The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

HOLY FAMILY MEMORIAL 2300 WESTERN AVE MANITOWOC, WI 54221 July 31, 2012
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on review of QAPI materials available, GB meeting minutes and staff interviews the 1 of 1 committee (Program Improvement (PI) Committee) established by the hospital to take responsibility for the QAPI projects failed to established clear expectations for safety.

Findings include:

From 07/30/12 at 9:30 AM through 07/31/12 at 4:45 PM, 14 of 16 of the QAPI specific materials requested were missing or incomplete.

Surveyors were unable to completely review all QAPI data to ensure compliance with the Conditions of Participation (COP) for the QAPI service.

On 07/31/12 from 3:00 PM to 4:45 PM, during a final review of all QAPI materials received, JCC-A, Adm Dir CSE-D and RM&PS-G confirmed there was no structured QAPI program for Surveyors to review for a complete and comprehensive picture of the QAPI program.

Although the PI Committee reports to the GB, no documentation was provided to confirm the PI Committee had been established or approved by the GB. JCC-A, Adm Dir CSE-D and RM&PS-G confirmed the PI Committee put together by the hospital staff.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed that the departments select their projects, the PI Committee does not.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed that the PI Committee did not establish clear expectations for safety.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on review of QAPI materials, hospital data and staff interviews the hospital failed to ensure the QAPI program defined the program scope for a total of 78 services (contracted and hospital based) or had the program approved by the governing board to analyze data and monitor the QAPI programs effectiveness.

Findings include:

On 07/30/12 during the entrance conference a list of 16 items specific to the QAPI program were requested from the facility.

From 07/30/12 at 9:30 AM through 07/31/12 at 4:45 PM, 14 of 16 items were missing or incomplete. Surveyors were unable to review or complete reviews for the following items as required for compliance with the Conditions of Participation (COP) for the QAPI service:

? Approved QAPI projects and current indicators to improve health outcomes
? QAPI budget approved
? QAPI program approval
? GB approved QAPI plan with defined methods for reviews/observations & frequency of data collection and methodology to analyze aggregate data (point in time, rates, unit specific)
? List of all current QAPI Activities and Projects include indicators and evaluations for the past 24 months.
? Rationale for QAPI projects selected for 2012.
? Hospital specific QAPI Projects
? Defined High Risk/High Volume & Problem Prone area(s) QAPI Activities
? Analysis of any Adverse Events for the last 24 months.
? Evidence of the investigation/analyzing of QAPI data
? Evidence of aggregate QAPI data broken down to unit or staff level
? Evidence of program improvements/interventions
? Evidence of monitoring post PI interventions for sustained compliance/program success
? 2011-2012 Causal Analysis list with details.

On 07/31/12 from 3:00 PM to 4:45 PM, during a final review of all materials received, JCC-A, Adm Dir CSE-D and RM&PS-G confirmed there was not a structured program for surveyors to review for a complete and comprehensive picture of the QAPI program.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed the GB had not reviewed or approved the QAPI program because currently there was not a defined program.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed there were 32 contracted services and 42 hospital based services.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed the GB had not defined or allocated a budget specific to the QAPI program. Money was available, however Adm Dir CSE-D responsible for the QAPI oversight confirmed D did not know how much money was available.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed the items required by CMS/NHSN and other certification programs that define specific QAPI data submission were completed for data submission. However, analysis for sustained compliance for all PI projects' success had not been completed.

RM&PS-G confirmed there was no causal analysis completed for 2011. G said there was 1 causal analysis started this year (2012), which was not completed or available for review at this time that was related to a fall with injury.

RM&PS-G confirmed that a fall with injury would trigger a causal analysis review.

Based on hospital data provided from August 2011 to present after a PI had been implemented, additional falls with injury had occurred. RM&PS-G confirmed there was no causal analysis completed for all the fall/injuries noted.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on review of QAPI materials, hospital data, and staff interviews the QAPI program failed to set priorities for 36 of 36 contracted services and 42 of 42 hospital based services to consider incidence, prevalence, and severity of problems or how they would affect health outcomes, patient safety, and quality of care.

Findings include:

On 07/30/12 during the entrance conference, a list of 16 items specific to the QAPI program were requested from the facility.
GB Meeting minutes for 2011 & 2012 with the following items flagged:
? Approved QAPI projects and current indicators to improve health outcomes
? QAPI budget approved
? QAPI program approval

QAPI materials Requested:
? GB approved QAPI plan with defined methods for reviews/observations & frequency of data collection and methodology to analyze aggregate data (point in time, rates, unit specific)
? List of all current QAPI activities and projects include indicators and evaluations for the past 24 months.
? Rationale for QAPI projects selected for 2012.
? Defined national benchmarks & hospital specific QAPI projects
? High Risk/High Volume & Problem Prone area(s) QAPI activities
? List of medical & medication errors/adverse events any occurrences reviewed for past 24 months
? Analysis of any adverse events for the last 24 months.
? Evidence of the investigation/analyzing of QAPI data
? Evidence of aggregate QAPI data broken down to unit or staff level
? Evidence of program improvements/interventions
? Evidence of monitoring post PI interventions for sustained compliance/program success.
? QAPI meeting minutes and reports for 2011 and the first 2 quarters of 2012.
? 2011-2012 causal analysis list with details.

From 07/30/12 at 9:30 AM through 07/31/12 at 4:45 PM 14 of 16 items were missing or incomplete. Surveyors were unable to review or complete reviews for the following items as required for compliance with the Conditions of Participation (COP) for the QAPI service:

? Approved QAPI projects and current indicators to improve health outcomes.
? QAPI budget approved.
? QAPI program approval.
? GB approved QAPI plan with defined methods for reviews/observations & frequency of data collection and methodology to analyze aggregate data (point in time, rates, unit specific).
? List of all current QAPI Activities and projects include indicators and evaluations for the past 24 months.
? Rationale for QAPI projects selected for 2012.
? Hospital specific QAPI projects.
? Defined high risk/high volume & problem prone area(s) QAPI activities.
? Analysis of any Adverse Events for the last 24 months.
? Evidence of the investigation/analyzing of QAPI data.
? Evidence of aggregate QAPI data broken down to unit or staff level.
? Evidence of program improvements/interventions.
? Evidence of monitoring post PI interventions for sustained compliance/program success.
? 2011-2012 causal analysis list with details.

On 07/31/12 from 3:00 PM to 4:45 PM, during a final review of all materials received and reviewed, JCC-A, Adm Dir CSE-D and RM&PS-G confirmed there was no structured program for surveyors to review for a complete and comprehensive picture of the QAPI program.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed that current QAPI projects had not have been approved by the governing board.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed because the hospital did not have a structured QAPI program, Adm Dir CSE-D responsible for the QAPI program had not used the data to identify opportunities for improvement and changes that would lead to improvement.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed there were no set priorities for QAPI's performance improvement activities and currently no consideration was given to incidence, prevalence, and severity of problems, unless it was linked to reimbursement or department specific certification or accreditation.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed the QAPI program was driven by press ganey reports (provides measurable goals to improve healthcare outcome and align business objectives), CMS required reporting and other accreditation or certification requirements and had not been comprehensively reviewed for their affects on health outcomes, patient safety, or quality of care.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed that although the QAPI program could track data to determine improvements or failures, there was no system in place to monitor and sustain new projects or systematically monitor changes made on older PI projects to ensure the projects actually worked.
VIOLATION: QAPI PERFORMANCE IMPROVEMENT PROJECTS Tag No: A0297
Based on review of QAPI materials, GB meeting minutes and staff interviews the QAPI department failed to have a defined QAPI program to make a determination if the number of projects and the scope and complexity of the program was proportional to 36 of 36 contracted services and 42 of 42 hospital based services.

Findings include:

From 07/30/12 at 9:30 AM through 07/31/12 at 4:45 PM, 14 of the 16 QAPI specific materials requested were missing or incomplete.

Surveyors were unable to review or complete reviews of the QAPI program required for compliance with the Conditions of Participation (COP) for the QAPI service.

On 07/31/12 from 3:00 PM to 4:45 PM during a final review of all QAPI and GB materials received, JCC-A, Adm Dir CSE-D and RM&PS-G confirmed there was not a structured QAPI program for Surveyors to review for a complete and comprehensive picture of the QAPI program.

If the projects were not linked to reimbursement or a specific certification or accreditation requirements, JCC-A, Adm Dir CSE-D and RM&PS-G confirmed A, D and K could not provide surveyors with a comprehensive list or completed QAPI materials for review of all projects and the scope and complexity of the projects for the 42 of 42 hospital based services.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed although they receive reports from each contracted service, the QAPI department or QAPI committee does not review 36 of 36 contracted services for inclusion in QAPI.
VIOLATION: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT Tag No: A0308
Based on review of QAPI program, GB meeting minutes, hospital provided lists of 42 hospital based and 36 contracted services, and staff interviews, the hospital failed to maintain and demonstrate evidence the QAPI program included 36 of the 36 contracted services or which of the 42 hospital based services were included in the QAPI program.

Finding include:

On 07/30/12 9:30 AM, during the entrance conference a list of QAPI documents were requested for review of the QAPI program.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed that the hospital was not able to provide surveyors with QAPI documentation and that there was no structured QAPI program.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed because there was no QAPI program A, D and G could not provide documentation to verify that 36 of 36 contracted services were being monitored for patient safety and quality assurance.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed because there was no QAPI program A, D and G could not provide documentation to verify what in the 42 hospital based services was being monitored for patient safety and quality assurance, and which of the 42 services were included or excluded because all PI projects stayed at the department level.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on review of QAPI material, GB meeting minutes and staff interviews the facility failed to provide documentation for 36 contracted services and 42 hospital based services ensuring that the GB determined the number of distinct improvement projects annually and that all improvement actions were evaluated.

Findings include:

On 07/30/12 at 9:30 AM during the entrance conference with surveyor, a list of 16 items specific to the QAPI program were requested from the facility.
GB Meeting minutes for 2011 & 2012 with the following items flagged:
? Approved QAPI projects and current indicators to improve health outcomes
? QAPI budget approved
? QAPI program approval

QAPI materials Requested:
? GB approved QAPI plan with defined methods for reviews/observations & frequency of data collection and methodology to analyze aggregate data (point in time, rates, unit specific)
? List of all current QAPI Activities and Projects include indicators and evaluations for the past 24 months.
? Rationale for QAPI projects selected for 2012.
? Defined national benchmarks & hospital specific QAPI Projects
? High Risk/High Volume & Problem Prone area(s) QAPI Activities
? List of Medical & Medication Errors/Adverse Events any occurrences reviewed for past 24 months
? Analysis of any Adverse Events for the last 24 months.
? Evidence of the investigation/analyzing of QAPI data
? Evidence of aggregate QAPI data broken down to unit or staff level
? Evidence of program improvements/interventions
? Evidence of monitoring post PI interventions for sustained compliance/program success
? QAPI meeting minutes and reports for 2011 and the first 2 quarters of 2012
? 2011-2012 Causal Analysis list with details.

From 07/30/12 at 9:30 AM through 07/31/12 at 4:45 PM 14 of 16 items were missing or incomplete. Surveyors were unable to review or complete reviews for the following items as required for compliance with the Conditions of Participation (COP) for the QAPI service:

? Approved QAPI projects and current indicators to improve health outcomes
? QAPI budget approved
? QAPI program approval
? GB approved QAPI plan with defined methods for reviews/observations & frequency of data collection and methodology to analyze aggregate data (point in time, rates, unit specific)
? List of all current QAPI Activities and Projects include indicators and evaluations for the past 24 months.
? Rationale for QAPI projects selected for 2012.
? Hospital specific QAPI Projects
? Defined High Risk/High Volume & Problem Prone area(s) QAPI Activities
? Analysis of any Adverse Events for the last 24 months.
? Evidence of the investigation/analyzing of QAPI data
? Evidence of aggregate QAPI data broken down to unit or staff level
? Evidence of program improvements/interventions
? Evidence of monitoring post PI interventions for sustained compliance/program success
? 2011-2012 Causal Analysis list with details.

On 07/31/12 from 3:00 PM to 4:45 PM, during a final review of all materials received and final interviews, surveyors along with JCC-A, Adm Dir CSE-D and RM&PS-G confirmed there was no structured QAPI program for surveyors to review for a complete and comprehensive picture of the QAPI projects.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed that the GB had not approved or determined the number of distinct improvement projects.

JCC-A, Adm Dir CSE-D and RM&PS-G confirmed the GB had not annually reviewed the QAPI program as a whole to evaluate all improvement actions so a budget could be determined and allocated.
VIOLATION: PROVIDING ADEQUATE RESOURCES Tag No: A0315
Based on QAPI budget review and staff interview, the facility failed to provide information regarding allocation of adequate resources for 36 contracted services and 42 hospital based services to ensure the hospitals QAPI program was sustained.

Findings include:

On 07/30/12 at 9:30 AM, during the entrance conference Surveyors requested the QAPI budget and GB meeting minutes that would confirm the budget was approved for their QAPI program.

On 07/31/12 from 3:00 PM to 4:45 PM surveyors during a final review of all QAPI materials received, GB meeting minutes and QAPI department budget and final interviews, JCC-A, Adm Dir CSE-D and RM&PS-K confirmed the GB had not defined or allocated a budget specific to the QAPI program. Money was available, however Adm Dir CSE-D responsible for the QAPI oversight confirmed D did not know how much money was available.