharged in the company of a responsible adult.

The CNO was interviewed on 9/21/17, beginning at 11:30 AM, and Patient #20's medical record was reviewed in her presence. She confirmed Patient #20's medical record did not indicate if he was discharged from the CAH in the company of a responsible adult. The CNO confirmed documentation should have included to whom Patient #20 was discharged, as he had received general anesthesia and narcotic pain medication.

The CAH failed to ensure Patient #20 was discharged in the company of a responsible adult following his surgical procedure.

Based on CAH quality document review, CAH policy review, and staff interview, it was determined the CAH failed to ensure its quality assurance program evaluated all patient care services and other services affecting patient health and safety. This failure prevented the CAH from analyzing all services provided to ensure patients' needs were met. Findings include:

A CAH policy "ORGANIZATIONAL PERFORMANCE IMPROVEMENT PLAN," dated 3/15/17, stated:

- "Incorporate quality planning throughout the facility."

- "Provide for a facility wide program that assures the facility designs processes (with special emphasis on design of new or revisions in established services) well and systematically measures, assesses and improves its performance to achieve optimal patient health outcomes in a collaborative, cross-departmental, interdisciplinary approach."

- "Assures that the improvement process is organization-wide, monitoring, assessing and evaluating the quality and appropriateness of patient care, patient safety practices and clinical performance to resolve identified problems and improve performance."

A CAH quality document "Quality Management Report 1st Quarter 2017," undated, listed status updates, basic data, and initiatives for all CAH and patient care service lines except Swing Beds and contracted services.

The Quality Assurance Manager was interviewed on 9/19/17, beginning at 3:05 PM, and the quarterly quality report was reviewed in her presence. She confirmed Swing Beds and contracted services were not included in the CAH quality program. The Quality Assurance Manager stated these areas of the hospital did not submit quality data. She stated, while EVS was included in the quarterly quality report, they did not currently submit quality data. The Quality Assurance Manager confirmed not all CAH services affecting patient health and safety were currently evaluated.

The CAH failed to ensure all patient care services and other services affecting patient health and safety are evaluated.

Based on OPO agreement review, eye bank agreement review, OPO training document review, and staff interview, it was determined the CAH failed to ensure written protocols were developed and implemented to address organ, tissue and eye procurement. This had the potential to result in a lack of identification of suitable organ, tissue, and eye donors. Findings include:

1. Refer to C-345 as it relates to the CAH's failure to ensure a valid agreement with an OPO.

2. Refer to C-346 as it relates to the CAH's failure to ensure a valid agreement with an eye bank.

3. Refer to C-347 as it relates to the CAH's failure to ensure potential donor families would be approached by an individual trained in the methodology for approaching potential donor families and requesting organ, tissue or eye donation.

4. Refer to C-349 as it relates to the CAH's failure to work cooperatively with the designated eye bank in to improve identification of potential donors.

The cumulative effect of these deficient practices created the potential for suitable organ, tissue, and eye donors to not be identified.

Based on OPO agreement review and staff interview, it was determined the CAH failed to ensure a valid agreement with an OPO. This had the potential to interfere with patient and family donor options regarding to organ donation for all CAH patients. Findings include:

A CAH OPO agreement "ORGAN TISSUE DONATION PARTNERSHIP AGREEMENT," dated 6/01/16, was reviewed. The agreement was written for, and referenced, CMS Conditions of Participation for Hospitals at CFR 482.45, not CMS Conditions for Participation for Critical Access Hospitals at CFR 485.643. The CAH OPO agreement did not address the correct regulatory requirements of a Critical Access Hospital.

The CEO was interviewed on 9/20/17, beginning at 11:40 AM, and the CAH OPO agreement was reviewed in his presence. He confirmed the CAH OPO agreement referenced the wrong CMS regulation set. The CEO notified the contracted OPO of the invalid agreement. Per the CEO, the OPO representative stated they would correct the issue.

The CAH failed to incorporate a valid agreement with an OPO.

Based on CAH eye bank agreement review and staff interview, it was determined the CAH failed to ensure a valid agreement with at least one eye bank. This had the potential to interfere with patient and family donor options in regarding tissue and eye donation for all CAH patients. Findings include:

A CAH eye bank agreement "Cooperation Agreement for Eye Donation Between [eye bank] And [CAH]," dated 12/21/09, was reviewed.

1. The eye bank agreement was written for, and referenced, CMS Conditions of Participation for Hospitals at CFR 482.45, not CMS Conditions for Participation for Critical Access Hospitals at CFR 485.643. The CAH eye bank agreement did not address the correct regulatory requirements of a Critical Access Hospital.

2. The eye bank agreement stated "This agreement shall become effective upon signature of all parties and shall remain in effect for three years." The eye bank agreement was signed on 12/21/09, and should have been renewed in 2012, but was not.

The CEO was interviewed on 9/20/17, beginning at 1:10 PM, and the CAH eye bank agreement was reviewed in his presence. He confirmed the CAH eye bank agreement expired 5 years ago and referenced the wrong CMS regulation set. The CEO notified the contracted eye bank to inform them of the invalid agreement. Per the CEO, the eye bank representative stated they would correct the issue.

The CAH failed to incorporate a valid agreement with an eye bank.

Based on CAH OPO training document review and staff interview, it was determined the CAH failed to ensure potential donor families would be approached by an individual trained in the methodology for approaching potential donor families, and requesting organ, tissue, or eye donation. This had the potential to result in failure of the CAH to inform the family of their donation options. Findings include:

An OPO provided training document "[OPO] Tissue Referral Flowchart," dated 4/17/17, stated "DO NOT talk with the family about donation."

A second OPO provided training document "Introduction to [OPO] Donor Services," undated, stated "DO NOT APPROACH THE FAMILY ABOUT DONATION."

Policy(s) governing the CAH's OPO processes and practice were requested from the DNS and CNO on 9/19/17 at 1:25 PM, but were not provided.

The DNS was interviewed on 9/19/17, beginning at 1:25 PM. She stated she was responsible for the CAH OPO program. She stated either she, or the on-duty charge nurse, would be responsible for approaching patient family members regarding potential donation issues.

The CNO was interviewed on 9/20/17, beginning at 8:30 AM, and Designated OPO Requestor training was requested, but was not provided.

The charge nurse on-duty on 9/20/17, was interviewed beginning 8:34 AM. When asked if she had OPO provided Designated Requestor training, the charge nurse stated no. When asked if she approached patient family members regarding donor issues, she stated she did "before or after death."

The CNO was interviewed a second time on 9/20/17, beginning at 9:52 AM. She confirmed the CAH did not have Designated Requestors or related training. The 2 OPO provided training documents were reviewed in the CNO's presence. She confirmed CAH staff should not approach patient families regarding potential donor issues. The CNO confirmed the CAH did not have policies outlining the donation process.

The CAH failed to ensure potential donor families would be approached by an individual trained in the methodology for approaching potential donor families and requesting organ, tissue or eye donation.

Based on CAH eye bank agreement review and staff interview, it was determined the CAH failed to work cooperatively with the designated eye bank in educating staff on donation issues. This had the potential to result in failure of CAH staff to identify potential eye donors, as well as failure to inform potential donor families of their donation options. Findings include:

A CAH eye bank agreement "Cooperation Agreement for Eye Donation Between [eye bank] And [CAH]," dated 12/21/09, stated the eye bank would "Provide hospital with periodic education to hospital medical and nursing [sic] staff regarding eye donation."

Eye bank provided education was requested from the DNS and CNO on 9/19/17 at 1:25 PM, but was not provided.

The CNO was interviewed on 9/20/17, beginning at 9:30 AM, and the CAH eye bank agreement was reviewed in her presence. She confirmed she could not locate education provided by the eye bank for CAH staff. The CNO confirmed the CAH did not have a policy which governed eye bank provided education.

The CAH failed to work cooperatively with the designated eye bank in educating staff on donation issues.

Based on Swing Bed admission paperwork review and staff interview, it was determined the CAH failed to ensure dental services were available to Swing Bed patients. This resulted in the potential for patients' dental needs to go unmet. Findings include:

The CEO and CNO were interviewed together on 9/21/17, beginning at 11:55 AM, and Swing Bed admission paperwork was reviewed in their presence. When asked if Swing Bed patients received dental care at the CAH, they stated no. The CEO and CNO stated they were unaware dental services needed to be provided to Swing Bed patients. They stated the CAH did not currently have a Swing Bed dental contract with a dentist or a policy that dictated how a Swing Bed patient would obtain routine and emergency dental care.

The CAH failed to ensure Swing Bed patients received routine and 24-hour emergency dental care.