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Based on observation and interview, the critical access hospital (CAH) failed to ensure that 3 of 3 air handling ventilation systems located in patient rooms were functioning properly. In the kitchen, the ventilation system above the grill was found to have a significant accumulation of debris/dust/grease and 5 of 5 fans used in the kitchen were observed to have dust/debris on the blades and grates. This had the potential of affecting all CAH patients who utilized food from the kitchen.

Findings include:

During the environmental tour with the manager of plant operations, on 8/13/13 at 8:30 a.m., the ventilation systems were checked in three patients rooms. In all three rooms it was determined the ventilation system was not functioning. The manager of plant operations stated at this time that he was unaware of this problem.

In an interview with the Administrator on 8/14/13 at 3:00 p.m., he stated upon further investigation, the malfunction of the air handling systems was believed to be the result of an electrical line being disconnected during construction currently being done in the CAH. The preventive maintained log for checking the ventilation function was not available at the time of survey.

During the kitchen tour on 8/12/13 at 11:00 a.m., 5 of 5 fans were found to have a significant accumulation of dust/debris accumulated on the blades and grates. One fan was located in an area where clean dishes were set, while another fan was directed toward a food preparation counter. The remaining fans were located in general areas throughout the kitchen.

The ventilation system directly above the grill had an accumulation of grease and dust. In reviewing the cleaning schedule, it reflected no cleaning of this system had taken place this year.

The facility's preventive maintenance policy indicated cleaning of the ventilation system was to be done every 6 months. The Manager of Plant Operations was unable to explain why this area in the cleaning schedule had not been completed when interviewed on 8/12/13 at 11:30 a.m. .

Based on document review and interview, the critical access hospital (CAH) was not in compliance with the Condition of Participation for Organizational Structure 485.627 due to failure of the governing body to assume full legal responsibility for determining, implementing and monitoring policies governing the CAH's total operation.

Findings include:

See C241 The governing body of the CAH failed to assume full legal responsibility for implementation of medical staff by-laws and quality assurance activity to ensure all patients received quality health care. This had the potential to affect all CAH patients.

See C330-Other related deficiencies can be reviewed under the Condition of Participation for Quality Assurance .

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.

Based on interview and document review, the critical access hospital (CAH) failed to ensure the Governing Board assumed responsibility for implementation of medical staff by-laws and quality assurance activities including ensuring that all physicians (P) and certified registered nurse anesthetists (CRNA) had been approved by the Governing Board in order to provide quality health care to all patients. The Governing Board of the CAH failed to provide documentation of current appointment to the medical staff for P-B, P-D, P-G, P-H, CRNA-A and CRNA-B in a timely manner in accordance with the established policies. In addition, P-B, P-G, P-M, CRNA-A and CRNA-B did not have current delineation of privileges reviewed and accepted by the Governing Board. The Governing Board also failed to ensure peer review was a component of the credentialing process. These deficient practices had the potential to affect all CAH patients.

Findings include:

Review of the physician and CRNA credential files with the Health Information Manager/Quality Manager (HIM/QA) was conducted at 2:25 p.m. on 8/14/13. It was noted that P-B had last been approved by the medical staff on 4/5/10 however, the file lacked evidence the Governing Board had subsequently approved the re-appointment to the medical staff. The file for P-D lacked evidence that the governing board had approved the re-appointment recommended by medical staff on 4/23/12. The files for P-G and P-H lacked evidence of medical staff or governing body approval since 2010. The credential files for CRNA-A, who currently provided services in the CAH, also lacked evidence of approval by the medical staff and governing board since April 2010.

Applications for delineation of privileges had not been reviewed and/or updated during the two year reappointment cycle as required in the CAH's medical staff bylaws for the following: P-B (application dated 12/8/08), P-G (application dated 9/21/98), P-M (application dated 9/18/06), and CRNA- B (application dated 7/8/10). In addition, the application for delineation of privileges for CRNA-A was missing from the credential file altogether.

Review of the May 2010 By-Laws of the Medical Staff revealed the Reappointment process included:

"4.1.1 Each application for appointment to the Staff or request for clinical privileges shall be in writing, submitted on the prescribed forms with all provisions completed and signed by the applicant.
4.2.2 The executive committee shall make a written report to the Governing Board, together with recommendations regarding appointment, clinical privileges and staff category.
4.2.3 Each recommendation for reappointment and clinical privileges shall be based on 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.
4.2.4 At the next regular meeting of the Governing Board, the Governing Board shall act on the matter.
4.3 Reappointment process: At least 90 days prior to the expiration date of the appointment of each Medical Staff member and/or individual with clinical privileges, the Chief Executive Officer or designee, shall mail an application for reappointment and submit an inquiry to the National Practitioner Data Bank. The reappointment application form shall include all information necessary to update and evaluate the qualifications of the applicant including, but not limited to, the matters set forth in Section 4.1.1, as well as other relevant matters. All provisions of the reappointment application form must be completed and signed by the applicant.
4.3.4 If a completed application for reappointment and/or renewal of clinical privileges is not received by the end of the current appointment period, a warning notice shall be sent via certified mail to the practitioner stating that if the Member or other individual with clinical privileges fails to submit an application for reappointment and/or renewal of privileges within thirty (30) days past the Reapplication Due Date, the Member shall be deemed to have voluntarily resigned membership in the Medical Staff and/or relinquished clinical privileges effective at the end of the current appointment period; unless membership or privileges are otherwise extended by the Medical Executive Committee with the approval of the Boards.
6.2.1 Requests from Allied Health Professionals to perform specified patient care services shall be process in the manner specified in Article IV.
7.1.3 Applicants for reappointment shall have their clinical privileges reviewed and adjusted based on direct observation of care provided, review of patient records, quality assurance reports and medical staff records which document the evaluation of the applicants delivery of care."

The health information manager/quality manager (HIM/QM) was interviewed on 8/14/13 at 2:25 p.m., she confirmed the credential files for physicians B, D, G, and physician H , as well as for CRNA-A and CRNA-B, lacked the appropriate documentation to confirm these providers had been reappointed as required by the current bylaws.

Interview with the HIM/QM on 8/14/13 at 9:50 a.m. confirmed that peer review had not been tied to the credentialing process. She indicated they had the tools to build the system but had not yet implemented the process.

The CAH's Quality Assurance and Performance Improvement Plan dated 5/26/10, indicated the following: The Governing Board is ultimately accountable for the quality, safety, and satisfaction of services provided... The The Board reviews the QA/PI (quality assurance/performance improvement) plan annually. The Board reviews quality activities at least quarterly. The performance improvement activities are presented regularly to the Quality Council and to the Governing Board. The Quality Council responds to the performance improvement reports and makes recommendations to accountable parties.

Quality council meeting minutes dated 2/8/13, 4/5/13 and 6/6/13, lacked documentation that hospital wide quality reports had been discussed at these meetings. In addition, a review of Governing Board meeting minutes dated 10/23/12, 11/27/12, 1/8/13, 2/19/13, 3/26/13, 4/23/13, 5/29/13, 6/25/13 and 7/23/13, lacked documentation of any QA/PI activity reported to Governing Board.

Interview with the administrator on 8/14/13 at 11:40 a.m., verified that he had been not been aware of any peer review having been conducted. He further concurred that he had not been aware of any quality information being communicated to the Governing Board since his appointment in October 2012. The administrator confirmed during additional interview on 8/14/13 at 2:00 p.m., that the CAH had no documentation of ongoing QA activity being reported to the Governing Board.

No further documentation of QA/PI activity, or medical staff accountability, having been referred to the Governing Board was made evident by the administrator as of 8/15/13.

Based on observation, document review and staff interview the critical access hospital (CAH) failed to ensure the infection control committee (ICC) followed and implemented their established policies, failed to conduct ongoing surveillance activity to ensure all patients received quality care, and failed to implement proper brainwashing for 2 of 2 patients (P10 and P3) observed during cares. This has the potential to affect all CAH patients.

Findings include:

During review of the infection control meeting minutes dated 12/4/12, 3/20/12, 5/31/13 and 7/14/13, it was noted that surveillance activity had not been discussed nor had infection control policies been reviewed.

During review of the CAH's undated policy, Infection Control Program, the following was noted: A multidisciplinary Infection Control Committee is established to develop and implement the Infection Control Program. Membership on the Committee included representation from the following: administration; OR/CSR; Nursing services, Environmental services, laboratory, medical staff, activities, dietary and clinic. The committee meets every other month. Findings of the Committee and recommended action are reported in writing to the QI (Quality Improvement) committee, Medical staff and PAC (Professional Activities Committee). Duties of the committee included: (4) assist in developing personnel health program and in orientation of new employees; (7) review policies and procedures annually. A schedule is developed so three to four are reviewed at each meeting; (9) provide a method of evaluating the effectiveness of the Infection Control program (enclose documentation to support this). Control Measures: Regular inservice training programs to update and acquaint all personnel with the Infection Control Program.

During review of the medical staff by-laws dated May 2010, the following description of the committee was noted:
"14.2.3 Infection Control: Monitors infection rates and establishes policies and procedures to minimize infections. Promotes infection prevention, reviews sterilization techniques, evaluates infection patterns and trends and makes recommendations to the Medical Staff and Chief Executive Officer to resolve identified issues."

During observation of care for P10 on 8/13/13 at 9:40 a.m., the following was observed:
RN (registered nurse)-A and RN-B donned gowns/gloves and entered a patient room to apply a dressing to wounds located on the buttocks and heel of P10, after his morning bath. Per interview at that time, RN-A and RN-B stated P10 had been placed in isolation, due to a diagnosis of vancomycin-resistant enterococcus (VRE) in the urine. Upon repositioning P10 onto the right side, it was observed P10 had been incontinent of stool. RN-A proceeded to cleanse the rectal area with the use of pre-moistened, disposable wipes. With gloved hands, she cleansed away the stool from the rectal area, and then repeatedly touched the lid of the wipes and P10's left hip while obtaining and utilizing several disposable wipes. After completion, RN-A removed her soiled gloves and without hand washing and/or use of a sanitizer, donned a sterile set of gloves. RN-A then proceeded to place a sterile Aquacel and duoderm dressing over the wound located on P10's left buttock. Upon completion of dressing the buttock wound, RN-A then proceeded to apply Aquacel and duoderm to the wound on the right heel. RN-A removed the sterile gloves after having completed the dressing changes for both the left buttock and right heel. RN-A tossed the sterile gloves in the garbage and washed her hands prior to leaving the room.

Upon interview with the Infection Control Officer (ICO) on 8/13/13 at 12:00 p.m., it was verified the RN should have utilized hand washing and/or waterless hand sanitizer after cleansing the rectum of stool and prior to the donning the sterile gloves. The ICO also stated the expectation would have been for the RN to change gloves between the dressing changes located on the patient's buttock and heel.

Review of the CAH's policy General Hand Washing revised on 3/12, indicated the following:
"Decontaminate hands (using waterless, alcohol-based agent): if moving from a contaminated body site to a clean body site during patient care."

During an observation on 8/14/13 at 9:00 a.m., RN-B dropped P3's medication onto the floor during the morning medication pass. RN-B was observed to pick up the medication from the floor while wearing gloves. Without changing the glove which touched the floor during retrieval of the pill, RN-B was observed to open a new container of Refresh eye drops and to administer the drops into P3's eyes. RN-B then proceeded to administer subcutaneous insulin into the abdomen of P3 with the use of an insulin pen. The RN had not removed her gloves or sanitized her hands during this entire observation. When finished with the medication pass for P3, RN-B removed her gloves and washed her hands.

During interview with the ICO at 9:15 a.m. on 8/14/13, it was confirmed she had not been involved in any quality performance activities. She indicated that she had been hired in February 2013, and the facility had hired two (2) registered nurses (RNs) on the medical unit and 1 RN in the surgical area. She was unaware of any mandatory requirement for ongoing infection control training for staff nor had she been involved with educating staff through inservice training. She further stated that if she observed staff violate an infection control policy, her role would be to talk with the staff 1:1. The ICO verified she had no documentation of such surveillance activity, nor had she implemented any ongoing system to assure staff compliance with hospital wide infection control policies. She also confirmed that information related to surveillance had not been reported to the CAH's ICC. Upon further interview with the ICO at 10:00 a.m. on 8/14/13, it was also confirmed that she was unaware of her role with quality assurance, other than reporting nosocomial data, of which the CAH had none since the beginning of 2013. During interview with the ICO on 8/14/13 at 12:00 p.m., she confirmed RNs should change gloves after retrieval of any item from the floor of a patient's room.

Based on document review and staff interview the critical access hospital (CAH) failed to review patient care policies at least annually by the required group of professional personnel. Lack of current policies has the potential to affect all patients admitted to the CAH.

Findings include:

The CAH failed to have patient care policies reviewed and revised by the group of professional personnel, including a community member at least annually. During review of the program evaluation dated November 2011, it was noted that the document identified: "members of the committee include a physician, mid-level provider, director of nursing, the performance improvement director/coordinator and a volunteer from the community."

During interview with the health information manager/quality manager (HIM/QM) on 8/13/13 at 11:00 a.m., the HIM/QM verified that policies had not been reviewed by the group of professional personnel since the November 2011 evaluation. She confirmed the CAH had not kept up with the required policy reviews.

Based on interview and medical record review the facility failed to ensure medical records were complete and contained all pertinent information necessary to monitor each patient's condition, progress and response to treatment for 2 of 20 records (P1, P2) reviewed.

Findings include:

P1 was admitted 7/23/13, and discharged 7/26/13. The medical record lacked any patient progress notes written by a physician during the hospitalization period.

P2 was admitted 7/29/13 and discharged 7/31/13. The medical record lacked any patient progress notes written by a physician while patient was hospitalized.

In an interview with the director of health information (HIM) services on 8/15/13 at 11:10 a.m., she stated that it would be expected that all patient records would contain progress notes made by a physician which would provide information on the patient's progress and response to treatment while hospitalized. The HIM director was unable to explain why these charts did not have progress notes.

Based on medical record reviews and policy review the critical access hospital (CAH) failed to ensure medical entries were properly authenticated, and/or authenticated with time/date for 14 of 20 inpatient records reviewed (P1, P3, P4, P5, P6, P7, P8, P9, P10, P11, P12, P13, P14 and P15).

Findings included:

P1 had verbal orders for care received by the nurse 7/25/13, that were not cosigned by the physician. In addition, P1's physician discharge orders dated 7/26/13, were not timed or dated.
P5 had verbal orders for care received by the nurse 4/29 and 4/30/13, that were not cosigned by the physician.
P6 had a telephone order for care received by the nurse 3/13/13, that was not signed by a physician.
P7's admission orders for a hospitalization stay beginning 2/26/13, were not dated nor timed by the physician.
P8 had a telephone order for care received by the nurse 3/7/13, that was not dated or timed by the physician.
P9's telephone order of 6/22/13, was not dated or timed by the physician.
P10's admission orders for an acute care stay beginning on 8/6/13, was not dated or timed by the physician.
P11 had a telephone order for care received by the nurse 8/9/13, for Cipro (antibiotic) 250 mg (milligrams) that was not dated or timed by the physician. P11's orders for physical and occupational therapy from 8/9/13, were not timed.

The CAH's policy (untitled and dated 7/7) stipulated "Telephone/verbal physician orders may be received by RN'S (registered nurse) or LPN (license practical nurse) only. These must be written on an order form by the nurse taking the order. The original order should be signed by the physician at his/her next visit or within 24 hours."

During review of four inpatient surgical records (P12, P13, P14 and P15), it was noted that surgeon-A failed to date and time his signature on the operative reports. Surgeon-A failed to date and time the following operative reports: Caesarean section reports dated 5/23/13 for P12, and 6/6/13 for P14; a laparoscopic cholecystectomy for P13 on 4/27/13; and an excision of right ischial decubitus ulcer operation from 7/18/13, for P15.

Interview with the surgical director on 8/13/13 at 10:30 a.m. confirmed the operative reports for these records lacked timed and dated physician signature.

During review of the medical staff by-laws dated May 2010, the following committee description was noted:
"14.2.6 Medical Record Review: Continually assess the key processes of completeness, accuracy and timeliness involved in comprehensive documentation in the patient's medical record. This assessment is accomplished by:
a. Reviewing records
b. Reviewing Medical Staff Rules and Regulations and hospital policies relating to medical records, including the topics of chart completion, form and formats, scanning, indexing, electronic data processing, storage, destruction and availability; and recommending methods of enforcement thereof and changes therein."

P3 was admitted 5/10/13, by a physician's assistant. The physician did not co-sign the order for P3's admission to the hospital.

P4 was admitted 8/7/13, by a physician's assistant. The physician did not co-sign the order for P4's admission to the hospital.

According to a CAH policy which was undated/untitled, "orders from a physician governing the care of a patient are written on the patient's chart on the Physician's Order Sheet and signed by the physician."

Medical staff meeting minutes dated 7/10/13, 6/12/13, 5/8/13, 1/14/13 and 10/8/12
lacked any mention of ongoing assessment related to completeness of patient medical records.

Based on document review and interview, the critical access hospital (CAH) failed to ensure a post-anesthesia evaluation had been conducted by the certified registered nurse anesthetist (CRNA) for 1 of 3 same day surgery (SDS-1) patient records reviewed, and 1 of 4 inpatient (P13) records reviewed.

Findings include:

It was noted during record review that the post-anesthesia evaluation was not evident for SDS-1, who received general anesthesia on 4/24/13, during a right medial meniscal tear repair. P13's record was also lacking a post anesthesia evaluation after the patient had general anesthesia administered on 4/27/13, during a laporoscopic cholecystectomy.

Review of the CAH's policy, Pre and Post Anesthesia Evaluation dated 4/10, indicated: "All patients receiving anesthesia or sedation and analgesia care shall have a post anesthesia evaluation completed and documented by a practitioner qualified to administer anesthesia, no later than 48 hours after surgery or a procedure requiring anesthesia services."

Interview with the surgical manager on 8/13/13 at 11:20 a.m., confirmed the post-anesthesia evaluations were missing in the documentation reviewed for each of these records. The surgical manager indicated that CAH policy had further dictated the evaluations were to be completed by the CRNA.

Based on document review and staff interview, the critical access hospital (CAH) failed to ensure that 2 of 2 contracted certified nurse anesthetists (CRNA-A and CRNA-B) had been granted privileges and reappointment according to medical staff bylaws. This has the potential to affect all surgical patients who required anesthesia services.

Findings include:

During review of medical staff files it was noted that CRNA-A did not have any application for delineation of privileges nor evidence of current CRNA licensure. CRNA-B's file contained an application dated 7/8/10, for delineation of privileges and evidence of CRNA licensure which had subsequently expired. It was further noted that neither CRNA-A nor CRNA-B had been reappointed by the medical staff and governing body since 4/27/10 and 7/27/10, respectively. In addition, the credentialing files lacked any information related to quality of care and/or evaluation of services for both CRNA-A and CRNA-B.

During interview with the health information manager/quality manager (HIM/QM) on 8/14/13 at 11:25 p.m., she verified that the CAH's reapplication for privileges protocol had not been kept up to date. The HIM/QM also verified that an application for continued privileges and current licensure evidence was lacking in CRNA-A's record.

Following the surveyor's request, the HIM/QM retrieved the current licenses for CRNA-A and CRNA-B from an online resource. The HIM/QM indicated on 8/14/13 at 2:00 p.m. that no further information was available regarding the rationale for the lack of reappointment of the two primary CRNA's utilized for the CAH's surgical cases. She confirmed that documentation regarding quality of services provided would not be evident as part of the reappointment process as a system had not been implemented yet.

During interview with the administrator on 8/14/13 at 4:00 p.m., he confirmed the CRNA's would need to request and apply for reappointment every two years, just like the medical staff. He was unaware that they had not been part of the reappointment process for over 3 years.

Review of the medical staff bylaws, dated as approved 7/27/10 by the Governing Body, indicated the following:
"3.3.3 Reappointment shall be for a two-year period, or until resignation.

6.1 Allied Health Professionals must: hold a current license, certificate;

4.3 The reappointment application form shall include all information necessary to update and evaluate the qualifications of the applicant; must be completed and signed by the applicant.

4.3.4 If a completed application for reappointment and/or renewal of clinical privileges is not received by the end of the current appointment period, a warning notice shall be sent via certified mail to the practitioner stating that if the Member or other individual with clinical privileges fails to submit an application for reappointment and/or renewal of privileges within thirty (30) days past the Reapplication Due Date, the Member shall be deemed to have voluntarily resigned membership in the medical staff and/or relinquished clinical privileges effective at the end of the current appointment period; unless membership or privileges are otherwise extended by the Medical Executive Committee with the approval of the Board.

7.1.3 Applicants for reappointment shall have their clinical privileges reviewed and adjusted based on direct observation of care provided, review of patient records, quality assurance reports and medical staff records which document the evaluation of the applicants delivery of care."

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 all patients receiving services from the CAH.

Findings include:

See C331- Based on document review and staff interview, the critical access hospital failed to conduct an annual evaluation of the its total program at least once a year. This has the potential to affect all CAH patients.

See C332- Based on document review and staff interview, the critical access hospital failed to conduct an evaluation at least once a year that included a review of all the services, including the number of patients served and the volume of services provided. This has the potential to affect all CAH patients.

See C334-Based on document review and staff interview, the CAH failed to review their health care policies as part of the annual program evaluation. This has the potential to affect all CAH patients.

See C335-Based on document review and staff interview, the critical access hospital had not determined the appropriateness of the services offered nor whether health care policies were appropriate as part of a yearly program evaluation to promote quality patient care. This has the potential to affect all CAH patients.

See C336-Based on document review and staff interview, the critical access hospital failed to have an effective program that evaluated on a continuous basis, the quality and appropriateness of the diagnosis and treatment furnished so that corrective actions could be implemented and evaluated to improve the quality of patient care. This has the potential to affect all CAH patients.

See C337-Based on document review and staff interview, the critical access hospital failed to have an effective program that evaluated on a continuous basis, the quality of all patient care services. This has the potential to affect all CAH patients.

See C338-Based on document review and staff interview, the critical access hospital failed to evaluate medication therapy utilized for nosocomial infections. This has the potential to affect all CAH patients.

See C342-Based on document review and staff interview, the critical access hospital failed to take appropriate action to address concerns identified in the quality council meeting minutes related to delayed arrival of emergency room physicians. This has the potential to affect all CAH patients.

Based on document review and staff interview, the critical access hospital (CAH) failed to conduct an annual evaluation of the its total program at least once a year. This had the potential to affect all CAH patients.

Findings include:

Documentation was lacking to indicate an annual review of the CAH's total program had been conducted since November 2011. Interview with the administrator on 8/13/13 at 8:30 a.m. confirmed the facility had not conducted an annual evaluation of its total program since November 2011, 21 months from the most recent evaluation. The administrator verified that no further information was available and indicated that he was aware the evaluation was deficient and overdue.

Based on document review and staff interview, the critical access hospital (CAH) failed to conduct an evaluation at least once a year that included a review of all the services, including the number of patients served and the volume of services provided. This has the potential to affect all CAH patients.

Findings include:

Documentation was lacking to indicate an annual review of the CAH's total program had been conducted in the past year. The only documentation presented by the administrator indicated the last review had been conducted in November 2011.

Review of monthly governing body minutes from 10/23/12 until 7/23/13 revealed that neither volume of services nor number of patients served had been part of the agenda and/or the discussion. Interview with the administrator on 8/14/13 at 2:00 p.m., verified the entire CAH evaluation had been lacking.

During interview with the Health Information Manager(HIM)/Quality Manager (QA) at 2:15 p.m. on 8/13/13, confirmed the CAH had not conducted an annual evaluation of its total program since November 2011, which included a review of the utilization of CAH services. It was verified the total program evaluation had been last evaluated 21 months ago, but was "on the schedule."

Based on document review and staff interview, the CAH failed to review their health care policies as part of the annual program evaluation. This had the potential to affect all CAH patients.

Findings include:

During review of the most recent annual program evaluation, it was noted that the last review of the CAH's patient care policies had been conducted November 2011, which was 21 months prior.

Interview with the Health Information Manager(HIM)/Quality Manager (QA) at 2:15 p.m. on 8/13/13, confirmed the CAH had not conducted an annual evaluation of its total program since November 2011, which included the CAH's health care policies. The HIM/QA manager confirmed the total program evaluation was overdue.

Based on document review and staff interview, the critical access hospital (CAH) had not determined the appropriateness of the services offered nor whether health care policies were appropriately followed as part of a yearly program evaluation to promote quality patient care. This has the potential to affect all CAH patients.

Findings include:

Documentation was lacking to indicate an evaluation had been conducted to determine whether the utilization of services had been appropriate, and whether policies had been followed, so that changes could be implemented timely. An annual evaluation had not been done related to the appropriateness of the services the CAH offered.

Interview with the health information manager/quality manager on 8/13/13 at 2:15 p.m., confirmed the CAH had not evaluated the appropriateness of delivery of services being offered as part of the total program evaluation for over a year. It was verified the most recent annual evaluation of its total program had been dated November 2011 (21 months prior.) It was verified the total program evaluation was overdue, and therefore the CAH had not reviewed the appropriateness of their care/services.

Interview with the administrator on 8/14/13 at 2:00 p.m., verified that documentation was lacking of an annual program evaluation. He indicated that "follow up" was lacking.

Based on document review and staff interview, the critical access hospital (CAH) failed to have an effective program that evaluated on a continuous basis, the quality and appropriateness of the diagnosis and treatment furnished so that corrective actions could be implemented and evaluated to improve the quality of patient care. This has the potential to affect all CAH patients.

Findings include:

Quality council meeting minutes dated 2/8/13, 4/5/13 and 6/6/13, lacked documentation that appropriate patient diagnoses and treatments had been evaluated, and there was no documentation of any follow-up discussion as part of the Governing Board meeting minutes dated 10/23/12, 11/27/12, 1/8/13, 2/19/13, 3/26/13, 4/23/13, 5/29/13, 6/25/13 and 7/23/13. Review of quality activity indicated the most recent review related to the evaluation of appropriate diagnoses had been conducted 10/10/12.

Interview with the health information manager (HIM)/quality manager (QM) on 8/14/13 at 9:50 a.m., confirmed that appropriateness of diagnosis and treatment had not been evaluated continuously. She indicated that a system had been discussed to contract with a network group to conduct peer review. The HIM/QM also indicated they had the tools to build the system but had not yet implemented the process.

Interview with the administrator on 8/14/13 at 11:40 a.m., verified that he had been not been aware of any peer review. He further concurred that he had not been aware of any quality information being communicated to the Governing Board since his appointment in October 2012. He further confirmed on 8/14/13 at 2:00 p.m., that documentation of ongoing QA activity being reported to Governing Board was not evident.

Interview with the director of nurses (DON) on 8/14/13 at 2:30 p.m., confirmed that documentation related to evaluating diagnosis and treatment was not available for review.

The Quality Assurance and Performance Improvement Plan dated 5/26/10, included: "The Medical Staff Executive Committee is responsible for ongoing quality of medical care and professional services provided by all individuals with clinical privileges. The Governing Board is ultimately accountable for the quality, safety, and satisfaction of services provided by Madison Lutheran Home."

No further documentation of quality assurance/performance activity or medical staff accountability to the Governing Board was made evident by the administrator as of 8/15/13.

Based on document review and staff interview, the critical access hospital (CAH) failed to have an effective quality assurance (QA) program that evaluated on a continuous basis, the quality of all patient care services. This deficient practice has the potential to affect all CAH patients.

Findings include:

Evidence was lacking to indicate that QA activity had been reported on an ongoing basis in the following areas: anesthesia, cardiac rehabilitation, dietetics, discharge planning/social services, emergency services, infection control, housekeeping/laundry, maintenance, nursing, organ recovery and surgical services. Review of the 2013 quality council meeting minutes dated 6/6/13, 4/5/13 and 2/8/13, lacked reports of projects and/or activities that had occurred to evaluate CAH services provide by the various departments. No ongoing discussions were evident and the CAH program work plan that had been identified for the fiscal year 2011-2012 had not been implemented as recommended at the last annual CAH program evaluation dated November 2011.

During review of the CAH's Quality Improvement Reporting Calendar, the following reporting schedule was noted: Governing Board Report-quarterly; Hospital QI-four times a year; and Community Committee Meeting-Policy Review; and Department Reports-reports due in writing by 15th of month to Quality Manger Coordinator summarizing previous two months' activities, findings and actions. The calendar had not been implemented as planned.

The CAH's Quality Assurance and Performance Improvement Plan dated 5/26/10, indicated the services included in the scope of performance improvement activities include the following: ambulatory care services, anatomical pathology services, care coordination and social services, clinical laboratory services, diagnostic radiology and imaging services, emergency services, information technology, nursing services, nutritional care services, pharmaceutical services, physical rehabilitation services, surgical and anesthesia services. All units, departments and committees are responsible for ongoing quality management. Departments are encouraged to monitor and evaluate the outcomes of care. Selected measures are collected regularly and reported to the Quality Council.

Interview with the Health Information Manager/Quality Manager (HIM/QM) at 9:45 a.m. on 8/14/13, confirmed the QA/PI (performance improvement) process had not been all inclusive nor had it been an ongoing process. It was also noted during QA/PI plan review that PI activities are "presented regularly to the quality council and to the Governing Board and the
Governing Board reviews quality activities at least quarterly". She indicated that she was unsure whether any activity had been reported to the Governing Board due to the limited activity that had occurred the past year.

During review of the monthly Governing Board minutes from 10/23/13 until 7/23/13 (dated 10/23/12, 11/27/12, 1/8/13, 2/19/13, 3/26/13, 4/23/13, 5/29/13, 6/25/13 and 7/23/13) documentation was lacking to indicate that any reporting of QA/PI activity had occurred. .

During interview with the Infection Control Officer (ICO) on 8/13/13 at 10:00 a.m., she confirmed she had not been involved in quality performance activities.

Interview with the surgical manager on 8/13/13 at 11:45 a.m. confirmed she had not received orientation related to QA and verified that no data had been collected since 9/30/12. She verified that she had not been aware of any anesthesia tracking and/or quality activity.

The QA/PI plan indicated that communication of information including regulatory expectations, performance data, improvements being implemented, new improvement methods and more will happen through journal articles, emails, newsletters, computer postings, bulletin boards, advertising and marketing and the committee structure Consistent communication is a key component of the QA/PI plan. No information was available for review to substantiate the plan had been implemented as written and approved on 5/26/10.

Interview with the HIM/QM on 8/13/13 at 2:15 p.m. confirmed the current QA/PI plan had not been implemented consistently within the CAH. She further verified that documentation was lacking in the reports of the quality council meeting minutes to reflect that monthly data from the various departments had been reviewed and acted upon.

The administrator stated during interview on 8/14/13 at 2:00 p.m., that he could not recall any QA/PI discussion at the board meetings since he had been hired as the current CEO (chief executive officer) in October 2012, and confirmed it was a problem.

Based on document review and staff interview, the critical access hospital (CAH) failed to evaluate medication therapy utilized for nosocomial infections. This had the potential to affect all CAH patients.

Findings include:

Medication therapy had not been evaluated as part of the quality assessment/performance improvement program in 2013. It was noted during review of the quality council meeting minutes that discussion was lacking related to medication therapy and evaluation of patient infections.

Review of the infection control meeting minutes dated 12/5/12, 3/20/13, 5/31/13 and 7/14/13, lacked mention of any analysis of medication therapy in relation to infections.
Interview with the Infection Control Officer (ICO) on 8/13/13 at 10:30 a.m., confirmed she had not been involved in quality performance activities.

Based on document review and staff interview, the critical access hospital (CAH) failed to take appropriate action to address concerns identified in the quality council meeting minutes related to delayed arrival of emergency room physicians. This has the potential to affect all CAH patients who visited the emergency room.

Findings include: The CAH failed to document remedial action to address deficiencies found through quality control audits. Review of the quality council meeting minutes dated 4/5/13, revealed the following documentation: "discussed concern that provider arrival in the ER (emergency room) continues to be delayed or absent for some ER visits." Interview with the director of nurses (DON) on 8/14/13 at 10:00 a.m., confirmed that provider arrival times in the ER had been an ongoing concern and further verified that no remedial action had occurred to improve the delayed response times by some of the physicians.

Review of ER documentation spreadsheets, which tracked the time physicians were called and their arrival time at the ER, revealed that in the months of April, May and June 2013, active staff physicians had delayed arrival time greater than 30 minutes. Documentation indicated delayed arrival times 7 times in April, 12 times in May, and 15 times in June 2013. No tracking documentation was available yet for the month of July 2013. Follow up to the concern identified in the April quality council meeting minutes was lacking.

During additional interview with the DON on 8/14/13 at 2:30 p.m., the DON confirmed that documentation was lacking to indicate a discussion had occurred since the 4/5/13 meeting at either quality council meetings, and/or medical staff meetings, to address the concern of delayed physician arrival times in the ER so that action could be taken to improve the response time in the ER.

Based on staff interview and document review of the critical access hospital's (CAH) in-service training programs, it was noted that the CAH had failed to ensure staff received ongoing education regarding organ/tissue donations. The CAH failed to incorporate data identified by the Organ Procurement Organization (OPO) into the QualityAssurance and Performance Improvement (QA/PI) program for evaluation.

Findings include:

Review of staff education/inservice material for the past three years did not reveal any evidence of training related to OPO.

In review of the QA/PI documentation, there was no evidence that the data received from the OPO was integrated into any formal quality activity. The only documentation available for review had been submitted by Life Source and reported as part of the last program evaluation dated November 2011.

In an interview with the director of nursing (DON) on 8/14/13 at 8:30 a.m., she stated at this time the CAH was not conducting any in-service training program for organ and tissue donation. She also acknowledged the CAH had not incorporated any of the statistics from the OPO into a QA/PI program.