HospitalInspections.org

The Condition of Participation for Governing Body has not been met.
Based on review of documentation, meeting minutes and reports, observation, and interviews with staff, the Governing Body failed to ensure that significant findings that had been identified in the hospital's pharmacy compounding area were remedied to ensure that the pharmacy met current standards of practice in accordance with USP (United States Pharmacopeia) 797.

Please refer to A263, A309, A490, A501, A505, A700, A701, A747 and A749.

Review of a report issued by a State Regulatory Agency (SRA) to the hospital on 11/3/15 identified that the pharmacy compounding area failed to meet USP 797 standards that became effective in 2014. As a result of the significant non-compliance, the pharmacy was instructed to compound IV (intravenous) medications not to exceed a 12-hour BUD (beyond-use-date) from the time of compounding to the time of use.
The hospital submitted a plan of action to the SRA on 12/11/15. The initial plan did not address the physical environment non-compliance pending "meeting to be scheduled". In addition, the hospital failed to ensure that all areas of non-compliance addressed in the report were corrected as evidenced by document reviews, observations, and interviews made on 1/10/17, 1/11/17, 1/12/17 and 1/13/17.

Review of Governing Body minutes between 11/3/15 and 1/10/17 identified that the hospital was conducting a "feasibility" study for a new compounding area followed by the enlistment of an Architect. The meeting minutes failed to include other areas of non-compliance as noted in the SRA report including policy review and/or revision and/or creation, documentation of staff training/retraining/competency, documentation of observation and oversight of the compounding area and the compounding staff, and evidence that USP 797 standards were followed and met. As of 1/10/17, the hospital had not submitted architectural plans to either of the two State Regulatory Agencies (Department of Public Health and Department of Consumer Protection).

Interview with the CEO and CMO on 1/13/17 at 1:00 PM identified that the Governing Body and Administration were aware of the need to build a USP 797 compliant compounding area, but were not aware of the other areas of significant and continued non-compliance.

Due to the continued non-compliance in the pharmacy compounding area, an action plan was requested by the Department on 1/13/17 and included moving from 12-hour BUD to a 1-hour BUD for all compounded drugs. Compounded drugs will be tracked and documented to ensure 1-hour BUD is adhered to and an infection control surveillance process will be implemented. The plan identified that on 1/13/17 the hospital would ensure that all pharmacy SOP's related to compounding will be reviewed and updated, staff will be educated/re-educated to the SOP's as they report to work, and education and competencies will be documented and tracked. A Pharmacist will provide oversight for pre and post compounding performed by technicians. Environmental cleaning and testing will be conducted and documented. All testing will be reported to the Infection Prevention Committee and the Quality Committee of the Board of Directors. The hospital submitted a timeline for the creation and completion of a new compounding area.


The areas of non-compliance identified in the 11/3/15 SRA report that have not been remediated include:
a. The report identified that a multidisciplinary approach including Infection Control, Quality, Facilities, and other disciplines was needed to analyze and review the sterile product preparation area. Review of documents and/or meeting minutes for the hospital's Governing Body, Quality, Performance Improvement, Pharmacy and Therapeutics, Infection Control, and Environment/Facilities failed to identified that the continued non-compliance was discussed, reviewed, analyzed, observed, and/or acted upon between identification on 11/3/15 and 1/10/17.

b. The report identified both hazardous and non-hazardous drugs are compounded in the same buffer room creating a positive pressure in the hazardous drug compounding LAFW (laminar air-flow workstation). The compounding of hazardous drugs is to occur in a negative pressure environment in accordance with USP 797. Observations and interviews with the Director of Pharmacy and Pharmacy Technician #1 on 1/10/17, 1/11/17 and on 1/12/17 at 1:15 PM identified that hazardous and non-hazardous drugs continue to be compounded in the same buffer room under the same positive pressure identified in the 11/3/15 SRA report.

c. The report identified that the physical structure of the ante room was non-compliant with USP 797 standards. Observations and interviews were made on 1/10/17, 1/11/17 and on 1/12/17 at 1:15 PM and identified that the ante room continued to be non-compliant with USP 797. The room lacks a ceiling mounted HEPA filter, ceiling tiles are not smooth and are not calked, a speaker in the ceiling is not cleanable, sprinkler heads are not flush with the ceiling, the walls are not painted with epoxy paint, there are integrity breaches in multiple areas of the walls and floor, and wall-mounted bins prevent appropriate cleaning in accordance with USP 797. Air pressure between the ante room and main pharmacy is not maintained when the door is opened. The doors to the ante room and buffer room are made of wood and the ante room sink is not appropriate to accommodate the specific hand washing technique in accordance with USP 797. The ante room is unable to be ISO (International Standards Organization) classified as a result of the physical structure non-compliance.

d. The physical structure of the buffer room continues to be non-compliant with USP 797 standards. Observations and interviews were made on 1/10/17, 1/11/17 and on 1/12/17 at 1:15 PM and identified that the buffer room continued to be non-compliant with USP 797. Ceiling tiles are not contiguously calked, the juncture between the walls and ceiling are not calked, a speaker in the ceiling is not cleanable, and sprinkler heads are not flush with the ceiling. As identified in the SRA report, due to the physical structure non-compliance the pharmacy was instructed to compound IV (intravenous) medications not to exceed a 12-hour BUD.

e. The report identified that the pharmacist was to perform and document random observations of technicians during compounding. Interview with the Director of Pharmacy on 1/12/17 at 1:15 PM identified that although observations may have been made between 11/3/15 and present, there was no documentation to verify this.

f. The report identified that the pharmacy did not have standard operating procedures (SOP) that included hand hygiene and garbing, cleaning of the ante and clean room and personnel gloved fingertip testing as well as a lack of documentation of staff education. Review of a form dated November 2015 identified "three new SOP's" for staff to sign acknowledgement and agreement to comply with the SOP's. The SOP's for hand hygiene and garbing and cleaning of the ante and clean room failed to be dated and the SOP for personnel gloved fingertip testing was dated 12/9/15, after the November 2015 training. Interviews with the Director of Pharmacy and Pharmacy Technician #1 on 1/12/17 at 1:15 PM identified that it could not be explained why the training document was dated prior to policy creation. The Pharmacy Technician identified that it was not until January 2016 that he/she completed the policies. It was identified that 2 staff members signed the November 2015 education sheet but were not hired until June 2016. It was identified that Pharmacists and Pharmacy Technicians are involved in the compounding of medications in the pharmacy department. The pharmacy department currently uses the Aseptic Technique Test and Challenge Kit (A.T.T.A.C.K) for Nurse and EMT (Emergency Medical Technician) compounding validation. The A.T.T.A.C.K instructions identify that the validation kit is used to validate Nurses and EMT's (who are not pharmacy staff) and who compound sterile products outside of the pharmacy. A.T.T.A.C.K identifies that it is the legal responsibility of the Pharmacy Director to ensure institution-wide safety, efficacy and accountability of all drug products used within the hospital and that a Pharmacy Supervisor or Preceptor is required to supervise the validation exercise. Review of a sample of A.T.T.A.C.K validations identified that the validations were not signed by the evaluator or were signed by various Pharmacy Technicians not identified as a Preceptor. In addition, the A.T.T.A.C.K validation kit does not include competency validation for the preparation of hazardous drugs.

Review of an environmental report dated 10/27/15 identified 8 CFU's (colony forming units) of fungus and 6 CFU's of bacteria noted in the ante room. Interview with the Director of Pharmacy on 1/12/17 at 1:15 PM identified that once known, he/she posted a note for staff to concentrate cleaning in the affected areas. The Director of Pharmacy did not document that appropriate remediation was performed and did not perform any retesting to ensure that the cleaning was effective. The next environmental testing was conducted on 3/16/16 and identified 1 CFU of fungus in the ante room.

The hospital arranged for an out-side consulting company to evaluate the pharmacy compounding area. The consultation report dated 8/31/16 identified that the compounding area does not comply with current USP 797 standards. Areas of identified non-compliance include: hazardous and non-hazardous drugs are compounded in the same room, non-compliant finishes including floors, walls, ceilings and HEPA filters, a comprehensive written environmental sampling plan including description of corrective actions needs to be developed, and required humidification is not provided.

The Condition of Participation for QAPI has not been met.
Based on review of documentation, meeting minutes, reports and interviews with staff, the hospital failed to ensure that the hospital-wide QAPI efforts addressed priorities for improved quality of care and patient safety that included significant findings identified in the hospital's pharmacy compounding area to ensure that the pharmacy met current standards of practice in accordance with USP (United States Pharmacopeia) 797.

Please refer to A309, A490, A501, A505, A700, A701, A747 and A749.

Based on review of documentation, meeting minutes, reports and interviews with staff, the hospital failed to ensure that the hospital-wide QAPI efforts addressed priorities for improved quality of care and patient safety that included significant findings identified in the hospital's pharmacy compounding area to ensure that the pharmacy met current standards of practice in accordance with USP (United States Pharmacopeia) 797. The findings include:

Review of a report issued by a State Regulatory Agency (SRA) to the hospital on 11/3/15 identified that the pharmacy compounding area failed to meet USP 797 standards that became effective in 2014. As a result of the significant non-compliance, the pharmacy was instructed to compound IV (intravenous) medications not to exceed a 12-hour BUD (beyond-use-date) from the time of compounding to the time of use.

Although the hospital submitted a plan of action to the SRA on 12/11/15, the hospital failed to ensure that all areas of non-compliance were corrected as evidenced by document reviews, observations and interviews made on 1/10/17, 1/11/17, 1/12/17 and 1/13/17.

The areas of non-compliance identified in the 11/3/15 SRA report that have not been remediated include in part, that a multidisciplinary approach including Infection Control, Quality, and other disciplines was needed to analyze and review the sterile product preparation area.

Review of documents and/or meeting minutes for the Quality and Performance Improvement committees failed to identified that the continued non-compliance was discussed, reviewed, analyzed, observed, and/or acted upon between identification on 11/3/15 and 1/10/17.

Interview with the Director of Quality and Risk Management on 1/13/17 at 3:45 PM identified that he/she was aware of the need to build a USP 797 compliant compounding area, but was not made aware of the other areas of significant and continued non-compliance. Had he/she been made aware of the details of the (11/3/15) report, the findings would have been incorporated into the quality and performance improvement program.

Due to the continued non-compliance in the pharmacy compounding area, an action plan was requested by the Department on 1/13/17 and included moving from 12-hour BUD to a 1-hour BUD for all compounded drugs. Compounded drugs will be tracked and documented to ensure 1-hour BUD is adhered to and an infection control surveillance process will be implemented. The plan identified that on 1/13/17 the hospital would ensure that all pharmacy SOP's related to compounding will be reviewed and updated, staff will be educated/re-educated to the SOP's as they report to work, and education and competencies will be documented and tracked. A Pharmacist will provide oversight for pre and post compounding performed by technicians. Environmental cleaning and testing will be conducted and documented. All testing will be reported to the Infection Prevention Committee and the Quality Committee of the Board of Directors. The hospital submitted a timeline for the creation and completion of a new compounding area.

The Condition of Participation for Pharmaceutical Services has not been met.
Based on review of documentation, meeting minutes and reports, observation, and interviews with staff, the Pharmacy Department failed to ensure that significant findings that had been identified in the hospital's pharmacy compounding area were remedied to ensure that the pharmacy met current standards of practice in accordance with USP (United States Pharmacopeia) 797 and failed to ensure that medications in patient care areas were not expired.


Please refer to A501 and A505

Based on review of documentation, meeting minutes and reports, observation, and interviews with staff, the Pharmacy Department failed to ensure that significant findings that had been identified in the hospital's pharmacy compounding area were remedied to ensure that the pharmacy met current standards of practice in accordance with USP (United States Pharmacopeia) 797. The findings include:

Review of a report issued by a State Regulatory Agency (SRA) to the hospital on 11/3/15 identified that the pharmacy compounding area failed to meet USP 797 standards that became effective in 2014. As a result of the significant non-compliance, the pharmacy was instructed to compound IV (intravenous) medications not to exceed a 12-hour BUD (beyond-use-date) from the time of compounding to the time of use.

The hospital submitted a plan of action to the SRA on 12/11/15. The initial plan did not address the physical environment non-compliance pending "meeting to be scheduled". In addition, the hospital failed to ensure that all areas of non-compliance addressed in the report were corrected as evidenced by document reviews, observations, and interviews made on 1/10/17, 1/11/17, 1/12/17 and 1/13/17.

The areas of non-compliance identified in the 11/3/15 SRA report that have not been remediated as of 1/10/17 include:
a. The report identified that a multidisciplinary approach including Infection Control, Quality, Facilities, and other disciplines was needed to analyze and review the sterile product preparation area. Review of documents and/or meeting minutes for the hospital's Governing Body, Quality, Performance Improvement, Pharmacy and Therapeutics, Infection Control, and Environment/Facilities failed to identified that the continued non-compliance was discussed, reviewed, analyzed, observed, and/or acted upon between identification on 11/3/15 and 1/10/17.

b. The report identified both hazardous and non-hazardous drugs are compounded in the same buffer room creating a positive pressure in the hazardous drug compounding LAFW (laminar air-flow workstation). The compounding of hazardous drugs is to occur in a negative pressure environment in accordance with USP 797. Observations and interviews with the Director of Pharmacy and Pharmacy Technician #1 on 1/10/17, 1/11/17 and on 1/12/17 at 1:15 PM identified that hazardous and non-hazardous drugs continue to be compounded in the same buffer room under the same positive pressure identified in the 11/3/15 SRA report.

c. The report identified that the physical structure of the ante room was non-compliant with USP 797 standards. Observations and interviews made on 1/10/17, 1/11/17 and on 1/12/17 at 1:15 PM identified that the ante room continued to be non-compliant with USP 797. The room lacks a ceiling mounted HEPA filter, ceiling tiles are not smooth and are not calked, a speaker in the ceiling is not cleanable, sprinkler heads are not flush with the ceiling, the walls are not painted with epoxy paint, there are integrity breaches in multiple areas of the walls and floor, and wall-mounted bins prevent appropriate cleaning in accordance with USP 797. Air pressure between the ante room and main pharmacy is not maintained when the door is opened. The doors to the ante room and buffer room are made of wood and the ante room sink is not appropriate to accommodate the specific hand washing technique in accordance with USP 797. The ante room is unable to be ISO (International Standards Organization) classified as a result of the physical structure non-compliance.

d. The report identified that the physical structure of the buffer room was non-compliant with USP 797 standards. Observations made on 1/10/17, 1/11/17 and 1/12/17 identified that buffer room continued to be non-compliant as the ceiling tiles are not contiguously calked, the juncture between the walls and ceiling are not calked, a speaker in the ceiling is not cleanable, and sprinkler heads are not flush with the ceiling. As identified in the SRA report, due to the physical structure non-compliance the pharmacy was instructed to compound IV (intravenous) medications not to exceed a 12-hour BUD.

e. The report identified that the pharmacist was to perform and document random observations of technicians during compounding. Interview with the Director of Pharmacy on 1/12/17 at 1:15 PM identified that although observations may have been made between 11/3/15 and present, there was no documentation to verify this.

f. The report identified that the pharmacy did not have standard operating procedures (SOP) that included hand hygiene and garbing, cleaning of the ante and clean room and personnel gloved fingertip testing as well as a lack of documentation of staff education. Review of a form dated November 2015 identified "three new SOP's" for staff to sign acknowledgement and agreement to comply with the SOP's. The SOP's for hand hygiene and garbing and cleaning of the ante and clean room failed to be dated and the SOP for personnel gloved fingertip testing was dated 12/9/15, after the November 2015 training. Interviews with the Director of Pharmacy and Pharmacy Technician #1 on 1/12/17 at 1:15 PM identified that it could not be explained why the training document was dated prior to policy creation. The Pharmacy Technician identified that it was not until January 2016 that he/she completed the policies. In addition, it was identified that 2 staff members signed the November 2015 education sheet but were not hired until June 2016.

Review of an environmental report dated 10/27/15 identified 8 CFU's (colony forming units) of fungus and 6 CFU's of bacteria noted in the ante room. Interview with the Director of Pharmacy on 1/12/17 at 1:15 PM identified that once known, he/she posted a note for staff to concentrate cleaning in the affected areas. The Director of Pharmacy did not document that appropriate remediation was performed and did not perform any retesting to ensure that the cleaning was effective. The next environmental testing was conducted on 3/16/16 and identified 1 CFU of fungus in the ante room.
It was identified that Pharmacists and Pharmacy Technicians are involved in the compounding of medications in the pharmacy department. The pharmacy department currently uses the Aseptic Technique Test and Challenge Kit (A.T.T.A.C.K) for Nurse and EMT (Emergency Medical Technician) compounding validation for Pharmacy Technicians. The A.T.T.A.C.K instructions identify that the validation kit is used to validate Nurses and EMT's (who are not pharmacy staff) and who compound sterile products outside of the pharmacy. A.T.T.A.C.K identifies that it is the legal responsibility of the Pharmacy Director to ensure institution-wide safety, efficacy and accountability of all drug products used within the hospital and that a Pharmacy Supervisor or Preceptor is required to supervise the validation exercise. Review of a sample of A.T.T.A.C.K validations identified that the validations were not signed by the evaluator or were signed by various Pharmacy Technicians not identified as a Preceptor. In addition, the A.T.T.A.C.K validation kit does not include competency validation for the preparation of hazardous drugs.


Review of Pharmacy and Therapeutics Committee meeting minutes between 1/1/15 and 9/30/15 failed to identify that the pharmacy's compounding area did not meet USP 797 standards related to the physical environment in the compounding area and to compounding practices. Review of committee meeting minutes dated 11/9/15 and 12/14/15 identified that staff were working on an action plan for survey findings and that renovation plans were discussed. Minutes dated 2/8/16 identified that staff were working on writing SOP's (standard operating procedures) in response to the findings in the IV room. Between 11/3/15 and 1/10/17 the committee failed to address the significant non-compliance identified in the 11/3/15 SRA report to enclude physical environment, lack of SOP's, lack of documented training/re-training/competency and proficiency testing, lack of appropriate environmental testing and documentation, and failed to address the recommended multidisciplinary approach to analyze and review the sterile product preparation area.


Review of Governing Body minutes between 11/3/15 and 1/10/17 identified that the hospital was conducting a "feasibility" study for a new compounding area followed by the enlistment of an Architect. As of 1/10/17, the hospital had not submitted architectural plans to either of the two State Regulatory Agencies (Department of Public Health and Department of Consumer Protection).

The hospital arranged for an out-side consulting company to evaluate the pharmacy compounding area. The consultation report dated 8/31/16 identified that the compounding area does not comply with current USP 797 standards. Areas of identified non-compliance include: hazardous and non-hazardous drugs are compounded in the same room, non-compliant finishes including floors, walls, ceilings and HEPA filters, a comprehensive written environmental sampling plan including description of corrective actions needs to be developed, and required humidification is not provided.

Due to the continued non-compliance in the pharmacy compounding area, an action plan was requested by the Department on 1/13/17 and included moving from 12-hour BUD to a 1-hour BUD for all compounded drugs. Compounded drugs will be tracked and documented to ensure 1-hour BUD is adhered to and an infection control surveillance process will be implemented. The plan identified that on 1/13/17 the hospital would ensure that all pharmacy SOP's related to compounding will be reviewed and updated, staff will be educated/re-educated to the SOP's as they report to work, and education and competencies will be documented and tracked. A Pharmacist will provide oversight for pre and post compounding performed by technicians. Environmental cleaning and testing will be conducted and documented. All testing will be reported to the Infection Prevention Committee and the Quality Committee of the Board of Directors. The hospital submitted a timeline for the creation and completion of a new compounding area.

Based on a tour of the facility, review of facility policies, review of facility documentation, observations and interviews the facility failed to ensure that medications in patient care areas were not expired. The finding includes:

A tour of the Ambulatory Care Unit (ACU) was conducted on 1/10/17 at 12:07 PM. Observation of the medication storage area identified two, unopened epinephrine boxes that had expired on 12/2016. Interview with the ACU Operations Manager on 1/10/17 at 12:09 PM noted that pharmacy and nursing check for expired medications and the medications expired at the end of December. Although the facility did not have a policy for single use vials, the policy entitled Multiple- Dose Medications- Beyond Use Dates identified that all expired vials will be discarded

The Condition of Participation for Physical Environment has not been met.
Based on review of documentation, meeting minutes and reports, observation, and interviews with staff, the hospital failed to ensure that significant physical environment non-compliance that had been identified in the hospital's pharmacy compounding area were remedied to ensure that the pharmacy met current standards of practice in accordance with USP (United States Pharmacopeia) 797. In addition, the hospital failed to ensure that annual environmental rounds in the pharmacy department included a review and/or assessment of the physical environment in the compounding area appropriate to current standards of practice.

Please refer to A701

Based on review of documentation, meeting minutes and reports, observation, and interviews with staff, the hospital failed to ensure that significant physical environment non-compliance that had been identified in the hospital's pharmacy compounding area were remedied to ensure that the pharmacy met current standards of practice in accordance with USP (United States Pharmacopeia) 797. In addition, the hospital failed to ensure that annual environmental rounds in the pharmacy department included a review and/or assessment of the physical environment in the compounding area appropriate to current standards of practice. The findings include:

Review of a report issued by a State Regulatory Agency (SRA) to the hospital on 11/3/15 identified that the pharmacy compounding area failed to meet USP 797 standards that became effective in 2014. The SRA report identified the need for documentation of observation and oversight of the compounding area, and evidence that USP 797 standards were followed and met.

The hospital submitted a plan of action to the SRA on 12/11/15. The initial plan did not address the physical environment non-compliance pending "meeting to be scheduled". Review of Governing Body minutes between 11/3/15 and 1/10/17 identified that the hospital was conducting a "feasibility" study for a new compounding area followed by the enlistment of an Architect. As of 1/10/17, the hospital had not submitted architectural plans to either of the two State Regulatory Agencies (Department of Public Health and Department of Consumer Protection).

The hospital failed to ensure that all areas of non-compliance addressed in the 11/3/15 report were corrected as evidenced by document reviews, observations, and interviews made on 1/10/17, 1/11/17, 1/12/17 and 1/13/17.

The areas of non-compliance identified in the 11/3/15 SRA report that have not been remediated as of 1/10/17 include:
a. The report identified that a multidisciplinary approach including Infection Control, Quality, Facilities, and other disciplines was needed to analyze and review the sterile product preparation area. Review of documents, reports and/or meeting minutes for the Environment of Care Committee between 11/3/15 and 1/10/17 failed to identified that the pharmacy's non-compliance in the compounding area was discussed, reviewed, analyzed, observed, and/or acted upon between identification on 11/3/15 and 1/10/17.

b. The report identified both hazardous and non-hazardous drugs are compounded in the same buffer room creating a positive pressure in the hazardous drug compounding LAFW (laminar air-flow workstation). The compounding of hazardous drugs is to occur in a negative pressure environment in accordance with USP 797. Observations and interviews with the Director of Pharmacy and Pharmacy Technician #1 on 1/10/17, 1/11/17 and on 1/12/17 at 1:15 PM identified that hazardous and non-hazardous drugs continue to be compounded in the same buffer room under the same positive pressure identified in the 11/3/15 SRA report.

c. The report identified that the physical structure of the ante room was non-compliant with USP 797 standards. Observations and interviews made on 1/10/17, 1/11/17 and on 1/12/17 at 1:15 PM identified that the ante room continued to be non-compliant with USP 797. The room lacks a ceiling mounted HEPA filter, ceiling tiles are not smooth and are not calked, a speaker in the ceiling is not cleanable, sprinkler heads are not flush with the ceiling, the walls are not painted with epoxy paint, there are integrity breaches in multiple areas of the walls and floor, and wall-mounted bins prevent appropriate cleaning in accordance with USP 797. Air pressure between the ante room and main pharmacy is not maintained when the door is opened. The doors to the ante room and buffer room are made of wood and the ante room sink is not appropriate to accommodate the specific hand washing technique in accordance with USP 797. The ante room is unable to be ISO (International Standards Organization) classified as a result of the physical structure non-compliance.

d. The report identified that the physical structure of the buffer room was non-compliant with USP 797 standards. Observations made on 1/10/17, 1/11/17 and 1/12/17 identified that buffer room continued to be non-compliant as the ceiling tiles are not contiguously calked, the juncture between the walls and ceiling are not calked, a speaker in the ceiling is not cleanable, and sprinkler heads are not flush with the ceiling. As identified in the SRA report, due to the physical structure non-compliance the pharmacy was instructed to compound IV (intravenous) medications not to exceed a 12-hour BUD.

e. Review of Pharmacy and Therapeutics Committee meeting minutes between 1/1/15 and 9/30/15 failed to identify that the pharmacy's compounding area did not meet USP 797 standards related to the physical environment in the compounding area and to compounding practices. Review of committee meeting minutes dated 11/9/15 and 12/14/15 identified that staff were working on an action plan for survey findings and that renovation plans were discussed. Minutes dated 2/8/16 identified that staff were working on writing SOP's (standard operating procedures) in response to the findings in the IV room. Between 11/3/15 and 1/10/17 the committee failed to address the significant non-compliance identified in the 11/3/15 SRA report to include physical environment, lack of SOP's, lack of documented training/re-training/competency and proficiency testing, lack of appropriate environmental testing and documentation, and failed to address the recommended multidisciplinary approach to analyze and review the sterile product preparation area.


f. Review of Governing Body minutes between 11/3/15 and 1/10/17 identified that the hospital was conducting a "feasibility" study for a new compounding area followed by the enlistment of an Architect. As of 1/10/17, the hospital had not submitted architectural plans to either of the two State Regulatory Agencies (Department of Public Health and Department of Consumer Protection).

The hospital arranged for an out-side consulting company to evaluate the pharmacy compounding area. The consultation report dated 8/31/16 identified that the compounding area does not comply with current USP 797 standards. Areas of identified non-compliance include: hazardous and non-hazardous drugs are compounded in the same room, non-compliant finishes including floors, walls, ceilings and HEPA filters, a comprehensive written environmental sampling plan including description of corrective actions needs to be developed, and required humidification is not provided.

Review of the annual Safety Inspection Checklist for the pharmacy dated 4/20/16 identified that the ceiling tiles were intact. However, the 11/3/15 SRA report and observation on 1/10/17, 1/11/17 and 1/12/17 at 1:15 PM identified that the ceiling tiles in the compounding area were not smooth and not calked in accordance with USP 797 standards.


The hospital's Safety Inspection Checklist identified that sprinkler heads were unobstructed and that stored items were at least 18 inches below the sprinkler deflector. However, the 11/3/15 SRA report and observation on 1/10/17, 1/11/17 and 1/12/17 at 1:15 PM identified that the sprinkler heads are not flush with the ceiling in accordance with USP 797. In addition, tour of the compounding area with the Director of Pharmacy on 1/11/17 at 11:00 AM identified that stored items were stacked approximately six inches from the ceiling and against the wall. A sprinkler head was visible in the middle of the room. The Director of Pharmacy identified that placement of items that close to the ceiling did not impede the function of the sprinkler system.

The Condition of Participation for Infection Control has not been met.
Based on review of documentation, meeting minutes, reports and interviews with staff, the hospital failed to ensure that the hospital-wide Infection Control efforts addressed priorities for infection prevention and patient safety that included significant findings identified in the hospital's pharmacy compounding area to ensure that the pharmacy met current standards of practice in accordance with USP (United States Pharmacopeia) 797. In addition, there were breeches in infection control practices and processes identified in the operating rooms/surgical services and in the central sterile processing area.

Please refer to A749

1. Based on review of documentation, meeting minutes, reports and interviews with staff, the hospital failed to ensure that the hospital-wide Infection Control efforts addressed priorities for infection prevention and patient safety that included significant findings identified in the hospital's pharmacy compounding area to ensure that the pharmacy met current standards of practice in accordance with USP (United States Pharmacopeia) 797. The findings include:

Review of a report issued by a State Regulatory Agency (SRA) to the hospital on 11/3/15 identified that the pharmacy compounding area failed to meet USP 797 standards that became effective in 2014. As a result of the significant non-compliance, the pharmacy was instructed to compound IV (intravenous) medications not to exceed a 12-hour BUD (beyond-use-date) from the time of compounding to the time of use.

Although the hospital submitted a plan of action to the SRA on 12/11/15, the hospital failed to ensure that all areas of non-compliance were corrected as evidenced by document reviews, observations and interviews made on 1/10/17, 1/11/17, 1/12/17 and 1/13/17.

The areas of non-compliance identified in the 11/3/15 SRA report that have not been remediated include in part, that a multidisciplinary approach including Infection Control and other disciplines was needed to analyze and review the sterile product preparation area.

Review of an environmental report dated 10/27/15 identified 8 CFU's (colony forming units) of fungus and 6 CFU's of bacteria noted in the ante room. Interview with the Director of Pharmacy on 1/12/17 at 1:15 PM identified that once known, he/she posted a note for staff to concentrate cleaning in the affected areas. The Director of Pharmacy did not document that appropriate remediation was performed and did not perform any retesting to ensure that the cleaning was effective. The next environmental testing was conducted on 3/16/16 and identified 1 CFU of fungus in the ante room.

Review of documents and/or meeting minutes for the Infection Control committee failed to identified that the continued non-compliance in the pharmacy compounding area was discussed, reviewed, analyzed, observed, and/or acted upon between identification on 11/3/15 and 1/10/17.

Interview with the Infection Preventionist (IP) on 1/13/17 at 1:50 PM identified that he/she was aware of the need to build a USP 797 compliant compounding area, but was not made aware of the other areas of significant and continued non-compliance related to infection control and prevention. The IP identified that his/her involvement with the pharmacy department was in regards to antibiotic stewardship and he/she was not involved in surveillance or tracking and trending of environmental culturing and testing of the compounding area.

Due to the continued non-compliance in the pharmacy compounding area, an action plan was requested by the Department on 1/13/17 and included moving from 12-hour BUD to a 1-hour BUD for all compounded drugs. Compounded drugs will be tracked and documented to ensure 1-hour BUD is adhered to and an infection control surveillance process will be implemented. The plan identified that on 1/13/17 the hospital would ensure that all pharmacy SOP's related to compounding will be reviewed and updated, staff will be educated/re-educated to the SOP's as they report to work, and education and competencies will be documented and tracked. A Pharmacist will provide oversight for pre and post compounding performed by technicians. Environmental cleaning and testing will be conducted and documented. All testing will be reported to the Infection Prevention Committee and the Quality Committee of the Board of Directors. The hospital submitted a timeline for the creation and completion of a new compounding area.



14528


2. Based on a tour of the facility, review of facility policies and practice, observations and interviews, the facility failed to ensure staff performed surgical skin preparation, medication administration, operating room (OR) cleaning, sterilization quality testing, donning of surgical attire, storage of surgical equipment and infection reporting in accordance with facility policies and/or manufacturer's guidelines and/or standards of practice. The finding includes:


a. A tour of the OR was conducted on 1/10/17 with the Quality Assurance (QA) Coordinator. Observation on 1/10/17 at 9:55 AM identified several laryngeal mask airways (LMA) stored on shelving in the anesthesia room. Further observation noted that one of the eight LMA's did not have an internal integrator inside of its packaging that would ensure that the device had been sterilized. Interview with the Manager of the Central Sterilizing department on 1/10/17 at 11:00 AM indicated that internal integrators are used with everything (sterilized). The facility policy entitled Wrapping Procedure Steam & ETO directed to put the article in the Steri- peel wrap along with integrator. The LMA without the integrator was subsequently removed from the anesthesia shelf for reprocessing.


b. A tour of the OR was conducted on 1/10/17 with the QA Coordinator. Observation on 1/10/17 at 10:03 AM identified that one of two waste management machines (Neptune) was clean and stored in the soiled utility room. Interview with the QA Coordinator at that time indicated that the cleaned machine was not supposed to be stored in a soiled area. Management staff subsequently directed OR staff to re- clean the machine and remove the machine from the soiled work area.


c. A tour of the OR was conducted on 1/10/17 with the QA Coordinator. Observation of OR #3 on 1/10/17 at 10:14 AM identified a locked glass cabinet that contained a bottle of isopropyl alcohol and a small stainless steel table with a drawer that contained white washcloths. Interview with RN #5 on 1/10/17 at 10:14 AM noted that the facility followed the Association of PeriOperative RN (AORN) standards in the operative setting. He/she further indicated that prior to the first case of the day OR staff wiped all horizontal surfaces with the isopropyl alcohol and a washcloth. Interview with the Infection Preventionist (IP) on 1/11/17 at 11:38 AM noted that Pericept and germicidal wipes were approved hospital cleaning solutions and was unaware that isopropyl alcohol was being used in the ORs. Although the OR infection control (IC) policy identified that all horizontal surfaces may be wiped with alcohol or hospital- approved disinfectant prior to the first case, the IC list of approved cleaning agents did not include 70% isopropyl alcohol as an OR cleaning agent. According to the 2016 AORN Guidelines for Perioperative Practice, page 8, alcohol should not be used to disinfect large environmental surfaces and is not an Environmental Protection Agency (EPA)- registered disinfectant.

d. Tour of the OR was conducted on 1/12/17 with the OR Operations Manager. Observation on 1/12/17 at 9:35 AM identified an orthopedic surgical case in progress in OR #3. The observations further noted that although the anesthesia provider donned a bouffant hair cover, wisps of hair was exposed at the front and sides of head. Interview with the OR Operations Manager at 9:34 Am on 1/12/17 indicated that all hair must be contained. An additional tour of the OR was conducted on 1/12/17 with the OR Operations Manager. Observation on 1/12/17 at 1:24 PM identified that the Surgeon for Patient #39 had donned a bouffant hair covering and sideburns were exposed approximately one inch on either side of the head. Interview with OR Operations Manager on 1/12/17 at 1:56 PM noted that sideburns should be covered.

The facility policy for OR dress code identified, in part, that all possible head and facial hair, including sideburns and neckline must be covered completely by a lint- free scrub hat or surgical hood in the restricted area of the surgical suite.


e. Patient #39 was admitted to the facility on 1/3/17. Observations of Patient #39's surgical procedure were conducted on 1/12/17. Observation on 1/12/17 at 1:24 PM noted that the nurse anesthetist opened the top of a medication vial (Versed) and accessed the rubber septum with needled syringe without the benefit of swabbing the vial first with an alcohol wipe. Interview with the Nurse Anesthetist on 1/12/17 at 1:56 Pm noted that he/she did not wipe the vial with an alcohol wipe because the vial was newly opened. Interview with the OR Operations Manager on 1/12/17 at 1:56 PM indicated that typically, if it was a newly opened vial, staff did not swab the septum with an alcohol wipe prior to access. Although the facility did not have a policy regarding single- use vials, the policy for multi- dose medication directed to disinfect the vials rubber septum before piercing by wiping (and using friction) with sterile 70% isopropyl alcohol solution. Allow the septum to dry before inserting a needle or other device into the vial.

According to the Centers for Disease Control and Prevention (CDC) March 2, 2011, parenteral medications should be accessed in an aseptic manner. This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it.

f. Patient #39 was admitted to the facility on 1/3/17. Observations of Patient #39's surgical procedure were conducted on 1/12/17. Observations at 1:24 PM identified that the circulator nurse, RN #5 was in the process of prepping the patient's right foot/lower leg with betadine (7.5%) for approximately four to five minutes and dried the area with disposable sterile towels. Observation at 1:28 PM noted that RN #5 painted the patient's right foot/lower leg with betadine (10%), the surgeon and RN #5 applied a stockinet to the patient's right foot/leg at 1:29 PM and an incision was made to the patient's right foot wound at 1:30 PM. The betadine was not allowed to air dry. A recap of the patient #39's surgical skin prep was provided to the IP on 1/13/17 at 2:20 PM. The IP indicated that the betadine needed time to dry to be effective. The facility IC policy for OR identified that the patient's operative site shall be prepped with a hospital approved antiseptic solution according to manufacturer's guidelines. Manufacturer's guidelines for betadine surgical scrub identified to apply scrub and scrub for 5 minutes, rinse with sterile gauze saturated with water and the area may be painted with betadine solution and allowed to dry. The manufacturer's recommendations for betadine 10% as a preoperative skin prep directed to clean the operative site prior to surgery, apply product and allow to dry.
In addition, OR staff meeting minutes dated 6/14/16 identified that physicians were not waiting for 3 minutes (ChloraPrep dry time (surgical skin prep)). IC, Quality and Department of Surgery meeting minutes dated 9/2016 through 11/2016 lacked documentation of and/or an action plan for the identified issue related to the skin prep. Department of Surgery meeting minutes dated 12/27/16 indicated that the WHO (surgical) checklist was discussed as well as skin prep drying time and draping. Interview with the IP on 1/13/17 at 2:16 PM noted that he/she was unaware of the inadequate waiting period for surgical prep dry- time. Although the issue related to skin prep dry time was identified during 9/2016, the issue was not discussed/addressed for greater than three months. The facility time- out form was revised 12/2016 to include the documentation for skin prep dry time. The facility IC policy for OR identified that the patient's operative site shall be prepped with a hospital approved antiseptic solution according to manufacturer's guidelines. The manufacturer's instructions for ChloraPrep directed to let the solution dry a minimum of 3 minutes.
According to the 2016 AORN Guidelines for Perioperative Practice, page 56, the antiseptic should be allowed to dry for the full time recommended in the manufacturer's instructions to improve the safety and efficacy of preoperative patient skin antisepsis.

g. Review of personnel files identified that Housekeeper #1 was employed by the facility from 7/21/16 to 12/6/16 and orientation on 7/26/15 included infection control. Interview with the Chief Medical Officer on 1/11/17 at 11:18 AM noted that Housekeeper #1 worked in the OR and Central Sterile Department for approximately two months with open hand/arm skin lesions. He/she further indicated that the areas were cultured and were methicillin sensitive. Interview with the IP on 1/11/17 at 11:26 AM noted that employees could not work with open lesions per policy and that once Housekeeper #1 was evaluated, he/she did not return to work. The facility IC training included the policy entitled Guidelines for IC in Health Care Personnel identified that health Care personnel must report promptly when they have certain illness/conditions such as generalized rash or skin lesions that are vesicular, pustular or weeping.

h. Review of personnel files identified that the OR Director was employed by the facility during 2016 and was terminated by the facility on 12/20/16. The termination leter for the OR Director dated 12/20/16 indicated that the OR Director floated three travel RNs to Central Sterile Supply (CSS) between 7/15/16 and 9/12/16. The letter further noted that although the OR Director reported that the three RNs had CSS experience, personnel file reviews identified that RN #7, #8 and #9 were travel RNs, worked in the OR, and had OR experience. However, There was no documentation that the RN's had experience, education, training and/or competency assessment to work in central sterile processing.
Interview with the Chief Nursing Officer (CNO) on 1/13/17 at 1:53 PM identified that RNS #7, #8 and #9 were sent to CSS by the OR Director and functioned as a Supervisor although they were not qualified to do so. He/she further indicated that although, as a result, issues were not identified, patients were placed at risk. The facility job description for CSS Supervisor identified that the ability to operate sterilizers/washers/decontaminators ultrasonic equipment and related equipment with knowledge of required standards and protocols for operating equipment and instrumentations was a required skill with at least 5 years CSS experience.