HospitalInspections.org

Based on review of records, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH's Medical Staff approved the blood bank agreement. Staff L, Laboratory staff, reported the laboratory had 12 units of blood products available to CAH patients.

Failure to ensure a current, approved blood bank agreement was in place could potentially interrupt the availability of blood products needed for emergencies resulting in patient harm and/or death.

Findings include:

1. Review of the undated "Blood Bank Services Agreement between the American Red Cross . . . and Grape Community Hospital. . . .", signed by Staff J, CEO (Chief Executive Officer), with amendments to the contract signed by the CEO on 6/2l/2011, lacked approval by the CAH's Medical Staff.

2. During an interview on 12/28/11 at 11:26 AM, Staff A, Administrative Assistant, acknowledged the Blood Bank Agreement and Amendment lacked approval by the CAH's Medical Staff.

Based on observation, review of records and staff interview the CAH (Critical Access Hospital) staff failed to remove expired nutritional supplements from the kitchenette in the nursing care area and the dietary department to assure the supplements were not available for patient use. The CAH administrative staff identified a census of 5 patients.

Failure to remove expired nutritional supplement from the kitchenette in the nursing care area could potentially result in patients receiving expired nutritional supplements, which may not be safe for patients.

Findings include:

1. During tour of the nursing care kitchenette on 12/27/11 at 11:34 AM, observation revealed the following expired items:
a. 23 of 23 cans of Jevity 1.2 calorie (oral nutritional supplement) with an expiration date of 10/01/11
b. 15 of 15 cans of Two Cal HN (oral nutritional supplement) with an expiration date of 03/01/11
c. 1 of 1 can of PulmoCort (oral nutritional supplement) with an expiration date of 12/01/11.

2. Review of CAH policy titled, "Outdates/Expiration-Materials Management Storage", dated 1/01/11, stated in part ". . . Materials Management department is responsible for monitoring outdates expiration dates of items within the storage areas monitored by this department. . . Each item having an outdate will be listed by our inventory number and by item description. . . ."

Review of the "Nursing Area Supplies Monthly Inventory Outdate Check", dated 9/29-11/30/11, lacked documentation that staff checked for outdated nutritional supplements.

3. During an interview on 12/27/11 at 11:34 AM, Staff G, Registered Nurse, verified the outdated supplies found in the nursing care area kitchenette. An additional interview at 1:48 PM, Staff F, Director of Purchasing, revealed the Materials Management staff are responsible for checking the outdates of various patient care supplies. The nutritional supplements were not included on the "Nursing Area Supplies Monthly Inventory Outdate Check" form.



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4. During the kitchen environment tour on 12/27/11 beginning at 11:05 AM, observation revealed 18 cans of Pulmocare (a liquid nutritional supplement for patients with lung disease) stored in the Hobart refrigerator (#12) and available for patient use, with an expiration date of 12/1/11.

Review of the policy titled, "Nutritional Services, General Responsiblities", dated 8/18/11, stated in part ". . .Materials Management provide tube feeding formulas to the pateint care units. . . ."

During an interview at the time of the tour, Staff D, Dietary Manager, reported staff are periodically reminded to check expiration dates and remove outdated product from storage areas, but confirmed a lack of a defined policy and/or procedure for the task.

Based on observation, document review and staff interview the Critical Access Hospital (CAH) administrative staff failed to ensure an emergency fuel arrangement was in place. The CAH had a census of 5 patients.

Failure to have a system in place to provide for emergency fuel needs could potentially result in the compromise of patient safety during the loss of power.

During the CAH environment tour on 12/28/11 beginning at 8:00 AM, Staff C, Chief Engineer, reported the facility had written agreements for an emergency fuel and water supply. Staff C displayed the written agreements which lacked signatures by the contracted parties.

In an interview on 12/29/11 at 1:10 PM, Staff C located a signed agreement for emergency water but confirmed the CAH lacked a signed agreement for emergency fuel.

Review of a document titled "Fuel Oil Agreement", with an effective date of 10/09 revealed an agreement between the CAH and Holt Gas Company, Inc for fuel oil to use in the emergency generator and heating boilers. The document lacked a signature from the representative of the gas company.

Based on review of policies/procedures, documentation, patient medical records, physician and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the Medical Staff had a system in place to monitor policies governing the appointment process to the medical staff, including peer review, to ensure quality of health care for patients.

The Administrative Assistant identified 84 medical staff members (Active - 4; Consulting - 73; Associate - 7).

This determination was evidenced by:

The Board of Directors failed to ensure the Medical Staff followed their bylaws that required all physicians/practitioners that ordered or provided services at the CAH be privileged to provide those services. (Refer to 241)

The CAH administrative staff failed to ensure the Medical Staff and Board of Directors granted and approved physician privileges for the patient care procedures performed at the CAH. (Refer to C 241)

The CAH administrative staff failed to ensure physicians received peer review by an outside entity prior to reappointment. (Refer to C 340)

The Board of Directors failed to enforce the Medical Staff Bylaws to ensure the Medical Staff followed their bylaws regarding Reference Physicians. (Refer to 241)

The Board of Directors failed to ensure the Medical Staff evaluated current professional competency of its members prior to reappointment. (Refer to C 241)

The cumulative effect of these systemic failures and deficient practices resulted in the CAH's inability to review and evaluate the quality of care provided by its medical staff.

I. Based on review of the Operating Room (OR) privilege list, documentation, Medical Staff Bylaws, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 1 orthopedic surgeon selected for review had privileges to provide surgical patient care services performed at the CAH.

The CAH administrative staff identified Physician A performed 12 arthroscopic knee surgeries from 4/8/11 to 12/29/11.

Failure to delineate privileges could potentially result in a physician performing a procedure the Board of Trustees had not authorized them to perform, potentially resulting in harm to a patient.

Findings include:

1. Review of Physician A's Delineation of Privileges Form located in the OR revealed an effective date 12/14/10. The Orthopedic Surgery Privilege List failed to document that Physician A could perform arthroscopic knee surgeries at the CAH.

2. Review of the OR log from 4/8/10 to 12/29/11 showed Physician A completed 12 arthroscopic knee surgeries for patients at the CAH.

3. Review of the Medical Staff Bylaws, dated 9/1/2011, stated in part, "Every practitioner providing clinical services at virtue of Medical Staff membership or otherwise, shall be entitled to exercise only those clinical privileges . . . specifically granted to him by the Board. . . ."

4. During an interview on 12/29/11 at 10:15 A.M., Staff A, Administrative Assistant, stated Physician A provided arthroscopic knee surgeries for patients at the CAH without current privileges to provide this type of surgery. Staff A said the CAH called Physician A's office and the office staff could not provide documentation for Physician A to perform arthroscopic knee surgeries.

5. During an interview on 12/29/11 at 10:40 A.M., Staff B, Surgery Manager stated Physician A performed arthroscopic knee surgeries without current privileges to perform the surgeries. The CAH only had one physician that performed arthroscopic knee surgeries, Physician A.


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II. Based on review of the Critical Access Hospital (CAH) documents and staff interviews, the Board of Directors failed to ensure the medical staff reviewed the required peer review by the Network Hospital before recommending 5 of 16 physicians for reappointment. (Physicians R, S, Q, T, U)

Failure of the medical staff to review the required peer review by the Network Hospital before recommendation to the Board of Directors could potentially result in the medical staff recommending a physician for reappointment that had provided inadequate or inappropriate care to patients at the CAH.

Findings include:

1. Review of the Medical Staff Bylaws, dated 9/1/2011, stated in part, ". . .Each applicant for appointment to the Medical Staff must, at the time of application and initial appointment and thereafter, demonstrate to the satisfaction of the appropriate authorities of the Medical Staff, subject to final review and decision by the Board, the following qualifications and any additional qualifications and procedural requirements as are set forth in other provisions of these Bylaws or in defined Hospital policies or plans. . . ."

2. Review of CAH policy/procedure titled "Physician External Peer Review", dated revised 1/24/2011, stated in part, ". . .George C. Grape Community Hospital is a Critical Access Hospital (CAH) and, as such, participates in an external network peer review process in accordance with Critical Access Hospital guidelines. . . These external peer reviews must be completed prior to the consideration of the physician's reappointment. Reappointment may not be finalized until the external peer review is completed and available to the medical staff and Board of Directors for review and consideration. . . ."

3. During an interview on 1/3/12 at 3:10 PM, Staff A, Administrative Assistant, acknowledged the lack of documented evidence that showed an evaluation of the quality and appropriateness of the diagnosis and treatment they furnished to CAH patients had occurred by the Network Hospital at or before the time of reappointment for Physicians R, S, Q, T, and U.

4. During an interview on 1/4/12 at 8:45 AM, Physician O stated the Medical Staff review peer information, performed by the Network Hospital, at the time of reappointment of Physicians. Physician O also stated that if the peer review information, performed by the Network Hospital, is not available at the time of reappointment, the administrative staff need to flag the credential file that the peer review by the Network Hospital is pending.

5. During an interview on 1/4/11 at 10:40 AM, Staff J, Chief Executive Officer, stated the Medical Staff review the peer information performed by the Network Hospital at the time of reappointment of Physicians. Staff J acknowledged the CAH's 'External Peer Review' policy required the completion of a Network Hospital physician peer review prior to the reappointment of physicians.

For additional information, refer to C-340


III. Based on document review and staff interview, the Board of Directors failed to enforce Critical Access Hospital (CAH) policies and procedures to ensure the medical staff evaluated current professional competency of its members during the reappointment process for 5 of 21 medical staff members. (Physician/Practitioners R, V, W, X, Y)


The CAH administrative staff identified Physician R provided care to 1 in-patient and 529 out-patients during the previous 12 months.

The CAH administrative staff identified Physician V provided care to 3 in-patients and 201 out-patients during the previous 12 months.

The CAH administrative staff identified Practitioner W provided care to 918 out-patients during the previous 12 months.

The CAH administrative staff identified Practitioner X provided care to 3 in-patients and 306 out-patients during the previous 12 months.

The CAH administrative staff identified Physician Y provided care to 1 in-patient and 9 out-patients during the previous 12 months.


Failure of the medical staff to evaluate the professional competency of its members during the reappointment process could potentially result in physicians/practitioners providing care to CAH patients that could potentially expose patients to inappropriate care or misdiagnoses.

Findings include:

1. Review of the Medical Staff Bylaws, dated 9/1/2011, stated in part, ". . . The reappointment application form shall request all of the information and certifications requested in the appointment application form, as described in Section 6.2, except for that information which cannot change over time, such as information regarding the member's premedical and medical education, date of birth, and so forth. . . [Section 6.2(2)] The application shall require detailed information including, but not limited to: . . . Peer references familiar with the applicant's professional qualifications, professional competency and ethical character. . . ."

2. Review of the Board of Directors Bylaws, dated revised May 2000, stated in part, ". . . Authority of the Board of Directors: Each member of the Hospital Board, is legally and morally responsible for all activities of Hospital. . . . "

3. Review of medical staff credential files on 12/29/11 and 1/3/12 revealed the following:

a. Physician R's, Oncologist, credential file lacked documented evidence of current professional competency prior to the Medical Staff recommendation for reappointment to the Medical Staff on 12/12/11. Additionally, the Board of Directors approved the Medical Staff's recommendation of reappointment of Physician R on 12/15/11. The credential file revealed the completion of peer reference documentation that showed the evaluation of medical knowledge, technical and clinical skills, and clinical judgment for Physician R on 7/2/10.

The peer reference that was familiar with the applicant's professional qualifications, professional competency and ethical character for Physician R was not current.

b. Physician V's, Surgeon, credential file lacked documented evidence of current professional competency prior to the Medical Staff recommendation for reappointment to the Medical Staff on 1/10/11. Additionally, the Board of Directors approved the Medical Staff's recommendation of reappointment of Physician V on 1/24/11. The credential file revealed the completion of peer reference documentation that showed the evaluation of medical knowledge, technical and clinical skills, and clinical judgment for Physician V on 10/22/2008.

The peer reference that was familiar with the applicant's professional qualifications, professional competency and ethical character for Physician V was not current.

c. Practitioner W's, Advanced Registered Nurse Practitioner, credential file lacked documented evidence of current professional competency prior to the Medical Staff recommendation for reappointment to the Medical Staff on 6/13/11. Additionally, the Board of Directors approved the Medical Staff's recommendation of reappointment of Practitioner W on 6/23/11. The credential file revealed the completion of peer reference documentation that showed the evaluation of medical knowledge, technical and clinical skills, and clinical judgment for Practitioner W on 1/16/2006.

The peer reference that was familiar with the applicant's professional qualifications, professional competency and ethical character for Practitioner W was not current.

d. Practitioner X's, Certified Registered Nurse Anesthetist, credential file lacked documented evidence of current professional competency prior to the Medical Staff recommendation for reappointment to the Medical Staff on 11/22/10. Additionally, the Board of Directors approved the Medical Staff's recommendation of reappointment of Practitioner X on 12/14/10. The credential file revealed the completion of peer reference documentation that showed the evaluation of medical knowledge, technical and clinical skills, and clinical judgment for Practitioner X on 11/1/2006.

The peer reference that was familiar with the applicant's professional qualifications, professional competency and ethical character for Practitioner X was not current.

e. Physician Y's, Teleradiolgist, credential file lacked documented evidence of current professional competency prior to the Medical Staff recommendation for reappointment to the Medical Staff on 2/14/11. Additionally, the Board of Directors approved the Medical Staff's recommendation of reappointment of Physician Y on 3/28/11. The credential file revealed the completion of peer reference documentation that showed the evaluation of medical knowledge, technical and clinical skills, and clinical judgment for Physician Y on 7/8/2009 and 8/5/2009.

The peer reference that was familiar with the applicant's professional qualifications, professional competency and ethical character for Physician Y was not current.

4. During an interview on 12/29/11 at 10:05 AM, Staff A, Administrative Assistant, verified the lack of current peer reference documentation used to evaluate the competency and current knowledge for the care of the patients at the CAH during the reappointment process for Physician/Practitioners R, V, W, X, Y.

5. During an interview on 1/4/12 at 10:40 AM, Staff J, Chief Executive Officer, verified the Medical Staff Bylaws required the Medical Staff members to have current peer references familiar with the applicant's professional competency available for review at the time of reappointment of Medical Staff members by the Medical Staff and Board of Directors.


IV. Based on review of Medical Staff Bylaws, Board of Directors Bylaws, documentation, and staff interviews, the Board of Directors failed to enforce the Medical Staff Bylaws to ensure the Medical Staff followed their bylaws that required all physicians/practitioners that ordered tests or procedures for patients at the CAH be granted permission to provide those services for 13 of 13 Reference Practitioners reviewed. (Physicians B, C, D, E, F, G, H, I, J, K, M, N and Practitioner L)

The CAH administrative staff identified a list that contained 148 Reference Physician's names. Physicians B, C, D, E, F, G, H, I, J, K, M, N and Practitioner L were not included on the list of Reference Physicians.


Failure to follow policies/procedures for reference physicians at the CAH could potentially result in physicians/practitioners ordering tests or procedures for care to patients at the CAH that lacked the appropriate licensure, potentially exposing patients to inappropriate care.

Findings include:

1. Review of the Medical Staff Bylaws, dated 9/1/2011, stated in part, ". . . Reference Practitioners. Reference Practitioners are those practitioners who are granted limited permission to refer their patients to the Hospital for outpatient diagnostic tests or therapeutic procedures to be performed by Hospital personnel without any personal service performed by the Reference Practitioner. Reference Practitioners are those who do not wish to apply or who do not qualify for privileges. Reference Practitioners are not members of the Medical Staff and do not hold privileges. . . Reference Practitioners must cooperate with any verification process established by the Hospital or the Medical Staff including proof of licensure to order the test or therapeutic procedure requested. . . ."

2. Review of the Board of Directors Bylaws, revised May 2000, stated in part, ". . . Authority of the Board of Directors: Each member of the Hospital Board, is legally and morally responsible for all activities of Hospital. . . . "

3. Review of a list identified by the CAH administrative staff revealed a list that contained 148 Reference Physician's names. Physicians B, C, D, E, F, G, H, I, J, K, M, N and Practitioner L were not included on the list of Reference Physicians.

4. During an interview on 12/27/11 at 2:50 PM, Staff A, Administrative Assistant, stated the CAH administrative staff maintains a list of Reference Physicians. The Reference Physicians only order tests for patients at the CAH. Staff A verifies licensure and insurance on the Reference Physicians. The Reference Physician files then go to the Medical Staff and Board of Directors for approval. The Reference Physician files go to the Medical Staff and Board of Director for approval only one time. The Reference Physicians do not hold privileges at the CAH.

Upon further interview on 12/28/11 at 9:20 AM, Staff A stated the Medical Staff and Board of Directors do not review Reference Physician files every 2 years. The Medical Staff and Board of Directors review the credential files for physicians on the medical staff every 2 years. Staff A stated credentialing staff (Staff A and P) periodically only verify current licensure and insurance. Staff A also stated Reference Physicians are not required to have a license from the State of Iowa per the CAH's practice. Staff A stated credentialing staff maintains a list of Reference Physicians on the computer that is available to ancillary departments. If the ancillary departments do not find the name of a Reference Physician on the computer, staff notifies Staff A. Staff A then sends out an application to that physician inviting them to become a Reference Physician. Staff A stated the CAH honors/allows the physician's first request without any verification. In addition to the list of Reference Physicians, the administrative staff maintains three binders that contain Reference Physician information including letters sent to the Reference Physician, applications, verification of licensure and insurance.

5. Review of 12 of 12 (Patients # 1 - 12) outpatient orders from 12/2010 to 12/2011, for laboratory, physical therapy, and radiology revealed 12 of 12 physicians/practitioners (Physicians B, C, D, E, F, G, H, I, J, K, M, N and Practitioner L) ordered tests and therapy as follows:

On 11/23/11, Physician B ordered strength training and range of motion for Patient #1 with a diagnosis of neck dissection and muscle weakness.

On 11/4/11, Physician C ordered strength training to decrease pain and to increase ambulation for Patient #2 with a diagnosis of arthritis and plantar fasciitis.

On 12/21/11, Physician D ordered increase in soft tissue mobility to decrease pain and muscle spasm for Patient #3 with a diagnosis of neck pain and muscle spasm.

On 11/29/11, Practitioner E ordered strength training and soft tissue mobility to decrease pain for Patient #4 with a diagnosis of impingement syndrome right shoulder tendonitis.

On 12/14/11, Physician F ordered a bilateral mammogram and ultrasound for Patient #5 with a diagnosis of a right breast lump.

On 12/23/11, Physician G ordered a left mammogram screening for Patient #6 with a diagnosis of right breast cancer.

On 11/22/11, Physician H ordered an abdomen flat plate x-ray for Patient #7 with a diagnosis of epigastric/left upper quadrant abdomen pain for 1 month.

On 10/13/11, Physician I ordered an ultrasound of the abdomen for Patient #8 with a diagnosis of splenomegaly (enlargement of the spleen).

On 12/28/11, Physician J ordered a lipid profile (a group of blood tests used to determine the risk of coronary disease including cholesterol), thyroid profile, complete blood count and blood chemistry level (measurement of various component in the blood) for Patient #9 with a history of weight gain and fatigue.

On 12/2/11, Physician K ordered a complete blood count, ferritin level (measurement of blood iron), and a thyroid profile for Patient #10 with an unknown diagnosis.

On 12/24/10, Practitioner L ordered a standing order for INR (measurement of blood clotting time) for Patient #11 with a diagnosis of atrial fibrillation (abnormal beating of the heart). The Admission Summary Sheet dated 12/14/11 revealed Practitioner N as the attending physician.

On 12/26/11, Physician M ordered a blood chemistry level and a vancomycin level (measurement of an antibiotic in the blood) for Patient #12 with a diagnosis of anemia and long term use of vancomycin.

6. During an interview on 1/4/12 at 9:35 AM, Staff A, verified the list of Reference Physicians lacked the names for Physicians B, C, D, E, F, G, H, I, J, K, M, N and Practitioner L. Staff A verified the three binders lacked any information, including application, proof of licensure or insurance, for Physicians B, C, D, E, G, H, J, K, M, N and Practitioner L.

Staff A verified the 3-ring binders contained information for Physician F of an application dated 5/11/09; approval to order ancillary services on outpatients from the Medical Staff on 7/15/09 and Board of Directors 8/31/09; License with expiration date of October 1, 2010; Certificate of Liability with expiration date of 12/1/09; a letter dated 9/1/09 from the CAH that notified Physician F of their "appointment to Reference Medical Staff with privileges to order ancillary tests and rehabilitation".

Physician F last ordered tests for Patient #5 on 12/14/11.

Staff A verified the three binders contained information for Physician I of a letter dated 10/17/11 from the CAH that invited Physician ". . . to become a Reference Member of the Medical Staff. This membership will allow you to order laboratory, radiology, physical therapy, respiratory therapy, cardiac rehab and pulmonary rehab services at George C. Grape Community Hospital. We noticed that recently you ordered outpatient services for a patient of yours who lives in our community. Our intention is to honor the first request, but require the enclosed form to be completed and returned to us along with a copy of you current license and liability insurance certificate before a second request is received. This will allow our facility to perform a brief, but necessary credentialing process. . . ." The information also contained an on-line verification of licensure with license expiration date of 10/1/12. Staff A acknowledged the lack of any documented response from Physician I to the letter dated 10/17/11.

7. During an interview on 12/28/11 at 3:00 PM, Staff K, Radiology Supervisor, stated when the department received an order from a physician they do not know, they type into the computer the patient name, ordered test, and the physician name. If the physician name does not appear on the computer, the physician's office is called and order received by fax. The radiology staff sends the physician's name to the front office and is unsure what happens after that. Staff K stated once the physician's name is in the computer for previously ordering tests, that physician's name remains in the computer for further reference. When asked how the CAH staff knows if the physician's license to practice medicine is current, Staff K responded when the physician's office calls the department and a faxed order is received, the physician's name is on that order.

Upon further interview on 1/4/12 at 3:11 PM, Staff K, verified when an outside [reference] provider ordered an exam requiring immediate attention, the radiology staff notifies that provider. If the radiology staff could not reach the provider that ordered the test, the radiology staff would notify the patient's local provider or the Emergency Department provider. The radiology staff would follow the [reference] provider's order for the exam. If the patient complained of other signs/symptoms, the radiology staff would notify the [reference] provider that ordered the test. All tests are treated the same, radiology staff check for prior exams to ensure the patient is getting the correct treatment/tests for the diagnosis.

8. During an interview on 1/4/12 at 7:45 AM, Staff M, Physical Therapist (PT), revealed Physical Therapy accepts orders from outlying physicians (physicians not practicing at the hospital). Staff M stated PT does not check if the outlying physicians have privileges to practice at Grape Community Hospital. Most of the outlying physicians are from large orthopedic groups in [other large cities] and have referred their patients here for many years. Occasionally we will have an obscure outlying physician (a physician we do not know) order treatments for patients. The admitting office verifies the physician and the patient's insurance.

Upon further interview on 1/4/12 at 3:35 PM, Staff M, verified that when physical therapy staff received an inappropriate patient order for Physical Therapy from an outlying physician, the physical therapy staff would contact the outlying physician. If the outlying physician was not available, the physical therapy staff would notify the local physician/practitioner. The patient would provide information regarding the outlying physician such as the specialty of the physician, and if the prescribed treatment was appropriate for the patient's diagnosis.

9. During an interview on 1/4/12 at 8:10 AM, Staff N and O, admitting staff, stated they verify outlying physicians by checking on-line using the National Provider Data Base (NPDB). If the physician is found in the NPDB then information for the physician is forwarded to Staff A (credentialing staff). The admitting staff assigns all providers a number for billing purposes. The admitting office staff assigns at least one new number a week to a new physician.

10. During an interview on 1/4/12 at 9:30 AM, Staff L, Laboratory Technician, stated the patient enters the hospital with orders and the admitting department registers the patient. The admitting department assigns a number to the physician after the admitting staff verified that the physician is a licensed physician. Then admitting checks with Staff A, Administrative Assistant, to verify the physician is qualified as a Reference Physician. The laboratory staff calls the ordering physician to verify the patient order.

Upon further interview on 1/4/12 at 3:20 PM, Staff L verified when an outlying provider (reference physician) orders a laboratory test requiring immediate attention, the laboratory staff notifies the outlying physician. Laboratory staff records this information in the computer and a paper log. Laboratory staff follows the physician's orders for the exams and when a diagnosis is available, the laboratory staff assess if the exam is appropriate for the patient.


V. Based on review of policies/procedures, Medical Staff Bylaws, documentation, and staff interviews, the Board of Directors failed to ensure Quality Assurance/Quality Improvement (QA/QI) staff identified, monitored and corrected problems identified with the peer review, performed by the Network Hospital, process. Problems included, the medical staff failed to ensure the outside entity peer review occurred prior to reappointment.

Failure of the QA/QI staff to develop and implement plans to correct problems identified with the peer review, performed by an outside entity, process resulted in the Board of Directors inability to evaluate the information and implement remedial action, if necessary, in respect to appropriate review and reappraisal of the quality of care provided to patients.

Findings include:

1. Review of CAH policy/procedure "Quality Improvement Plan 2011", approved by the Board of Directors 1/24/11, revealed in part, ". . . Authority: The Board of Directors of George C. Grape Community Hospital is ultimately responsible for assuring that high quality care is provided to our patients. The Board delegates the responsibility for implementing this plan to the Medical Staff, the Quality Council, and the Administrative Council. . . ."

2. Review of the Board of Directors Bylaws, dated revised May 2000, stated in part, ". . . Authority of the Board of Directors: Each member of the Hospital Board, is legally and morally responsible for all activities of Hospital. . . Continuous Quality Improvement Program: The Board has ultimate responsibility for the Continuous Quality Improvement program and for the resolution of problems affecting patient care. The entire Board will receive monthly reports from the Continuous Quality Improvement Committee. . . ."

3. Review of the Medical Staff Bylaws, dated 9/1/2011, stated in part, ". . . Each applicant for appointment to the Medical Staff must, at the time of application and initial appointment and thereafter, demonstrate to the satisfaction of the appropriate authorities of the Medical Staff, subject to final review and decision by the Board, the following qualifications and any additional qualifications and procedural requirements as are set forth in other provisions of these Bylaws or in defined Hospital policies or plans. . . ."

4. Review of CAH policy/procedure titled "Physician External Peer Review", dated revised 1/24/2011, stated in part, ". . .George C. Grape Community Hospital is a Critical Access Hospital (CAH) and, as such, participates in an external network peer review process in accordance with Critical Access Hospital guidelines. . . These external peer reviews must be completed prior to the consideration of the physician's reappointment. Reappointment may not be finalized until the external peer review is completed and available to the medical staff and Board of Directors for review and consideration. . . ."

5. During an interview on 1/3/12 at 3:10 PM, Staff A, Administrative Assistant, acknowledged the lack of documented evidence that showed an evaluation of the quality and appropriateness of the diagnosis and treatment they furnished to CAH patients had occurred by the Network Hospital at the time of reappointment for Physicians R, S, Q, T, and U.

6. During an interview on 1/4/12 at 8:45 AM, Physician O stated the Medical Staff review the peer information, performed by the Network Hospital, at the time of reappointment of Physicians. Physician O also stated that if the peer review information from the Network Hospital is not available at the time of reappointment, the administrative staff need to flag the credential file that the peer review information from the Network Hospital is pending.

7. During an interview on 1/3/12 at 1:20 PM, Staff H, Quality, stated quality staff send charts of patients cared for by CAH physicians to the Network Hospital staff for an evaluation of the quality and appropriateness of the diagnosis and treatment furnished to CAH patients. Staff H acknowledged the lack of documented evidence that showed an evaluation of the quality and appropriateness of the diagnosis and treatment they furnished to CAH patients had occurred by the Network Hospital at the time of reappointment for Physicians R, S, Q, T, and U.

8. During an interview on 1/4/11 at 10:40 AM, Staff J, Chief Executive Officer, stated the Medical Staff review the peer review information performed by the Network Hospital at the time of reappointment of Physicians. Staff J acknowledged the CAH's 'External Peer Review' policy required the completion of an evaluation of the quality and appropriateness of diagnosis and treatment for all physicians prior to the reappointment of physicians.

For additional information, refer to C-340

Based on review of policies and procedures, Medical Staff minutes, and staff interviews, the Critical Access Hospital (CAH) failed to report a change in the person responsible for medical direction.

Failure to report a change in the person responsible for medical direction could potentially result in improper notification of the person responsible for medical direction.

Findings include:

1. Review of CAH policy/procedure titled "Changes in Operating Officials, Chief of Staff or Ownership", dated revised January 2010, stated in part, "Policy: Community Hospital Inc., dba George C. Grape Community Hospital, will report any changes in operating officials, Chief of Staff, or changes of ownership interest. . . Chief of Staff: The Administrator/C.E.O. will notify DIA for reporting changes in the Chief of Staff. The Chief of Staff is defined as the person responsible for medical direction of the Hospital. . . Standard Disclosure: The Department of Inspections and Appeals will be notified of these changes within 30 days or sooner in writing by a written memorandum signed by the Administrator/C.E.O. to the following address: Department of Inspections and Appeals (DIA). . . ."

2. Review of Medical Staff minutes, dated January 10, 2011, stated in part, "The election of Officers was held. [Physician O] presented a motion to recommend [Physician P], to Chief of Staff. [Physician Q] seconded the motion. Motion carried. . . ."

3. During an interview on 12/28/11 at 8:50 AM, Staff A, Administrative Assistant, stated they did not notify the Department of Inspections and Appeals of any change in Chief of Medical Staff when changed January 2011.

4. During an interview on 1/3/12 at 4:10 PM, Staff J, Chief Executive Officer, stated they did not send a letter to the Department of Inspections and Appeals when there was a change in Chief of Medical Staff in January 2011.

Based on policy review and staff interviews the Critical Access Hospital (CAH) administrative staff failed to ensure Employee Health and Human Resources policies and procedures were adequately reviewed and revised to avoid inconsistent statements. Administrative staff reported a census of 5 in-patients at the time of the survey.

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 consistency between employee health and human resources policies and procedures could potentially result in confusion for staff and failure to perform the expected practices in the required time period potentially resulting in negative outcomes to patients from exposure to communicable diseases.

Findings include:

1. Review of an Employee Health policy titled "Pre-Employment Requirements", last reviewed and approved in 1/2011, revealed in part "It is the policy of this organization to assess each employee's physical ability to perform the job applied for by performing a pre-employment physical examination and annual laboratory assessment each year on the employee's employment anniversary date . . . These physical examinations will contain the following items . . . PPD (Purified Protein Derivative is a diagnostic tool for tuberculosis) skin test or chest x-ray at the time of hire and on an annual basis . . . Physical exam by our physician or private physician . . . ".

2. Review of an Employee Health policy titled "Tuberculosis Screening Program", last reviewed and approved in 1/2011 revealed in part "It is the policy of this medical group to properly screen all employees for the presence of inactive or active Tuberculosis at the time of employment and at least every three years thereafter . . .".

3. Review of a Human Resources policy titled "Employee Health Program", last reviewed and approved in 9/2011 revealed in part " . . . It is the policy of George C. Grape Community Hospital (GCGCH) to assess the physical ability of each employee to perform the job applied for by performing a pre-employment physical examination with follow-up exams as designated below. These physical examinations will contain the following items . . . PPD skin test or chest x-ray at the time of hire and on a bi-annual basis; Physical exam by GCGCH Active Medical Staff Physician at time of hire and every 4 years thereafter . . . ".

4. During an interview on 12/28/11 at 1:30 PM, Staff E, Director of Human Resources, reported the CAH had previously required a tuberculosis test for all staff every 2 years, but made a change in practice last year, to every 3 years. In addition, Staff E reported a change at the same time, from the requirement for a physician to complete the employee health exams, and allow for the employee health nurse to complete the health exams.

5. During an interview on 12/29/11 at 9:20 AM, Staff B, Employee Health/Surgery Manager, confirmed a new employee health policy for tuberculosis screening was created at the end of last year, which changed the frequency from every 2 to every 3 years. Staff B further reported at the same time, the change was made to allow the employee health nurse to complete the employee health exams, rather than a physician. Staff B acknowledged the policies titled "Pre-Employment Requirements" and "Tuberculosis Screening Program" conflicted and appeared confusing. He/she attributed the failure to update the policies to an oversight,. Staff B verified the current CAH practice is to perform employee tuberculosis screening every 3 years and a physical exam by the employee health nurse, or the employees private physician, every 4 years.

6. During an interview on 12/29/11 at 10:25 AM, Staff E acknowledged the current Human Resources policy titled "Employee Health Program", and Employee Health policies titled "Tuberculosis Screening Program" and "Pre-Employment Requirements", conflicted with each other on tuberculosis screening and physical exams. Staff E verified the current CAH practice included employee tuberculosis screening every 3 years and a physical exam by the employee health nurse, or the employees private physician, every 4 years.

Based on observation, review of records and staff interview the CAH (Critical Access Hospital) pharmacy staff failed to remove expired stock medications from the acute care medication cart. The CAH administrative staff identified a census of 5 patients.

Failure to remove expired medications from the acute care stock could potentially result in dosing patients with expired medications, that potentially were ineffective placing the patient at risk.

Findings include:

1. An observation on 12/27/11 at 11:34 AM, during the tour of patient care area with Staff G, Registered Nurse, revealed the following expired stock medication in the acute care medication cart available for patient use:

a. 1 of 1 bottle, 1/2 empty, of oral Ibuprofen suspension (pain medication) 50 mg (milligram)/1.25 ml (milliliter) with expiration date of 3/11

b. 1 of 1 16 ounce bottle, 3/4 empty, of liquid suspension Potassium Chloride (mineral given to balance electrolytes) with expiration date of 7/11

c. 1 of 1 4 ounce bottle, 1/2 empty, of oral Acetaminophen suspension (pain medication) with expiration date of 6/11

d. 1 of 1 8 ounce bottle, 3/4 empty, of oral Diatrizoate Meglumine for GI (Gastro Intestinal) Bonding Iodine (for x-rays) with expiration date of 6/11.

2. Review of CAH policy titled, "Expired Medications", dated 8/2009, stated in part ". . . Outdated and/or unusable medications shall be removed and stored away from usable stock until proper disposition can be affected . . . Routine inspection of all medication storage areas are performed on a monthly basis by the pharmacist or designee and expired medications and medication that outdate in the upcoming month will be pulled from the shelf. . . ."

3. Review of "Medication Outdate Log", dated 2011, documented monthly checks of the nursing care floor medications by Staff I, Pharmacy Technician.

4. During an interview on 12/29/11, at 10:30 AM Staff I, Pharmacy Technician, verified they checked monthly for outdates on the nursing care unit. Staff I reported they have not been checking the stock medications found in the medication cart.

I. Based on document review, staff interview, and policy review, the Critical Access Hospital (CAH) failed to ensure that surgery staff followed manufacturers' instructions for the use of a hospital approved disinfectant product (Rapicide) when cleaning patient care equipment (endoscopy scopes) in the Operating Room (OR). The CAH administrative staff reported the CAH completes an average of 5 endoscopic procedures a week in the OR.

Failure to use disinfectant products as directed by the manufacturer potentially puts patients at risk for exposure to infections and blood borne pathogens.

Findings include:

1. Review of the manufacturers' product insert for Rapicide, provided by Staff B, Surgery Supervisor, revealed in part ". . .4. Monitoring of Germicide to Ensure Specifications Are Met: During the usage of RAPICIDE High-Level Disinfectant and Sterilant as a high-level disinfectant or sterilant, it is recommended RAPICIDE High-Level Disinfectant and Sterilant be tested with Medivators Rapicide Glutaraldehyde Indicator Test Strips, (ML02-0120), chemical indicator strips prior to each reprocessing cycle. This is to ensure that the appropriate concentration of glutaraldehyde is present to guard against dilution and polymerization that lower the effectiveness of the solution below its MRC. . . ."

2. Review of the CAH document, "Endoscope reprocessing the way it should be, Medivators" revealed staff tested the water flow, air flow, HLD level and temperature one time a shift when providing endoscopic procedures for patients in the OR.

3. Review of the CAH document scope cleaning record, showed the CAH surgery staff performed endoscopic procedures for more than one patient each day endoscopy procedures were performed. The CAH surgery staff failed to document testing of the Medivator solution when cleaning the endoscopes between patients.

4. During an interview on 12/27/11 at 2:30 PM, Staff B, Surgery Manager, stated the OR staff were not testing the Rapicide solution when cleaning endoscopes between patients. Staff B said the OR staff do provide more than one endoscopic test for patients most days this procedure is done in the OR. The OR staff are not testing the Rapicide disinfectant between patients as specified in the manufactures' instructions. Staff B said the CAH does not have a current policy for use of the Rapicide, but are in the process of completing this policy.


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II. Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to follow established policies and procedures when completing required employee health exams for 7 of 15 employee records reviewed.

Written policies and procedures provide guidance and consistency among staff and serves as a resource for staff in the provision of care. Failure to follow established Employee Health policies and procedures could potentially cause harm to patients through exposure of communicable diseases.

Findings include:

1. Review of an Employee Health policy titled, "Pre-Employment Requirements", last reviewed and approved 1/2011, revealed in part ". . . It is the policy of this organization to assess each employee's physical ability . . . Physical exam by our physician or private physician . . . ."

2. Review of a Human Resources policy titled, "Employee Health Program", last reviewed and approved 9/2011, revealed in part ". . .It is the policy of George C. Grape Community Hospital (GCGCH) to assess the physical ability of each employee . . . Physical exam by GCGCH Active Medical Staff Physician . . . Employee may choose to go to their own physician . . . ."

3. Review of employee health files on 12/28/11 revealed 7 of 15 employee health exams were completed by a registered nurse or licensed practical nurse.

4. During an interview on 12/28/11 at 1:30 PM, Staff E, Director of Human Resources, reported the CAH changed the requirement for a physician to complete the employee health exam last year and now allow the employee health nurse to complete the exam. Staff E acknowledged the CAH staff failed to update the Human Resources policy to reflect the change in practice.

5. During an interview on 12/29/11 at 9:20 AM, Staff B, Employee Health/Surgery Manager, reported at the end of last year, the CAH changed the practice to allow the employee health nurse to complete the employee health exams, rather than a physician. Staff B acknowledged the CAH staff failed to update the Employee Health policy to reflect the change in practice.


III. Based on observation, document review and staff interview the Critical Access Hospital (CAH) administrative staff failed to establish a system for routine cleaning of an ice machine utilized for ice in patient beverages. The administrative staff reported a census of 5 swing-bed patients and the Dietary Manager reported an average of 27 patient meals served daily.

Failure to perform regular cleaning of an ice machine could potentially result in contamination of patient beverages.

Findings include:

1. During an interview on 12/28/11 at 8:50 AM, Staff D, Dietary Manager, reported the utilization of the Hoshizaki ice machine, located in the cafeteria, for patient beverages. Staff D further reported dietary staff was responsible to clean the outside of the Hoshizaki ice machine but do not empty and clean the inside of the ice machine.

2. During an interview on 12/28/11 at 10:05 AM, Staff C, Chief Engineer, reported maintenance staff do not empty and clean the inside of the ice machine. Staff C confirmed the manufacturer's recommendations included annual cleaning. Staff C reported the assignment of annual cleaning of the ice to maintenance personnel as a routine task. In a follow-up interview on 12/28/11 at 2:30 PM, Staff C provided a copy of the ice machine instruction manual, to verify manufacturer's recommendations, and estimated the age of the ice machine to be at least 5 years old.

3. Review of pages 17-19 of the instruction manual for the Hoshizaki ice machine revealed in part " . . . 1. Cleaning instructions. Warning - 1. Hoshizaki recommends cleaning this unit at least once a year. . . ." The remainder of the material provided instructions to remove all ice and proceeded with instructions for cleaning and sanitizing.

Based on review of Critical Access Hospital (CAH) documentation, policies/procedures, and staff interviews, the CAH administrative staff failed to ensure an effective quality assurance program was in place to identify and correct problems with the peer review, performed by the Network Hospital, process. Additionally, the quality staff failed to implement quality assurance policies and procedures to ensure the evaluation of all patient care services including documentation of any remedial actions taken for 11 of 16 hospital departments.

This determination was evidenced by:

The CAH administrative staff failed to provide full disclosure of the information derived from the peer review, performed by the Network Hospital, process in their total program evaluation. (Refer to C-331)

The CAH administrative staff failed to ensure the periodic evaluation of its total CAH program included the services of Reference Physicians. (Refer to C-332)

The CAH administrative staff failed to ensure the periodic evaluation of its total CAH program included the evaluation of the appropriateness of Reference Physician services. (Refer to C-335)

The CAH quality staff failed to ensure the quality improvement program included activities for all patient care services to the Governing Board. (C-336)

The CAH quality and administrative staff failed to ensure an effective quality assurance program was in place to identify and correct problems with the peer review, performed by the Network Hospital, process. (Refer to C-336)

The CAH quality and administrative staff failed to ensure the evaluation of all contracted patient care services. (Refer to C-337)

The Board of Directors failed to ensure a peer review, performed by the Network Hospital, occurred before the Medical Staff recommended physician's reappointment. (Refer to C-340)

The CAH quality staff failed to document the outcomes of remedial actions taken through the quality improvement program. (Refer to C-343)

The Board of Directors failed to ensure the Medical Staff followed their bylaws that required all physicians/practitioners that ordered tests or procedures for patients at the CAH be granted permission to provide those services. (Refer to C-241 IV)

The cumulative effect of these systemic failures and deficient practices resulted in the CAH's inability to review and evaluate the quality of care provided to patients in a safe environment.

Based on review of policies/procedures, Annual Program Evaluation, documentation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to provide full disclosure of the information derived from the peer review, performed by the Network Hospital, process in their total program evaluation.

Failure to include the peer review, performed by the Network Hospital, process and provide full disclosure of the information derived from the annual program evaluation to the Board of Directors could result in the Board of Directors lack of access to the information. Failure to have access to the information could result in the Board's inability to evaluate the information and implement remedial action, if necessary, in respect to appropriate review and reappraisal of the quality of care provided to patients at the CAH.

Findings include:

1. Review of the "George C. Grape Community Hospital Annual Program Evaluation FY 2010", signed by Staff J, Chief Executive Officer (CEO), stated in part, ". . . George C. Grape Community Hospital does participate with [Network Hospital] Critical Access Hospital Network in external peer review. . . ."

The total program evaluation lacked documentation of information derived from the peer review, performed by the Network Hospital, process to include evaluation of the quality and appropriateness of diagnosis and treatment for all physicians providing services at the CAH.

2. Review of CAH policy/procedure titled "Physician External Peer Review", dated revised 1/24/2011, stated in part, ". . .George C. Grape Community Hospital is a Critical Access Hospital (CAH) and, as such, participates in an external network peer review process in accordance with Critical Access Hospital guidelines. . . George C. Grape Community Hospital has established a comprehensive peer review plan that incorporates external review of clinical records to evaluate the quality and appropriateness of diagnosis and treatment for all physicians providing services at GCGCH. . . These external peer reviews must be completed prior to the consideration of the physician's reappointment. Reappointment may not be finalized until the external peer review is completed and available to the medical staff and Board of Directors for review and consideration. . . ."

3. Review of the Board of Directors' Bylaws, dated revised May 2000, stated in part, ". . . Authority of the Board of Directors: Each member of the Hospital Board, is legally and morally responsible for all activities of Hospital. . . . "

4. Review of CAH policy/procedure "Quality Improvement Plan 2011", approved by the Board of Directors 1/24/11, revealed in part, ". . . Authority: The Board of Directors of George C. Grape Community Hospital is ultimately responsible for assuring that high quality care is provided to our patients. The Board delegates the responsibility for implementing this plan to the Medical Staff, the Quality Council, and the Administrative Council. . . ."

5. Review of Board of Director's Meeting Minutes, dated March 28, 2011, revealed the CAH Annual Report presented by Staff J, CEO.

6. During an interview on 1/5/12 at 11:10 AM, Staff J, CEO, acknowledged the total program evaluation failed to address information derived from the peer review, performed by the Network Hospital, process to include evaluation of the quality and appropriateness of diagnosis and treatment for all physicians providing services at the CAH.

For additional information, refer to C-340

Based on review of Medical Staff Bylaws, documentation, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the periodic evaluation of its total CAH program included the services of Reference Physicians.

The CAH administrative staff provided a list that contained 148 Reference Physician's names.

Failure to include Reference Physicians in the periodic evaluation of its total CAH program could result in failure to identify potential changes needed in services provided.

Findings include:

1. Review of the Medical Staff Bylaws, dated 9/1/2011, stated in part, ". . . Reference Practitioners. Reference Practitioners are those practitioners who are granted limited permission to refer their patients to the Hospital for outpatient diagnostic tests or therapeutic procedures to be performed by Hospital personnel without any personal service performed by the Reference Practitioner. Reference Practitioners are those who do not wish to apply or who do not qualify for privileges. Reference Practitioners are not members of the Medical Staff and do not hold privileges. . . Reference Practitioners must cooperate with any verification process established by the Hospital or the Medical Staff including proof of licensure to order the test or therapeutic procedure requested. . . ."

2. Review of the Board of Directors Bylaws, dated revised May 2000, stated in part, ". . . Authority of the Board of Directors: Each member of the Hospital Board, is legally and morally responsible for all activities of Hospital. . . . "

3. Review of a list identified by the CAH administrative staff revealed a list that contained 148 Reference Physician's names. Physicians B, C, D, E, F, G, H, I, J, K, N and Practitioner L were not included on the list of Reference Physicians. Physicians B, C, D, E, F, G, H, I, J, K, N and Practitioner L were not included on the list of medical staff members.

4. During an interview on 12/27/11 at 2:50 PM, Staff A, Administrative Assistant, stated the CAH administrative staff maintains a list of Reference Physicians. The Reference Physicians only order tests for patients at the CAH. Staff A verifies licensure and insurance on the Reference Physicians. The Reference Physician files then go to the Medical Staff and Board of Directors for approval. The Reference Physician files go to the Medical Staff and Board of Director for approval only one time. The Reference Physicians do not hold privileges at the CAH.

Upon further interview on 12/28/11 at 9:20 AM, Staff A stated the Medical Staff and Board of Directors do not review Reference Physician files every 2 years. The Medical Staff and Board of Directors review the credential files for physicians on the medical staff every 2 years. Staff A stated the staff only verifies current licensure and insurance. Staff A also stated Reference Physicians are not required to have a license from the State of Iowa. Staff A stated staff maintains a list of Reference Physicians on the computer that is available to ancillary departments. If the ancillary departments do not find the name of a Reference Physician on the computer, staff notifies Staff A. Staff A then sends out an application to that physician inviting them to become a Reference Physician. Staff A stated the CAH honors/allows the physician's first request without any verification. In addition to the list of Reference Physicians, the administrative staff maintains 3 binders that contain Reference Physician information including letters sent to the Reference Physician, applications, verification of licensure and insurance.

Upon further interview on 1/4/12 at 9:35 AM, Staff A verified Physicians B, C, D, E, F, G, H, I, J, K, N and Practitioner L were not included on the list of Reference Physicians, in the binders of Reference Physicians, and not included on the list of medical staff members.

5. Review of the "George C. Grape Community Hospital Annual Program Evaluation FY 2010", signed by Staff J, Chief Executive Officer (CEO), lacked documentation that included the services of Reference Physicians.

6. During an interview on 1/5/12 at 11:10 AM, Staff J, CEO, acknowledged the total program evaluation failed to address information regarding Reference Physicians.

7. During an interview on 1/5/12 at 10:45 AM, Staff H, Quality Manager, acknowledged the CAH's Quality Improvement Program failed to include information regarding Reference Physicians.

For additional information, refer to C-241 - IV

Based on review of Medical Staff Bylaws, documentation, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the periodic evaluation of its total CAH program included the evaluation of the appropriateness of tests/procedures ordered by Reference Physicians.

The CAH administrative staff provided a list that contained 148 Reference Physician's names.

Failure to include Reference Physicians in the periodic evaluation of its total CAH program could result in failure to identify potential changes needed in services provided.

Findings include:

1. Review of the Medical Staff Bylaws, dated 9/1/2011, stated in part, ". . . Reference Practitioners. Reference Practitioners are those practitioners who are granted limited permission to refer their patients to the Hospital for outpatient diagnostic tests or therapeutic procedures to be performed by Hospital personnel without any personal service performed by the Reference Practitioner. Reference Practitioners are those who do not wish to apply or who do not qualify for privileges. Reference Practitioners are not members of the Medical Staff and do not hold privileges. . . Reference Practitioners must cooperate with any verification process established by the Hospital or the Medical Staff including proof of licensure to order the test or therapeutic procedure requested. . . ."

2. Review of the Board of Directors Bylaws, dated revised May 2000, stated in part, ". . . Authority of the Board of Directors: Each member of the Hospital Board, is legally and morally responsible for all activities of Hospital. . . . "

3. Review of a list identified by the CAH administrative staff revealed a list that contained 148 Reference Physician's names. Physicians B, C, D, E, F, G, H, I, J, K, N and Practitioner L were not included on the list of Reference Physicians. Physicians B, C, D, E, F, G, H, I, J, K, N and Practitioner L were not included on the list of medical staff members.

4. During an interview on 12/27/11 at 2:50 PM, Staff A, Administrative Assistant, stated the CAH administrative staff maintains a list of Reference Physicians. The Reference Physicians only order tests and treatments for patients at the CAH. Staff A verifies licensure and insurance on the Reference Physicians. The Reference Physician files then go to the Medical Staff and Board of Directors for approval. The Reference Physician files go to the Medical Staff and Board of Director for approval only one time. The Reference Physicians do not hold privileges at the CAH.

Upon further interview on 12/28/11 at 9:20 AM, Staff A stated the Medical Staff and Board of Directors do not review Reference Physician files every 2 years. The Medical Staff and Board of Directors review the credential files for physicians on the medical staff every 2 years. Staff A stated the staff only verifies current licensure and insurance. Staff A also stated Reference Physicians are not required to have a license from the State of Iowa. Staff A stated staff maintains a list of Reference Physicians on the computer that is available to ancillary departments. If the ancillary departments do not find the name of a Reference Physician on the computer, staff notifies Staff A. Staff A then sends out an application to that physician inviting them to become a Reference Physician. Staff A stated the CAH honors/allows the physician's first request without any verification. In addition to the list of Reference Physicians, the administrative staff maintains 3 binders that contain Reference Physician information including letters sent to the Reference Physician, applications, verification of licensure and insurance.

5. Review of the "George C. Grape Community Hospital Annual Program Evaluation FY 2010", signed by Staff J, Chief Executive Officer (CEO), lacked documentation that included the services of Reference Physicians.

6. During an interview on 1/5/12 at 11:10 AM, Staff J, CEO, acknowledged the total program evaluation failed to address information regarding Reference Physicians, including whether the utilization of services was appropriate.

7. During an interview on 1/5/12 at 10:45 AM, Staff H, Quality Manager, acknowledged the CAH's Quality Improvement Program failed to include information regarding evaluation of Reference Physicians.

For additional information, refer to C-241 - IV

I. 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 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 11 of 16 patient care services 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, Cardiac Rehab, Dietary, Emergency Room, Laboratory, Nursing, Outpatient Treatment Center, Pharmacy, Radiology, Social Services, Surgery.

The CAH administrative staff identified a census of 5 in-patients at the time of the survey.

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 of Director'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 CAH policy/procedure "Quality Improvement Plan 2011", approved by the Board of Directors 1/24/11, revealed in part, ". . . Authority: The Board of Directors of George C. Grape Community Hospital is ultimately responsible for assuring that high quality care is provided to our patients. The Board delegates the responsibility for implementing this plan to the Medical Staff, the Quality Council, and the Administrative Council. . . The Quality Improvement Program encompasses the following activities: All direct patient care services and indirect services affecting patient health and safety (C-337). . . Each manager, Coordinator and Supervisor is responsible for identifying quality indicators, collecting and analyzing data, developing and implementing changes to improve service delivery, monitoring to assure that improvement is made and sustained, and reporting the data/results to the Quality Council. . . The Quality Council provides oversight and functions as the central clearing house for quality data and information collected throughout the facility. The Quality Council tracks trends and aggregates data from all sources to prepare reports for the governing board and the medical staff. The Quality Council minutes document the outcome of all remedial action (C-343). . . ."

". . . The Quality Council consists of the following individuals: The CEO, Medical Quality Director/Designee, The Director of Patient Care Services/SS-Discharge Planner, The Quality Improvement/Utilization Review Coordinator, Director of Pharmacy, Director of Lab/Infection Control Officer, Director of Health Information Management/Compliance Officer, Home Care Clinical Coordinator, two community representatives, and other specific departmental Directors/Managers as assigned. . . ."

2. Review of the Board of Directors Bylaws, dated revised May 2000, stated in part, ". . . Authority of the Board of Directors: Each member of the Hospital Board, is legally and morally responsible for all activities of Hospital. . . . "

3. Review of Quality Council Meeting Minutes and Quality Improvement activities from January 2011 through November 2011 revealed lack of documentation of analysis of data, conclusions, recommendations, actions taken to improve quality/performance for Anesthesia, Cardiac Rehab, Dietary, Emergency Room, Laboratory, Nursing, Outpatient Treatment Center, Pharmacy, Radiology, Social Services, Surgery.

The performance improvement reports documented "continue to monitor" with the section titled "Council Recommendations for Next Quarter (if any)" was left blank.

4. Review of "Schedule for Reporting Monitors to the Quality Council" for 2010 and 2011 revealed departmental monitors/indicators were unchanged from 2010 to 2011 for Anesthesia, Cardiac Rehab, Dietary, Emergency Room, Laboratory, Nursing, Outpatient Treatment Center, Pharmacy, Radiology, Social Services, Surgery.

5. Review of the Board of Directors Meeting minutes from January 2011 through November 2011 showed the Quality Improvement staff presented "Data Collection Graph" reports and summary of Quality Improvement activities to the Board of Directors monthly. The Data Collection Graph reports and summary of Quality Improvement activities failed to include documentation that showed evaluation of each areas of ongoing monitoring, conclusions, recommendations, and/or actions taken to improve quality/performance for all patient care areas.

6. During an interview on 1/5/12 at 10:35 AM, Staff H, Quality Manager, confirmed performance improvement reports lacked documentation of evaluation of the data and remedial actions taken to address problems identified through the quality assurance program. Staff H also confirmed the Quality Council Meeting Minutes and information provided to the Board of Directors lacked evidence of evaluation/analysis of the data, any remedial actions taken to address identified problems, and outcomes of the remedial actions taken. Staff H stated the Medical Staff and the Board of Directors receive a copy of the Quality Council Meeting Minutes.

7. During an interview on 1/5/11 at 10:15 AM, Staff Q, Director of Nursing, stated they report nursing quality information at the Board of Directors Meetings and the Quality staff provides a summary sheet of quality improvement activities for the rest of the departments. Staff Q acknowledged the Emergency Room monitors have remained the same for 3 years. Staff Q acknowledged the quality improvement reports for Nursing and Emergency Room lacked evaluation/analysis of the data, any remedial actions taken to address identified problems, and outcomes of the remedial actions taken.

8. During an interview on 1/4/12 at 3:30 PM, Staff K, Radiology Manager, acknowledged the quality improvement reports for Radiology lacked evaluation/analysis of the data, any remedial actions taken to address identified problems, and outcomes of the remedial actions taken.



For additional information, refer to C-343


II. Based on review of policies/procedures, Annual Program Evaluation, documentation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure an effective quality assurance program was in place to identify and correct problems with the peer review, performed by the Network Hospital, process.

Failure to ensure an effective quality assurance program was in place to identify and evaluate problems in the peer review, performed by the Network Hospital, process and provide full disclosure of the information derived through the quality assurance program to the Medical Staff and Board of Directors could result in the Medical Staff and Board of Directors lack of access to the information. Failure to have access to the information could result in the Medical Staff and Board of Director's inability to evaluate the information and implement remedial action, if necessary, in respect to appropriate review and reappraisal of the quality of care provided to patients at the CAH.

Findings include:

1. Review of CAH policy/procedure "Quality Improvement Plan 2011", approved by the Board of Directors 1/24/11, revealed in part, ". . . Authority: The Board of Directors of George C. Grape Community Hospital is ultimately responsible for assuring that high quality care is provided to our patients. The Board delegates the responsibility for implementing this plan to the Medical Staff, the Quality Council, and the Administrative Council. . . ."

2.. Review of the "George C. Grape Community Hospital Annual Program Evaluation FY 2010", signed by Staff J, Chief Executive Officer (CEO), stated in part, ". . . George C. Grape Community Hospital does participate with [Network Hospital] Critical Access Hospital Network in external peer review. . . ."

The total program evaluation lacked documentation of information derived from the peer review, performed by the Network Hospital, process to include evaluation of the quality and appropriateness of diagnosis and treatment for all physicians providing services at the CAH.

3. Review of CAH policy/procedure titled "Physician External Peer Review", dated revised 1/24/2011, stated in part, ". . .George C. Grape Community Hospital is a Critical Access Hospital (CAH) and, as such, participates in an external network peer review process in accordance with Critical Access Hospital guidelines. . . George C. Grape Community Hospital has established a comprehensive peer review plan that incorporates external review of clinical records to evaluate the quality and appropriateness of diagnosis and treatment for all physicians providing services at GCGCH. . . These external peer reviews must be completed prior to the consideration of the physician's reappointment. Reappointment may not be finalized until the external peer review is completed and available to the medical staff and Board of Directors for review and consideration. . . ."

4. Review of Board of Director's Meeting Minutes, dated March 28, 2011, revealed the CAH Annual Report presented by Staff J, CEO to the Board of Directors.

5. During an interview on 1/5/12 at 11:10 AM, Staff J, CEO, acknowledged the total program evaluation failed to address information derived from the peer review, performed by the Network Hospital, process to include evaluation of the quality and appropriateness of diagnosis and treatment for all physicians providing services at the CAH.

6. During an interview on 1/5/12 at 10:45 AM, Staff H, Quality Manager, acknowledged the CAH's Quality Improvement Program failed to address information derived from the peer review, performed by the Network Hospital, process to include evaluation of the quality and appropriateness of diagnosis and treatment for all physicians providing services at the CAH.

Based on review of the Quality Improvement Plan, Quality Improvement activities, and staff interviews, the Critical Access Hospital (CAH) quality staff failed to ensure the evaluation of all patient care services provided for 3 of 8 contracted services. (Nuclear Medicine, MRI, Bone Density)

The CAH Radiology administrative staff reported the following number of patients served for the 12 months prior to the survey for Nuclear Medicine - 1 inpatient and 77 outpatients; MRI - 5 inpatients and 175 outpatients; Bone Density - 125 outpatients.

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 CAH policy/procedure "Quality Improvement Plan 2011", approved by the Board of Directors 1/24/11, revealed in part, ". . . Authority: The Board of Directors of George C. Grape Community Hospital is ultimately responsible for assuring that high quality care is provided to our patients. The Board delegates the responsibility for implementing this plan to the Medical Staff, the Quality Council, and the Administrative Council. . . The Quality Improvement Program encompasses the following activities: All direct patient care services and indirect services affecting patient health and safety (C-337). . . ."

2. Review of the Board of Directors Bylaws, dated revised May 2000, stated in part, ". . . Authority of the Board of Directors: Each member of the Hospital Board, is legally and morally responsible for all activities of Hospital. . . . "

3. Review of Quality Improvement activities from January 2011 through November 2011 revealed a Performance Indicator Report with an indicator name "Contracted services submitting appropriate monitors". The indicator report lacked evidence the contracted services monitored, evaluated and reported quality improvement activities regarding patient care services for Nuclear Medicine, MRI, Bone Density.

4. During an interview on 1/5/12 at 9:45 AM, Staff K, Radiology Supervisor, acknowledged the performance indicator report for contracted services included "Contracted services submitting appropriate monitors" and combined Nuclear Medicine, MRI, and Bone Density. Staff K stated the monitors for Nuclear Medicine and Bone Density only included Quality Assurance for their machines. Staff K acknowledged the performance improvement reports sent to Quality Council for Nuclear Medicine, MRI, and Bone Density failed to evaluate the services provided to the patients at the CAH.

5. During an interview on 1/3/12 at 1:20 PM, Staff H, Quality Manager, acknowledged the performance improvement reports sent to Quality Council for Nuclear Medicine, MRI, and Bone Density failed to evaluate the services provided to the patients at the CAH.

Based on review of policies/procedures, medical staff credential files, documentation, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure 5 of 16 physicians selected for review received peer review performed by the Network Hospital prior to reappointment. (Physicians R, S, Q, T, U) The Administrative Assistant identified medical staff members as 4 active and 73 consulting physicians.

The CAH administrative staff identified Physician R, consulting staff, provided care to 1 in-patient and 529 out-patients during the previous 12 months.

The CAH administrative staff identified Physician S, consulting staff, provided care to 408 out-patients during the previous 12 months.

The CAH administrative staff identified Physician Q, active staff, provided care to 66 in-patient and 823 out-patients during the previous 12 months.

The CAH administrative staff identified Physician T, consulting staff, provided care to 771 total patients during the previous 12 months - December 2011 included 2 in-patients and 33 out-patients .

The CAH administrative staff identified Physician U, consulting staff, provided care to 0 in-patient and 3 out-patients during the previous 12 months.

Failure to ensure an appropriate external entity evaluated the quality and appropriateness of the diagnosis and treatment furnished by physicians at the CAH then provide that information to the Medical Staff and Board of Directors for review, prior to credentialing, could potentially result in medical staff members misdiagnosing patients and/or providing inappropriate or substandard patient care without the knowledge of the Medical Staff and Board of Directors.

Findings include:

1. Review of CAH policy/procedure titled "Physician External Peer Review", dated revised 1/24/2011, stated in part, ". . .George C. Grape Community Hospital is a Critical Access Hospital (CAH) and, as such, participates in an external network peer review process in accordance with Critical Access Hospital guidelines. . . George C. Grape Community Hospital has established a comprehensive peer review plan that incorporates external review of clinical records to evaluate the quality and appropriateness of diagnosis and treatment for all physicians providing services at GCGCH. . . These external peer reviews must be completed prior to the consideration of the physician's reappointment. Reappointment may not be finalized until the external peer review is completed and available to the medical staff and Board of Directors for review and consideration. . . ."

2. Review of medical staff credential files on 12/29/11 and 1/3/12 revealed the following:

a. Physician R's, Oncologist, credential file lacked documented evidence of peer review performed by the Network Hospital prior to the Medical Staff approval of reappointment to the Medical Staff on 12/12/11. Additionally, the Board of Directors approved the Medical Staff's recommendation of reappointment of Physician R on 12/15/11. The credential file lacked documentation that showed the completion of peer review performed by the Network Hospital prior to the time the Medical Staff and Board of Directors reappointed Physician R.

b. Physician S's, Podiatrist, credential file lacked documented evidence of peer review performed by the Network Hospital prior to the Medical Staff approval of reappointment to the Medical Staff on 9/20/10. Additionally, the Board of Directors approved the Medical Staff's recommendation of reappointment of Physician S on 9/27/10. The credential file showed the completion of peer review performed by the Network Hospital on 10/19/10 and not available at the time of reappointment.

c. Physician Q's, Family Practice, credential file lacked documented evidence of peer review performed by the Network Hospital prior to the Medical Staff approval of reappointment to the Medical Staff on 4/10/10. Additionally, the Board of Directors approved the Medical Staff's recommendation of reappointment of Physician Q on 4/22/10. The credential file lacked documentation that showed the completion of peer review performed by the Network Hospital at the time the Medical Staff and Board of Directors reappointed Physician Q.

d. Physician T's, Radiologist, credential file lacked documented evidence of peer review performed by the Network Hospital prior to the Medical Staff approval of reappointment to the Medical Staff on 4/10/10. Additionally, the Board of Directors approved the Medical Staff's recommendation of reappointment of Physician T on 4/22/10. The credential file showed the completion of peer review performed by the Network Hospital on 4/23/10 and not available at the time the Medical Staff and Board of Directors reappointed Physician T.

e. Physician U's, Teleradiologist, credential file lacked documented evidence of peer review performed by the Network Hospital prior to the Medical Staff approval of reappointment to the Medical Staff on 1/18/10. Additionally, the Board of Directors approved the Medical Staff's recommendation of reappointment of Physician U on 1/25/10. The credential file showed the completion of peer review performed by the Network Hospital on 4/23/10 and not available at the time the Medical Staff and Board of Directors reappointed Physician U.

3. During an interview on 1/3/12 at 3:10 PM, Staff A, Administrative Assistant, acknowledged the lack of documented evidence that showed an evaluation of the quality and appropriateness of the diagnosis and treatment they furnished to CAH patients had occurred by the Network Hospital at the time of reappointment for Physicians R, S, Q, T, and U.

4. During an interview on 1/4/12 at 8:45 AM, Physician O stated the Medical Staff review peer information performed by the Network Hospital at the time of recommendation for reappointment of Physicians. Physician O also stated that if the peer review information, performed by the Network Hospital, is not available at the time of reappointment, the CAH administrative staff need to flag the credential file that the peer review performed by the Network Hospital is pending.

5. During an interview on 1/4/11 at 10:40 AM, Staff J, Chief Executive Officer, stated the Medical Staff review peer review information performed by the Network Hospital at the time of reappointment of Physicians. Staff J acknowledged the CAH's 'External Peer Review' policy required the completion of physician peer review performed by the Network Hospital prior to the Medical Staff recommending the physician for reappointment and the Board of Directors approving the reappointment of physicians.

Based on review of the Quality Improvement Plan, Quality Improvement activities, and staff interview, the Critical Access Hospital (CAH) quality staff failed to document the outcomes of remedial actions taken through the quality improvement program for 11 of 16 departments. (Anesthesia, Cardiac Rehab, Dietary, Emergency Room, Laboratory, Nursing, Outpatient Treatment Center, Pharmacy, Radiology, Social Services, Surgery)

Failure to ensure the quality staff documented the outcomes of remedial actions taken through the quality improvement program could result 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 CAH policy/procedure "Quality Improvement Plan 2011", approved by the Board of Directors 1/24/11, revealed in part, ". . . Authority: The Board of Directors of George C. Grape Community Hospital is ultimately responsible for assuring that high quality care is provided to our patients. The Board delegates the responsibility for implementing this plan to the Medical Staff, the Quality Council, and the Administrative Council. . . The Quality Improvement Program encompasses the following activities: All direct patient care services and indirect services affecting patient health and safety (C-337). . . The Quality Council provides oversight and functions as the central clearing house for quality data and information collected throughout the facility. The Quality Council tracks trends and aggregates data from all sources to prepare reports for the governing board and the medical staff. The Quality Council minutes document the outcome of all remedial action (C-343). . . ."

2. Review of the Board of Directors Bylaws, dated revised May 2000, stated in part, ". . . Authority of the Board of Directors: Each member of the Hospital Board, is legally and morally responsible for all activities of Hospital. . . . "

3. Review of Quality Improvement activities from January 2011 through November 2011 revealed lacked documented evidence of discussions related to departmental QA, any remedial actions taken to address identified problems, and outcomes of the remedial actions taken for Anesthesia, Cardiac Rehab, Dietary, Emergency Room, Laboratory, Nursing, Outpatient Treatment Center, Pharmacy, Radiology, Social Services, Surgery.

The performance improvement reports documented "continue to monitor" with the section titled "Council Recommendations for Next Quarter (if any)" left blank.

4. During an interview on 1/5/12 at 10:35 AM, Staff H, Quality, confirmed the lack of documented evidence of remedial actions taken to address problems identified through the quality assurance program. Staff H also confirmed the Quality Council Meeting Minutes lacked evidence of evaluation of the data, any remedial actions taken to address identified problems, and outcomes of the remedial actions taken. Staff H stated the Medical Staff and the Board of Directors receive a copy of the Quality Council Meeting Minutes.