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Based on staff interview and administrative document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital as an institution when:

1. No Quality Assessment and Performance Improvement (QAPI) program was established and on-going. No QAPI projects were identified and the hospital did not provide data documenting an on-going program of quality improvement and patient safety was in place. (Refer A 309)

2. The hospital failed to ensure the provision of pharmaceutical services in a manner that met the needs of patients. (Refer to A490)

3. The hospital did not have an Infection Control Program that was capable of preventing, controlling and investigating infections and communicable diseases. (Refer to A747)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on staff interview and administrative record review, the hospital failed to ensure contracted management for the provision of pharmaceutical (pharmacy) services and care met the needs of the patients. The hospital did not implement a quality assessment and performance program (QAPI), to ensure that all services furnished under contract were reviewed on a routine basis to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities, as required by the contract. These failures resulted in the potential for 23,616 patients, from 8/31/12 through 8/31/13, to experience medication errors due to the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner.

Findings:

During an interview, on 9/12/13 at 9 a.m., Registered Nurse (RN 1) was asked to provide the Pharmacy Consultant's (Pharm 1) job description and personnel file.

During an interview, on 9/12/13 at 10 a.m., RN 1 was requested to provide, for the past year, the Pharmacy Consultant's quarterly recommendations regarding pharmaceutical services.

During an interview, on 9/12/13 at 11:15 p.m., RN 1 stated the hospital did not have, for the past year, the Pharmacy Consultant's quarterly recommendations regarding pharmaceutical services. She acknowledged the description of duties required quarterly reports from the Pharmacy Consultant.

During an interview, on 9/12/13 at 11:30 a.m., RN 1 was asked to describe the hospital reporting structure for the Pharmacy. She stated Pharm 1 reported to the Director of Clinical Services (RN 1). She further stated the Director of Clinical Services reported to the Chief Executive Officer (CEO). RN 1 acknowledged she was not aware of the requirement for the Pharmacy Consultant to submit a quarterly recommendation regarding pharmaceutical services. She further stated the CEO was not aware of the requirement for the Pharmacy Consultant to submit a quarterly recommendation regarding pharmaceutical services.

During a concurrent interview and administrative record review, on 9/12/13 at 12:50 p.m., RN 1 identified the [Hospital's], Proposal for Pharmacy Services (signed 9/1/09) and Addendum (signed June 12, 2012). She stated that the hospital did not meet, for the past year, the addendum requirements for the Governing Board, through the HOSPITAL's quality assessment and performance program (QAPI), to ensure that all services furnished under the contract were reviewed on a routine basis to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities.

An administrative record review of the hospital's policy and procedure for Pharmacy General Operations (#PH.002, Revision Date: 18-Mar-10(10)) showed, Policy: "The Pharmacist/Pharmacist Consultant Service is responsible for providing to the patients of [Hospital] pharmaceutical services, defined as: Coordination and supervision of drug information, and clinical services. The Pharmacy Consultant is responsible for quality assessment, improvement and outcomes."

An administrative record review of the hospital's Pharmacy Consultant Description of Duties (#PH.001 HRJD.036, Revised Date: 30-Apr-09(2)) showed, Position Summary, "The Pharmacist Consultant shall have the overall responsibility for: The procurement, storage and distribution of all drugs as well as the development, coordination, supervision and review of pharmaceutical services. Further review showed Duties and Responsibilities, "Furnish the administrator with no less than quarterly reports with recommendations regarding pharmaceutical services."

An administrative record review of [Hospital's], Proposal for Pharmacy Services (signed 9/1/09) showed, an Addendum (signed June 12, 2012). The Addendum indicated, "That pursuant to the requirements of CMS Conditions of Participation Standard 482.12(e), HOSPITAL ensures that it retains responsibility for all services furnished to HOSPITAL by SERVICE PROVIDER...HOSPITAL'S Governing Board, through the HOSPITAL's quality assessment and performance program (QAPI), ensures that all services furnished under said contract are reviewed on a routine basis to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities."

An administrative record review, of the [Hospital's]: 2013 Volumes, showed, from 8/31/12 to 8/31/13, the hospital took care of 23,616 patients.

Based on staff interview and administrative document review, the hospital failed to ensure processes were in place to prevent abuse of patients when four of four employee files were lacking evidence of any pre-employment screening and Staff stated they did not do pre-employment screening.

These failures resulted in the potential for abuse of patients.

Findings:

On 9/12/13 at 10:45 a.m., in the human resources department, concurrent employee personnel file review and interview with the Human Resources Director (HRD) was conducted. The following four staff files were reviewed: RN 4, RN 5, ORT 1, and RadT 1. Four of four employee personnel files reviewed lacked any documentation indicating a pre-employment screening was done.

On 9/12/13 at 10:45 a.m., the HRD stated, "We don't do any pre-employment screening here. The HRD was asked what if anything was done to ensure patients would be free from all forms of abuse, neglect, or harassment. "He stated, "I can't answer that."

On 9/12/13 at 12:20 p.m., during an interview, the Director of Clinical Services (RN 1) stated, "[ HRD] said we aren't checking with the Department of Justice for pre-employment screening or doing background checks on any applicants, for any of our job descriptions. I thought we did and we should. We need to screen our employees and do everything possible to protect our patients'. We don't have a P&P on pre-employment screening."

A P&P was requested on pre-employment screening and none was provided.

Based on staff interview and administrative document review, the hospital's governing body failed to be responsible and accountable for ensuring an ongoing, hospital wide, date-driven Quality Assessment and Performance Improvement (QAPI) program was established when:

1. The hospital's governing body failed to ensure a QAPI program for quality improvement and patient safety was defined, implemented and maintained. The hospital did not provide evidence of on-going and current QAPI projects aimed at quality improvement and patient safety. (Refer to A 309)

2. The hospital did not implement a quality assessment and performance program (QAPI), to ensure that all services furnished under contract were reviewed on a routine basis to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities, as required by the contract. (Refer to A490)

3. The hospital did not have an Infection Control Program that was capable of performing QAPI functions. (Refer to A747)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on staff interview and administrative document review, the hospital's governing body failed to be responsible and accountable for ensuring that an ongoing, hospital wide, date-driven Quality Assessment and Performance Improvement (QAPI) program was established when:

(a) The hospital's governing body failed to ensure a QAPI program for quality improvement and patient safety was defined, implemented and maintained.

(b) The hospital's governing body failed to ensure distinct improvement projects that reflected the complexity of the hospital services were conducted and documented annually. These failures resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Findings:

On 9/9/13 at 1:30 p.m., the hospital Medical Staff Bylaws were reviewed. It indicated on page 52 "10.5 PERFORMANCE IMPROVEMENT/RISK MANAGEMENT COMMITTEE 10.5-1 COMPOSITION The Performance Improvement/Risk Management Committee shall consist of at least one representative from each clinical service, the Director of Nursing, the Infection control Nurse, Director of Quality, Lab Director, Pharmacist, representation from hospital administration and management. 10.5-2 DUTIES The duties of the Performance Improvement/Risk Management Committee shall include: (y) Recommend for approval of the Medical Executive Committee plans for maintaining quality patient care within the hospital. These may include mechanisms to: (1) establish systems to identify potential problems in patient care; (2) set priorities for action on problem correction; (3) refer priority problems for assessment and corrective action to appropriate departments of committees; (4) monitor the results of quality assessment and improvement activities throughout the hospital; and (5) Coordinate quality assessment and improvement activities. (6) Submit regular confidential reports to the Medical Executive Committee on the quality of medical care provided and on quality assessment and improvement activities conducted."

On 9/10/13 at 8:55 a.m., a group interview with the Chief Executive Officer (CEO), the Director of Clinical Services (RN 1), and a staff nurse (RN 2), was conducted. The CEO stated he knew the hospital did not have an adequate quality program. He stated there was not a full time person in charge of the quality program. He stated he was responsible for the lack of personnel and resources required to implement and maintain a QAPI program.


RN 1 stated she was not the responsible individual in charge of QAPI. She stated there was not adequate personnel and resources for a QAPI program. RN 1 stated she reported this directly to the CEO. She stated she had conveyed to CEO the need for personnel and resources as a means of the correcting the situation. RN 1 stated the current quality projects were based on data which had been collected two years ago.

Based on observation, interview and record review, the hospital failed to ensure the implementation of policy and procedures for the administration of epidural (space around the spinal cord) fentanyl (narcotic pain reliever) to Patient 36. The hospital started the administration of epidural fentanyl at 1 milliliter (ml) per hour. After 7.5 hours the epidural fentanyl rate was 6 ml per hour. The medical record did not document the required pump (device to control administration) double checks at the time the infusion rates were changed.

These failures resulted in the potential for patients to be exposed to avoidable medication errors.

Findings:

A concurrent interview and medical record review, on 9/10/13 at 10 a.m., showed Patient 36 was admitted to the hospital on 9/5/13. Review of the medical records showed a Continuous Infusion Epidural Analgesia (pain relief) Order, dated 9/5/13. The order indicated "2. Medications: Fentanyl, 10 mcg (microgram)/ml (milliliter), 3. Begin continuous dose at 1 mL/hour: 4. Maximum hourly dose 6 mL/hour. May increase continuous dose by 1 mL increments per hour to maximum dosage stated." Further reviewed showed a Handoff Communication, PostAnesthesia Care Unit/surgical Nursing Unit at 10:48 a.m., Operating Room Intake, "Continuous epidural Yes-started @ 1035." Continued review showed Patient Progress Notes, dated 9/5/13 5:51 p.m., Intervention: "INTRATHECAL PUMP in use, increased to 6 ml/hr.continue to monitor Movement/positioning, Disease Process." There was no documentation of the fentanyl epidural pump program changes from the initial dose of 1 ml/hour to the final 6ml/hour dose at 5:51 p.m.. Registered Nurse (RN 7) reviewed the medical records and acknowledged the above. RN 7 stated that the hospital required two staff to verify pump program changes.

During an administrative record review, of the hospital's policy and procedure for High Alert Medication Double Check (# PH.053.3, Revision Date: 5-Dec-12), showed, Procedure:, Additional Procedures for High Alert Medications Prior to Administration:, 5. Epidural Infusion:, d. "Required double checks: document the following double checks on NU.0023 Epidural Narcotic Flow Record (see Attachment I), i, Initiation of pump and rate changes."

Based on observation, interview, and record review, the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients as evidenced by:

1. The hospital failed to ensure contracted management for the provision of pharmaceutical (pharmacy) services and care met the needs of the patients. The hospital did not implement a quality assessment and performance program (QAPI), to ensure that all services furnished under contract were reviewed on a routine basis to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities, as required by the contract. These failures resulted in the potential for 23,616 patients, from 8/31/12 through 8/31/13, to experience medication errors due to the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner (refer to A-0084).

2. The hospital failed to ensure the development and implementation, of policies and procedures for compounding (mixing) sterile (germ free) parenteral (for injection) medication in patient care areas. Sterile parenteral lidocaine (anesthetic) 0.91% with (unreadable) HCO3 (bicarbonate) 0.68% was compounded at the outpatient surgery center (Campus 2). The hospital did not have policies and procedures for the compounding of parenteral medications in patient care areas. This failure resulted in the potential for patients to experience avoidable medication errors and infections (refer to A-0491).

3. The hospital failed to ensure the implementation of a policy and procedure for the substitution of medications in short supply. A dopamine (drug used in a life threatening cardiac emergency) kit (vial of drug and intravenous (IV, directly into a vein) bag) was substituted for a dopamine premixed IV bag in an emergency cart (supply of drugs used in a life threatening emergency). The substitution was not approved by the hospital. This failure resulted in the potential for patients to experience a delay in receiving medications needed in a life threatening emergency (refer to A-0511).

The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services

Based on observation, interview and administrative record review, the hospital failed to ensure the development and implementation, of policies and procedures for compounding (mixing) sterile (germ free) parenteral (for injection) medication in patient care areas. Sterile parenteral lidocaine (anesthetic) 0.91% with (unreadable)HCO3 (bicarbonate) 0.68% was compounded at the outpatient surgery center (Campus 2). This failure resulted in the potential for patients to be exposed to avoidable medication errors and infections.

Findings:

During a concurrent observation and interview, on 9/11/13 at 1:30 p.m., at Campus 2, Registered Nurse (RN 4) identified the pre/post op (before/after surgery) patient area. Inspection of the area showed a drawer. Inside the drawer was a blue plastic bin. In the blue bin was a vial of lidocaine and 4 syringes. Inspection of the 1% 10 mg/ml 50 ml lidocaine vial showed 9/11/13 was handwritten on the label. Nothing else was handwritten on the lidocaine label. Inspection of the syringes showed each was labeled with Lidocaine 0.91% with (unreadable)HCO3 (bicarbonate) 0.68% 1ml, expires 9/11. Further inspection of the 4 syringes did not show there was 1 ml of medication in each one. RN 4 inspected the lidocaine vial and syringes and acknowledged the above. RN 4 stated that Physician 1 compounded the syringes at 11:45 a.m. She further stated that the syringes were to be used for patients throughout the day. RN 4 acknowledged that Physician 1 was not within sight of the syringes.

During an interview, on 9/11/13 at 3:30 pm, Registered Nurse (RN 1) was requested to provide the hospital's policy and procedure for assigning expiration dating to compounded sterile parenteral medications.

An administrative record review of the hospital's policy and procedure for Compounding Parenteral Admixtures (#: PN.032, Revised Date: 6-1-07(2)) showed, Policy: "Compounding of intravenous [IV, directly into a vein] solutions in the Nursing areas will be done for emergent and product stability purposes." Further review did not show a procedure for the batch (greater than 1) compounding of lidocaine 0.91% with (unreadable)HCO3 (bicarbonate) 0.68% 1ml. Continued review did not show a procedure for assigning expiration dating to sterile parenteral medications compounded in patient care areas.

An administrative record review of the hospital's policy and procedure for Pharmacy General Operations (#PH.002, Revision Date: 18-Mar-10(10)) showed, Policy: "The Pharmacist/Pharmacist Consultant Service is responsible for providing to the patients of [the hospital] pharmaceutical services, defined as: Coordination and supervision of drug information, and clinical services. The Pharmacy Consultant is responsible for quality assessment, improvement and outcomes."

An administrative record review of the hospital's Pharmacy Consultant Description of Duties (#PH.001 HRJD.036, Revised Date: 30-Apr-09(2)) showed, Position Summary, "The Pharmacist Consultant shall have the overall responsibility for: The procurement, storage and distribution of all drugs as well as the development, coordination, supervision and review of pharmaceutical services."

An administrative record review, of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 34), showed Medium-Risk Level CSPs (compounded sterile drugs), Medium-Risk Conditions-, 1. "Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP that will be administered either to multiple patients or to one patient on multiple occasions." The lidocaine 0.91% with (unreadable)HCO3 0.68% 1ml was a medium-risk level compounded medication.

An administrative record review of the United States Pharmacopeia 797 (USP <797>), Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 36), showed Immediate-Use CSPs, "The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP...Immediate-use CSPs are not intended for storage for anticipated needs or batch compounding. Preparations that are medium-risk level and high-risk level CSPs shall not be prepared as immediate-use CSPs."

Based on observation, interview, and administrative record review, the hospital failed to ensure the implementation of a policy and procedure for the substitution of medications in short supply. A dopamine (drug used in a life threatening cardiac emergency) kit (vial of drug and intravenous (IV, directly into a vein) bag) was substituted for a dopamine premixed IV bag in an emergency cart (supply of drugs used in a life threatening emergency). The substitution was not approved by the hospital. This failure resulted in the potential for patients to experience a delay in receiving medications needed in a life threatening emergency.

Findings:

During a concurrent observation and interview, on 9/9/13 at 2:45 p.m., in pre-op (pre-surgery area), the pediatric emergency cart was identified. Inspection of the cart showed that it contained a dopamine kit (two medications held together by a rubber band). The two medications were 5% dextrose (sugar water) IV bag and dopamine 400 milligram (mg) (40mg/ml) 10 ml vial. Pharmacy Consultant (Pharm 1) stated the hospital was unable to purchase premixed dopamine and substituted the kit. The Broselow (pediatric) Emergency Cart Contents (dated and signed on 9/5/13) document, on the crash cart, was identified. Inspection of the document showed, PINK Drawer, DRIPS, "DOPamine in D5W 400mg [1600mcg (microgram)/ml] 250."

During an interview, on 9/11/13 at 3:45 p.m., the hospital's substitution of a dopamine kit for a dopamine premixed bag was described. Registered Nurse (RN 1) was asked to describe the hospital approval process for drug substitution. RN 1 stated that the substitution of the dopamine kit, for the dopamine premixed bag, did not go through a hospital approval process.

An administrative record review, of the hospital's policy and procedure for Dopamine Infusion (#PN.036, Revision Date: 22-Mar-10 (3)) showed, Procedure: II. Pharmacy Specifics, A. "Pre-mixed dopamine solution with 400mg in Dextrose 5% water /250mL (1600mcg/mL) is kept in Drug Room B and on Crash Carts (emergency)."

An administrative record review of the hospital's policy and procedure for Managing Drug Shortages (#PH.060, Approved: 28-June-2012) did not show the hospital followed the steps outlined in the document.

Based on observation, staff interviews and administrative document review the facility failed to ensure there was an active infection control program when:

1) The facility failed to have a designated infection control officer or officers to develop and implement an ongoing infection control program. (refer to Tag A748)

2) The facility failed to ensure the development and implementation of an active infection control and prevention program. (refer to Tag A749)

3) The facility failed to have an infection control program that could identify potential issues for review by a quality assessment and performance improvement program. (refer to Tag A756)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Infection Control.

Based on observation, staff interview and administrative document review the facility failed to designate an infection control officer or officers to maintain a active ongoing program when hospital staff stated there was no infection control officer.

This failure resulted in the potential for hospital to be unable to track or prevent infections.

Findings:

On 9/9/13 at 9:30 a.m., in the conference room, an interview was conducted with the CEO, RN1 and RN2. During the interview the CEO stated he was not aware of the requirements for an Infection Control Nurse. He stated, "RN2 was responsible for the Infection Control Director duties." In the same Interview, RN2 stated that is a title the CEO has given her but that she had informed the CEO when she was given the title that she could not perform the duties required. RN 2 further stated she has continued to inform CEO that Infection Control Director duties are not being performed.

On 9/9/13 at 10:15 a.m., during a concurrent observation and interview with RN1 and RN 2, the Surveyor requested documentation identifying an appointed Infection Control Officer, qualifications of Infection control officer, current documentation of an infection control program, and policy and Procedures of the facility's Infection Control program. During the interview with RN1, she identified RN 2 as the Infection Control Officer. RN1 stated " RN2 retired November 2012 but has come back when asked to help out." RN2 was observed to be wearing a staff ID badge with her name and Titled Infection Control Director. However, RN2 stated she was not the infection control nurse but that RN1 had those responsibilities. RN2 further stated, "I gave my resignation November 2012. There has not been an IC Nurse since [previous employee] left last June after the last survey."

On 9/9/13 at 1:41 p.m., during an interview to clarify and identify the facility's designated Infection Control Nurse, RN2, stated, "We do not have an Infection Control Nurse or Program since [previous employee] left. I am a staff RN per diem. I am not the infection control nurse."

On 9/10/13 at 9:20 a.m., during an interview, CEO stated "The IC program is not where it should be and that is my fault. We tried an experiment, which failed (referring to spreading IC duties across many staff and not designating an assigned IC Nurse or officer) in an area we should not have tried in the first place."

Review of the hospital's infection control study reports indicated the studies were all performed in 2009-2011. No current studies or documentation of studies was performed or provided for the timeframe after 2011.

On 9/9/13 at 10:15 a.m., the infection control committee minutes were requested and the facility staff failed to provide any minutes.

Based on observation, interview and administrative document review, the hospital failed to ensure an infection control officer developed an active infection control and prevention program when the hospital did not have an infection control officer and no documentation of an infection control program was available.

This failure resulted in the hospital's inability to provide care in a safe and effective manner

Findings:

On 9/10/13 at 9:20 a.m., during an interview, CEO stated "The IC program is not where it should be and that is my fault. We tried an experiment, which failed (referring to spreading IC duties across many staff and not designating an assigned IC Nurse or officer) in an area we should not have tried in the first place."

On 9/9/13 at 9:30 a.m., in the conference room, an interview was conducted with the CEO, RN1 and RN2. During the interview the CEO stated he was not aware of the requirements for an Infection Control Nurse. He stated, "RN2 was responsible for the Infection Control Director duties." In the same Interview, RN2 stated Infection Control Director is a title the CEO has given her but that she had informed the CEO when she was given the title that she could not perform the duties required. RN 2 further stated she has continued to inform CEO that Infection Control Director duties are not being performed.

Review of the hospital's infection control study reports indicated the studies were all performed in 2009-2011. No current studies or documentation of studies were performed or provided by hospital staff for the timeframe after 2011.

On 9/9/13 at 10:15 a.m., infection control committee minutes were requested and not provided by hospital staff.

Based on observation, staff interview and administrative document review the facility failed to ensure a quality assessment and performance improvement program addressed problems identified by the infection contol officer when there was not a designated infection control officer and an infection control program was not in place to identify problems.
These failures resulted in the hospital's inability to provide care in a safe and effective manner.

Findings:

1.On 9/9/13 at 10:15 a.m. during an interview with RN1 and RN 2, the Surveyor requested documentation identifying an appointed Infection Control Officer, qualifications of the Infection control officer, current documentation of an infection control program and policy and procedures of the facility's Infection Control program. During the interview with RN1, she identified RN 2 as the Infection Control Officer. RN1 stated, "RN2 retired November 2012 but has come back when asked to help out."

On 9/9/2013 at 10:15 a.m. RN2 she was observed to be wearing a staff ID badge with her name and Titled Infection Control Director. In a concurrent interview, RN2 stated she was not the infection control nurse but that RN1 had those responsibilities. RN2 further stated, "I gave my resignation November 2012. There has not been an IC Nurse since [a previous employee] left last June after the last survey."

On 9/9/2013 at 1:41 p.m., during an interview to clarify and identify the facility ' s designated Infection Control Nurse, RN2, stated, " We do not have an Infection Control Nurse or Program since [a previous employee] left. I am a staff RN per diem. I am not the infection control nurse."

On 9/10/13 at 9:20 a.m. the CEO, stated, "The IC program is not where it should be and that is my fault. We tried an experiment, which failed (referring to spreading IC duties across many staff and not designating an assigned IC Nurse") in an area we should not have tried in the first place."

2. On 9/9/13 at 9:30 a.m. in the conference room an interview was conducted with the CEO, RN1 and RN2. During the interview, the CEO indicated he was not aware of the requirements for an Infection Control Nurse. He stated, " RN2 was responsible for the Infection Control Director duties." In the same Interview RN2 stated, that is a title the CEO has given her but that she had informed the CEO when she was given the title that she could not perform the duties required. RN 2 further stated she has continued to inform CEO that Infection Control Director duties are not being performed.

On 9/9/13 at 1:41 p.m., review of the hospital ' s infection control study reports showed the studies were all performed on 2009-2011 with no current studies or documentation of studies performed after 2011.

On 9/9/13 at 10:15 a.m. infection control committee minutes were requested and not provided.