HospitalInspections.org

Based on the manner and degree of deficiencies cited the facility failed to be in compliance with the Condition of Participation of Organizational Structure. The facility failed to have a governing body or responsible individual that ensured the hospital was in compliance with applicable standards and conditions of participation. Specifically, the facility's governing body failed to ensure that the hospital's medical and nursing staff adhered to the facility's policies which resulted in Sample Patient #1 being placed at increased risk of an unfavorable outcome when staff allowed the patient to be sent to an outpatient dialysis treatment clinic, unaccompanied by trained staff.

The facility failed to be in compliance with the following standard under the Condition of Participation of Organizational Structure:

C0241 - Governing Body or Responsible Individual: The governing body of the facility failed to adequately determine, implement and monitor the policies governing the CAH's total operation and to ensure that those policies were administered so as to provide quality health care in a safe environment in multiple departments and functions of the facility. The failures created the potential for negative patient outcomes.

In addition, the Governing Body of the facility failed to ensure the following other Conditions of Participations were met:

C0250 - Condition of Staffing and Staff Responsibilities: The facility failed to ensure that staff adhered to the facility's policies and delivered care in a safe and effective manner. Additionally, the facility failed to ensure that the care provided by mid-level practitioners was reviewed for all inpatients as required.

C0270 - Condition of Provision of Services: The facility failed to ensure that services provided to patients were performed in a safe and effective manner that adhered to facility policies/procedures and standards of practice.

C0330 - Condition of Periodic Evaluation and QA Review: The facility failed to ensure that it had an effective and comprehensive program to periodically evaluate the care provided in the CAH as well as conduct quality assurance activities that were required in these regulations.

Based on tours/observations, staff/physician interviews and review of medical records and facility documents, the governing body of the facility failed to adequately determine, implement and monitor the policies governing the CAH's total operation and to ensure that those policies were administered so as to provide quality health care in a safe environment in multiple departments and functions of the facility. The failures created the potential for negative patient outcomes.

The findings were:

Reference Tag C0257 - Responsibilities of MD or DO: the facility failed to ensure that the Medical Director provided direction for the facility's healthcare activities and medical supervision of the healthcare staff.

Reference Tag C0260 - Responsibilities of MD or DO: the facility failed to ensure that a doctor of medicine or osteopathy periodically reviewed and signed the records of all inpatients under the care of physician assistants, nurse practitioners, or clinical nurse specialists.

Reference Tag C0266 - PA, NP, & CNS Responsibilities: the facility failed to ensure that Allied Health Practitioners, specifically Nurse Practitioners, periodically reviewed patient records for completeness and adherence to facility policies.

Reference Tag C0267 - PA, NP, & CNS Responsibilities: the facility failed to ensure that a policy existed that addressed the transfer, care, and safety of patients to and from an outpatient dialysis facility.

Reference Tag C0268 - PA, NP, & CNS Responsibilities: the facility failed to ensure that a patient was transferred out of the facility per facility policy and in a safe manner.

Reference Tag C0275 - Patient Care Policies: the facility failed to ensure that the policies included guidelines for the medical management of health problems that included the conditions requiring medical consultation and/or patient referral. Specifically, the facility did not have a policy that addressed how patients needing dialysis treatments would be handled.

Reference Tag C0276 - Patient Care Policies - Safe Medication Storage: the facility failed to ensure that staff adhered to the facility's policies/procedures for safe storage of drugs and biologicals. Specifically, the facility failed to ensure that staff did not use single-dose vials for multiple patients and discarded expired medications.

Reference Tag C0294 - Nursing Services: the facility failed to ensure that nursing services were provided that met the needs of patients. Specifically, the facility failed to ensure that the facility's nursing staff adhered to the facility's policies/procedures. The facility's nursing staff failed to ensure that a patient (Sample Patient #1) was safely transported to an outside facility for treatment. The facility's nursing staff did not advocate for the patient when an outside transportation company refused to take oxygen with the patient when the patient was receiving supplemental oxygen which placed the patient in danger.

Reference Tag C0304 - Records Systems: the facility failed to ensure that medical records contained evidence of properly executed informed consents in 1 (Sample Patient #1) of 20 records reviewed. Specifically, the facility failed to document that Sample Patient #1 provided informed consent for three transfers to an outside facility via an unskilled transportation van without trained hospital personnel.

Reference Tag C0306 - Records Systems: the facility failed to ensure that each patient's medical record contained, as applicable, orders from doctors of medicine or osteopathy or other practitioners, reports of treatments and medications, nursing notes and documentation of complications, and other pertinent information necessary to monitor the patient's progress, such as temperature graphics and progress notes describing the patient's response to treatments in 1 (Sample Patient #1) of 20 records reviewed.

Reference Tag C0337 - Quality Assurance: the facility failed to ensure that the CAH had an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes. The facility's program failed to evaluate all patient care services and other services affecting patient health and safety. Specifically, the records of Sample Patient #1 were not reviewed by the facility's QA program after the patient had to return to the hospital emergently by ambulance after being transferred inappropriately to an outpatient dialysis treatment clinic.

Reference Tag C0339 - Quality Assurance: the facility failed to ensure that the facility's Quality Assurance (QA) program included the quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners, clinical nurse specialists, and physician assistants at the CAH were evaluated by a member of the CAH staff who is a doctor of medicine or osteopathy. Specifically, the records of nurse practitioners were not regularly reviewed for all inpatients cared for by nurse practitioners. In addition, Sample Patient #1's record was not reviewed by the facility's QA program. Additionally, when the patient had to return to the hospital emergently by ambulance, the patient's record and care was not automatically reviewed.

Based on the manner and degree of deficiencies cited, the facility failed to be in compliance with the Condition of Participation of Staffing and Staff Responsibilities. The facility failed to ensure that staff adhered to the facility's policies and delivered care in a safe and effective manner. Additionally, the facility failed to ensure that the care provided by mid-level practitioners was reviewed for all inpatients as required.

The facility failed to meet the following standards under the Condition of Participation of Staffing and Staff Responsibilities:

C0256 - Responsibilities of MD or DO: The facility failed to ensure that Physicians (MDs or DOs) participated in periodic review of patient records in order to ensure that policies were being adhered to and that an appropriate level of care was being provided to patients by all staff, including midlevel practitioners.

C0257 - Responsibilities of MD or DO: The facility failed to ensure that the Medical Director provided direction for the facility's healthcare activities and medical supervision of the healthcare staff.

C0260 - Responsibilities of MD or DO: The facility failed to ensure that a doctor of medicine or osteopathy periodically reviewed and signed the records of all inpatients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants.

C0264 - PA, NP, & Clinical Nurse Specialist Responsibilities: The facility failed to ensure that Physician Assistants, Nurse Practitioners, or Clinical Nurse Specialists participated in review of written policies and periodic review of patient records in order to ensure that policies were being adhered to and that an appropriate level of care was being provided to patients.

C0266 - PA, NP & Nurse Specialist Responsibilities: The facility failed to ensure that the Physician Assistant, Nurse Practitioner, or Clinical Nurse Specialist participated in periodic review of patients' medical records.

C0267 - PA, NP & Nurse Specialist Responsibilities: The facility failed to ensure that, to the extent they were not being performed by a doctor of medicine or osteopathy, services were provided in accordance with the CAH policies.

C0268 - PA, NP & Nurse Specialist Responsibilities: The facility failed to ensure that the Physician Assistant, Nurse Practitioner, or Clinical Nurse Specialist, to the extent they were not being performed by a doctor of medicine or osteopathy, transferred patients out of the facility per facility policy and in a safe manner.

Based on the manner and degree of deficiencies cited, the facility failed to be in compliance with this standard. The facility failed to ensure that Physicians (MDs or DOs) participated in periodic review of patient records in order to ensure that policies were being adhered to and that an appropriate level of care was being provided to patients by all staff, including mid-level practitioners..

The facility failed to meet the following standards for Responsibilities of MD or DO:

C0257 - Responsibilities of MD or DO: The facility failed to ensure that the Medical Director provided direction for the facility's healthcare activities and medical supervision of the healthcare staff.

C0260 - Responsibilities of MD or DO: The facility failed to ensure that that a doctor of medicine or osteopathy periodically reviewed and signed the records of all inpatients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants.

Based on interviews and review of facility documents the facility failed to ensure that the Medical Director provided direction for the facility's healthcare activities and medical supervision of the healthcare staff.

Findings:

On 4/09/2012 at approximately 4:00 PM an interview with the Chief Nursing Officer (CNO), who was also the facility's Director Of Quality, revealed that s/he was not familiar with issues regarding the transfer of Sample Patient #1 to an outpatient dialysis clinic on three occasions,1/31/2012, 2/2/2012 and 2/4/2012. S/he stated that Sample Patient #1 had not been discussed in quality or nursing meetings.

On 4/10/2012 at approximately 9:00 AM an interview with the facility's Medical Director was conducted. The Medical Director stated that s/he was unaware of Sample Patient #1's admission or any issues during the patient's hospitalization. When informed of issues regarding the transfer of the patient to dialysis by unskilled transport staff when the patient was unstable, the lack of transfer documentation and consents signed by the patient, the lack of documentation of the patient's status after receiving dialysis treatments, and the lack of a progress note for this patient on 2/2/2012, the Medical Director stated that s/he "would never keep a dialysis patient here" and "we should not be admitting dialysis patients to this facility." The Medical Director stated that the transfers to the outpatient dialysis clinic were "inappropriate" and that this case was not brought to his/her attention by staff. S/he stated concern that the patient was not followed by the admitting physician. The Medical Director confirmed that the facility had no written policy regarding admitting or not admitting to the facility patients who receive outpatient dialysis treatments. The Medical Director stated that only a sample of all mid-level providers (Physician Assistants, Nurse Practitioners, and Clinical Nurse Specialist) patient records were reviewed by medical staff. S/he stated that mid-level providers could always "call a physician if there was a concern." The Medical Director stated that the admitting physician for Sample Patient #1 was new to the facility and might not have understood some expectations of the facility's healthcare activities.

On 4/10/2012 at approximately 9:30 AM an interview with Physician #1 was conducted. The physician stated that s/he remembered seeing the patient in the Emergency Department. S/he reviewed the patient's record and confirmed that s/he wrote an order on 1/30/2012 for the patient to be transported to an outpatient dialysis clinic on 1/31/2012 by a local transportation company and not by ambulance. The physician stated that s/he had not used this transportation service before and did not know if the staff for this company held any medical expertise or training similar to ambulance staff. S/he stated than s/he was "trying to save a few bucks and the patient was probably stable enough to go out this way." The physician stated that s/he was not aware of the outpatient dialysis clinic's staffing or ability to care for acute patients and did not phone the dialysis clinic prior to writing an order for dialysis on 1/30/2012. When asked who the nurse practitioner would contact with questions or concerns regarding a patient s/he stated, "probably me."

On 4/9/2012 the facility's Quality Assurance documents were reviewed. No reference to Sample Patient #1 was found in meeting minutes for Nursing, Quality, or Medical Staff.

Based on interview, review of facility documents, and review of patient records the facility failed to ensure that a doctor of medicine or osteopathy periodically reviewed and signed the records of all inpatients under the care of physician assistants, nurse practitioners, or clinical nurse specialists.

Findings:

On 4/9/2012 a review of the facility's policy titled "Critical Access Hospital-Responsibilities of Physician Assistant and Nurse Practitioner" last revised 10/17/2000 stated the following, in pertinent parts:
"The Medical Staff of (the CAH), individually and as a whole, is responsible for provision of medical direction and decision-making for the care of patients as described in 42CFR Section 485.531 (b). In addition (as described in 42CFR Section 485.631 (c)), any physician assistant, nurse practitioner, or clinical nurse specialist members of ... (the CAH's) staff shall:...
b. Participate with a doctor of medicine or osteopathy in a review of patients' health records. Every record established by the Mid-level shall be signed off by the Physician.

On 4/10/2012 at approximately 9:00 an interview with the facility's Medical Director was conducted. The Director stated that not all of the patient records of mid-level practitioners, Physician Assistants and Nurse Practitioners, were reviewed by medical staff but instead a random sample of records were reviewed.

On 4/10/2012, 20 patient records were reviewed. Sixteen of the 20 records (#1, #2, #3, #4,#6, #7, #9, #10, #11, #12, #13, #14, #15, #16, #19, and #20) showed that a Nurse Practitioner was involved in care for the patients. All of the 16 records showed that no physician had signed off on or reviewed the record per facility policy.

Based on the manner and degree of deficiencies cited, the facility failed to be in compliance with this standard. The facility failed to ensure that Physician Assistants, Nurse Practitioners, or Clinical Nurse Specialists participated in review of written policies and periodic review of patient records in order to ensure that policies were being adhered to and that an appropriate level of care was being provided to patients.

The facility failed to meet the following standards for PA, NP, and Clinical Nurse Specialist Responsibilities:

C0266 - PA, NP & Nurse Specialist Responsibilities: The facility failed to ensure that the physician assistant, nurse practitioner, or clinical nurse specialist participated in periodic review of patients' medical records.

C0267 - PA, NP & Nurse Specialist Responsibilities: The facility failed to ensure that, to the extent they were not being performed by a doctor of medicine or osteopathy, services were provided in accordance with the CAH policies.

C0268 - PA, NP & Nurse Specialist Responsibilities: The facility failed to ensure that the physician assistant, nurse practitioner, or clinical nurse specialist, to the extent they were not being performed by a doctor of medicine or osteopathy, transferred patients out of the facility per facility policy and in a safe manner.

Based on interviews and document review the facility failed to ensure that mid-level practitioners, specifically Nurse Practitioners, periodically reviewed patient records for completeness and adherence to facility policies.

Findings:

On 4/9/2012 review of the facility's policy titled "Critical Access Hospital - Responsibilities of Physician Assistant and Nurse Practitioner" dated 10/17/2000 revealed, in pertinent parts:
"...any physician assistant, nurse practitioner, or clinical nurse specialist members of (the CAH's) staff shall...
b. Participates with a doctor of medicine or osteopathy in a review of patients' health records..."

On 4/9/2012 review of the facility's policy titled, "Temporary Transfer to Another Facility Procedure" last revised 9/30/2008 stated the following, in pertinent parts:
"Purpose:
To obtain authorization and consent to transfer to and return from another facility for the purpose of receiving treatment/procedure.
Equipment:
Temporary Transfer Form
Copies of necessary chart forms, as requested per receiving facility
Complete and send with patient: Face sheet, necessary chart forms
Essential Steps:
Written order by physician on chart for treatment/procedure.
Call and make appointment at specified facility. Obtain name of physician who will perform procedure.
Decide mode of transportation and make necessary arrangements.
Arrange staff based on competency for accompaniment of patient.
Complete and have patient sign an authorization for and consent for temporary transfer and treatment/procedure at another facility.
Clinical Record:
Consent form becomes part of patient's chart
Record time and mode of transportation
Record time returned.
Note: If patient is to use own transportation or is to be accompanied by a support person other than the hospital staff, patient must sign temporary release form for transfer to another facility."

On 4/9/2012 review of the record for Sample Patient #1 revealed that the record did not contain the above listed documents related to the patient's transfer for outpatient dialysis on three dates (1/31/2012, 2/2/2012 and 2/4/2012). Specifically, a Temporary Transfer Form, physician's order for the patient to receive dialysis as an outpatient on 2/2/2012 and 2/4/2012, consent for transfer signed by the patient, and a temporary release for transfer signed by the patient were not present in the patient's record. In addition, documentation could not be found in the patient's record of a progress note for 2/4/2012 while the patient was under the care of a Nurse Practitioner.

On 4/10/12 at approximately 8:30 AM an interview with LPN #1 revealed that s/he did not recall sending documentation with Sample Patient #1 on 1/31/2012 when the patient was transferred out for dialysis, did not remember completing the transfer documents for the patient to sign and did not receive any documentation from the dialysis facility when the patient returned from treatment. S/he stated that s/he did not coordinate or communicate with the dialysis clinic prior to sending the patient out for treatment.

On 4/11/2012 at approximately 8:45 AM an interview with RN #1 revealed that s/he did not send "paperwork" with Sample Patient #1 when s/he transferred the patient for dialysis treatment on 2/2/2012 and did not receive "paperwork " from the dialysis clinic upon the patient's return. RN #1 stated that s/he did not call the dialysis clinic to inform staff of the patient's status, specifically that the patient was in need of oxygen and that oxygen was not transported with the patient. RN #1 stated that s/he had never before transferred a hospitalized patient for outpatient dialysis.

On 4/10/2012 an interview with Physician #1, admitting physician for Sample Patient #1, revealed that s/he wrote an order for the patient to be transported to outpatient dialysis on 1/31/2012 but did not call the dialysis facility to coordinate with staff there. The physician stated that s/he did not have knowledge regarding how the dialysis clinic was staffed or the staff's ability to care for acute patients.

An interview on 4/11/2012 at 9:10 AM with NP #1 was conducted. The NP confirmed that s/he cared for Sample Patient #1 during the patient's hospitalization from 1/31/2012 through discharge on 2/5/2012. The NP reviewed the patient's record and could not locate a progress note from 2/4/2012. S/he stated, "I don't know what to tell you. That was the day he was discharged and came back. I am almost positive that I wrote something because I think I saw him when he came back from dialysis." The NP stated that s/he was not aware of documents missing from the patient's record regarding the transfer of the patient to and from outpatient dialysis.

Based on interviews and document review the facility failed to ensure that a policy existed that addressed the transfer, care, and safety of patients to and from an outpatient dialysis clinic.

Findings:

On 4/10/2012 at approximately 9:00 AM during an interview with the facility's Medical Director s/he stated that the facility did not have a policy which addressed End Stage Renal Disease (ESRD) patients who needed regular dialysis treatments and how dialysis would be obtained for these patients as the facility did not have the capability to administer dialysis treatments. The Medical Director stated that s/he was not aware of the issues that occurred in the facility regarding the transfer, care, and safety of Sample Patient #1 to outpatient dialysis and stated that the transfers that occurred for the patient were "inappropriate."

From 4/9/2012 through 4/10/2012 review of facility policies revealed no policy specifically addressing the dialysis needs of ESRD patients and either how to transfer these patients to and from outpatient dialysis treatments or the necessity of transferring these patients out of the facility altogether to a facility than could provide dialysis during hospitalization.

Based on interviews and document review the facility failed to ensure that a patient was transferred out of the facility per facility policy and in a safe manner.

Findings:

On 4/9/2012 review of the facility's policy titled "Critical Access Hospital - Responsibilities of Physician Assistant and Nurse Practitioner" dated 10/17/2000 revealed, in pertinent parts:
"...any physician assistant, nurse practitioner, or clinical nurse specialist members of (the CAH's) staff shall:...
b. Arranges for, or refers patients to, needed services that cannot be furnished at the CAH, and assures that adequate patient health records are maintained and transferred as required when patients are referred..."

On 4/9/2012 review of the record for Sample Patient #1 revealed that the record did not contain required documents for the patient's transfer to and from outpatient dialysis on three dates, 1/31/2012, 2/2/2012 and 2/4/2012. Specifically, a Temporary Transfer Form, consent for transfer signed by the patient, and a temporary release for transfer signed by the patient were not present in the patient's record. In addition, the record did not contain documentation of an Emergency Department (ED) visit at a nearby hospital that occurred on 2/2/2012 after the patient received outpatient dialysis and prior to being transported back to the CAH.

On 4/10/2012 at approximately 8:30 AM an interview with LPN #1 was conducted. S/he stated that s/he did not recall sending any part of the patient's medical record on 1/31/2012 when the patient was transferred to outpatient dialysis, did not remember completing transfer documents for the patient to sign and did not receive medical record/treatment record from the dialysis clinic upon the patient's return.

On 4/11/2012 at approximately 8:45 AM an interview with RN #1 revealed that s/he did not send any part of the patient's medical record when s/he transferred Sample Patient #1 for dialysis treatment on 2/2/2012 and did not receive medical record/treatment record from the dialysis clinic upon the patient's return. RN #1 stated that the patient was receiving oxygen prior to being transferred to dialysis on 2/2/2012 and that transportation staff did not want to transport oxygen for the patient because of lack of room in the vehicle. RN #1 stated that s/he did not communicate the need for the patient to receive oxygen to the receiving clinic by phone or through transfer of the patient's medical record.

On 4/11/2012 an interview with NP #1 revealed that s/he received a phone call from the ED physician who saw Sample Patient #1 on 2/2/2012. S/he stated that the ED physician believed the patient was stable and because the patient was inpatient at the CAH, s/he would transfer/transport the patient back to the CAH by ambulance. The NP stated that no "paperwork" was sent with the ambulance transfer from the ED to the CAH and confirmed that this documentation was not present in the patient's record.

Based on the manner and degree of deficiencies cited, the facility failed to be in compliance with the Condition of Participation of Provision of Services. The facility failed to ensure that services provided to patients were performed in a safe and effective manner that adhered to facility policies/procedures and standards of practice.

The facility failed to meet the following standards under the Condition of Participation of Provision of Services:

C0275 - Patient Care Policies: The facility failed to ensure that the policies included guidelines for the medical management of health problems that included the conditions requiring medical consultation and/or patient referral. Specifically, the facility did not have a policy that addressed how patients needing dialysis treatments would be handled.

C0276 - Patient Care Policies: The facility failed to ensure that staff adhered to the facility's policies/procedures for safe storage of drugs and bioligicals. Specifically, the facility failed to ensure that staff did not use single-dose vials for multiple patients and discarded expired medications.

C0294 - Nursing Services: The facility failed to ensure that nursing services were provided that met the needs of patients. Specifically, the facility failed to ensure that the facility's nursing staff adhered to the facility's policies/procedures. The facility's nursing staff failed to ensure that a patient (Sample Patient #1) was safely transported to an outside facility for treatment. The facility's nursing staff did not advocate for the patient when an outside transportation company refused to take oxygen with the patient when the patient was receiving supplemental oxygen which placed the patient in danger.

Based on staff interview, review of the facility's policies/procedures, facility documents, and medical records the facility failed to ensure that the policies included guidelines for the medical management of health problems that included the conditions requiring medical consultation and/or patient referral. Specifically, the facility did not have a policy that addressed how patients needing dialysis treatments would be handled.

Findings:

On 4/9/2012 review of the facility's policy titled "Critical Access Hospital - Responsibilities of Physician Assistant and Nurse Practitioner" dated 10/17/2000 revealed, in pertinent parts:
"...any physician assistant, nurse practitioner, or clinical nurse specialist members of (the CAH's) staff shall:...
b. Arranges for, or refers patients to, needed services that cannot be furnished at the CAH, and assures that adequate patient health records are maintained and transferred as required when patients are referred..."

From 4/9/2012 through 4/10/2012 review of facility policies revealed that the facility had no policy that specifically addressed the dialysis needs of ESRD patients and either how to transfer these patients to and from outpatient dialysis treatments or addressed the necessity of transferring these patients out of the facility altogether to a facility that could provide dialysis during hospitalization.

On 4/10/2012 at approximately 8:30 AM an interview with LPN #1 was conducted. S/he stated that s/he prepared Sample Patient #1 for transportation to outpatient dialysis on 1/31/2012. S/he stated that this was the first dialysis patient she had cared for during the past six or seven years that s/he had worked at the facility. S/he stated that s/he had no knowledge of the skill level of the transportation staff to care for the patient while in route to the dialysis clinic. S/he stated that transfers of hospitalized patients for treatments or procedures were usually done so by ambulance and that s/he did not question anyone about the transport of this patient by a local service but instead "went by the order" the admitting physician had written for transportation. The LPN stated that s/he did not contact the receiving facility prior to transporting the patient or after the patient arrived back from dialysis and that the transportation paperwork, per facility policy, was not completed for this patient.

On 4/10/2012 at approximately 9:00 AM during an interview with the facility's Medical Director s/he stated that the facility did not have a policy which addressed End Stage Renal Disease (ESRD) patients who need regular dialysis treatments and how dialysis would be obtained for these patients as the facility did not have the capability to administer dialysis treatments. The Medical Director stated that s/he was not aware of the issues that occurred in the facility regarding the transfer, care, and safety of Sample Patient #1 to outpatient dialysis and stated that the transfers that occurred for Sample Patient #1 were "inappropriate."

On 4/10/2012 at approximately 9:30 AM an interview with Physician #1 was conducted. S/he stated that s/he wrote an order for Sample Patient #1 to be transported to outpatient dialysis on 1/31/2012 but did not call the dialysis clinic to coordinate with staff there. The physician stated that s/he did not have knowledge regarding how the dialysis clinic was staffed or the staff's ability to care for acute patients. The physician stated that s/he wrote an order for a local transportation service to transport the patient to outpatient dialysis but s/he had no knowledge of the skill level, if any, of the transportation staff to transport an acute patient.

On 4/11/2012 at approximately 8:45 AM an interview with RN #1 was conducted. The RN confirmed that she was the nurse for Sample Patient #1 on 2/2/2012 when the patient was transferred to outpatient dialysis for treatment. The RN stated that there was no order present in the patient's record for outpatient dialysis on this date and that the transportation service would not take the patient's oxygen canisters which the patient was in need of. The RN confirmed that the patient was sent to outpatient dialysis on 2/2/2012 without oxygen, and that s/he did not send paperwork with the transportation service and did not phone the dialysis facility to report the patient's status.

Based on observations, staff interview, and review of the facility's policies/procedures the facility failed to ensure that staff adhered to the facility's policies/procedures for safe storage of drugs and biologicals. Specifically, the facility failed to ensure that staff did not use single-dose vials for multiple patients and discarded expired medications.

The findings were:

A review of the facility's policies/procedures revealed the following:
A facility policy titled, "Dating of Sterile Products", last revised 8/18/2009, stated the following, in pertinent parts:
"...Various sterile dosage forms have different periods of time they remain chemically stable or biologically safe to use after entering, compounding, or activating.
Both Nursing and Pharmacy shall be responsible for the proper labeling of all parenteral products.
Procedures:
1. Single dose vials (SDV) are to be discarded immediately after use. These are vials without a preservative and should be labeled as such. Any SDV found with the plastic safety cap removed is not to be used.
2. Multi-dose vials (MDV-vials of drug product with a preservative¿ usually benzyl alcohol or a paraben). Discard multi-dose vials when empty, when suspected or visible contamination occurs, or 28 days after opening. Multi-dose vials are to be labeled with the date when they are opened, the nurse must initial vial. If multi-dose vial is unlabeled it must be discarded.
3. IV solutions and Mini-bags mixed by Nursing must begin administration immediately and are not to hang more than 24 hours beyond preparation time unless a long time is approved by a separate policy or shorter time is required due to medication stability. They are to be labeled with the green "Medication Added" labels..."
A facility policy titled, "Destruction of Medication", last revised 3/14/2010, stated the following, in pertinent parts:
"...Policy: Medications that are no longer fit for use will be destroyed and appropriate documentation filed as required.
Procedures...
2. Partial vials, open multi-dose containers and non returnable outdates (such as open-unit dose tablets and partial liquids) shall be disposed of in a receptacle lined with a "red" bag or a sharps container. This will be collected by Environmental Services...
Non-controlled medication and controlled substances that are outdated will be disposed of every 34 months according to protocols."

Observations of the medication room for the facility were conducted on 4/10/2012 at approximately 4:45 PM with the facility's Chief Nursing Officer (CNO). The room contained 1 liter of IV solution (0.45 Normal Saline Solution with 20 mEq of Potassium Chloride) that had been removed from the outer wrapping and had the rubber stopper removed, thus compromising the sterile integrity of the solution contained within the bag. Additionally the room contained a total of 11 bags of 50 ml Normal Saline Solution bags that had expired 3/1/2012. Also within the room was a multidose vial of Lantus insulin that had been opened 3/10/2012, and should have been discarded 4/8/2012 (28 days after opening).
The medication room of the Emergency Department (ED) was observed with the CNO on 4/11/2012 at approximately 10:45 AM. The cabinet contained a vial of Magnesium Sulfate that was labeled as a single-dose vial. The diaphragm of the vial had been punctured. A staff member had written on the vial that the vial was to be discarded on 4/17/2012, indicating that the vial had been used and could be reused until that date.

An interview with the RN that was present in the ED was conducted in the presence of the facility's CNO on 4/11/2012 at approximately 10:45 AM. The RN stated that the facility used the solution for patients with headaches and used the vial for multiple patients. S/he stated that s/he was unaware that the vial was labeled as a single dose vial.

Based on medical record review, review of the facility's policies/procedures, and staff interview the facility failed to ensure that nursing services were provided that met the needs of patients. Specifically, the facility failed to ensure that the facility's nursing staff adhered to the facility's policies/procedures. The facility's nursing staff failed to ensure that a patient (Sample patient #1) was safely transported to an outside facility for treatment. The facility's nursing staff did not advocate for the patient when an outside transportation company refused to take oxygen with the patient when the patient was receiving supplemental oxygen which placed the patient in danger.

The findings were:

A facility policy titled "Temporary Transfer to Another Facility Procedure" last revised 9/30/2008 stated the following, in pertinent parts:
"Purpose:
To obtain authorization and consent to transfer to and return from another facility for the purpose of receiving treatment/procedure.
Equipment:
Temporary Transfer Form
Copies of necessary chart forms, as requested per receiving facility
Complete and send with patient: Face Sheet, necessary chart forms
Essential Steps:
Written order by physician on chart for treatment/procedure.
Call and make appointment at specified facility. Obtain name of physician who will perform procedure.
Decide mode of transportation and make necessary arrangements.
Arrange staff based on competency for accompaniment of patient.
Complete and have patient sign an authorization for and consent for temporary transfer and treatment/procedure at another facility.
Clinical Record:
Consent Form becomes part of patient's chart
Record time and mode of transportation
Record time returned.
NOTE: If patient is to use own transportation or is to be accompanied by a support person other than hospital staff, patient must sign temporary release form for transfer to another facility."

A review of Sample Patient #1's record revealed the following, in pertinent parts:
"...The patient presented to the hospital's emergency department on 1/28/2012 via an ambulance. The patient had experienced a fall due to syncope and was diagnosed with rib fractures and atrial fibrillation. The patient was placed into an observation status. The patient's record contained a physician's order written by Physician #1 on 1/30/2012 at approximately 7:45 AM. The order stated to call the unskilled transportation company that Sample Patient #1 normally took from his/her home to dialysis and to provide the patient with a wheelchair to take to dialysis and back..."
The nursing notes for 1/31/2012 stated that the patient was receiving supplemental oxygen of 5 liters per minute and transferred to an outpatient dialysis treatment clinic at approximately 5:25 AM via an unskilled transportation service. The patient returned to the facility via the unskilled transportation service at approximately 11:55 AM. An order was written by Physician #1 to place the patient into an inpatient status. A physician's order written by NP #1 on 2/2/2012 at approximately 8:00 AM for a "VQ Scan" for "chest pain, hypoxia, with an urgent read" was present in the patient's chart. The chart did not contain an order for the patient to be sent to dialysis or define the transportation needed for such a transfer. The nursing notes on 2/2/2012 stated that the patient was receiving supplemental oxygen at an undocumented rate and was then transported by the unskilled transportation company to the outpatient dialysis treatment clinic at approximately 5:10 AM. The nurses notes stated that at 7:00 AM, the outpatient dialysis treatment clinic called and stated that the patient arrived at the clinic "very weak" with "oxygen saturations of 70% on arrival and when [they] put oxygen [onto the patient, s/he got up] to 84% on 6 LPM NC" the nurse documented that s/he notified NP #1 of the "situation". The nurse documented that NP #1 ordered for the patient to get a VQ scan after the patient's return from dialysis and that arrangements were then made. The nurses notes documented that at 10:00 AM the facility received a call from the dialysis treatment clinic that the patient had become hypoxic and hypotensive and had a change in level of consciousness. The dialysis treatment clinic called 911 and the patient returned to the hospital at 10:40 AM. The nurses notes stated that the patient arrived back to the facility "on 12 LPM non-rebreather and very sweaty." The patient was transferred to an acute care hospital for a VQ scan at approximately 1:30 PM. The patient returned to the hospital at approximately 3:20 PM.

An interview with RN #1,the nurse that transferred the patient to the outpatient dialysis treatment clinic on 2/2/2012, was conducted on 4/11/2012 at approximately 8:45 AM. S/he stated that when the unskilled transportation company came to pick the patient up, s/he went to obtain 2 portable oxygen tanks to send with the patient as the patient was currently receiving supplemental oxygen via a nasal cannula of 2 LPM. S/he stated that the company's staff stated that they would not take the oxygen with them since the patient "never uses it" and that it would not fit in their vehicle. S/he stated that the company then took the patient to dialysis without the oxygen. S/he stated that s/he was not comfortable with the company taking the patient to dialysis, but did not state his/her discomfort to anyone in the hospital. S/he stated that later that day s/he was contacted by the outpatient dialysis treatment clinic who had stated that the patient arrived at the facility hypoxic at 70% oxygen saturations on room air. S/he stated that s/he did not send any paperwork with the patient to the outpatient dialysis treatment clinic and confirmed that the medical record did not contain an order to send the patient to the dialysis treatment clinic.

Based on staff interviews, review of facility documents, and review of medical records the facility failed to ensure that medical records contained evidence of properly executed informed consents in 1 (Sample Patient #1) of 20 records reviewed. Specifically, the facility failed to document that Sample Patient #1 provided informed consent for three transfers to an outside facility via an unskilled transportation van without trained hospital personnel.

Findings:

On 4/9/2012 review of the facility's policy titled, "Temporary Transfer to Another Facility Procedure" last revised 9/30/2008 stated the following, in pertinent parts...
"Purpose:
To obtain authorization and consent to transfer to and return from another facility for the purpose of receiving treatment/procedure.
Equipment:
Temporary Transfer Form
Copies of necessary chart forms, as requested per receiving facility
Complete and send with patient: Face sheet, necessary chart forms
Essential Steps:
Written order by physician on chart for treatment/procedure.
Call and make appointment at specified facility. Obtain name of physician who will perform procedure.
Decide mode of transportation and make necessary arrangements.
Arrange staff based on competency for accompaniment of patient.
Complete and have patient sign an authorization for and consent for temporary transfer and treatment/procedure at another facility.
Clinical Record:
Consent form becomes part of patient's chart
Record time and mode of transportation
Record time returned.
Note: If patient is to use own transportation of is to be accompanied by a support person other than the hospital staff, patient must sign temporary release form for transfer to another facility

On 4/9/2012 review of the record for Sample Patient #1 revealed that the record did not contain the above listed documents related to the patient's transfer for outpatient dialysis on three dates (1/31/2012, 2/2/2012 and 2/4/2012). Specifically, a Temporary Transfer Form, consent for transfer signed by the patient, and a temporary release for transfer signed by the patient were not present in the patient's record.

On 4/10/2012 at approximately 8:30 AM an interview with LPN #1 revealed that s/he did not have Sample Patient #1 sign consents for transfer to outpatient dialysis on 3/31/2012. S/he confirmed that the consents were not present in the medical record for Sample Patient #1.

On 4/11/2012 at approximately 8:45 AM an interview with RN #1 revealed that s/he did not have Sample Patient #1 sign consents for transfer to outpatient dialysis on 2/2//2012. S/he confirmed that the consents were not present in the medical record for Sample Patient #1.

Based on staff interviews and review of the facility's medical records the facility failed to ensure that each patient's medical record contained, as applicable, orders from doctors of medicine or osteopathy or other practitioners, reports of treatments and medications, nursing notes and documentation of complications, and other pertinent information necessary to monitor the patient's progress, such as temperature graphics and progress notes describing the patient's response to treatments in 1 (Sample patient #1) of 20 records reviewed.

Findings:

On 4/9/2012 review of the medical record for Sample Patient #1 was conducted. The following documentation could not be found in the patient's record: physician's order for outpatient dialysis on 2/2/2012 and 2/4/2012, documentation of the patient's status sent to the outpatient dialysis clinic on 3/31/2012, 2/2/2012 and 2/4/2012, and dialysis treatment reports from 3/31/2012 and 2/4/2012.

On 4/10/2012 at approximately 8:30 AM an interview with LPN #1 was conducted. The LPN confirmed that s/he was the nurse for Sample Patient #1 on 3/31/2012 when the patient was transferred to outpatient dialysis for treatment. S/he stated that at the time of transfer the patient's blood pressure and pulse were elevated and the patient's pulse oximetry was 94% on 5 liters of oxygen. S/he stated that the patient was transferred while receiving oxygen, 5 liters on nasal cannula. S/he confirmed that there was no documentation of communication on 1/31/2012 with the unskilled transportation staff or with outpatient dialysis staff in the patient's medical record. The LPN confirmed that s/he did not send documentation with the patient when the transfer occurred and did not phone the dialysis clinic to report the patient's medical status. S/he stated that s/he remembered receiving a phone call from an RN at the dialysis facility inquiring if the patient was currently inpatient at the CAH. S/he confirmed that there was no documentation of this phone call in the patient's medical record. The LPN stated that s/he did not receive documentation from the dialysis clinic regarding the patient's dialysis treatment and status post treatment and that s/he did not phone the dialysis facility to inquire about the patient's status. S/he confirmed that the transportation service did not provide documentation of the patient's transport from the dialysis facility to the CAH.

On 4/11/2012 at approximately 8:45 AM an interview with RN #1 was conducted. The RN confirmed that s/he was the nurse for Sample Patient #1 on 2/2/2012 when the patient was transferred to outpatient dialysis for treatment. Upon review of the medical record for Sample Patient #1, the RN confirmed that there was no order for outpatient dialysis or for transportation found in the record for 2/2/2012. S/he stated that on 2/2/2012 when preparing the patient for transport with the unskilled service, s/he was told by the transportation staff that the patient did not receive oxygen when being transported from home and that the oxygen would not fit into the vehicle. S/he stated that prior to transport the patient was receiving 2 liters of oxygen by nasal cannula. The RN confirmed that the patient was sent to outpatient dialysis on 2/2/2012 without oxygen, and that s/he did not send paperwork with the transportation service and did not phone the dialysis facility to report the patient's status. The RN confirmed that s/he did not document in the patient's record the need for the patient to be transported with oxygen and that transport occurred without oxygen. The RN stated that s/he received a phone call from the dialysis staff reporting that the patient arrived at the facility having "trouble breathing" and in need of 6 liters of oxygen in order to improve oxygenation.

Based on the manner and degree of deficiencies cited the facility failed to be in compliance with the Condition of Participation of Periodic Evaluation and Quality Assurance Review. The facility failed to ensure that it had an effective and comprehensive program to periodically evaluate the care provided in the CAH as well as conduct quality assurance activities that were required in these regulations.

The facility failed to meet the following standards under the Condition of Periodic Evaluation and Quality Assurance Review:

C0337 - Quality Assurance: The facility failed to ensure that the CAH had an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes. The facility's program failed to evaluate all patient care services and other services affecting patient health and safety. Specifically, the records of Sample Patient #1's were not reviewed by the facility's QA program after the patient had to return to the hospital emergently by ambulance after being transferred inappropriately to an outpatient dialysis treatment clinic.

C0339 - Quality Assurance: The facility failed to ensure that the facility's Quality Assurance (QA) program included the quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners, clinical nurse specialists, and physician assistants at the CAH were evaluated by a member of the CAH staff who is a doctor of medicine or osteopathy. Specifically, the records of nurse practitioners were not regularly reviewed for all inpatients cared for by nurse practitioners. In addition, Sample patient #1's record was not reviewed by the facility's QA program. Additionally, when the patient had to return to the hospital emergently by ambulance, the patient's record and care was not automatically reviewed.

Based on review of the facility's polices/procedures, facility document review, medical record review, and staff interview the facility failed to ensure that the CAH had an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes. The facility's program failed to evaluate all patient care services and other services affecting patient health and safety. Specifically, the records of Sample patient #1's were not reviewed by the facility's QA program after the patient had to return to the hospital emergently by ambulance after being transferred inappropriately to an outpatient dialysis treatment clinic.

The findings were:

Cross Reference to C-0260 - Responsbilities of MD or DO: for findings related to the facility's failure to ensure that a doctor of medicine or osteopathy periodically reviewed and signed the records of all inpatients under the care of physician assistants, nurse practitioners, or clinical nurse specialists.

Cross Reference to C-0294 - Nursing Services: for findings related to the facility's failure to ensure that nursing services were provided that met the needs of patients. Specifically, the facility failed to ensure that the facility's nursing staff adhered to the facility's policies/procedures. The facility's nursing staff failed to ensure that a patient (Sample patient #1) was safely transported to an outside facility for treatment. The facility's nursing staff did not advocate for the patient when an outside transportation company refused to take oxygen with the patient when the patient was receiving supplemental oxygen which placed the patient in danger.

Based on review of the facility's polices/procedures, facility document review, medical record review, and staff interview the facility failed to ensure that the facility's Quality Assurance (QA) program included the quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners, clinical nurse specialists, and physician assistants at the CAH were evaluated by a member of the CAH staff who is a doctor of medicine or osteopathy. Specifically, the records of nurse practitioners were not regularly reviewed for all inpatients cared for by nurse practitioners. In addition, Sample patient #1's record was not reviewed by the facility's QA program. Additionally, when the patient had to return to the hospital emergently by ambulance, the patient's record and care was not automatically reviewed.

The findings were:

Cross Reference to C-0260 - Responsibilities of MD or DO: for findings related to the facility's failure to ensure that a doctor of medicine or osteopathy periodically reviewed and signed the records of all inpatients under the care of physician assistants, nurse practitioners, or clinical nurse specialists.