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Based on review of facility policies, quality assurance, governing board, medical staff documentation and staff interview, it was determined the Governing Body of the Critical Access Hospital (CAH) failed to assume full legal responsibility for determining, implementing and monitoring policies governing the CAH's total operation. The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to maintain an effective organizational structure therefore they were unable to meet this condition. This had the potential to affect any patients receiving services from the CAH.

The findings include: The Governing Body of the CAH failed to assume full legal responsibility for determining, implementing, and monitoring policies governing the CAH's total operation for ensuring that policies were implemented to provide quality health care in a safe environment (Refer to C241).

Other related deficiencies can be reviewed under the Condition of Participation for Quality Assurance at (C330).

Based on staff interview and review of medical staff bylaws and meeting minutes and review of credential files, the critical access hospital (CAH) failed to ensure the governing body implemented and monitored policies governing the CAH's total operation in order to provide quality health care.

Findings include: The governing body failed to ensure that CAH policy had been administered, monitored and implemented under it's total operation in order to provide quality health care.

The governing board of the CAH failed to provide evidentiary documentation that re- appointments to the medical staff for 11 of 12 physician files reviewed had been followed in a timely manner in accordance with medical staff bylaws, rules and regulations.

Review of the physician and CNP credential files with the Health Information Manager/Quality Manager was conducted on 9/9/10 at 4:15 p.m. The files of physicians E, F, L and N lacked evidence of the date the governing board had approved their re-appointment to the medical staff. The physician files for primary surgeon- G, active staff physician- I and physician- O lacked evidence the governing board had given any approval for re-appointment. The credential file for physician-M had medical staff approval dated 9/12/08 and yet the governing board approval had not been signed until 9/9/10, the date the surveyor requested the file for review. The file for physician -H lacked medical staff approval but also had governing board approval signature dated 9/9/10, the date the file had been requested. The files of physicians E, L and N lacked dated signatures by the Chief of Staff to confirm the date of recommended re-appointment. According to the pathology meeting minutes, the consulting pathologist, physician-O, had been in attendance since 9/16/09 at these meetings. However, the credential file for physician-O lacked any approval by neither medical staff nor governing body.

During review of the file for Chief of Staff physician-J , it was noted that no action by medical staff had been initiated for re-appointment and the governing board signed the re-appointment recommendation on 9/9/10, the date the file had been requested. Interview with the administrator on 9/9/10 at 4:30 p.m. confirmed he had no further documentation of approval for physician-J even though the application had been dated 1/16/09 (20 months prior).

The credential file for CNP-K lacked any documentation of approval by the medical staff and/or governing body. Interview with the administrator on 9/9/10 at 4:30 p.m. revealed the last credential file he could locate had been in 2005.

Review of the By-Laws of the Medical Staff dated 6/25/10 revealed the Reappointment process included: 5.3 Appointments, denials, suspensions and revocations of appointments to the Medical Staff shall be made as set forth in these bylaws, but only after there has been a recommendation from the Medical Staff. 5.4 Reappointment shall be for a period of up to two years. 5.5-6. Each recommendation concerning the appointment or clinical privileges to be granted to an applicant shall be based on the following information, gathered from Quality Improvement and other review activities conducted by the Hospital as required by these Bylaws, and pertinent information concerning clinical performance in care settings where a practitioner exercises the clinical privileges requested. 5.5-7 The Board may accept the recommendation of the Medical Executive Committee or may refer the matter back to the MED for further consideration, stating the purpose for such referral and setting a time limit within which a subsequent recommendation shall be made. 5.5-8 Notice of the Board's final decision shall be given, through the Administrator, to the Chairman of the MEC and to the applicant by means of special notice.

Interview with the Health Information Manager on 9/9/10 at 5:00 p.m. confirmed the staff files that were dated 9/9/10 as recommended by the governing board had not been discussed at a board meeting, but that the Chairman of the Board had "stopped" by the CAH to sign. She confirmed the re-appointment process had not followed the CAH rules and regulations.

During review of the "Quality Assurance Plan" the following responsibility of the committee had been included: Review, revise and recommend to the board a semi-annual report. The "Quality Function" Committee as required by medical staff bylaws dated 6/25/10 stated: the Medical Staff shall provide effective mechanisms to monitor and evaluate the quality and appropriateness of patient care and the clinical performance of all individuals with delineated clinical privileges. No further documentation of quality assurance/performance activity nor medical staff accountability to the Governing Board was made evident by the administrator as of 9/9/10.

The CAH's "Quality Assurance Plan" dated 5/24/10 indicated that Infection Control Services "shall be reviewed and be required to participate in quality activities through peer review, appropriateness review, problem identification and resolution". The objectives included (1) to monitor and evaluate the quality and appropriateness of patient care and clinical performance (2) to maintain an on-going evaluation system for review of patient related activities delivered by all personnel directly or indirectly involved with patient care (3) to maintain a system of corrective action and follow-up of problems identified in the hospital and (4) to develop a reporting mechanism to the governing body, providing it with sufficient data to assist it in fulfilling its responsibility for the quality of patient care. The Department's QA activities and monitoring reports will be reported to the QA Committee. The Department's D.A. reports will be also included in the semi-annual Q.A. report to the governing body. Review of meeting minutes of the medical staff and PAC (Professional Activities Committee) for 2009 and 2010 lacked documentation related to infection control practices and/or hospital quality activities related to infection control. The only discussion noted had been related to the policy review of MRSA (Methicillin Resistant Staphylococcus Aureus) and TB (tuberculosis) plans. Evidence was lacking to indicate that an active infection control surveillance program, including program evaluation and corrective actions had been implemented.







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Based on observation, interview and review of facility policies, personnel records review, Medical Staff Bylaw review, Pharmacy and Therapeutics Committee minutes review and Infection Control minutes review, it was determined the Critical Access Hospital (CAH) failed to adequately ensure provision of services for pharmaceutical services, infection control and nursing. The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to meet this condition. This had the potential to affect any patients receiving services from the CAH.

The findings include: The CAH failed to meet the Condition of Provision of Services: The CAH failed to ensure the Pharmacy and Therapeutics Committee (P & T) convened and implemented drug utilization review and failed to ensure that medications were securely stored throughout the hospital (Refer to C276).

The CAH failed to assure the IC committee followed and implemented the established Infection Control Program policies (Refer to C278).

The CAH failed to assure that new Registered Nurses had successfully completed orientation (Refer to C294).

Based on policy review, committee meeting minute review, medical staff bylaw review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the Pharmacy and Therapeutics Committee (P & T) convened and implemented drug utilization review as directed by the current CAH policy and failed to develop policies that defined emergent, urgent and routine medication usage to assure quality pharmaceutical services were provided; In addition, based on observation and staff interview, the CAH failed to ensure that medications were securely stored throughout the hospital. These deficient practices had the potential to affect any patients receiving care and services from the hospital.

Findings include: Evidence was lacking to indicate the P&T committee had implemented a medication program as outlined in the medical staff bylaws. Pharmacy policies lacked definitions of emergent, urgent and routine medication usage. Review of the CAH's pharmacy policies on 9/9/10 revealed the CAH had not defined medications in categories of emergent, urgent, or routine in order to assure quality of pharmacy services. Review of the
P & T committee minutes for the past year revealed this committee had met in conjunction with the Professional Activities Committee (PAC). During review of the medical staff bylaws approved by medical staff on 5/24/10, and the governing body on 6/25/10 related to the Pharmacy and Therapeutics/drug usage evaluation committee, the following actions were to be taken to achieve continual assessment of medications: develop and review a formulary or drug list for use in the hospital, review and evaluate medication variances, review untoward drug reactions and evaluate antibiotic usage.

Review of P & T committee meeting minutes lacked discussion of any antibiotic usage and/or evaluation, medication variances and/or drug formulary review. Interview with the Pharmacist at 3:30 p.m. on 9/9/10, confirmed that documentation was lacking to indicate medication variances had been discussed at P & T committee meetings. During interview with the DON at 4:30 p.m. on 9/9/10, she confirmed that she had no further information for review.

Additional findings included: Unlocked medications were noted in the CT scanner room.

During a tour of the radiology department with the Radiology/Laboratory Manager staff (L) at 9:40 a.m. on 9/08/10 the door to the CT scanner room was noted to have been unlocked. The CT scanner room was located in the main traffic corridor leading to the nurses' station. A cart located in the CT room containing medications for emergency use was observed to have been unlocked. Medications located in the unlocked top drawer of this cart, (which was capable of being locked), included injectable forms of Epinephrine and Diphenhydramine. Interview with staff L at this time indicated he was not aware of the medication storage in the CT room nor was he aware of the location of the key to lock the cart. The following day, on 9/09/2010 at 2:00 p.m., the door to the CT scanner room was again noted to be unlocked with the same emergency medications accessible in the cart which remained unlocked. No staff were present in the hallway/area when the observation was noted.

Interview with the DON (Director of Nursing) at 4:30 p.m. on 9/9/10, she stated she was not aware of the medications stored in the CT room and confirmed that all medications in the CAH were to be locked.

Based on review of infection control (IC) committee meeting minutes, policy review and staff interview the Critical Access Hospital (CAH) failed to assure the IC committee followed and implemented the established Infection Control Program policies. This had the potential to affect all residents who received care from the hospital.

Findings include: The infection control committee had not functioned according to the CAH's established policy nor had infection control services been integrated as part of the quality assurance process.

During review of the infection control meeting minutes on 9/9/10 for the years 2009 and 2010, it was noted the meetings lacked any attendance by the hospital nursing staff and/ or other department representatives as needed. Meetings had not been held quarterly in 2009 as noted: 1/6/09, 6/10/09 and 9/8/09. The CAH failed to have adequate surveillance of employee and patient infections. There was no surveillance being conducted for staff infections, and only limited surveillance related to patient infections. The only discussion noted in the documented meeting minutes of 2009 reflected one nosocomial infection identified during the first and third quarters and committee review of the MRSA infection control plan. The committee minutes lacked mention of any antibiotic usage, evaluation of new products, cleaning procedures/agents, evaluation of aseptic techniques employed in the CAH, and/or any discussion of environmental problems.

Interview with the Director of Nurses (DON)/Infection Control Officer at 4:15 p.m. on 9/9/10, confirmed that documentation was minimal related to patient surveillance related to infection control. She also confirmed that documentation was lacking to indicate surveillance of staff infection control practices having been implemented. The DON indicated that she was hoping to "start this month" with surveillance of staff infections. During interview with the Director of Laboratory Services/ Infection Control Officer at 10:30 a.m. on 9/9/10, he confirmed that he could not recall any infection control study having been implemented at the CAH in the past year.

The Infection Control Committee policy indicated the following: " 2.1 The infection control program shall be monitored by a multidisciplinary Infection Control Committee. This Committee shall include representation from 2.1.1 the medical staff, 2.1.2 administration-Director of Nursing Service from the hospital, 2.1.3 Nursing services, 2.1.4 laboratory and 2.1.5 housekeeping, laundry, dietary, maintenance, pharmacy, central service and surgery on an as needed basis. The committee will meet quarterly. Responsibilities: 3.1 The Infection Control Committee will be responsible for the initiation and supervision of an active facility wide infection control program which will include: 3.1.3 ongoing review and evaluation of every aseptic, isolation and sanitation technique employed in the hospital. Such techniques will be defined and described in departmental manual, and will be reviewed annually and revised as necessary; 3.1.7. Coordination with medical staff on actions resulting from antibiotic usage review; 3.1.10 the development and revision of all forms used for the collection and evaluation of data relative to the program, 3.1.11 Periodic review of cleaning procedures, agents and schedules in use throughout the facility, and consultation regarding any major change in cleaning products or techniques. 3.1.12 monitoring the findings of any concurrent or retrospective patient care evaluation studies that relate to infections, 3.1.13 evaluation of facility systems for disposal of liquid and solid waste. Infection Control Committee Minutes: 4.1 The Committee must concern itself with certain areas of the infection control program and the minutes of the committee meeting must reflect these elements: 4.1.1 Discussion of clusters of infections, 4.1.2 Discussion of new or unusual organisms, 4.1.4 Discussion of environmental problems, 4.1.6 Evaluation of reports of new products with impact on infection control and 4.1.7 reports regarding antibiotic usage. 4.2 Minutes must be reviewed each meeting and any problems that may have been identified must have corrective action documented. Evidence was lacking in the Committee meeting minutes for 2009 and 2010 to confirm the Committee had carried out their duties as defined."

The CAH's "Quality Assurance Plan" dated 5/24/10 indicated that Infection Control Services "shall be reviewed and be required to participate in quality activities through peer review, appropriateness review, problem identification and resolution". The objectives included: "(1) to monitor and evaluate the quality and appropriateness of patient care and clinical performance (2) to maintain an on-going evaluation system for review of patient related activities delivered by all personnel directly or indirectly involved with patient care (3) to maintain a system of corrective action and follow-up of problems identified in the hospital and (4) to develop a reporting mechanism to the governing body, providing it with sufficient data to assist it in fulfilling its responsibility for the quality of patient care. The Department's QA activities and monitoring reports will be reported to the QA Committee. The Department's D.A. reports will be also included in the semi-annual Q.A. report to the governing body."

Review of meeting minutes of the medical staff and PAC (Professional Activities Committee) for 2009 and 2010 lacked documentation related to infection control practices and/or hospital quality activities related to infection control. The only discussion noted had been related to the policy review of MRSA (Methicillin Resistant Staphylococcus Aureus) and TB (tuberculosis) plans. Evidence was lacking to indicate that an active infection control surveillance program, including program evaluation and corrective actions had been implemented.







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Based on review of personnel files and staff interview, the Critical Access Hospital (CAH) failed to assure that 3 of 3 newly hired RN's (Registered Nurses- A, B & C) had completed orientation as set forth in their orientation skills inventory list.

Findings include: Completion of orientation skills checklist was not evident for 3 currently employed RN personnel files reviewed. Documentation was lacking in the personnel files for RN's- A, B and C to indicate the achievement of the orientation skills inventory list required during orientation. The skill inventory list included the following categories: admission, discharge and transfer of patients, oxygen therapy, suction, non-invasive monitoring, emergency patient situations, transfusion therapy, medications, invasive procedures, orthopedic care, surgical patients, ENT (ear, nose and throat), Eye, GYN (gynecological) care, endoscopy, mast trousers, sexual assault informed consents, standard precautions-isolation, obstetrics-nursery, communications, reporting/recording, safety protocol, employee health, charts/forms, nursing services department and personnel policies.

The orientation skills inventory checklist had not been signed and dated as complete for RN-A, hired on 8/24/09; or for RN-C, hired on 11/2/08. The column defined as "review of skill/demonstrates per procedure" was noted to have been left essentially blank.

The personnel file for RN-B, hired on 8/18/08, lacked any documentation of completion of the orientation skills inventory checklist.

Interview with the DON (Director of Nursing) at 4:20 p.m. on 9/9/10 confirmed these RNs had been working with patients and verified the documentation of satisfactory orientation completion had not been completed as required.

Based on record review and staff interview, the Critical Access Hospital (CAH) failed to ensure that each medical entry was properly authenticated with a timed and dated signature for 6 of 7 surgical patient records reviewed (S2, S3, S4, S5, S6, and S7 ); and for 6 of 8 emergency room patient records reviewed (E2, E4, E5, E6, E7, and E8);.

Findings include: Six of seven surgical records (S2, S3, S4, S5, S6, and S7 ) reviewed lacked proper authentication of entries by the surgeon. Entries lacking proper authentication included the operative reports:

S2 had a surgical procedure 2/4/10 and the operative report had not been timed and/or dated by the surgeon.

S3 had a surgical procedure 5/6/10 and the operative report had not been timed and/or dated by the surgeon.

S4 had a surgical procedure 5/20/10 and the operative report had not been timed and/or dated by the surgeon.

S5 had a surgical procedure 12/3/09 and the operative report had not been timed and/or dated by the surgeon.

S6 had a surgical procedure 12/30/09 and the operative report had not been timed and/or dated by the surgeon.

S7 had a surgical procedure 11/2/09 and the operative report had not been timed and/or dated by the surgeon.

Surgeon B or R had failed to properly authenticate their signatures for each of these operative reports.

Physician authentication of Emergency Room records lacked dated and timed signatures on records. Emergency room documentation lacking proper authentication included physician and/or certified nurse practitioner (CNP) handwritten notes and orders for medication, laboratory and/or radiology orders. Examples of patients reviewed included:

E2 seen in the emergency department (ED) 7/8/10; E4 seen in the ED on 5/24/10; E5 seen in the ED on 4/19/10; E6 seen in the ED on 3/16/10; E7 seen in the ED on 2/8/10; and E8 who had been seen in the ED on 9/1/10.

Interview was conducted with the Health Information Manager at 4:00 p.m. on 9/9/10. It was verified that entries in the medical records reviewed lacked consistent authentication of the time and/or date the entries had been made by the author.

Based on review of personnel files, surgical privileges list, policy and Medical Staff By-Law review, and staff interview, the Critical Access Hospital (CAH) failed to assure 1 of 2 surgeons (Surgeon G) had been appointed according to the hospital's policies, and that a current roster listing each practitioner's surgical privileges had been updated and made available in the surgical suite.

Findings include: Surgeon G did not have current credentialing. The CAH also failed to have an updated and current surgical privilege roster available for the surgical staff.

Review of the physician credential files with the Health Information Manager/Quality Manager was conducted on 9/9/10 at 4:15 p.m. The file for primary surgeon- G lacked evidence the governing board had given approval for re-appointment.

Review of the By-Laws of the Medical Staff dated 6/25/10 revealed the Reappointment process included: 5.3 Appointments, denials, suspensions and revocations of appointments to the Medical Staff shall be made as set forth in these bylaws, but only after there has been a recommendation from the Medical Staff. 5.4 Reappointment shall be for a period of up to two years. 5.5-6. Each recommendation concerning the appointment or clinical privileges to be granted to an applicant shall be based on the following information, gathered from Quality Improvement and other review activities conducted by the Hospital as required by these Bylaws, and pertinent information concerning clinical performance in care settings where a practitioner exercises the clinical privileges requested. 5.5-7 The Board may accept the recommendation of the Medical Executive Committee or may refer the matter back to the MED for further consideration, stating the purpose for such referral and setting a time limit within which a subsequent recommendation shall be made. 5.5-8 Notice of the Board's final decision shall be given, through the Administrator, to the Chairman of the MEC and to the applicant by means of special notice.

In addition, upon interview with the OR (operating room) Manager/DON (Director of Nursing) at 1:35 p.m. on 9/9/10, it was indicated she was unable to locate the notebook which had been kept in the operating suite that delineated each practitioner's surgical privileges. She stated they had maintained a roster but "could not find it anywhere".

During review of CAH Operating Room policy #625, the following procedure was noted: "A notebook is maintained in the operating room that contains copies of the 'Delineation of Medical Privileges Desired' checklists from all practitioners who have been granted surgical privileges. The checklists define what procedures the Practitioner has been granted privileges to perform". The CAH failed to maintain the availability of a current roster listing each practitioners's surgical privileges for review by surgical staff.

Based on record review and staff interview, the Critical Access Hospital (CAH) failed to document in 3 of 4 outpatient surgical records (S1, S3 and S4) that the surgical patient had been discharged in the company of a responsible adult.

Findings include: Documentation was lacking in the records of S1, S3 and S4 to indicate the patients had been discharged in the company of a responsible adult after surgery requiring anesthesia.

It was noted during record reviews that S1 had received general anesthesia during a bronchoscopy on 8/24/2010; S3 had received general anesthesia during a hernia repair on 5/6/10; and S4 had received general anesthesia during a tonsillectomy on 5/20/10 . Documentation on the Nursing Progress notes form was left blank ["Method of Discharge: __ Per:__"]. There was nothing documented to indicate the patients had left the hospital in the company of a responsible adult.

Upon interview with the Health Information Manager at 2:30 p.m. on 9/8/10, it was verified that this information in these records was lacking.

Based on review of facility policies, quality assurance documentation and interview, it was determined the Critical Access Hospital (CAH) failed to ensure periodic evaluation and Quality review of their services. The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to maintain effective quality assurance processes in order to ensure provision of quality health care. Therefore, the CAH was unable to meet this condition of participation. These deficient practices have the potential to impact any patients receiving services from the CAH. The findings include:

The CAH failed to conduct an annual evaluation of the its total program (Refer to C331).

The CAH failed to evaluate the utilization of services, including at least the number of patients and the volume of services (Refer to C332).

The CAH failed to evaluate their health care policies as a component of an overall CAH annual review (Refer to C334).

The CAH failed to evaluate the appropriateness of services provided to patients (Refer to C335).

The CAH failed to have an effective quality assurance plan to evaluate the quality and appropriateness of diagnosis and treatment (Refer to C336).

The CAH failed to evaluate all patient care (Refer to C337).

The CAH failed to evaluate nosocomial infections and medication therapy (Refer to C338).

The CAH failed to document the outcome of all remedial action (Refer to C343).

Based on review of policy and governing board meeting minutes, and on staff interview, the Critical Access Hospital (CAH) failed to conduct an annual evaluation of its total program at least once a year. This had the potential to impact any patients receiving services from the CAH.

Findings include: Documentation was lacking to indicate an annual review of the CAH's total program had been conducted. Review of the governing board minutes for the past 2 years was conducted. It was noted there was NO mention of an annual review of the CAH's total program documented in the minutes.

Interview was conducted with the Director of Nursing (DON) at 3:15 p.m. on 9/9/10, regarding the facility process for the annual CAH evaluation. It was learned the DON, who had been employed by the CAH for 30 years, was not aware of the requirement for the annual review. It was also learned the facility had not conducted an annual evaluation of its total program during the past year. In addition, the DON stated she was unable to determine the last time an annual CAH review had been conducted.

During interview with the CAH's Administrator at 3:30 p.m. on 9/9/10, it was learned he was not aware of ANY evaluation of the CAH's total program since the time he had been hired approximately 14 months previous.

The surveyor requested the current CAH policy regarding the annual CAH review from the DON at 3:30 p.m. on 9/9/10. Facility staff were unable to locate this required policy.

It was confirmed during interview with the Administrator, the DON, and the Chief Financial Officer at 6:00 p.m. on 9/9/10, that an evaluation of the CAH's total program had not been conducted in the required time frames.

Based on review of governing board minutes and staff interview, the Critical Access Hospital (CAH) failed to conduct an evaluation at least once a year that included a review of the utilization of CAH services with respect to numbers of patients and the scope of CAH services provided. This had the potential to impact any patients receiving services at the CAH.

Findings include: The CAH failed to conduct an annual evaluation of its total program which included a review of the utilization of CAH services.

Documentation was lacking in the governing body board minutes, or in any of the quality assurance documents/minutes, to indicate an annual review of the CAH's total program had been conducted, including a review of utilization of services.

Interview with the DON at 3:30 p.m. on 9/9/10, confirmed the CAH had not conducted an annual evaluation of its total program for several years, thus, no review of the utilization of CAH services was available to surveyors for review. In addition, CAH staff were not able to locate a written policy delineating the process for conducting the annual review.

Based on review of meeting minutes documentation, and staff interview, the Critical Access Hospital (CAH) had not determined the appropriateness of the services offered including evaluation of health care policies. This had the potential to affect any patients receiving services at the CAH.

Findings include: Documentation was lacking to indicate an overall program evaluation had been conducted to include: whether health care policies were followed and/or whether any revisions to the health care policies were needed.

Documentation was lacking in the governing body board minutes, or in any of the quality assurance documents/minutes, to indicate an annual review of the CAH's total program had been conducted, including a review of health care policies.

Although the health care policies had been reviewed by the CAH policy review committee 5/19/10, there was no evidence that the policies had not been reviewed as a part of an overall CAH program review. Interview with the DON at 3:30 p.m. on 9/9/10, confirmed the CAH had not conducted an annual evaluation of its total program for several years.

Based on review of meeting minutes documentation, and staff interview, the Critical Access Hospital (CAH) had not determined the appropriateness of the services offered including evaluation of policy implementation and/or if any changes were required. This had the potential to affect any patients receiving services at the CAH.

Findings include: Documentation was lacking to indicate an evaluation had been conducted to determine whether the utilization of services was appropriate, whether policies were followed & whether any changes were needed.

Documentation was lacking in the governing body board minutes, or in any of the quality assurance documents/minutes, to indicate an annual review of the CAH's total program had been conducted, including a review of appropriateness of utilization of services.

Interview with the DON at 3:30 p.m. on 9/9/10, confirmed the CAH had not conducted an annual evaluation of its total program for several years, thus, no review of the appropriateness of utilization of CAH services was available to surveyors for review. In addition, CAH staff were not able to locate a written policy delineating the process for conducting the annual review.

Based on review of quality assurance policies and meeting minutes, governing board meeting minutes, medical staff bylaws, and staff interview, the Critical Access Hospital (CAH) failed to have an effective program that evaluated the quality and appropriateness of the diagnosis and treatment furnished in the CAH, and of the treatment outcomes, so that corrective actions could be evaluated, and measures implemented, to improve quality on a continuous basis. This had the potential to affect any patients served by the CAH.

Findings include: It was noted during review of the quality assurance (QA) plan that although all patient services were to be evaluated, the CAH had not conducted ongoing evaluation of the services including nursing, emergency services, surgical services, anesthesia, discharge planning/swing bed, infection control, and organ/tissue donation. The quality assurance responsibility for these identified CAH services had been assigned to the director of nursing services (DON).

During interview with the Health Information Manager (HIM)/QA coordinator at 2:00 p.m. on 9/9/10, regarding quality activities, she stated that department information was to be submitted semi annually to the QA committee for review. She also stated that no QA activity reports had been formally submitted to the committee for the services of nursing, emergency care, surgical services, discharge planning/swing bed, infection control, or organ/tissue donation since the 4th quarter of 2009.

The DON was interviewed regarding QA activities and reporting of quality data at 3:30 p.m. on 9/9/10. The DON confirmed she had not submitted data to the QA committee "since December 2009 or January 2010" due to having been "just too busy."

Additionally, review of the documented QA reports lacked any evidence that rehabilitation services (OT/PT) had been evaluated as part of the QA process during the past year.

Interview with the HIM/QA Coordinator at 4:00 p.m. on 9/9/10, confirmed the quality assurance process had not been all inclusive nor on-going as described by the CAH's QA Plan. It was learned that although physician and physician extender peer review for appropriateness of diagnosis and treatment was conducted, documentation of these QA activities was not reflected in the QA meeting minutes. It was also indicated that physician/nurse practitioner charts had not been sent out for peer review between January 2010 (data for the 4th quarter of 2009) and 8/27/10.

Review of the Governing Board minutes for the past 2 years revealed no evidence that QA activities had been reported to the governing board. NO evidence of discussion of QA activities was evident in the minutes. The last reference to the CAH's QA plan documented in the minutes was dated 5/19/09 and reflected only that the QA plan had been presented to the board and approved.

Interview with the HIM/QA Coordinator at 10:30 a.m. on 9/9/10, confirmed that QA information was to be presented to the Governing Board by the administrator but she was not sure when this had last occurred.

Interview with the Administrator at 2:00 p.m. on 9/9/10, revealed he had presented QA information to the governing board on one occasion since hired in 7/09, however, he could not recall when this had occurred. It was confirmed the governing board minutes lacked any evidence of discussion related to the CAH's QA activity.

Further interview with the HIM/QA Coordinator on 9/9/10 at 4:00 p.m. confirmed the QA committee was to report performance improvement activities at least semi annually to the governing body. The CAH's QA plan indicated the administrator was to "make a verbal report of the quality assurance issues to the governing board periodically." The QA plan indicated the Governing Board was to "keep minutes reflecting quality assurance issues reported, discussed, actions taken, etc., maintaining confidentiality of patients and practitioners."

The medical staff bylaws, dated 6/25/10, stated the responsibility of the 'Professional Activities Committee' (PAC) included: "Review, revise and recommend to the board a semi-annual report." In addition the medical staff bylaws indicated, " 'Quality Function' Committee: the Medical Staff shall provide effective mechanisms to monitor and evaluate the quality and appropriateness of patient care and the clinical performance of all individuals with delineated clinical privileges."

The Administrator was unable to provide any further documentation of quality assurance/performance activity or medical staff accountability to the Governing Board as of 9/9/10. Per review of PAC minutes for the past 2 years, the only mention of any QA activities was dated 1/16/09.

The CAH's "Quality Assurance Plan" dated 5/24/10 indicated that Infection Control Services "shall be reviewed and be required to participate in quality activities through peer review, appropriateness review, problem identification and resolution". The objectives included (1) to monitor and evaluate the quality and appropriateness of patient care and clinical performance (2) to maintain an on-going evaluation system for review of patient related activities delivered by all personnel directly or indirectly involved with patient care (3) to maintain a system of corrective action and follow-up of problems identified in the hospital and (4) to develop a reporting mechanism to the governing body, providing it with sufficient data to assist it in fulfilling its responsibility for the quality of patient care. The Department's QA activities and monitoring reports will be reported to the QA Committee. The Department's Q.A. reports will be also included in the semi-annual Q.A. report to the governing body."

Review of meeting minutes of the medical staff and PAC (Professional Activities Committee) for 2009 and 2010 lacked documentation related to CAH quality activities related to infection control. Evidence was lacking to indicate that an active infection control surveillance program had been integrated into the quality assurance process. Interview with the Director of Laboratory Services/ Infection Control Officer on 9/9/10 at 10:30 a.m. confirmed that he could not recall any infection control study having been implemented at the hospital in the past year.

Interview with the HIM/QA Coordinator at 4:00 p.m. on 9/9/10, confirmed the current quality assurance/performance improvement plan had not been implemented consistently within the CAH.

Based on review of quality assurance (QA) meeting minutes and on staff interview, the Critical Access Hospital (CAH) failed to have an effective program that evaluated all patient care services. This had the potential to impact all patients receiving services from the CAH.

Findings include: It was noted during review of the QA plan and QA information, that although all patient services were to be evaluated, the CAH had not evaluated the services provided by Physical Therapy (PT)/ Occupational Therapy (OT) or the services of organ tissue donation as part of the QA evaluation process. Reports of QA activities for those areas had not been submitted to the QA committee during the past year.

During interview with the QA coordinator at 4:00 p.m. on 9/9/10, it was confirmed the QA process had not evaluated PT/OT services nor were organ/tissue donation services evaluated as no reports had been submitted to the committee during the past year. It was confirmed that department QA information was to be reported to the QA committee at least semi- annually.

In addition, the CAH had not conducted ongoing evaluation of services including: nursing, emergency services, surgical services, anesthesia, discharge planning/swing bed, or infection control. The quality assurance responsibility for these identified CAH services had been assigned to the director of nursing services (DON).

During interview with the Health Information Manager (HIM)/QA coordinator at 2:00 p.m. on 9/9/10, regarding quality activities, she stated that department information was to be submitted semi annually to the QA committee for review. She also stated that no QA activity reports had been formally submitted to the committee for the services of nursing, emergency care, surgical services, discharge planning/swing bed or infection control since the 4th quarter of 2009.

The DON was interviewed regarding QA activities and reporting of quality data at 3:30 p.m. on 9/9/10. The DON confirmed she had not submitted data to the QA committee "since December 2009 or January 2010" due to having been "just too busy."

Based on review of committee meeting minutes and staff interview the Critical Access Hospital (CAH) failed to evaluate medication therapy utilized for nosocomial infections. This had the potential to impact any patients who received services from the CAH.

Findings include: Medication therapy had not been evaluated as part of the quality assurance program. It was noted during review of the quality assurance meeting minutes that discussion was lacking related to medication therapy and evaluation of nosocomial infections.

Review of the infection control meeting minutes lacked mention of any analysis of medication therapy in relation to infections. Interview with the Director of Nursing (DON)/Infection Control Officer at 4:30 p.m on 9/9/10, confirmed she had not documented any quality assurance activities related to this area.

Based on review of quality assurance meeting minutes, medical staff meeting minutes, and staff interview, the CAH failed to document the outcome of all remedial action. This had the potential to affect any patients receiving services from the CAH.

Findings include: Documentation was lacking in CAH quality assurance meeting minutes to confirm the outcome of all remedial action.

During record review it was noted that physician signatures lacked time and date. During interview with the Health Information Manager(HIM) at 4:45 p.m. on 9/9/10, she confirmed she had been aware of this problem. She further indicated the problem had not been part of the discussion within the quality assurance process so that remedial action could be taken.

Interview with the Director of Nurses (DON)/Infection Control Officer at 4:15 p.m. on 9/9/10, confirmed that documentation was lacking to indicate surveillance of staff infection control practices so that corrective actions could be implemented. The DON also indicated that although she had identified a potential infection problem regarding common use equipment, a plan had not been developed to correct the identified problem.

Review of quality assurance meeting minutes for the past year lacked evidence of identified problems and therefore the remedial action required to improve quality of care had not been identified. The minutes were minimal and lacked evidence of progress toward improvement in set goals. The facility staff were unable to provide any additional evidence of documentation regarding quality assurance activities related to remedial action as of 9/9/10.