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I. Based on review of the Network Hospital Agreement, documentation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the Network Hospital staff reviewed the CAHs credential files in accordance with the approved Network agreement. The CAH administrative staff reported a current census of 17 in-patients.

Failure to ensure the Network hospital reviewed the CAH ' s credential files, in accordance with the agreement for quality assurance, could potentially result in the CAHs Medical Staff and Board of Directors failing to recognize problems and/or incidents that had occurred with practitioners during the 2 years since the last credentialing period, which could adversely affect patient care.

Findings include:

1. Review of the Network Agreement, dated 11/9/07, revealed in part. ". . .Annually, the Consulting Hospital will review the CAH's credential files. This review will include, but is not limited to, review of current licensure and certification, delineation of privileges and comparison of delineated privileges to the scope of services provided by the CAH."

2. Review of documentation titled, "Critical Access Hospital Annual Network Review", last edited January 8, 2010, revealed in part. ". . .Findings . . . [Network Hospital] completes a Critical Access Hospital Network Review annually as required by the Critical Access Hospital Medicare Rural Hospital Flexibility Program, Master Network Participation Agreement."

The findings lacked evidence the Network Hospital completed an annual review of the CAH's credential files as required by the Network Agreement.

3. During an interview on 11/10/10 at 11:15 AM, the Director of Quality acknowledged the lack of documented evidence the Network Hospital completed an annual review of the CAH's credential files as required by the Network Agreement.


II. Based on review of the Network Hospital Agreement, documentation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure representatives of the Network Hospital met annually with the CAH Quality Assurance Committee to review and/or assist the CAH ' s quality staff in reviewing and implementing their quality plan. The CAH staff reported a current census of 17 in-patients.

Failure to ensure the CAH Network Hospital Quality Assurance Program review takes place annually, in accordance with the agreement, could potentially result in the CAH's quality staffs failure to identify and act on patient care related issues and potentially cause adverse patient outcomes.

Findings include:

1. Review of the Network Agreement, dated 11/9/07, revealed in part. ". . .CAH Quality Assurance. . . [Network Hospital], through personnel designated by [Network Hospital], shall meet with the CAH's QA representatives no less than on an annual basis to assist the CAH in implementing its QA Plan, to review findings under the CAH's QA Plan, and to propose improvement plans and/or recommendations."

2. Review of documentation titled, "Critical Access Hospital Annual Network Review", last edited January 8, 2010, revealed in part. ". . .Findings . . . [Network Hospital] completes a Critical Access Hospital Network Review annually as required by the Critical Access Hospital Medicare Rural Hospital Flexibility Program, Master Network Participation Agreement."

Review of documentation related to the annual CAH Network Hospital Quality Assurance Plan and Implementation review, showed the quality staff failed to document the date the review occurred, indicating the meeting occurred annually. Additionally, the quality staff failed to document the results/findings of the meeting and any interventions that occurred as a result of the review.

3. During an interview on 11/10/10 at 11:15 AM, the Director of Quality acknowledged the lack of documented evidence that verified the date personnel, designated by the Network Hospital, met with the CAH's QA representatives. The Director of Quality further acknowledged the documentation lacked results of the meeting that showed the Network Hospital had assisted the CAH in implementing its QA Plan, reviewed findings under the CAH's QA Plan, and to proposed improvement plans and/or recommendations, if needed, as stated in the Network Agreement.

I. Based on observation, staff interviews and policy/procedure review, the CAH failed to:

1. Complete biomedical checks on 10 of 10 new Datascopes (vital sign machines) and 4 of 4 new fetal monitors prior to use on 6/2010.

2. The CAH Obstetrics staff failed to ensure a system was in place to check supplies for outdates on a routine basis, in accordance with CAH policy " Outdated Products. "

The CAH had a current census of 17 patients.

Failure to complete biomedical checks on new equipment could potentially cause harm to patients if the equipment does not function correctly.

Failure to check for outdated supplies could potentially cause harm to patients if the outdated supplies are used for patient care.

Findings include:

1. Observations, during the environmental tour of the medical/ surgical unit, on 11/8/2010 at 3:55 PM, revealed 1 Datascope in use without staff completing a biomedical check. Additional observation revealed nine additional Datascopes in use throughout the CAH without evidence of a biomedical check. Four fetal monitors were available in obstetrics for use without staff completing a biomedical check.

During an interview on 11/9/2010 at 11:45 AM, the Chief Operations Officer said the CAH staff used the equipment without completing a biomedical check.

During an interview on 11/9/2010 at 2:15 PM the biomedical District Service Technician said the CAH staff used the equipment without completing a biomedical check.

Review of the CAH policy titled Electrical Equipment Condition and Maintenance, dated 7/19/2004 revealed, all electrical equipment brought into the hospital, purchased, leased or for trial use must be inspected by the maintenance department before put in use.

2. Observation, during the obstetrics environmental tour, on 11/8/2010 at 3:55 PM, revealed the following expired items available for patient use. The ante partum room had 26 of 38 insyte 18 ga (gauge) X 1.16 in (inch) intravenous (IV) needles with expiration dates of 3/10, 9/09, 3/08, 12/8, and 5/10. Seven of 7 povidone/iodine swab sticks with expiration dates of 6/09 and 9/09. Thirty-one of 31 vicryl 4-0 sutures with an expiration date of 7/08. Thirty-six of 36 vicryl 3-0 sutures with an expiration date of 1/10. Fifteen of 15 chromic gut 2-0 sutures with an expiration date of 1/10.
During an interview on 11/8/2010 at 4:10 PM, Staff P, Registered Nurse (RN) said staff did not routinely check for outdated supplies in the obstetrics unit.

Review of the CAH policy titled Outdated Products, Tracking of dated 1/19/2009 revealed the ward clerks/ nursing assistants shall be responsible for checking supplies for outdates and arranging with materials management staff for replacement. An inventory list of supplies that outdate shall be maintained in the clean supply room and monthly checks done, with supplies replaced accordingly.


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II. Based on observation, policy/procedure review, and staff interview, the Critical Access Hospital (CAH) maintenance staff failed to secure 1 of 1 nitrogen gas cylinders and 1 of 6 carbon dioxide cylinders in 1 of 1 gas storage rooms. The CAH administrative staff reported a census of 17 patients.

Failure to secure the gas cylinders could potentially result in an explosion or a gas leak causing harm to patients and/or staff.

Findings include:

1. An observation on 11/08/10 at 10:20 AM, with the Facilities Director, revealed a Gas Storage Room/Nitrous Oxide Room on the lower level. The storage room contained 1 of 1 large unsecured nitrogen cylinder, and 1 of 6 large unsecured carbon dioxide cylinders. The unsecured nitrogen and carbon dioxide cylinders lacked a chain or cart for security. A sign posted inside the storage room stated, "Cylinders must be chained at all times."

2. Review of the policy titled, "Cylinder Safety", dated 8/25/10, and on 10/09/10 stated in part. "....Storage: Large cylinders shall be properly secured in the storage area so as to offer some protection against being knocked over. Provision shall be made for racks or fastenings to protect cylinders from accidental damage .....Transportation & Handling: Cylinders shall always be secured by a strap, stand, or a cart to prevent tip over."

3. During an interview on 11/08/10 at 10:20 AM, the Facilities Director acknowledged the 2 unsecured gas cylinders in the storage room, and stated maintenance is responsible for securing the gas cylinders.

Based on observation, staff interview, and policy/ procedure review, the Critical Access Hospital (CAH) failed to secure medications stored in the pre-eclampsia kit and neonatal resuscitation program box located in the Ante partum room of the obstetrics unit. The CAH reported a current census of 1 obstetrical patient.

Failure to secure medications in the ante partum room could cause harm to patients or visitors that have access to the area if ingesting the medications or diverting the medications from the CAH.

Findings include:

1. Observation, during the obstetrics environmental tour, on 11/8/2010 at 3:55 PM, revealed a pre-eclampsia kit and neonatal resuscitation program kit in the ante partum room unsecured. The kits had various medications including epinephrine, sodium bicarbonate, Narcan, diazepam, phenobarbital and terbutaline.

2. During an interview on 11/8/2010 at 4:00 PM, Staff P, Registered Nurse (RN) verified the unsecured storage of the medications and that patients and/or visitors could have access to the medications.

3. Review of CAH policy titled Security of Staff and Drugs, dated 7/1/2003 revealed lockable storage units or lockable drug carts, if necessary, shall be provided for drug storage areas throughout the facility. Drugs shall be kept in locked storage or be inaccessible to patients, visitors and unauthorized staff.

Based on review of policies and procedures, medical records, documentation, contracts/agreements, observation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the safe provision of hemodialysis services provided to the CAH swing-bed in-patients.

1. This determination was evidenced by:

a. Failure of the CEO to ensure the CAH had written policies, procedures, and systems in place regarding the provision of hemodialysis services for the CAH swing-bed in-patients. (Refer to C241)

b. Failure of the CAH Chief Executive Officer (CEO) to ensure a contract/agreement was in place with the entity that provided chronic outpatient hemodialysis services, Outpatient Dialysis Facility A, to the swing-bed in-patients of the CAH. (Refer to C241)

2. The cumulative effect of these systemic failures and deficient practices resulted in the CAH's inability to ensure the safe provision of care for CAH swing-bed in-patients who received dialysis services from Outpatient Dialysis Facility A while a swing-bed in-patient at the CAH.

Based on review of policies and procedures, observation, medical records, and staff interview, the Critical Access Hospital (CAH) Chief Executive Officer (CEO) failed to
ensure the CAH had written policies, procedures, and systems in place regarding provision of hemodialysis services for the CAH swing-bed in-patients. In addition, the CEO failed to ensure a contract/agreement was in place with the entity that provided chronic outpatient hemodialysis services, Outpatient Dialysis Facility A, to the swing-bed in-patients of the CAH.

Failure of the CEO to ensure the CAH had a contract/agreement, policies, procedures, and systems in place for the provision of dialysis services for the CAH swing-bed in-patients could potentially result in the patients receiving less than optimal care or failure to provide the patient with the care and services needed resulting in patient harm, illness, or even patient death.

The CAH administrative staff reported a swing-bed in-patient census of 2 and reported that these current swing-bed in-patients were not receiving dialysis services from Outpatient Dialysis Facility A at the time of the survey. The CAH had 2 swing-bed patients (Patient D1 and D2) in the last 12 months who received dialysis services from Outpatient Dialysis Facility A, while the patients were swing-bed in-patients of the CAH.

Findings include:

1. The CEO failed to ensure the CAH had written policies, procedures, and systems in place regarding the provision of hemodialysis services for the CAH swing-bed in-patients
(Please refer to C271 and C273 for further information and findings regarding the provision of dialysis services and the services furnished through arrangement or agreement with Outpatient Dialysis Facility A.)

2. The CEO failed to ensure a contract/agreement was in place with the entity that provided chronic outpatient hemodialysis services, Outpatient Dialysis Facility A, to the swing-bed in-patients of the CAH. (Please refer to C285 for further information and findings regarding the lack of a written contract/agreement with Outpatient Dialysis Facility A.)

3. During an interview on 11/10/10 at 12:25 PM, the CEO acknowledged the CAH lacked
written policies, procedures, and systems in place regarding the provision of hemodialysis services for the CAH swing-bed in-patients. In addition, during the interview, the CEO acknowledged the CAH lacked a contract/agreement with the chronic outpatient hemodialysis facility that addressed the provision of care regarding communication, integration and coordination of patient care for swing-bed patients receiving dialysis treatments from Outpatient Dialysis Facility A.

Based on review of policies and procedures, medical records, documentation, contracts/agreements, observation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the safe provision of hemodialysis services provided to the CAH swing-bed in-patients as evidenced by:

1. Failure to ensure development and implementation of written policies and procedures that addressed the provision of hemodialysis services provided by a chronic outpatient hemodialysis facility, Outpatient Dialysis Facility A, to the swing-bed in-patients of the CAH. (Refer to C271)

2. Failure to ensure the written policies included a description regarding the chronic outpatient hemodialysis service the CAH furnished through agreement or arrangement with Outpatient Dialysis Facility A. (Refer to C273)

3. Failure to ensure a contract/agreement with the entity that provided chronic outpatient hemodialysis services, Outpatient Dialysis Facility A, to the swing-bed in-patients of the CAH. (Refer to C285)

4. Failure to maintain a list of contracted services that described the nature and scope of services provided. (Refer to C291)

5. Failure of the CAH Chief Executive Officer (CEO) to ensure a contract/agreement was in place with the entity that provided chronic outpatient hemodialysis services, Outpatient Dialysis Facility A, to the swing-bed in-patients of the CAH. In addition, the CEO failed to ensure the CAH had written policies, procedures, and systems in place regarding the provision of hemodialysis services for the CAH swing-bed in-patients. (Refer to C292)

6. Failure to ensure the entity that provided hemodialysis treatments and services to the swing-bed in-patients of the CAH, Outpatient Dialysis Facility A, had systems place to ensure that Outpatient Dialysis Facility A met all the applicable conditions of participation and standards for contracted services. (Refer to C293)

The CAH administrative staff reported a swing-bed in-patient census of 2 and reported that these current swing-bed in-patients were not receiving dialysis services from Outpatient Dialysis Facility A at the time of the survey. The CAH had 2 swing-bed patients (Patient D1 and D2) in the last 12 months who received dialysis services from Outpatient Dialysis Facility A, while the patients were swing-bed in-patients of the CAH.

The cumulative effect of these systemic failures and deficient practices resulted in the CAH's inability to ensure the safe provision of care for CAH swing-bed in-patients who received dialysis services from Outpatient Dialysis Facility A while a swing-bed in-patient at the CAH.

Based on review of medical records, observation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure development and implementation of written policies and procedures that addressed the provision of hemodialysis services provided by a chronic outpatient hemodialysis facility, Outpatient Dialysis Facility A, to the swing-bed in-patients of the CAH. The CAH administrative staff failed to ensure development and implementation of policies and procedures addressing transportation of the CAH swing-bed in-patient to and from Outpatient Dialysis Facility A, verbal report requirements or communication that occurred between the CAH staff and Outpatient Dialysis Facility A staff including before and after the dialysis treatment, the informed consent process for a CAH swing-bed in-patient to receive dialysis services and treatments from Outpatient Dialysis Facility A, accessibility of medical record information and patient information between the CAH and Outpatient Dialysis Facility A, and incorporation into the medical record for the CAH swing-bed in-patient, the doctor's orders, reports of treatments and medications, nursing notes, progress notes, laboratory reports, assessments and other pertinent information from Outpatient Dialysis Facility A.

Written policies and procedures provide guidance and consistency among staff and serves as a resource for staff in the provision of care. Failure to maintain policies and procedures for staff reference failed to provide staff with guidance for the expected practices and performances in the provision of patient care. The lack of policies and procedures in the provision of patient care could potentially result in the patients receiving less than optimal care or failure to provide the patient with the care and services needed resulting in patient harm, illness, or even patient death.

The CAH administrative staff reported a swing-bed in-patient census of 2 and reported that these current swing-bed in-patients were not receiving dialysis services from Outpatient Dialysis Facility A at the time of the survey. The CAH had 2 swing-bed patients (Patient D1 and D2) in the last 12 months who received dialysis services from Outpatient Dialysis Facility A, while the patients were swing-bed in-patients of the CAH.

Findings for 2 of 2 closed medical records reviewed (Patient D1 and D2) include:

1. During an interview on 11/9/10 at 8:40 AM, the Medical Surgical Nurse Manager reported the CAH did not have provisions for providing hemodialysis services to acute care patients. However, further interview with the Medical Surgical Nurse Manager revealed patients admitted to the CAH swing-bed if needed received outpatient hemodialysis services from Outpatient Dialysis Facility A, a separately certified chronic outpatient hemodialysis facility located at the CAH. Observation on 11/8/10 at 4:30 PM and interview with the Medical Surgical Nurse Manager on 11/9/10 at 8:40 AM showed Outpatient Dialysis Facility A was located on the first floor of the CAH and that CAH staff, usually nurses, transported the swing-bed in-patient to and from the dialysis facility for the patient's hemodialysis treatment.

2. The CAH administrative staff failed to ensure a written policy and procedure that addressed transportation of the CAH swing-bed in-patient to and from Outpatient Dialysis Facility A. In addition, the CAH administrative staff failed to ensure a written policy and procedure that addressed the verbal report requirements including a system for documenting the reports or communication that occurred between the CAH staff and Outpatient Dialysis Facility A staff regarding the patient.

a. Interview on 11/9/10 at 8:40 AM with the Medical Surgical Nurse Manager showed communication regarding the patient occurred between the CAH staff and Outpatient Dialysis Facility A staff through verbal report when the CAH staff, usually nurses, transported the patients to and from the dialysis facility and/or through communication by phone. However, interview on 11/9/10 at 8:40 AM and 11:05 AM with the Medical Surgical Nurse Manager and review of Patient D1's and D2's CAH swing-bed in-patient medical records showed the CAH staff did not always document the verbal reports between the CAH staff and the dialysis facility staff. (Please refer to C302 for further information regarding the specific findings for the communication between the CAH staff and Outpatient Dialysis Facility A staff regarding the CAH patients.)

b. Interview on 11/9/10 at 8:40 AM and at 11:05 AM with the Medical Surgical Nurse Manager revealed the facility lacked policies and procedures addressing the facility's system for transporting the patients to and from Outpatient Dialysis Facility A. In addition, interview with the Medical Surgical Nurse Manager showed the CAH lacked policies and procedures addressing the verbal report and communication requirements. Interview on 11/10/10 at 12:15 PM with the Medical Surgical Nurse Manager and at 12:25 PM with the CEO (Chief Executive Officer) showed the CAH should have written policies and procedures in place addressing the provision of hemodialysis treatments and services for the CAH swing-bed in-patients, including the CAH's verbal report and communication requirements.

3. The CAH administrative staff failed to ensure written policies and procedures that addressed the provision of hemodialysis services provided by Outpatient Dialysis Facility A to the CAH swing-bed in-patients including policies and procedures that addressed the informed consent process for a CAH swing-bed in-patient to receive dialysis services and treatments from Outpatient Dialysis Facility A and accessibility of medical record information and patient information between the CAH and Outpatient Dialysis Facility A. In addition, the CAH administrative staff failed to ensure written policies and procedures that addressed incorporation into the medical record for the CAH swing-bed in-patient, the doctor's orders, reports of treatments and medications, nursing notes, progress notes, laboratory reports, assessments and other pertinent information from Outpatient Dialysis Facility A.

a. Review of the medical records for Patient D1 and D2 showed the patients received dialysis at Outpatient Dialysis Facility A while the patients were swing-bed in-patients at the CAH. However, the medical records lacked a dated and signed informed consent form for the dialysis treatments.

Interview on 11/9/10 at 8:40 AM with the Medical Surgical Nurse Manager revealed the CAH did not have a system in place including policies and procedures regarding an informed consent for the patient to receive dialysis treatments and services at Outpatient Dialysis Facility A. During the interview, the Medical Surgical Nurse Manager reported the CAH did not complete an informed consent form for the CAH swing-bed in-patients who received dialysis treatments from Outpatient Dialysis Facility A. (Please refer to C304 for further information regarding the specific findings for the lack of an informed consent process.)

Interview on 11/10/10 at 12:15 PM with the Medical Surgical Nurse Manager and at 12:25 PM with the CEO showed the CAH should have written policies and procedures in place addressing the provision of hemodialysis treatments and services for the CAH swing-bed in-patients.

b. Interview on 11/9/10 at 8:40 AM with the Medical Surgical Nurse Manager showed each facility, the CAH and Outpatient Dialysis Facility A, maintained separate medical records for the care and services provided by each facility for the CAH swing-bed patient. During the interview, the Medical Surgical Nurse Manager reported Outpatient Dialysis Facility A was considered a different facility and that the CAH and Outpatient Dialysis Facility A did not routinely review the medical record documentation from the other facility. The interview with the Medical Surgical Nurse Manager revealed the CAH did not incorporate, into the CAH patient medical record, documentation from Outpatient Dialysis Facility A such as the dialysis flow sheets (documentation completed by the dialysis facility for each patient hemodialysis treatment), laboratory report results, progress notes, medications administered, and doctor orders.

Interview on 11/10/10 at 11:50 AM with Outpatient Dialysis Facility A RN (registered nurse) DB and DC showed Outpatient Dialysis Facility A had an interdisciplinary team caring for the patient which included a physician, registered nurse, dietitian, and social worker.

Interview on 11/9/10 at 8:40 AM and 11:05 AM with the Medical Surgical Nurse Manager and on 11/10/10 at 11:50 AM with Outpatient Dialysis Facility A RN DB and DC showed the CAH staff and Outpatient Dialysis Facility A staff did not routinely provide documentation to each other regarding treatments and medications administered at each facility or doctor orders and lab results obtained at each facility. Interview on 11/9/10 at 11:05 AM with the Medical Surgical Nurse Manager showed the CAH do not send the patient CAH medical record, documentation of the medications administered, or documentation of lab reports to Outpatient Dialysis Facility A and that Outpatient Dialysis Facility A did not routinely send the dialysis flow sheets, medications administered during treatment, or documentation of the lab report results to the CAH.

Interview with the Medical Surgical Nurse Manager showed the Medical Surgical Nurse Manager thought that if the CAH staff wanted to review the Outpatient Dialysis Facility A patient medical record, for a CAH swing-bed in-patient receiving dialysis at Outpatient Dialysis Facility A, the CAH staff would need to complete a medical record request to review the record because Outpatient Dialysis Facility A was considered a different facility.

Review of the medical records for Patient D1, with a swing-bed admission date of 9/21/10 and a discharge date of 10/11/10, and for Patient D2, with a swing-bed admission date of 5/28/10 and a discharge date of 6/28/10, showed the medical records lacked physician orders for the dialysis treatment prescription, medications administered at Outpatient Dialysis Facility A, and any treatments provided, progress notes, assessments, and/or laboratory report results from Outpatient Dialysis Facility A. (Please refer to C302 and C306 for further information regarding the specific findings for: The lack of accessibility of medical record and patient information between the CAH and Outpatient Dialysis Facility A; and Incorporation into the CAH medical record for the swing-bed in-patients, the doctor's orders, reports of treatments and medications, nursing notes, progress notes, laboratory reports, assessments and other pertinent information from Outpatient Dialysis Facility A.)

Interview on 11/10/10 at 12:15 PM with the Medical Surgical Nurse Manager and at 12:25 PM with the CEO verified the lack of written policies and procedures that addressed the provision of hemodialysis services provided by Outpatient Dialysis Facility A to the CAH swing-bed in-patients including policies and procedures that addressed accessibility of the medical record information and patient information between the CAH and Outpatient Dialysis Facility A. In addition, interview with the Medical Surgical Nurse Manager and CEO verified the lack of written policies and procedures that addressed incorporation into the medical record for the CAH swing-bed in-patient, the doctor's orders, reports of treatments and medications, nursing notes, progress notes, laboratory reports, assessments and other pertinent information from Outpatient Dialysis Facility A. During the interviews, the Medical Surgical Nurse Manager and the CEO acknowledged the CAH should have written policies and procedures in place addressing the provision of hemodialysis treatments and services for the CAH swing-bed in-patients.

Based on review of policies, procedures, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the policies included a description regarding the chronic outpatient hemodialysis service the CAH furnished through agreement or arrangement with Outpatient Dialysis Facility A.

Failure to have a description of the service the CAH furnished through agreement or arrangement could potentially result in failure of the facility to ensure availability of the heath care service to the CAH patients.

The CAH administrative staff reported a swing-bed in-patient census of 2 and reported that these current swing-bed in-patients were not receiving dialysis services from Outpatient Dialysis Facility A at the time of the survey. The CAH had 2 swing-bed in-patients in the last 12 months who received dialysis services from Outpatient Dialysis Facility A, while the patients were swing-bed in-patients at the CAH.

Findings include:

1. During an interview on 11/9/10 at 8:40 AM, the Medical Surgical Nurse Manager reported the CAH did not have provisions for providing hemodialysis services to acute care patients. However, further interview with the Medical Surgical Nurse Manager revealed patients admitted to the CAH swing-bed if needed received outpatient hemodialysis services from Outpatient Dialysis Facility A, a separately certified chronic outpatient hemodialysis facility located at the CAH.

2. The CAH had a policy and procedure titled "Provision of Services," effective date 6/21/2004, which stated in part, "PURPOSE: To assure services, whether provided directly by the Shenandoah Medical Center or by arrangement, are available to ensure safe and efficient operations. POLICY: A description of the service provided at the Shenandoah Medical Center furnished directly or under arrangement... PROCEDURE: The following lists the scope of services provided at the Shenandoah Medical Center..." The policy included a list of services provided at the Shenandoah Medical center by direct services or services provided under arrangement. However, review of the listed services revealed the list did not include the service of the chronic outpatient dialysis facility, Outpatient Dialysis Facility A.

3. During an interview on 11/10/10 at 12:45 PM, the CEO (Chief Executive Officer) reported the CAH had an agreement/arrangement with Chronic Outpatient Dialysis Facility A and verified that the policy did not include the chronic outpatient hemodialysis facility.

I. Based on observation, review of hospital policies/procedures, and staff interview, the Critical Access Hospital (CAH) staff failed to ensure outdated medications were not available for patient use in the medical/ surgical unit and operating room. The CAH had a census of 17 current patients.

Failure to remove outdated medications for patient care areas could potentially result in patients receiving outdated and ineffective medications.

Findings include:

1. Observation, during the environmental tour, on 11/9/2010 at 8:10 AM, revealed the following outdated medications and supplies available for patient use in the crash cart located on the Medical/Surgical Unit. 3 Amiodarone hydrochloride injection 3ml (milliliter) vials expired 9/2010 and 2 arterial blood gas collection syringes, 1 expired 1/2010 and 1 expired 2/2010.

a. Review of the CAH policy titled Crash Cart Use and Maintenance dated 8/11/2003 showed pharmacy staff shall be responsible for checking the medications in the crash cart every month for outdated items.

b. During an interview on 11/9/2010 at 8:30 AM, the medical surgical supervisor said staff check for outdated medications on a quarterly basis and verified the outdated medications.

c. During an interview on 11/9/2010 at 2:20 PM, the pharmacy technician said pharmacy staff send out a sheet monthly to all areas of the CAH instructing staff to check the area for outdated medications. Staff return the sheet and pharmacy staff replace the outdated medications.

2. Observation, during the environmental tour, on 11/10/2010 at 8:35 AM, revealed the following outdated items available for patient use in the operating room. One 16 oz (ounce) bottle of hydrogen peroxide expired 3/2009 in OR #1. The crash cart in the OR recovery room contained 1 Lidocaine hydrochloride 2 percent jelly, 30 ml that expired 8/2010 and 2 magnesium sulfate injections, 50 percent that expired 10/2010.

a. During an interview on 11/10/2010 at 8:35 AM Staff Q Registered Nurse (RN) said staff check for outdated medications monthly and replace them.

b. During an interview on 11/10/2010 at 8:40 AM Staff R, RN said staff failed to replace the expired medications. Staff R was unsure why staff had not removed and replaced the expired medications.

II. Based on observation, review of hospital policies/ procedures and staff interview the CAH failed to store succinylcholine chloride injection and zemuron (muscle relaxers) according to manufacturers guidelines in 4 of 4 anesthesia carts in the operating room (OR). The CAH had an average OR census 41 to 58 patients a month.

Findings include:

1. Observation, during the environmental tour, on 11/10/2010 at 8:35 AM, revealed 4 anesthesia carts in the OR that contained Succinylcholine and Zemuron. Anesthesia staff had stored the medications in the anesthesia carts without dating or refrigerating the vials.

a. Review of the CAH policy titled, Storage: General, dated 7/1/2003 showed drugs shall be stored according to the provisions of the USP/NF and /or the specifications of the manufacturer so that their integrity, stability and effectiveness are maintained.

b. Review of the manufacturer guidelines for Succinylcholine chloride injection showed to store refrigerated at 36 to 46 degrees and multidose vials are stable for up to 14 days at room temperature. Refrigeration of the undiluted agent will assure full potency until expiration date.

c. Review of the manufacturer's guidelines for Zemuron showed to store refrigerated at 36 to 46 degrees. Upon removal from refrigeration to room temperature storage conditions, use within 60 days or if opened use within 30 days.

During an interview on 11/10/2010 at 1:40 PM Staff U pharmacist said the CAH policy states to store all medications according to manufacturers guidelines.

During an interview on 11/10/2010 at 12:40 PM Staff V CRNA (certified registered nurse anesthetist) stated pharmacy stores the succinylcholine and zemuron refrigerated. The CRNA obtains the medications from pharmacy and stores in the anesthesia carts unrefrigerated until used. Staff do not date the medications when placed in the anesthesia carts.

III. Based on observation, staff interview, and record review, the Critical Access Hospital (CAH) pharmacy staff failed to develop and maintain a system where sample drugs are controlled and distributed through the pharmacy or through a process developed in cooperation with the pharmacy, for pharmacy oversight in 2 of 3 offices at the Shenandoah Clinic. The clinic manager reported an average monthly patient volume of 230 visits with approximately 4 patients receiving sample medications a week.

Failure to provide oversight could potentially result in expired medications available to patients, and the potential theft of medications by unauthorized persons.

Observation on 11/09/10 at 3:17 PM during tour of the Shenandoah Clinic revealed 2 of 3 offices with sample drug rooms. The sample drug room in the Bowery Clinic measured approximately 5 ft x 5 ft and contained drugs used to lower cholesterol, reduce pain, improve cardiovascular functions, treat depression, reduce flu symptoms, improve calcium absorption, improve sexual function, reduce migraine headaches, improve memory, reduce blood sugars and lower blood pressure.

The sample drug room in the Women's Care Clinic measured approximately 8 ft x 5 ft and contained drugs used to lower blood pressure, reduce migraine headaches, reduce pain, improve calcium absorption, treat depression, fight infections, decrease congestion and control pregnancy.

During an interview on 11/10/10 at 8:00 AM, Staff S, clinic LPN (Licensed Practical Nurse), said the physician directs the use and dispensing of the sample drugs. Staff S documents the dispensed sample drugs in the patients' medical record but not in the sample drug logbook. Staff S also failed to document receipt and disposition of sample drugs in the log book. The CAH administrative staff failed to train Staff S to document receipt and distribution of sample medications. Staff S used the computer system to track sample drugs in case a drug recall occurred. The pharmacy lacked involvement in overseeing the sample drugs.

During an interview on 11/09/10 at 8:15 AM with Staff T, clinic LPN (Licensed Practical Nurse), said the physician directs the use and dispensing of the sample drugs. Staff T documents the dispensing of sample drugs in the patients ' medical record but not in the sample drug logbook. Staff T failed to document receipt and disposition of sample drugs. The CAH administrative staff failed to train Staff T on documenting the receipt and disposition of sample drugs. Staff T lacked knowledge regarding computer system tracking for patients receiving sampled drugs if a recall occurred. The pharmacy lacked involvement in overseeing sample drugs.

During an interview on 11/10/10 at 10:00 AM with Staff U, staff pharmacist, said the clinics check their own sample drugs for expiration dates. The pharmacist lacked involvement in overseeing sample drugs in the clinic.

During an interview on 11/10/2010 at 11:05 AM with Staff W, ARNP (Advanced Registered Nurse Practitioner), said the clinic had a perpetual log for sample drugs, but unsure if clinic nurses charted when sampled drugs were received from the pharmaceutical company.

Review of the Bowery Clinic sample drug logbook on 11/10/10 revealed 67 drugs. The sample drug room contained 30 drugs not documented in the logbook.

Review of the Women's Care Clinic sample drug logbook on 11/10/10 showed clinic staff failed to document receipt of sampled drugs from the pharmaceutical company. The sample drug room contained 20 drugs of various types.

Review of the hospital policy titled, " Drugs and Nutritional Samples " dated 2/25/09, on 11/10/10 stated, in part. ...F, The Clinic Practitioner and Clinic Nurse shall be responsible for the maintenance and control of samples in the clinics....H. Samples given to the patient in quantities beyond a temporary trial must be documented in the clinic by a mechanism that can easily identify the lot number, date, drug, or nutritional (brand name in order to identify the manufacturer), strength and patient medical record number....

Based on personnel record reviews, staff interview and hospital policy/ procedure review the Critical Access Hospital (CAH) failed to provide tuberculosis (TB) skin tests every 4 years for 12 of 25 hospital staff (Staff A,B,C,D,E,F,G,H,I,J,K and L) and 5 of 6 volunteer staff (Volunteer A,B,C,D and E) working at the CAH. The CAH had a census of 17 current patients.

Failure to provide TB skin testing for staff and volunteers every 4 years could potentially place patients at risk for contacting an infectious disease.

Findings include:

Review of the CAH personnel records on 11/10/2010 revealed 12 of 25 current hospital staff and 5 of 6 volunteers lacked documentation of TB skin tests completed every 4 years after the initial TB skin test completed upon hire.

During an interview on 11/10/2010 at 3:50 PM Staff N, Employee Health/ Utilization Review and Occupational Health Nurse said staff and volunteers receive a TB skin test upon hire. A TB screen/ assessment is then completed yearly, but a TB skin test is not completed every 4 years. The CAH is a low risk hospital and no active cases of TB have been reported.

During an interview on 11/10/2010 at 4:00 PM Staff O, Infection Control Nurse said the TB skin test is completed on hire of staff and volunteers and then a yearly TB screen/ assessment is completed. TB skin tests are not completed every 4 years. According to Centers for Disease Control(CDC) guidelines do not require low risk hospitals to complete TB skin tests every 4 years after the initial TB skin test when hired.

Review of the CAH policy titled TB Exposure Pre-employment and Annual Employee Screening dated 8/5/2009 revealed employees and volunteers must complete TB skin testing within 3 weeks of hire date and then complete the Employee Health Tuberculosis Screening/Assessment yearly. Employees and volunteers were not required to complete a TB skin tests every 4 years.

Based on review of policies/procedures, meeting minutes, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure review of all patient care policies annually by the required group of professionals that included at least one mid-level practitioner for 11 of 15 CAH departments. (Food Service, Nursing, Surgery, Anesthesia, Emergency Room, Therapies (Physical Therapy, Occupational Therapy, Speech Therapy), Radiology, Laboratory, Pharmacy, Respiratory, Cardiac Rehabilitation) The CAH reported a census of 17 patients.

Findings include:

1. Review of policy/procedure titled, "CAH Professional Advisory Committee", dated 7/16/2010, revealed in part. "The committee shall consist of the Administrator/CEO or his designee, one medical staff member, one mid-level practitioner, Chief Nurse Executive and one Board appointed member who shall represent the community."

2. Review of Critical Access Hospital Professional Advisory Committee Meeting minutes from 11/25/1009 through 9/22/10 revealed in part.

a. The 11/25/10 meeting minutes lacked documented evidence that showed a mid-level practitioner was present when the committee approved the following patient care policies. food Service and "all department policy review not in need of updates."

b. 1/20/10 meeting lacked documented evidence that showed a mid-level practitioner was present when the committee approved the following patient care policies: Nutrition, Emergency Room.

3. During an interview on 11/10/10 at 12:50 PM, the Chief Executive Officer (CEO) acknowledged CAH Professional Advisory Committee members included the required group of professionals, which included a mid-level practitioner. The committee's responsibility included review of patient care policies. The CEO stated that when the mid-level practitioner missed a CAH Professional Advisory Committee, the committee provided the mid-level with a copy of the minutes. The CEO verified the lack of a system to ensure the mid-level is involved in the annual review of patient care policies when the mid-level is not present at a meeting.

Based on review of contracts/agreements and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure a contract/agreement was in place with the entity that provided chronic outpatient hemodialysis services, Outpatient Dialysis Facility A, to the swing-bed in-patients of the CAH.

Shenandoah Medical Center is a CAH with acute care and swing-bed services provided under the hospital license. Patients in a CAH swing-bed are at a skilled nursing facility level of care, however the CAH swing-beds are not a separately certified skilled nursing facility. The CAH must have an agreement/contract with an entity that provides services to the CAH patients, such as the chronic outpatient hemodialysis facility, to ensure the safe and effective provision of care to the CAH patients. Contracts provide for consistency and delineate responsibilities and accountabilities between the contracted entity or the outpatient entity and CAH for the provision of patient care. The lack of a contract between the CAH and the chronic outpatient hemodialysis dialysis facility providing care to the CAH swing-bed in-patients could potentially result in the lack of communication regarding the patient condition, laboratory results and treatments and in the lack of coordination of patient care which could result in poor patient outcomes and even death to the patient.

The CAH administrative staff reported a swing-bed in-patient census of 2 and reported that these current swing-bed in-patients were not receiving dialysis services from Outpatient Dialysis Facility A at the time of the survey. The CAH had 2 swing-bed in-patients in the last 12 months who received dialysis services from Outpatient Dialysis Facility A, while the patients were swing-bed in-patients at the CAH.

Findings include:

1. During an interview on 11/9/10 at 8:40 AM, the Medical Surgical Nurse Manager reported the CAH did not have provisions for providing hemodialysis services to acute care patients. However, further interview with the Medical Surgical Nurse Manager revealed patients admitted to the CAH swing-bed if needed received outpatient hemodialysis services from Outpatient Dialysis Facility A, a separately certified chronic outpatient hemodialysis facility located at the CAH.

2. The CEO (Chief Executive Officer) presented an agreement/contract with Outpatient Dialysis Facility A titled "NURSING HOME DIALYSIS TRANSFER AGREEMENT" dated 6/1/10 and signed by the CAH's CEO and a representative from Outpatient Dialysis Facility A. However, review of the agreement revealed the agreement addressed a skilled nursing facility and was not specific for the CAH swing-bed patients for the provision of dialysis services.

3. During interview on 11/10/10 at 12:25 PM, the CEO acknowledged and verified the findings. Continued interview with the CEO showed the CAH should have a contract/agreement with the chronic outpatient hemodialysis facility that addressed the provision of care regarding communication, integration and coordination of patient care for swing-bed patients receiving dialysis treatments from Outpatient Dialysis Facility A.

Based on review of policies/procedures, documentation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to maintain list of contracted services that described the nature and scope of the services provided. The CAH identified a list of 20 contracted services.

Lack of delineation of the nature and scope of contracted services could potentially result in failure of compliance of the contracted services' responsibilities.

Findings include:

1. Review of policy/procedure titled, "Services By Agreement/Arrangement", dated 6/21/04, revealed in part. ". . . The Shenandoah Medical Center will maintain a list of all services furnished under arrangement or agreement. The list will describe the nature and scope of the service provided."

2. Review of the list of contracted services revealed the list lacked delineation of the nature and scope of services each contracted entity would provide.

3. During an interview on 11/10/10 at 1:55 PM, the Chief Financial Officer acknowledged the list of contracted services lacked a description of the nature and scope of the services provided.

Based on review of policies and procedures, observation, medical records, and staff interview, the Critical Access Hospital (CAH) Chief Executive Officer (CEO) failed to ensure a contract/agreement with the entity that provided chronic outpatient hemodialysis services, Outpatient Dialysis Facility A, to the swing-bed in-patients of the CAH. In addition, the CEO failed to ensure the CAH had written policies, procedures, and systems in place regarding the provision of hemodialysis services for the CAH swing-bed in-patients.

Failure of the CEO to ensure the CAH had a contract/agreement, policies, procedures, and systems in place for the provision of dialysis services for the CAH swing-bed in-patients could potentially result in the patients receiving less than optimal care or failure to provide the patient with the care and services needed resulting in patient harm, illness, or even patient death.

The CAH administrative staff reported a swing-bed in-patient census of 2 and reported that these current swing-bed in-patients were not receiving dialysis services from Outpatient Dialysis Facility A at the time of the survey. The CAH had 2 swing-bed patients (Patient D1 and D2) in the last 12 months who received dialysis services from Outpatient Dialysis Facility A, while the patients were swing-bed in-patients of the CAH.

Findings include:

1. The CEO failed to ensure a contract/agreement was in place with the entity that provided chronic outpatient hemodialysis services, Outpatient Dialysis Facility A, to the swing-bed in-patients of the CAH. (Please refer to C285 for further information and findings regarding the lack of a written contract/agreement with Outpatient Dialysis Facility A.)

2. The CEO failed to ensure the CAH had written policies, procedures, and systems in place regarding the provision of hemodialysis services for the CAH swing-bed in-patients
(Please refer to C271 and C273 for further information and findings regarding the provision of dialysis services and the services furnished through arrangement or agreement with Outpatient Dialysis Facility A.)

3. Interview on 11/10/10 at 12:25 PM with the CEO showed the CAH should have a contract/agreement with the chronic outpatient hemodialysis facility that addressed the provision of care regarding communication, integration and coordination of patient care for swing-bed patients receiving dialysis treatments from Outpatient Dialysis Facility A. In addition, during the interview, the CEO acknowledged the CAH should have written policies, procedures, and systems in place regarding the provision of hemodialysis services for the CAH swing-bed in-patients.

Based on review of contracts/agreements, medical records, observation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the entity that provided hemodialysis treatments and services to the swing-bed in-patients of the CAH, Outpatient Dialysis Facility A, had systems place to ensure that Outpatient Dialysis Facility A met all the applicable conditions of participation and standards for contracted services.

Failure of a service furnished through a contact/agreement to meet all applicable conditions of participation and standards for contracted services could potentially result in a patient receiving less than optimal care or failure to provide the patient with the care and services needed resulting in patient harm, illness, or even patient death.

The CAH administrative staff reported a swing-bed in-patient census of 2 and reported that these current swing-bed in-patients were not receiving dialysis services from Outpatient Dialysis Facility A at the time of the survey. The CAH had 2 swing-bed patients (Patient D1 and D2) in the last 12 months who received dialysis services from Outpatient Dialysis Facility A, while the patients were swing-bed in-patients of the CAH.

Findings include:

1. The CAH lacked a contract/agreement specific for the CAH and Outpatient Dialysis Facility A that would assure Outpatient Dialysis Facility A would provide services for the CAH swing-bed in-patients in a manner that ensured the CAH maintained compliance with all applicable Conditions of Participation. CAH staff failed to establish written policies and procedures for the provision of hemodialysis services provided by Outpatient Dialysis Facility A to the swing-bed in-patients of the CAH. (Please refer to C271 for further information regarding the specific findings for the lack of policies and procedures. Please refer to C285 for further information regarding the lack of a contract/agreement with Outpatient Dialysis Facility A.)

2. Interview on 11/10/10 at 12:15 PM with the Medical Surgical Nurse Manager and at 12:25 PM with the CEO (Chief Executive Officer) verified the lack of written policies, procedures and a contract/agreement that addressed the provision of hemodialysis services provided by Outpatient Dialysis Facility A to the swing-bed in-patients of the CAH.

Based on review of medical records, observation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure accessibility and communication of the medical record information and patient information for the CAH swing-bed in-patient, such as current lab results, medications, doctor orders, treatments, nursing notes, progress notes, assessments, and patient condition or change in status, between the CAH and the outpatient hemodialysis facility providing care to the CAH swing-bed in-patients, Outpatient Dialysis Facility A. In addition, the CAH administrative staff failed to ensure accurate and complete documentation regarding patient care and services, the patient intake and output, and communication that occurred between the CAH staff and the staff of Outpatient Dialysis Facility A regarding the patient.

Failure to ensure access and communication between the CAH and Outpatient Dialysis Facility A regarding medical record and patient information could result in over-treatment of the patient condition or of the facilities not providing the care and services needed to treat the patient which could cause severe patient harm and even patient death. The lack of accurate and complete documentation could potentially result in the lack of continuity of care or failure of the staff to identify a concern or change in condition which could result in failure to provide the care and services needed for the patient and negative outcomes for the patient including patient harm and even patient death.

Accurate intake and output is important for dialysis patients whose kidneys have failed because the kidneys can no longer remove excess fluids and wastes from the body. Accurate intake and output documentation assists in evaluation of the patient condition in the provision of care and services needed for the patient's well-being. Failure to monitor intake and output could potentially result in the failure to identify a concern or problem with the patient and failure of the staff to provide the care and services needed for the patient's well-being.

The CAH administrative staff reported a swing-bed in-patient census of 2 and reported that these current swing-bed in-patients were not receiving dialysis services from Outpatient Dialysis Facility A at the time of the survey. The CAH had 2 swing-bed patients (Patient D1 and D2) in the last 12 months who received dialysis services from Outpatient Dialysis Facility A, while the patients were swing-bed in-patients of the CAH.

Findings for 2 of 2 closed medical records reviewed (Patient D1 and D2) include:

1. During an interview on 11/9/10 at 8:40 AM, the Medical Surgical Nurse Manager reported the CAH did not have provisions for providing hemodialysis services to acute care patients. However, further interview with the Medical Surgical Nurse Manager revealed patients admitted to the CAH swing-bed if needed received outpatient hemodialysis services from Outpatient Dialysis Facility A, a separately certified chronic outpatient hemodialysis facility located at the CAH. Observation on 11/8/10 at 4:30 PM and interview with the Medical Surgical Nurse Manager on 11/9/10 at 8:40 AM showed Outpatient Dialysis Facility A was located on the first floor of the CAH and that CAH staff, usually nurses, transported the swing-bed in-patient to and from the dialysis facility for the patient's hemodialysis treatment.

2. Interview on 11/9/10 at 8:40 AM with the Medical Surgical Nurse Manager showed each facility, the CAH and Outpatient Dialysis Facility A, maintained separate medical records for the care and services provided by each facility for the CAH swing-bed patient. During the interview, the Medical Surgical Nurse Manager reported Outpatient Dialysis Facility A was considered a different facility and that the CAH and Outpatient Dialysis Facility A did not routinely review the medical record documentation from the other facility. The interview with the Medical Surgical Nurse Manager revealed the CAH did not incorporate, into the CAH patient medical record, documentation from Outpatient Dialysis Facility A such as the dialysis flow sheets (documentation completed by the dialysis facility for each patient hemodialysis treatment), laboratory report results, progress notes, medications administered, and doctor orders. Interview on 11/10/10 at 11:50 AM with Outpatient Dialysis Facility A RN (registered nurse) DB and DC showed Outpatient Dialysis Facility A had an interdisciplinary team caring for the patient which included a physician, registered nurse, dietitian, and social worker.

Interview on 11/9/10 at 8:40 AM and 11:05 AM with the Medical Surgical Nurse Manager and on 11/10/10 at 11:50 AM with Outpatient Dialysis Facility A RN DB and DC showed the CAH staff and Outpatient Dialysis Facility A staff did not routinely provide documentation to each other regarding treatments and medications administered at each facility or doctor orders and lab results obtained at each facility. Interview on 11/9/10 at 11:05 AM with the Medical Surgical Nurse Manager showed the CAH do not send the patient CAH medical record, documentation of the medications administered, or documentation of lab reports to Outpatient Dialysis Facility A and that Outpatient Dialysis Facility A did not routinely send the dialysis flow sheets, medications administered during treatment, or documentation of the lab report results to the CAH. Interview with the Medical Surgical Nurse Manager showed the Medical Surgical Nurse Manager thought that if the CAH staff wanted to review the Outpatient Dialysis Facility A patient medical record, for a CAH swing-bed in-patient receiving dialysis at Outpatient Dialysis Facility A, the CAH staff would need to complete a medical record request to review the record because Outpatient Dialysis Facility A was considered a different facility.

3. Interview on 11/9/10 at 8:40 AM with the Medical Surgical Nurse Manager showed communication regarding the patient occurred between the CAH staff and the dialysis facility staff through a verbal report when the CAH staff, usually nurses, transported the patients to and from the dialysis facility and/or through communication by phone if needed. Interview on 11/9/10 at 8:40 AM and at 11:05 AM with the Medical Surgical Nurse Manager showed the verbal reports between the staff of the CAH and staff of Outpatient Dialysis Facility A included information such as a change in the patient condition or status, significant lab results, pertinent doctor orders, and intake and output regarding dialysis. However, the interviews with the Medical Surgical Nurse Manager showed the CAH staff did not always document the verbal reports between the CAH staff and the dialysis facility staff.

a. Review of the CAH medical record for Patient D1 showed Patient D1 had a swing-bed admission date of 9/21/10 and a discharge date of 10/11/10. Review of the physician orders in the CAH medical record, dated 9/21/10 to 10/11/10 on forms titled "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES," revealed the lack of a physician order for the patient to receive dialysis treatments while a swing-bed in-patient at the CAH. Patient D1's medical record contained documentation by the physician on forms titled "INPATIENT PROGRESS NOTE" and "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES," reviewed from 9/21/10 to 10/11/10, which showed Patient D1 received dialysis services during this time. An "INPATIENT PROGRESS NOTE" dated 10/4/10 included that Patient D1 was on dialysis 3 days a week.

i.) Review of documentation in the CAH patient medical record on the "Daily Nursing Assessment Flowsheet" showed Patient D1 was transported to dialysis or down to dialysis, back or returned from dialysis and/or in dialysis on 9/22/10, 9/24/10, 9/26/10, 9/29/10, 10/1/10, 10/4/10, 10/6/10, and 10/8/10 and discharged to dialysis on 10/11/10. Documentation on the "Daily Nursing Assessment Flowsheet" for the specified dates did not reflect communication or a report regarding the patient between the CAH and Outpatient Dialysis Facility A. Documentation on the "Daily Nursing Assessment Flowsheet" dated "9-24/25-10" did include "... Coumadin taken down to Dialysis for pt (patient) to swallow" with a staff signature. Documentation on the "Daily Nursing Assessment Flowsheet" dated "9-29/30-10" did include "... Coumadin 3 mg (milligrams) taken to pt in Dialysis" with a staff signature.

ii.) The physician orders on the form titled "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES" dated 9/21/10 for Patient D1 included in part, "... 1.5 l [liter] Fluid restriction..." However, review of documentation in the CAH medical record on forms titled "VITAL SIGNS/I [intake] & O [output] FLOW SHEET AND GRAPH," from 9/21/10 through 10/11/10 showed the documentation did not reflect the intake and output regarding the patient dialysis treatment.

b. Review of the CAH medical record for Patient D2 showed Patient D2 had a swing-bed admission date of 5/28/10 and a discharge date of 6/28/10. Review of the physician orders in the CAH medical record on forms titled "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES" showed a physician order dated 5/28/10 for dialysis treatments which included, "dialysis on T [Tuesday], Th [Thursday], Sat [Saturday] @ [at] 0610 [6:10 AM]."

i.) Review of documentation in the CAH patient medical record on the "Daily Nursing Assessment Flowsheet" did not reflect Patient D2 received a dialysis treatment on Saturday 5/29/10. Documentation on the forms "Daily Nursing Assessment Flowsheet" showed Patient D2 was transported/taken to dialysis or down to dialysis, back or returned from dialysis and/or in or at dialysis on Tuesday, Thursday, Saturday from 6/1/10 through 6/19/10. Documentation on the forms "Daily Nursing Assessment Flowsheet" then showed Patient D2 was transported/taken to dialysis or down to dialysis, back from dialysis and/or in dialysis on Monday, Wednesday, and Friday from 6/21/10 through 6/25/20. The CAH medical record contained 2 nursing narrative entries with the same date of 6/27-28/10 on the forms titled "Daily Nursing Assessment Flowsheet." Documentation on one "Daily Nursing Assessment Flowsheet" dated "6/27-28/10" included "1030 [10:30 AM] Walked [with] therapy to wc [wheelchair] to go to Dialysis ... pt taken to Dialysis... 1530 [3:30 PM], pt back from Dialysis..." Documentation on the forms "Daily Nursing Assessment Flowsheet" did not reflect communication or a report between the CAH and Outpatient Dialysis Facility A. In addition, review of the physician orders on the forms titled "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES" showed the lack of a physician order reflecting the change in dialysis treatments from Tuesday, Thursday, Saturday to Monday, Wednesday, Friday.

ii.) The physician orders on the form titled "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES" dated 5/28/10 for Patient D2 included fluid restriction with specific amounts of fluid included in the physician order. The CAH medical record contained a care plan titled "Excess Fluid Volume" which included in part, "... instruct patient regarding fluid restriction as appropriate 1250 ml [milliliter]/24 [hour]... Monitor intake and output closely." However, review of documentation in the medical record on forms titled "VITAL SIGNS/I & O FLOW SHEET AND GRAPH," from 5/28/10 through 6/28/10 showed the documentation did not reflect the intake and output related to the patient dialysis treatment.

4. During interview on 11/10/10 at 12:15 PM with the Medical Surgical Nurse Manager and at 12:25 PM with the CEO (Chief Executive Officer), the Medical Surgical Nurse Manager and the CEO acknowledged the findings and verified the facility failed to ensure accessibility and communication of the medical record information and patient information between the CAH for the swing-bed patient and Outpatient Dialysis Facility A. During the interview, the Medical Surgical Nurse Manager and the CEO verified the lack of access and communication could potentially result in patient harm or the patient not receiving the care and services needed.

Interview on 11/10/10 at 12:15 PM with the Medical Surgical Nurse Manager verified the findings regarding the intake and output documentation, the lack of a physician order for dialysis for Patient D1, and that documentation on the CAH flowsheets did not consistently show communication that occurred with Outpatient Dialysis Facility A's staff. Continued interview with the Medical Surgical Nurse Manager showed communication, including the patient's intake and output, occurred between the CAH staff and Outpatient Dialysis Facility A staff and that staff should document the communication, intake and output findings. In addition, interview with the Medical Surgical Nurse Manager showed the CAH swing-bed medical records should include an order for the patient to receive dialysis.

Based on review of medical records, observation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure an informed consent process and lacked an informed consent form for the CAH swing-bed in-patients that received dialysis treatments and services at a chronic outpatient hemodialysis facility, Outpatient Dialysis Facility A, while a swing-bed in-patient at the CAH.

Informed consent means the CAH gave the patient or patient representative the information, explanations, consequences, and options needed in order to consent to a procedure or treatment. Informed consent forms containing required information provide written evidence that the CAH informed the patient or the patient representative of the information, explanations, consequences, and options and that the patient or patient representative consented to the procedure or treatment. Failure to provide the patient with information needed to make an informed decision could potentially result in the patient receiving a treatment or procedure which the patient did not want or agree to which could cause the patient adverse physical and/or mental outcomes.

The CAH administrative staff reported a swing-bed in-patient census of 2 and reported that these current swing-bed in-patients were not receiving dialysis services from Outpatient Dialysis Facility A at the time of the survey. The CAH had 2 swing-bed patients (Patient D1 and D2) in the last 12 months who received dialysis services from Outpatient Dialysis Facility A, while the patients were swing-bed in-patients of the CAH.

Findings for 2 of 2 closed medical records reviewed (Patient D1 and D2) include:

1. During an interview on 11/9/10 at 8:40 AM, the Medical Surgical Nurse Manager reported the CAH did not have provisions for providing hemodialysis services to acute care patients. However, further interview with the Medical Surgical Nurse Manager revealed patients admitted to the CAH swing-bed if needed received outpatient hemodialysis services from Outpatient Dialysis Facility A, a separately certified chronic outpatient hemodialysis facility located at the CAH. Observation on 11/8/10 at 4:30 PM and interview with the Medical Surgical Nurse Manager on 11/9/10 at 8:40 AM showed Outpatient Dialysis Facility A was located on the first floor of the CAH and that CAH staff, usually nurses, transported the swing-bed in-patient to and from the dialysis facility for the patient's hemodialysis treatment.

2. Review of the medical records for Patient D1 and D2 showed the patients received dialysis at Outpatient Dialysis Facility A while the patients were swing-bed in-patients at the CAH. However, the medical records lacked a dated and signed informed consent form for the dialysis treatments.

a. Review of the CAH medical record for Patient D1 showed Patient D1 had a swing-bed admission date of 9/21/10 and a discharge date of 10/11/10. Review of documentation from 9/21/10 to 10/11/10 in the CAH medical record on forms titled "INPATIENT PROGRESS NOTE" and "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES" showed Patient D1 received dialysis services during this time. An "INPATIENT PROGRESS NOTE" dated 10/4/10 included that Patient D1 was on dialysis 3 days a week.

Review of documentation in the CAH patient medical record on the forms titled "Daily Nursing Assessment Flowsheet," dated 9/21/10 to 10/11/10, showed Patient D1 was transported to dialysis or down to dialysis, back or returned from dialysis and/or in dialysis on 8 of the 20 days and discharged to dialysis on 10/11/10.

The CAH swing-bed in-patient medical record lacked a dated and signed informed consent form for the dialysis treatments.

b. Review of the CAH medical record for Patient D2 showed Patient D2 had a swing-bed admission date of 5/28/10 and a discharge date of 6/28/10. Review of the physician orders in the CAH medical record on forms titled "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES" showed a physician order dated 5/28/10 for dialysis treatments 3 times a week.

Review of documentation in the CAH patient medical record on the forms titled "Daily Nursing Assessment Flowsheet," dated 5/28 to 6/28/10, showed Patient D2 was transported/taken to dialysis or down to dialysis, back or returned from dialysis and/or in or at dialysis on 13 of the 32 days.

The CAH swing-bed in-patient medical record lacked a dated and signed informed consent form for the dialysis treatments.

3. Interview on 11/9/10 at 8:40 AM with the Medical Surgical Nurse Manager revealed the CAH did not have a system in place regarding informed consent for the patient to receive dialysis treatments and services at Outpatient Dialysis Facility A. During the interview, the Medical Surgical Nurse Manager reported the CAH did not complete an informed consent form for the CAH swing-bed in-patients who received dialysis treatments from Outpatient Dialysis Facility A.

Interview on 11/10/10 at 12:15 PM with the Medical Surgical Nurse Manager and at 12:25 PM with the CEO (Chief Executive Officer) showed the CAH should have written policies and procedures in place addressing the provision of hemodialysis treatments and services for the CAH swing-bed in-patients.

Based on review of medical records, observation, and staff interview, the Critical Access Hospital (CAH) failed to ensure a system for incorporation into the medical record for the CAH swing-bed in-patient, the doctor's orders, reports of treatments and medications, nursing notes, progress notes, laboratory reports, assessments and other pertinent information from the chronic outpatient dialysis facility, Outpatient Dialysis Facility A, where CAH swing-bed patients received hemodialysis treatments. In addition, the CAH failed to ensure the CAH medical record for each swing-bed patient who received dialysis treatments at the chronic outpatient dialysis facility contained a doctor's order for the patient to receive dialysis treatments.

Failure to incorporate documentation into the CAH swing-bed medical record, for the care and services provided by the chronic outpatient dialysis facility to the CAH swing-bed in-patient, could potentially result in the CAH failing to provide the care and services needed for the patient and result in patient harm or even patient death. The lack of a physician order for the patient to receive dialysis treatments failed to ensure the patient received the dialysis treatment as ordered by the physician. Dialysis is a life-sustaining treatment which could cause severe patient illness and patient death if not provided at the frequency ordered by the physician.

The CAH administrative staff reported a swing-bed in-patient census of 2 and reported that these current swing-bed in-patients were not receiving dialysis services from Outpatient Dialysis Facility A at the time of the survey. The CAH had 2 swing-bed patients (Patient D1 and D2) in the last 12 months who received dialysis services from Outpatient Dialysis Facility A, while the patients were swing-bed in-patients of the CAH.

Findings for 2 of 2 closed medical records reviewed (Patient D1 and D2) include:

1. Interview on 11/9/10 at 8:40 AM with the Medical Surgical Nurse Manager showed the CAH did not have provisions for providing hemodialysis services to acute care patients. However, further interview with the Medical Surgical Nurse Manager revealed patients admitted to the CAH swing-bed if needed received outpatient hemodialysis services from Outpatient Dialysis Facility A, a separately certified chronic outpatient hemodialysis facility located at the CAH. Observation on 11/8/10 at 4:30 PM and interview with the Medical Surgical Nurse Manager on 11/9/10 at 8:40 AM showed Outpatient Dialysis Facility A was located on the first floor of the CAH and that CAH staff, usually nurses, transported the swing-bed in-patient to and from the dialysis facility for the patient's hemodialysis treatment.

2. Interview on 11/9/10 at 8:40 AM with the Medical Surgical Nurse Manager revealed the CAH did not incorporate, into the CAH patient medical record, the documentation from Outpatient Dialysis Facility A, such as the dialysis flow sheets (documentation completed by the dialysis facility for each patient hemodialysis treatment), laboratory report results, progress notes, medications administered, and doctor orders.

Interview on 11/10/10 at 11:50 AM with Outpatient Dialysis Facility A RN (registered nurse) DB and DC showed Outpatient Dialysis Facility A had an interdisciplinary team caring for the patient that included a physician, registered nurse, dietitian, and social worker.

Interview on 11/9/10 at 8:40 AM with the Medical Surgical Nurse Manager showed communication regarding the patient occurred between the CAH staff and the dialysis facility staff through a verbal report when the nurses transported the patients to and from the dialysis facility and/or through communication by phone if needed. However, continued interview with the Medical Surgical Nurse Manager showed the CAH staff did not always document the verbal reports between the CAH staff and the dialysis facility staff.

3. Interview on 11/9/10 at 8:40 AM with the Medical Surgical Nurse Manager showed the physician for a swing-bed in-patient at the CAH wrote a general order for dialysis which did not include the dialysis prescription or orders for administration of medications or treatments in Outpatient Dialysis Facility A. During the interview, the Medical Surgical Nurse Manager reported the patient's physician at Outpatient Dialysis Facility A, a different physician than the CAH swing-bed in-patient physician, wrote orders specific for the dialysis treatment. Continued interview with the Medical Surgical Nurse Manager revealed Outpatient Dialysis Facility A obtained physician orders, from a physician of Outpatient Dialysis Facility A, for treatments and medications provided and labs obtained at Outpatient Dialysis Facility A and the CAH swing-bed staff did not receive the orders or incorporate these orders into the CAH swing-bed patient record.

4. Review of the medical records for Patients D1, with a swing-bed admission date of 9/21/10 and a discharge date of 10/11/10, and for Patient D2, with a swing-bed admission date of 5/28/10 and a discharge date of 6/28/10, showed the medical records lacked physician orders for the dialysis treatment prescription, medications administered at Outpatient Dialysis Facility A, and any treatments provided, progress notes, assessments, and/or laboratory report results from Outpatient Dialysis Facility A.

In addition, review of the physician orders for Patient D1, dated 9/21/10 to 10/11/10 on forms titled "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES" showed the lack of a physician order for the patient to receive dialysis treatments while a swing-bed in-patient at the CAH. Patient D1's medical record contained documentation by the physician on forms titled "INPATIENT PROGRESS NOTE" and "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES," reviewed from 9/21/10 to 10/11/10, which showed Patient D1 received dialysis services during this time. An "INPATIENT PROGRESS NOTE" dated 10/4/10 included that Patient D1 was on dialysis 3 days a week. The medical record for Patient D2 contained a physician order dated 5/28/10 on the form titled "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES" for the dialysis treatments which included, "dialysis on T [Tuesday], Th [Thursday], Sat [Saturday] @ [at] 0610 [6:10 AM]."

5. Interview on 11/10/10 at 12:15 PM with the Medical Surgical Nurse Manager and with the CEO (Chief Executive Officer) at 12:25 PM verified the lack of integration and incorporation of the doctor's orders, reports of treatments and medications, nursing notes, progress notes, laboratory reports, assessments and other pertinent information from Outpatient Dialysis Facility A into the CAH swing-bed in-patient medical records. During the interview, the Medical Surgical Nurse Manager and the CEO verified the lack of integrating and incorporating the information could potentially result in patient harm. Interview on 11/10/10 at 12:15 PM with the Medical Surgical Nurse Manager verified the lack of a physician order in Patient D1's medical record and showed the medical record should have contained a physician order for dialysis.

Based on observation, policy/procedure review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the security of the patient's medical records in 2 of 8 areas with medical record storage. The CAH administrative staff reported a census of 17 patients.

Failure to secure a patient's medical record could potentially result in access to patient information by unauthorized users.

Findings include:

1. Observation, during a tour of the Purchasing Department on 11/09/10 at 10:10 AM, with the Facilities Director and Purchasing Manager, revealed 3 rows of open files with 5 shelves each and 20 feet long. The shelves contained radiology film jackets on 12 1/2 of 15 shelves. The radiology film jackets contained patient identification information and test results.

Failure to secure the medical records stored in the Purchasing Department allowed unauthorized access to patients ' protected health and personnel information.

During an interview on 11/8/10 at 10:10 AM, the Purchasing Manager stated, during the day the purchasing staff close the door when the department is empty. Purchasing staff lock the door at the close of business each day. The purchasing department cleans the department.

During an interview on 11/09/10 at 9:30 AM, with Director of Radiology, stated approximately 8,000 jackets containing patient films and reports are stored in purchasing and that the purchasing department staff lack involvement in patient care and lack authorization to access to the patient records.

2. During an observation and interview on 11/08/10 at 2:45 PM, the Laboratory Director, revealed 3, 4-drawer file cabinets and 10 drawers without a locking mechanism. The 10 drawers contained approximately 4000 laboratory results. The results contained patient identification information and test results. The laboratory is open 24 hours a day. When staff leave to draw blood during the 3-11 PM and 11-7 AM shifts the laboratory is unattended.

3. Review of the policy titled, "HIM (Health Information Management) Department Security", dated 6/1/08, on 10/09/10 stated in part. "...Policy: the policy of Shenandoah Medical Center to establish procedures for the physical security of health information."

Based on review of the Quality Improvement Plan, Quality Improvement activities, Governing Body Bylaws and Meeting minutes, and staff interviews, the Critical Access Hospital (CAH) quality improvement staff failed to ensure the Quality Improvement staff communicated and reported Quality Improvement activities for all patient care areas to the Board of Directors. The CAH administrative staff reported a census of 17 patients.

1. This determination was evidenced by:

a. The quality improvement staff failed to ensure an effective quality assurance program was in place. (Refer to C-336)

b. The CAH administrative staff failed to ensure the quality improvement staff communicated and reported Quality Improvement activities to the Board of Directors for all patient care areas. Additionally, the Quality Improvement staff failed to ensure appropriate evaluations occurred for all patient care services provided to patients of the CAH. (Refer to C-337)

2. The cumulative effect of these systemic failures and deficient practices resulted in the CAH's inability to ensure the evaluation of the services provided to the inpatients and outpatients of the CAH.

Based on review of the Quality Improvement Plan, Quality Improvement activities, Governing Body Bylaws and Meeting minutes, and staff interviews, the Critical Access Hospital (CAH) quality improvement staff failed to ensure an effective quality assurance program was in place. The CAH administrative staff failed to ensure the Quality Improvement staff communicated and reported Quality Improvement activities for all patient care areas to the Board of Directors. The Administrative staff failed to ensure the Quality Improvement staff evaluated all patient care services provided in the following areas. Anesthesia, contracted dialysis services provided to swing bed patients, Positron Emission Tomography (PET), and Magnetic Resonance Imaging (MRI) services. The CAH administrative staff reported a census of 17 patients.

Failure to ensure an effective quality assurance program was in place to evaluate ongoing monitoring and data collection for problem prevention, identification, and data analysis regarding all departmental quality assurance activities and provide full disclosure of the information derived through the quality assurance program to the Board of Directors resulted in the Board of Director's not having full access to the information. Failure to have access to the information resulted in Board's inability to evaluate the information and implement remedial action, if necessary, in respects to potential patient quality of care concerns.

Findings include:

1. Review of the "Quality/Performance Improvement and Customer Service Plan 2010" revealed in part. ". . . Objectives . . . Ensure communication and reporting among Quality Management personnel, Department Directors, Administration, Medical Staff, and Board of Directors. . . . The final authority to ensure that quality patient care is provided rests with the Board of Directors. By approval of this program, the Board of Directors authorizes the Administration and the Medical Staff to establish a quality/performance improvement program. . . Each Department Director is responsible for developing a Quality/Performance Improvement Report that identifies important aspects of care or functions and the process for monitoring them. . . The findings, conclusions, recommendations, actions taken to improve quality/performance, and the results of actions are documented and reported through established channels. . . Quality/Performance Improvement activities are reported to the Medical Staff Committee and Board of Directors on a quarterly basis. . . ."

2. The Quality Improvement Committee Meeting minutes from December 16, 2008 through September 22, 2010 lacked documentation of ongoing monitoring, conclusions, recommendations, actions taken to improve quality/performance for anesthesia, contracted dialysis services provided to swing bed patients, PET, and MRI services.

3. Review of the Board of Directors Bylaws, reviewed/revised 6/31/1998, revealed in part. ". . .Quality Assurance. Board Responsibility. The Board shall establish, maintain, support and exercise oversight of an ongoing quality assurance program that includes specific and effective review, evaluation and monitoring mechanisms to assess, preserve and improve the overall quality and efficiency of patient care in the hospital. . . ."

4. Review of the Board of Directors Meeting minutes from January 27, 2010 through September 27, 2010 showed the Quality Improvement staff presented quality "Dashboard" reports to the Board of Directors quarterly. The Dashboard reports included core measure results for Congestive Heart Failure, Community Acquired Pneumonia, Surgical Care (Hysterectomy & Colon Surgery), Acute MI - Inpatient, Acute MI - ER, Acute Coronary Syndrome, Medication Errors, Obstetrics, Falls Acute & Swing Bed, and Health Care Worker Safety. The Dashboard reports failed to include documentation that showed evaluation of each areas ongoing monitoring, conclusions, recommendations, and/or actions taken to improve quality/performance for all patient care areas.

5. During an interview on 10/10/10 at 2:30 PM, the Director of Quality and Risk Management stated the "Dashboard" reports go the the Board of Directors quarterly and the Dashboard reports do not include all patient care departments. The Director of Quality acknowledged the departmental reports in the quality improvement meeting minutes lacked documentation that showed ongoing monitoring and data collection for problem prevention, identification, and data analysis. The director of Quality further reported that the Quality Improvement Committee Meeting minutes do not go the the Board of Directors.

Based on review of the Quality Improvement Plan, Quality Improvement activities, and staff interview, the Critical Access Hospital (CAH) quality improvement staff failed to evaluate all patient care services provided for anesthesia, contracted dialysis services provided to swing bed patients, Positron Emission Tomography (PET), and Magnetic Resonance Imaging (MRI) services. The CAH administrative staff reported a census of 17 patients.

Failure to monitor and evaluate all patient care services for quality of care could potentially expose patients to inappropriate and/or substandard care.

Findings include:

1. Review of the "Quality/Performance Improvement and Customer Service Plan 2010" revealed in part. ". . . The hospital Administrator, by approval of this program plan, authorizes and directs all hospital departments, their directors, and their members to participate in the quality/performance improvement program. . . . Each Department Director is responsible for developing a Quality/Performance Improvement Report that identifies important aspects of care or functions and the process for monitoring them. . . The findings, conclusions, recommendations, actions taken to improve quality/performance, and the results of actions are documented and reported through established channels. . . ."

2. The Quality Improvement Committee Meeting minutes from December 16, 2008 through September 22, 2010 lacked documentation that showed the Quality Improvement staff evaluated services provided to CAH patients through ongoing monitoring, conclusions, recommendations, and actions taken to improve quality/performance for the following areas. Anesthesia, contracted dialysis services provided to swing bed patients, PET, and MRI services.

3. During an interview on 11/10/10 at 2:30 PM, the Director of Quality and Risk Management acknowledged the lack of participation in the quality improvement process to include ongoing monitoring, conclusions, recommendations, actions taken to improve quality/performance for anesthesia, contracted dialysis services provided to swing bed patients, PET, and MRI services.

Based on review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to include all practitioners that provided care and services to the CAH patients, in their external peer review process for 10 of 10 applicable practitioners. (Practitioners A, B, C, D, E, F, G, H, I, J) The CAH reported a census of 17 patients.

Failure to ensure an external entity evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors at the CAH could potentially result in medical staff members misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of policy/procedure titled, "Credentialing Peer Review", dated 2/27/10, revealed in part. ". . .Shenandoah Medical Center (SMC) shall work cooperatively with Alegent Health Critical Access Hospital Network to establish and provide a collaborative approach for SMC to objectively and systematically monitor and evaluate the appropriateness of diagnosis and treatment, quality of patient care, and clinical outcomes. The quality monitoring data shall be utilized as one of the aspects of the credentialing process for physicians and independent licensed practitioners. . . . Results of peer review will be considered at the end of each physician's probationary period and prior to reappointment to the Medical Staff. . . ."

2. Review of peer review documentation for the past credentialing period of 2 years revealed the CAH staff failed to include all Practitioners (Practitioners A, B, C, D, E, F, G, H, I, J) in the CAH's external peer review process.

3. During an interview on 11/10/10 at 9:50 AM, the Director of Quality acknowledged the CAH quality staff failed to send out records of patients cared by Practitioners A, B, C, D, E, F, G, H, I, J for external peer review for the last credentialing period. The Director of Quality verified Practitioners A, B, C, D, E, F, G, H, I, J had provided services to patients of the CAH during the last credentialing period.

Based on medical record review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the care plan, for a patient receiving hemodialysis services, included a frequency for monitoring the patient's weight based on the patient's individualized needs.

Monitoring weight is in indication of food and fluid intake and output. A patient with end-stage renal (kidney) disease has kidneys that can no longer remove excess fluids and wastes from the body. Monitoring the patient's weight daily assists in evaluation of the patient condition in the provision of care and services needed for the patient's well-being. Failure to obtain a daily weight could potentially result in the facility's failure to identify an excessive weight gain and excess fluid in the patient's body which can cause, for example, shortness of breath, difficulty breathing, swelling of the eyelids, ankles, feet, hands, abdomen, or lower back.

The CAH administrative staff reported a swing-bed in-patient census of 2 and reported that these current swing-bed in-patients were not receiving dialysis treatments and services from a chronic outpatient hemodialysis facility, Outpatient Dialysis Facility A, at the time of the survey. The CAH had 2 swing-bed patients (Patient D1 and D2) in the last 12 months who received dialysis services from Outpatient Dialysis Facility A, while the patients were swing-bed in-patients of the CAH.

Findings for 1 of 2 closed medical records reviewed (Patient D1) include:

1. During an interview on 11/9/10 at 8:40 AM, the Medical Surgical Nurse Manager reported the CAH did not have provisions for providing hemodialysis services to acute care patients. However, further interview with the Medical Surgical Nurse Manager revealed patients admitted to the CAH swing-bed if needed received outpatient hemodialysis services from Outpatient Dialysis Facility A, a separately certified chronic outpatient hemodialysis facility located at the CAH.

2. Review of Patient D1's CAH medical record showed Patient D1 received dialysis at Outpatient Dialysis Facility A while the patient was a swing-bed in-patient at the CAH.

a. Review of the CAH medical record for Patient D1 showed Patient D1 had a swing-bed admission date of 9/21/10 and a discharge date of 10/11/10. The "DISCHARGE SUMMARY" dated 10/11/10 including the admitting and discharge diagnoses of end-stage renal disease on dialysis and multiple myeloma on oral chemotherapy. Review of documentation from 9/21/10 to 10/11/10 in the CAH medical record on forms titled "INPATIENT PROGRESS NOTE" and "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES" showed Patient D1 received dialysis services during this time. An "INPATIENT PROGRESS NOTE" dated 10/4/10 included that Patient D1 was on dialysis 3 days a week.

b. Patient D1 had a written plan of care titled "SMC (Shenandoah Medical Center) MULTIDISCIPLINARY CARE PLAN" dated 9/28/10 that included a "Needs/Problems" of nutrition at risk with interventions that included "monitor wt (weight)" and "monitor intake" with the disciplines of dietitian and nursing specified. In addition, a physician order on the form titled "PHYSICIAN'S ORDER SHEET AND PROGRESS NOTES" included "1.5 l (liter) Fluid restriction."

c. The CAH medical record contained forms titled "VITAL SIGNS/I (intake) & O (output) FLOW SHEET AND GRAPH" where CAH staff documented the patient's weight. Review of the "VITAL SIGNS/I & O FLOW SHEET GRAPH" revealed 2 dates with the patient's weight documented, the day of admission on 9/21/10 and on 10/6/10. The documented weights included 144 pounds on 9/21/10 and 136.4 per bedscale on 10/6/10.

3. During interview on 11/10/10 at 12:15 PM, the Medical Surgical Nurse Manager verified the medical record documentation and acknowledged that a patient receiving dialysis should have a weight documented every day.