HospitalInspections.org

Based on observation, interview, and document review, the Critical Access Hospital (CAH) failed to ensure the Laminar flow hood (venting hood where medications are mixed in order to maintain sterility) had the required preventative maintenance every six months.
Findings include:
On 12/6/16 at 2:30 p.m. the Laminar flow hood in the pharmacy, was observed to have a service sticker indicating the last time the equipment had been tested and serviced was on 3/21/16. The sticker indicated the next scheduled service date was supposed to be September of 2016. The pharmacist, present during the observation, was unaware when the equipment had last been serviced, or when it was supposed to be serviced again. The pharmacist stated nursing staff use the hood to mix medications, mostly antibiotics.
On 12/7/16, at 10:00 a.m. the administrator stated the bio-hood was supposed to be serviced every 6 months. The administrator stated, after the last test date in March the company had sent an email to set up the next scheduled maintenance date however, the email was not received because the hospital had changed their email address.
The facility policy, Chemotherapy: Laminar Flow Hood, Care & Use dated 2/7/08, indicated the flow hood was supposed to be serviced according to manufacturer's recommendations, and was to be recertified every six months.

A copy of the manufacturer's recommendations were requested and not received.

Based on observation, interview and document review, the Critical Access Hospital (CAH) failed to ensure 1 of 1 negative pressure room (Room 1) was properly maintained and monitored.
Findings include:



32601

On 12/6/16, at 1:00 p.m. during the physical plant tour, inpatient Room 1 was observed to have the capabilities of being converted to a negative pressure room (a room which had a ventilation system that generated a negative pressure to allow air to flow into the isolation room, while preventing contaminated air from escaping the isolation room). At the time of the tour, the maintenance director confirmed Room 1 had been a negative pressure room since about 1996. The maintenance director further stated the staff at the CAH had not routinely tested or monitored the negative pressure ventilation system in Room 1.
A policy for routine maintenance and monitoring of the negative pressure room was requested however, none was provided.

Based on interview and document review, the critical access hospital (CAH) failed to develop a plan to ensure the amount of propane needed was available in the event of an emergency. This had the potential to affect all patients and staff who received services at the CAH.
Findings include:
The Emergency Fuel Oil and Propane Back-Up Agreement between the CAH and Superior Fuel Company was signed on 12/6/16. The agreement indicated the Superior Fuel Company would deliver propane to the CAH at any time, and set up an emergency tank or other means so the CAH would have a supply of propane until the CAH repaired the problem. However, the agreement lacked specifications of the amount of propane that would be needed or made available in the event of an emergency.
On 12/6/16, at 1:00 p.m. the maintenance director confirmed the emergency fuel agreement with Superior Fuel Company had just been signed. In addition, he stated the CAH had a prior agreement with Superior Fuel Company, however they had been unable to locate it, so a new one had been obtained today.
On 12/7/16, at 9:00 a.m. the maintenance director verified the Emergency Fuel Oil and Propane Back-Up Agreement between the CAH and Superior Fuel Company, failed to indicate the quantity of propane that would be needed in the event of an emergency, nor did the CAH have an emergency fuel preparedness plan/policy.

Based on staff interview and document review, the critical access hospital (CAH) failed to ensure there was an effective governing body, or individual to assume full legal responsibility to determine, implement and monitor policies governing the total operation and to ensure policies were implemented to provide quality health care in a safe environment. The CAH's failure to ensure the governing body monitored, reviewed and approved the hospital policies and procedures to provide quality health care in a safe environment had the potential to affect all patients who receive care at the CAH.

The findings include:

Review of the CAH's pharmacy policies revealed the following policies and procedures had not been reviewed annually, or revised when appropriate, to reflect current hospital practices:
Pharmacy: Crash Cart Policy & Procedures failed to reflect a review or revision date since the policy's effective date of 9/2008. The policy indicated medications that were stocked were to be suggested by the P&T committee. However, when interviewed on 12/6/16 at 2:00 p.m., the CAH's pharmacist stated the hospital no longer utilized a P&T committee, but rather the committee's functions were now part of the medical staff meetings.
Pharmacy: Narcotic Procedure-Inpatient and Narcotic Procedure-Swing Bed did not reflect review or revision since the policy effective date of 7/2009. Per the interview with the pharmacist at 2:00 p.m. on 12/6/16, the hospital used electronic cabinets for dispensing which was not consistent with the policy.
Pharmacy: Adverse Drug Reactions and Drug Interactions Investigation Of, did not reflect a review or revision since the effective date of 12/2008. The procedure instructed staff to complete a paper form. Per interview with the pharmacist at 2:00 p.m. on 12/6/16, the facility currently utilized a computer program for medication monitoring/reporting.
Pharmacy: Medication and Treatment Errors, was last reviewed/revised on 8/15/06 with no evidence of annual review since that date. The procedure instructed staff to complete a paper form. Per interview with the pharmacist at 2:00 p.m. on 12/6/16, the facility currently utilized a computer program to record medication error reports and investigations.
Pharmacy: Self Administration of Medications by Patients, was last reviewed/revised in March of 2006 with no further evidence of annual review since that date.
Pharmacy: Prescriptions-Dispensing Medication from the Pharmacy was last reviewed/revised in September of 2008 with no further evidence of annual review since that time.
Pharmacy: Emergency Access was last reviewed/revised on 12/19/06 with no further evidence of annual review since that time.
Pharmacy: Medication Brought To the Hospital By the Patient was last reviewed/revised in July of 2009 with no further evidence of annual review since that time.
Chemotherapy: Laminar Flow Hood, Care and Use was last reviewed/revised on 9/9/08 with no evidence of annual review since that time. Policies for compounding medications had not been developed although CAH staff routinely compounded antibiotic medication.
During an interview on 12/7/16 at 9:30 a.m., the hospital pharmacist indicated up until recently hours at the hospital pharmacy had been limited to 2-3 hours per day so there had been limited opportunity to review policies. The pharmacist verified the pharmaceutical policies required review and editing. The pharmacist further indicated she had a total of 34 policies that were waiting for review.
The CAH's infection control policies had not been reviewed and revised since 4/1/14, and policies for clostridium difficile (C-diff) and antibiotic stewardship, had not been developed or implemented. Further, policies directing appropriate techniques for cleaning and disinfecting procedures rooms between patients had not been developed. Nor had the CAH's policies for infection surveillance, including identification and monitoring of nosocomial infections, been implemented.

3. Surgical services policies including policies and procedures related to colonoscopy, had not been reviewed and revised since 3/14/14. The following colonoscopy policies and procedures had an effective date of 3/14/14 with no evidence of annual review since that time: Colonoscopy, Disposal of Cidex OPA Solution, Sedation, and Use of Electrosurgical Unit.
4. Nursing services policies that had not been developed included: policy development for mandatory training requirements and policies to ensure continued competencies in special areas such as administering medication for moderate sedation, reprocessing of endoscopes, personal protective equipment use.
Review of the CAH's Governing Body By-Laws dated as effective 5/19/16, indicated the Administrator was an executive representative of the Board in management of the hospital, and shall have all the duties and authority which such a position would customarily require, including, but not limited to the following: Being responsible for implementing established policies in the operation of the Hospital.

The governing body meeting minutes were reviewed from December 2015-December 2016. The meeting minutes lacked any documented evidence the governing body had reviewed and approved the duties and authority of the administrator's responsibilities.

Based on interview and document review the Critical Access Hospital (CAH) failed to ensure policies and procedures that govern compounded sterile preparations (CSPs) had been developed, lacked evidence of medical staff involvement for development and annual review of pharmacy policies and procedures, failed to have documented training and competency testing of staff who compounded medications, and failed to complete routine testing to verify accuracy and sterility according to Untied States Pharmacopeial Convention chapter <797> (USP <797>).
Findings include:
Compounded Sterile Preparations
On 12/6/16, pharmacist stated the CAH compounded medications on site, was performed by registered nurses, and were mostly intravenous (IV) antibiotics and indicated the preparation were low risk. Pharmacist stated all medications that are compounded have to be mixed underneath the Laminar Venting Hood. Pharmacist explained she was a contracted employee and her liability insurance did not permit to compound medications. Pharmacist stated she was in the process of becoming a full time hospital employee at which time she would be under hospital insurance that would allow her to compound medications.
On 12/7/16, pharmacist stated she did not know anything about the Laminar venting hood testing, what training and competency requirements were, and was not aware if training or competency testing had been completed, and was not aware of any routine testing to ensure sterility and accuracy of the prepared medications.
On 12/7/16, registered nurse (RN)-G stated she had compounded antibiotics and all medications had to be mixed under the venting hood. RN-G stated she had received on the job training by watching someone else, and a formal checklist had not been used. RN-G stated the personal protective equipment that was required was gloves. RN-G was not aware of any kind of testing to ensure sterility or accuracy of the compounded medications.
On 12/7/16, RN-H stated all mixing was done under the venting hood, personal protective equipment was dependent upon the medication that was being mixed and was unable to give specific examples. RN-H was not aware of any specific actual procedures for compounding different medications or testing and was not aware of any specific training required. RN-H indicated they had not tested for accuracy or sterility of any of their [RN-H} compounded medications.
On 12/7/16, the administrator stated an unawareness if training and competency testing had been completed by nursing compounding medications.
On 12/8/16, RN-C stated she was just put in charge of infection control a short time ago. Stated she was not able to find policies and procedures for compounding medications, and stated there should be. RN-C reported she was not able to locate training and competencies for staff who compounded medications. RN-C was not aware of any specific infection control procures pertaining to compounding medications.
UPS<797> Pharmaceutical Compounding Sterile Preparations included the following as requirements for compounding sterile preparations (CSPs):
Qualified licensed healthcare professionals who supervise compounding and dispensing of CSPs shall ensure that the following objectives are achieved: Compounding personnel are adequately skilled, educated, instructed, and trained to correctly perform and document the following activities in their sterile compounding duties: Perform antiseptic hand cleansing and disinfection of nonsterile compounding duties: a. perform antiseptic hand cleansing and disinfection of nonsterile compounding surfaces; b. select and appropriately don protective garb.
UPS <797> indicated the following requirements for low risk CSPs:
-Personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel, multi-media instruction sources, and professional publications in the theoretical principals and practical skill of garbing procedures, aseptic work practices, achieving and maintaining ISO Class 5 environment conditions, and cleaning and disinfection procedures.
-This training shall be completed and documented before any compounding personnel begin to prepare CSPs.
-Compounding personnel shall complete didactic training, pass written competence assessments, undergo skill assessment using observational tools and media-fill testing.
-Media-fill testing of aseptic work skills shall be performed initially before beginning to prepare CSPs and at least annually thereafter for low and medium risk level compounding.
-Compounding personnel must demonstrate proficiency of proper hand hygiene, and garbing, and consistent cleaning procedures in addition to didactic evaluation and aseptic media-fill.
-Support personnel shall routinely undergo performance evaluations of proper hand hygiene, garbing, and all applicable cleaning and disinfecting procedures conducted by a qualified compounding expert.
Pharmacy policies and procedures
Policies and procedures were reviewed; the medical staff meeting minutes for the last year lacked evidence of medical staff or governing body involvement for recommendations of policy development or involvement in annual policy review and/or revision.
Pharmacy policy review revealed the following policies and procedures had not been annually reviewed and when appropriate revised to reflect current hospital practices:
Pharmacy: Crash Cart Policy & Procedures did not reflect a review or revision date since the policy effective date of 9/08. The policy indicated the medications that were stocked are suggested by the P&T committee. Per interview with the pharmacist on 12/6/16, the hospital no longer utilized a P&T committee and the committee's functions were now part of the medical staff meetings.
Pharmacy: Narcotic Procedure-Inpatient and Narcotic Procedure-Swing Bed did not reflect review or revision since the policy effective date of 7/09. Per interview with the pharmacist on 12/6/16, the hospital used electronic cabinets for dispensing which was not consistent with the policy.
Pharmacy: Adverse Drug Reactions and Drug Interactions Investigation Of, did not reflect a review or revision since the effective date of 12/08. The procedure instructed staff to complete a paper form. Per interview with the pharmacist on 12/6/16, the facility used a computer program called Clarity.
Pharmacy: Medication and Treatment Errors, was last reviewed/revised on 8/15/06, with no evidence of annual review since that date. The procedure instructed staff to complete a paper form. Per interview with the pharmacist on 12/6/16, the facility used a computer program call Clarity for medication error reporting and investigating.
Pharmacy: Self Administration of Medications by Patients, was last reviewed/revised 3/06, with no further evidence of annual review since that date.
Pharmacy: Prescriptions-Dispensing Medication from the Pharmacy was last reviewed/revised 9/08, with no further evidence of annual review since that time.
Pharmacy: Emergency Access was last reviewed/revised on 12/19/06, with no further evidence of annual review since that time.
Pharmacy: Medication Brought To the Hospital By the Patient was last reviewed/revised 7/09, with no further evidence of annual review since that time.
Chemotherapy: Laminar Flow Hood, Care and Use was last reviewed/revised on 9/9/08, with no evidence of annual review since that time.
Policies that were requested and not received included: administration of sedation by qualified staff other than a physician, compounding of medications, and competency and training requirements for compounding medications.
During an interview on 12/7/16, hospital pharmacist indicated up until recently hours at the hospital pharmacy were limited to 2-3 hours per day, and has not had the opportunity to review the policies. Pharmacist stated they do need to be reviewed. Pharmacist further indicated she had a total of 34 policies that were waiting for review.
Per interview on 12/8/16, with registered nurse (RN)-C the policies requested could not be found.
On 12/7/16, the administrator stated policies and procedure review is completed when staff have opportunities, and as changes occur; the focus is always patient care first and then paperwork.
The CAH's Medical Staff Bylaws last revised 8/12 included the Chief of the Medical Staff would receive and interpret the policies of the Board to the Medical Staff. The Chief would report to the Board on the performance and maintenance of quality, with respect to delegated responsibilities of the Medical Staff to provide medical care. The medical staff shall develop and recommend procedures relating to selection, distribution, handling, use and administration of drugs and diagnostic testing materials.
Pharmacy Services Agreement signed by the pharmacist and administrator on 10/14/16, indicated services provided by the pharmacist would include:
-Collaboration with facility leadership and staff to coordinate all pharmacy and pharmacist services
-Maintain thorough knowledge about facility pharmacy practices, management and requirements
-Evaluate develop, revise and implement pharmacy policies and procedures consistent with all applicable regulatory requirements. Review and verify that pharmacy policies and procedures are being followed.
-Oversee the Facility's procedures for control and accountability of all drugs and biologicals throughout the facility and assure that such drugs and biologicals are approved, dispensed, and stored in compliance with federal and state laws, included but not limited to the controlled substance act and the facilities own policies and procedures.
-Develop written procedures regarding the reporting and analysis of adverse drug reactions and errors in administration of drugs.
The CAH's policy and procedure CAH Policy Review was last reviewed/revised 11/10. The policy directed "To ensure that recommended review and revisions of department policies and Medical Staff Bylaws with a group of professionals are implemented." The policy directed policies to be reviewed included rules for the storage, handling, dispensation, and administration of drugs and biologicals; procedures for reporting adverse reactions and errors in administration of drugs; department policies and procedures; and Medical Staff Bylaws and Rules and Regulations will be reviewed annually. The policy indicated pharmacy policies and procedures would be completed annually in December.

Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure medical staff involvement with development and annual review/revision of hospital policies, and failed to ensure annual policy reviews were conducted to ensure adequacy of the policies. These failures had the potential to affect any patients who receive services at the CAH.
The findings include:

Review of the CAH's pharmacy policies revealed the following policies and procedures had not been reviewed annually, or revised when appropriate, to reflect current hospital practices:

Pharmacy: Crash Cart Policy & Procedures failed to reflect a review or revision date since the policy's effective date of 9/2008. The policy indicated medications that were stocked were to be suggested by the P&T committee. However, when interviewed on 12/6/16 at 2:00 p.m., the CAH's pharmacist stated the hospital no longer utilized a P&T committee, but rather the committee's functions were now part of the medical staff meetings.

Pharmacy: Narcotic Procedure-Inpatient and Narcotic Procedure-Swing Bed did not reflect review or revision since the policy effective date of 7/2009. Per the interview with the pharmacist at 2:00 p.m. on 12/6/16, the hospital used electronic cabinets for dispensing which was not consistent with the policy.

Pharmacy: Adverse Drug Reactions and Drug Interactions Investigation Of, did not reflect a review or revision since the effective date of 12/2008. The procedure instructed staff to complete a paper form. Per interview with the pharmacist at 2:00 p.m. on 12/6/16, the facility currently utilized a computer program for medication monitoring/reporting.

Pharmacy: Medication and Treatment Errors, was last reviewed/revised on 8/15/06 with no evidence of annual review since that date. The procedure instructed staff to complete a paper form. Per interview with the pharmacist at 2:00 p.m. on 12/6/16, the facility currently utilized a computer program to record medication error reports and investigations.

Pharmacy: Self Administration of Medications by Patients, was last reviewed/revised in March of 2006 with no further evidence of annual review since that date.

Pharmacy: Prescriptions-Dispensing Medication from the Pharmacy was last reviewed/revised in September of 2008 with no further evidence of annual review since that time.

Pharmacy: Emergency Access was last reviewed/revised on 12/19/06 with no further evidence of annual review since that time.

Pharmacy: Medication Brought To the Hospital By the Patient was last reviewed/revised in July of 2009 with no further evidence of annual review since that time.

Chemotherapy: Laminar Flow Hood, Care and Use was last reviewed/revised on 9/9/08 with no evidence of annual review since that time. Policies for compounding medications had not been developed although CAH staff routinely compounded antibiotic medication.

During an interview on 12/7/16 at 9:30 a.m., the hospital pharmacist indicated up until recently hours at the hospital pharmacy had been limited to 2-3 hours per day so there had been limited opportunity to review policies. The pharmacist verified the pharmaceutical policies required review and editing. The pharmacist further indicated she had a total of 34 policies that were waiting for review.

The CAH's infection control policies had not been reviewed and revised since 4/1/14, and policies for clostridium difficile (C-diff) and antibiotic stewardship, had not been developed or implemented. Further, policies directing appropriate techniques for cleaning and disinfecting procedures rooms between patients had not been developed. Nor had the CAH's policies for infection surveillance, including identification and monitoring of nosocomial infections, been implemented.

3. Surgical services policies including policies and procedures related to colonoscopy, had not been reviewed and revised since 3/14/14. The following colonoscopy policies and procedures had an effective date of 3/14/14 with no evidence of annual review since that time: Colonoscopy, Disposal of Cidex OPA Solution, Sedation, and Use of Electrosurgical Unit.

4. Nursing services policies that had not been developed included: policy development for mandatory training requirements and policies to ensure continued competencies in special areas such as administering medication for moderate sedation, reprocessing of endoscopes, personal protective equipment use.

Per interview with registered nurse (RN)-C the policies requested could not be found.

Review of the CAH's Governing Body By-Laws dated as effective 5/19/16, indicated the Administrator was an executive representative of the Board in management of the hospital, and shall have all the duties and authority which such a position would customarily require, including, but not limited to the following: Being responsible for implementing established policies in the operation of the Hospital.

The governing body meeting minutes were reviewed from December 2015-December 2016. The meeting minutes lacked any documented evidence the governing body had reviewed and approved the duties and authority of the administrator's responsibilities.

On 12/7/16 at 9:30 a.m., the administrator stated policy and procedure reviews were completed when staff have the opportunity, and as changes occur. The administrator further stated the focus is always patient care first, then paperwork.
The CAH's Medical Staff Bylaws last revised 9/12 included; The Chief of the Medical Staff would receive and interpret policies of the Board to the Medical Staff. The Bylaws indicated the Chief of the Medical Staff would report to the board on the performance and maintenance of quality with respect to delegated responsibilities of the Medical Staff to provide medical care. The medical staff shall develop and recommend procedures relating to selection, distribution, handling, use and administration of drugs and diagnostic testing materials.

The CAH's policy and procedures for policy reviews last reviewed/revised November of 2010, directed "To ensure that recommended review and revisions of department policies and Medical Staff Bylaws with a group of professionals are implemented." The policy indicated CAH policies to be reviewed included: Rules for the storage, handling, dispensation, and administration of drugs and biologicals, procedures for reporting adverse reactions and errors in administration of drugs, and department policies and procedures, Medical Staff Bylaws and Rules and Regulations were to be reviewed annually. The policy indicated pharmacy policies and procedures would be completed annually in December.

Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure policies and procedures that govern compounded sterile preparations (CSPs) had been developed, lacked evidence of medical staff involvement for development and annual review of pharmacy policies and procedures, failed to have documented training and competency testing of staff who compounded medications, and failed to complete routine testing to verify accuracy and sterility according to Untied States Pharmacopeial Convention chapter <797> (USP <797>).
Findings include:
Compounded Sterile Preparations
On 12/6/16, pharmacist stated the registered nurses (RNs) at the CAH compounded medications on site, mostly intravenous (IV) antibiotics, and that the preparations were considered low risk. The pharmacist stated any medications that are compounded have to be mixed underneath the Laminar Venting Hood. The pharmacist further explained she was a contracted employee so her liability insurance did not permit her to compound medications. Pharmacist stated she was in the process of becoming a full time hospital employee at which time she would be under hospital insurance that would allow her to compound medications.
During interview on 12/7/16, at 2:00 p.m., the pharmacist stated she did not know anything about the Laminar vent hood maintenance including testing, what training and competency requirements were required for use, and she stated she was unaware whether training or competency testing had been completed for the RNs, and was not aware of any routine testing to ensure sterility and accuracy of the prepared medications.
On 12/7/16 at 2:30 p.m., RN-G stated she had compounded antibiotics and all medications had to be mixed under the venting hood. RN-G stated she had received on the job training by watching someone else, but that a formal checklist had not been used. RN-G stated the personal protective equipment required included to wear gloves. RN-G was not aware of any kind of testing to ensure sterility or accuracy of the compounded medications.
On 12/7/16 at 3:00 p.m., RN-H stated all compounding of antibiotics was done under the venting hood, and stated personal protective equipment utilized was dependent upon the medication that was being mixed however, she was unable to give specific examples. RN-H was not aware of any specific procedures for compounding different medications or testing, and was not aware of any specific training required.
On 12/7/16, at 3:15 p.m., the administrator stated an unawareness as to whether training and competency testing had been completed for RNs who compounded medications.
On 12/8/16 at 8:30 a.m., RN-C stated she had just been assigned to be in charge of the CAH's infection control program recently. RN-C stated she was unable to find policies and procedures for compounding medications. RN-C also stated she was unable to locate training and competencies for RNs who compounded medications. RN-C was not aware of any specific infection control procedures pertaining to compounding medications.
UPS<797> Pharmaceutical Compounding Sterile Preparations included the following as requirements for compounding sterile preparations (CSPs):
Qualified licensed healthcare professionals who supervise compounding and dispensing of CSPs shall ensure that the following objectives are achieved: Compounding personnel are adequately skilled, educated, instructed, and trained to correctly perform and document the following activities in their sterile compounding duties: Perform antiseptic hand cleansing and disinfection of nonsterile compounding duties: a. perform antiseptic hand cleansing and disinfection of nonsterile compounding surfaces; b. select and appropriately don protective garb.
UPS <797> indicated the following requirements for low risk CSPs.
-Personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel, multi-media instruction sources, and professional publications in the theoretical principals and practical skill of garbing procedures, aseptic work practices, achieving and maintaining ISO Class 5 environment conditions, and cleaning and disinfection procedures.
-This training shall be completed and documented before any compounding personnel begin to prepare CSPs.
-Compounding personnel shall complete didactic training, pass written competence assessments, undergo skill assessment using observational tools and media-fill testing.
-Media-fill testing of aseptic work skills shall be performed initially before beginning to prepare CSPs and at least annually thereafter for low and medium risk level compounding.
-Compounding personnel must demonstrate proficiency of proper hand hygiene, and garbing, and consistent cleaning procedures in addition to didactic evaluation and aseptic media-fill.
-Support personnel shall routinely undergo performance evaluations of proper hand hygiene, garbing, and all applicable cleaning and disinfecting procedures conducted by a qualified compounding expert.
Pharmacy policies and procedures
Review of the CAH's pharmacy policies revealed the following policies and procedures had not been reviewed annually, or revised when appropriate, to reflect current hospital practices:

Pharmacy: Crash Cart Policy & Procedures failed to reflect a review or revision date since the policy's effective date of 9/2008. The policy indicated medications that were stocked were to be suggested by the P&T committee. However, when interviewed on 12/6/16 at 2:00 p.m., the CAH's pharmacist stated the hospital no longer utilized a P&T committee, but rather the committee's functions were now part of the medical staff meetings.

Pharmacy: Narcotic Procedure-Inpatient and Narcotic Procedure-Swing Bed did not reflect review or revision since the policy effective date of 7/2009. Per the interview with the pharmacist at 2:00 p.m. on 12/6/16, the hospital used electronic cabinets for dispensing which was not consistent with the policy.

Pharmacy: Adverse Drug Reactions and Drug Interactions Investigation Of, did not reflect a review or revision since the effective date of 12/2008. The procedure instructed staff to complete a paper form. Per interview with the pharmacist at 2:00 p.m. on 12/6/16, the facility currently utilized a computer program for medication monitoring/reporting.

Pharmacy: Medication and Treatment Errors, was last reviewed/revised on 8/15/06 with no evidence of annual review since that date. The procedure instructed staff to complete a paper form. Per interview with the pharmacist at 2:00 p.m. on 12/6/16, the facility currently utilized a computer program to record medication error reports and investigations.

Pharmacy: Self Administration of Medications by Patients, was last reviewed/revised in March of 2006 with no further evidence of annual review since that date.

Pharmacy: Prescriptions-Dispensing Medication from the Pharmacy was last reviewed/revised in September of 2008 with no further evidence of annual review since that time.

Pharmacy: Emergency Access was last reviewed/revised on 12/19/06 with no further evidence of annual review since that time.

Pharmacy: Medication Brought To the Hospital By the Patient was last reviewed/revised in July of 2009 with no further evidence of annual review since that time.

Chemotherapy: Laminar Flow Hood, Care and Use was last reviewed/revised on 9/9/08 with no evidence of annual review since that time. Policies for compounding medications had not been developed although CAH staff routinely compounded antibiotic medication.

During an interview on 12/7/16 at 9:30 a.m., the hospital pharmacist indicated up until recently hours at the hospital pharmacy had been limited to 2-3 hours per day so there had been limited opportunity to review policies. The pharmacist verified the pharmaceutical policies required review and editing. The pharmacist further indicated she had a total of 34 policies that were waiting for review.
The medical staff meeting minutes for the last year lacked evidence of medical staff or governing body involvement for recommendations of policy development or involvement in annual policy review
On 12/7/16, the administrator stated policies and procedure review is completed when staff have opportunities and as changes occur; the focus is always patient care first and then paperwork.
The CAH's Medical Staff Bylaws revised 8/12, directed The Chief of the Medical Staff would receive and interpret the policies of the Board to the Medical Staff. The Chief would report to the board on the performance and maintenance of quality with respect to delegated responsibilities of the Medical Staff to provide medical care. The medical staff shall develop and recommend procedures relating to selection, distribution, handling, use and administration of drugs and diagnostic testing materials.
The facility's Pharmacy Services Agreement signed by the pharmacist and administrator on 10/14/16, indicated services provided by the pharmacist would include:
-Collaboration with facility leadership and staff to coordinate all pharmacy and pharmacist services
-Maintain thorough knowledge about facility pharmacy practices, management and requirements
-Evaluate develop, revise and implement pharmacy policies and procedures consistent with all applicable regulatory requirements. Review and verify that pharmacy policies and procedures are being followed.
-Oversee the Facility's procedures for control and accountability of all drugs and biologicals throughout the facility and assure that such drugs and biologicals are approved, dispensed, and stored in compliance with federal and state laws, included but not limited to the controlled substance act and the facilities own policies and procedures.
-Develop written procedures regarding the reporting and analysis of adverse drug reactions and errors in administration of drugs.
The CAH policy for Policy Review reviewed/revised November 2010, included: "To ensure that recommended review and revisions of department policies and Medical Staff Bylaws with a group of professionals are implemented." The policy indicated policies to be reviewed included: Rules for the storage, handling, dispensation, and administration of drugs and biologicals, procedures for reporting adverse reactions and errors in administration of drugs, and Department policies and procedures and Medical Staff Bylaws and Rules and Regulations will be reviewed annually. The policy indicated pharmacy policies and procedures would be completed annually in December.

Based on interview and document review, the critical access hospital (CAH) failed to develop and maintain an ongoing, comprehensive infection control surveillance program related to the tracking and trending of infections. In addition, the CAH failed to ensure the physical therapy (PT), occupational therapy (OT), radiology and endoscopy departments were appropriately disinfecting equipment between patients. This deficient practice had the potential to affect any patients who might receive PT, OT, radiology or endoscopy services at the CAH.

Findings include:

During interview regarding the CAH's infection control practices, on 12/7/16 from 9:00-11:00 a.m., registered nurse (RN)-C stated she was responsible for the CAH's infection control program. RN-C stated she'd been newly assigned the responsiblity. RN-C further stated the facility did not have an infection control committee. RN-C stated there was limited information shared regarding infections in the hospital at the facility's monthly quality assurance (QA) meetings. She stated the CAH had no current system, or historical data, to show how the CAH tracked cultures, catheter use, need for patients on isolation precautions, or hospital acquired infections.

RN-C was asked to supply the last 12 months of infection control logs for CAH inpatients. RN-C stated that she had no infection control logs to provide for any of the months requested, but had initiated an inpatient infection tracking log earlier that morning. RN-C also stated the CAH currently had two patients on the nursing unit in isolation precautions for C-difficile and pneumonia. When RN-C was asked to provide the CAH's policy related to caring for patients with C-difficile, RN-C stated the facility did not have policies/procedures for caring for patients with C-difficile.

The CAH's infection control policy and procedures were reviewed with RN-C. The CAH infection control policy and procedure 3125-IC-C9 dated 4/1/14, identified the facility Administrator was responsible and accountable for the facility's overall infection control program which was designated to prevent or reduce the risk of transmission of potentially infectious agents between patients, employees and visitors. Infection control policy and procedure 3125-IC-F1 dated 4/1/14, identified: A total house surveillance will be done on all Hospital and Care Center positive cultures to monitor for nosocomial infections. The procedure directed the infection control officer to complete a chart review of each patient who had a positve culture to determine community acquired versus nosocomial infection, and each chart logged on the Report of Infection Control Data Sheet where quarterly the infections would be evaluated and summarized and negative trends would be communicated. Further review of CAH policies revealed the CAH infection control program had not developed or implemented any antibiotic stewardship policies or procedures.

Review of the Cook County North Shore Hospital and Care Center Medical Staff Bylaws approved by the Medical Staff 8/15/12, identified the following related to Infection Control Functions: "The Medical Staff shall be responsible for the surveillance of inadvertent Hospital infection potentials, the review and analysis of actual infections, the promotion of a preventive and corrective program designed to minimize infection hazards and the supervision of infection control in all phases of the Hospital's activities." Additionally, under the section Pharmacy and Therapeutics Functions the Bylaws directed the Medical Staff to "Review the appropriateness, safety, and effectiveness of the prophylactic, empiric and therapeutic use of antibiotics in the Hospital."

The Medical Director was interviewed on 12/8/16, at 11:45 a.m. and confirmed that there were no members of the active medical staff involved with infection control surveillance or the review and analysis of actual infections, infection control policy & procedure development and implementation, or antibiotic stewardship activities.





32601

On 12/6/16, during the initial tour of the PT/OT department from 2:00 p.m. until 2:45 p.m. the physical therapy director (PTD) stated the exercise equipment in the PT/OT area were only cleaned by housekeeping staff about three times a week. PTD confirmed the PT/OT staff had not routinely cleaned the exercise equipment after each patient use, this included equipment such as the parallel bars, exercise bikes, weights, Nu-Step, treadmills, exercise balls and sensory items (not an inclusive list). Located on a metal shelving unit was a large tumble ball which had a 3 inch by 1 ½ inch chunk gauged out of it which exposed yellow foam. PTD confirmed it was not a cleanable surface and the tumble ball "should possibly be tossed". Located in the physical therapy treatment rooms identified as the "traction room" and "mat room" were large metal coffee/juice cans that had been covered with a white hand towel which had turned a dingy gray on the edges of the towel. The towels were taped to the cans. PTD stated the towel covered/padded cans were used on patients as they placed the cans under the patients' knees as an extender. PTD was unsure of when the last time the towels had been washed and confirmed the towels looked dingy. In addition, in the OT gym area PTD confirmed the foam floor mats were not disinfected after each patient use, nor the patient care equipment such as the balls and sensory items.
On 12/7/16, during the initial tour of the radiology department the radiology supervisor (RS) stated the mammogram machine's compression paddles receptor plate were sprayed and wiped down with soap and water solution after each patient use, unless the patient's breast had a discharge, then the Oxivar Tb Wipe (an EAP approved disposable disinfecting wipe) was used.
SPD/Infection Control policy dated 7/11, indicated all equipment that comes in contact with a patient must be wiped down after each use with an Oxivar clothe.
Maintenance and Cleaning Compression Paddles and Receptor Plate policy dated 8/1/16, indicated a lint free cloth or pad and applied diluted dishwashing liquid or Oxivir Tb wipe would be used to clean the mammography machine between each patient use.
Cook County North Shore Hospital & Care Center Infection Control Manual & Exposure Plan - Section E1 &: Physical Therapy indicated all physical therapy equipment used in conjunction with treatment of the patient having open wounds and/or known infection shall be cleaned appropriately to prevent the spread of infection to other patients and staff.






34985

DISINFECTING/SANITIZATION OF PROCEDURE ROOM BETWEEN PATIENTS
Following the colonoscopy procedure on 12/6/16, RN-D, RN-E, and RN-F wiped down procedure room surfaces and equipment using Sani-Cloth Germicidal Wipes. The areas that were wiped down remained moist for less than 1.5 minutes. RN-D and RN-E both stated they were not aware of any contact time requirement or if the Sani-Cloths were effective against Clostridium Difficile (C-Diff: a contagious bacterial organism that is prevalent in the gastrointestinal track) when used appropriately, and reported they changed to the Sani-Cloths some time ago, however could not remember when.
The label on the Sani-Cloth Germicidal wipes in bold letters directed, "Contact time is 10 minutes unless otherwise noted below" and the wipes were not effective against Clostridium Difficile. No other contact times were listed. The instructions also directed treated surfaces must remain visibly wet for a full 10 minutes, and to let air dry. The label also included direction, not to be used as a terminal/high level disinfectant on any surface The manufacturer's pamphlet provided indicated the wipes were a low level disinfectant and were bleach free.
During an interview on 10/7/16, the infection control registered nurse RN-C expressed an unawareness of how the room was disinfected between patients, and what was being used to disinfect the room. RN-C stated the disinfectant used should be effective against C-Diff, because of the procedures being performed. RN-C indicated a bleach solution should be used as a disinfectant against C-Diff. RN-C was not able to find a policy or procedure for procedure room cleaning/disinfecting.
During an interview on 10/7/16, the administrator was not aware of how the procedure room was cleaned.

Based on observation, interview and document review, the facility failed to implement systems to ensure surgical services would be provided in a safe manner, including appropriate cleaning of surgical suites and equipment, administration of anesthesia, and obtaining properly executed informed consents for 2 of 2 surgical patients (S1, S2) whose records were reviewed. The cumulative effect of this systemic problem resulted in the CAH's inability to ensure the provision of quality health care in a safe environment.

The findings include:
DISINFECTING/SANITIZATION OF PROCEDURE ROOM BETWEEN PATIENTS
Following observation of a colonoscopy procedure on 12/6/16, registered nurses (RN)-D, RN-E, and RN-F were observed to wipe down the procedure room surfaces and equipment using Sani-Cloth Germicidal Wipes. The areas that were wiped down remained moist for less than 2 minutes. RN-D and RN-E were interviewed at the time and both stated they were unaware of a required contact time. In addition, neither of these RNs were aware whether Sani-Cloths were effective against Clostridium Difficile (C-Diff: a contagious bacterial organism that is prevalent in the gastrointestinal track). RN-D and RN-E stated the hospital had begun using the Sani-Cloths "some time ago", however could not remember exactly when.
When reviewed, the label on the Sani-Cloth Germicidal wipes in bold letters directed, "Contact time is 10 minutes unless otherwise noted below." The label on the wipes did not indicate effectiveness against Clostridium Difficile. The instructions directed: treated surfaces must remain visibly wet for a full 10 minutes, and allowed to air dry. The label also included, "not to be used as a terminal/high level disinfectant on any surface."
During an interview on 10/7/16, the hospital's infection control nurse RN-C, expressed an unawareness of how the colonoscopy procedure room should be disinfected between patients, nor what products staff should utilize to disinfect the room. However, RN-C stated the disinfectant used should be effective against C-Diff, because of the procedures being performed. RN-C verified a bleach solution should be used as a disinfectant against C-Diff. RN-C was not able to find a policy or procedure for cleaning/disinfecting the colonoscopy procedure room.
During an interview on 10/7/16, the administrator was not aware of how the procedure room should be cleaned.
REPROCESSING OF THE ENDOSCOPE
During an observation on 12/6/16, following observation of a colonoscopy procedure, RN-E put the endoscope in a basin, and completed the initial cleaning of the endoscope.
During an interview on 12/7/16, RN-D stated nurses always did the initial cleaning, the nurses had received training on endoscope cleaning, and had previously completed competency testing. RN-A, present at that time, was not aware of when the last time training had been offered or received, and stated annual competency testing was not required or performed at the facility.
During an observation on 12/6/16, health unit coordinator (HUC)-A was observed to remove the endoscope from a Cidex OPA solution (high level disinfectant) and put it into a sink that was approximately ¼ of the way full with tap water. HUC-A flushed the scope 3 times with 30 cc's of water down each channel for a total of 90 cc's pushed down each channel. HUC then pushed 30 cc's air in the same fashion and then pushed 10 cc's of Isopropyl Alcohol down each channel followed by 30 cc's of air three times in each channel. HUC-A did not change the water during the rinsing process. During a subsequent observation later the same day, HUC-A was observed to rinse another scope in the same fashion.
During an interview on 12/6/16, HUC-A stated she had received training for three or four weeks prior to being allowed to clean the endoscopes alone. HUC-A stated she did not have to complete any tests or competencies, and to her knowledge there was no mandatory annual or periodic education required. in addition, HUC-A stated there was no written procedure to follow for the endoscope reprocessing.
During an interview on 12/7/16, HUC-B stated she had been trained on cleaning of the endoscopes by HUC-A. HUC-B stated she had not completed any competency testing, and was not aware of any annual or periodic training or testing for reprocessing of the endoscopes. HUC-B explained both HUC-A and HUC-B had developed a rudimentary checklist for the endoscope reprocessing, because there was not an all inclusive CAH procedure. HUC-B stated she was unsure who she would ask if she or HUC-A had questions or concerns about the cleaning process.
During an interview on 12/8/16, RN-C stated that from an infection control standpoint, procedures for cleaning the endoscopes should be readily available, to ensure patient safety.

During an interview on 12/7/16, with the endoscope manufacturer's representative, the representative stated on average there should be at least 90 cc's of alcohol flushed down each channel for effective drying. The representative recommended the facility follow Cidex OPA instructions.

During an interview on 12/8/16, endoscopic education specialist (EES)-A reiterated the process outlined by the Cidex manufacturer, and reiterated 90 cc's of alcohol for the suction channel and 30 cc's for each auxiliary and air/water channels are required according to manufacturer's recommendations.

The hospital's policy Colonoscopy, (endoscope reprocessing procedure), dated 1/09, directed staff to rinse after disinfection, to flush all channels three times and to follow manufacturer's recommendations. The policy instructed staff to flush all channels with 70% alcohol; the policy did not direct how much to use.

The CAH policy, SPD (sterilization processing department) Staff Qualification effective 3/14/14, indicated staff were required to complete an orientation check sheet to the SPD area and show competence in all areas of SPD.

The CAH policy Sterilization Processing Department last revised on 5/31/16, indicated the manager of the department would be a licensed practical nurse that was also a Certified Registered Central Services Technician (CRCST) that would report to the DON.

ADMINISTRATION OF ANESTHESIA
During a colonoscopy procedure observation on 12/6/16, S1 was observed to have conscious sedation medications including Fentanyl and Versed administered intravenously (IV) by the registered nurse (RN)-D as directed by the physician at the bedside.
The hospital's policy for Colonoscopy/Sedation #3825-3 reviewed 3/14/14, directed "Only licensed physicians that are trained in professional standards and techniques to administer pharmacologic agents to predictably achieve desired levels of sedation and to monitor patients carefully in order to maintain them at the desired level of sedation, will provide sedation." The policy did not address the responsibility of the nurse to actually administer the medications as ordered by the physician.
During interview with RN-D on 12/7/16, RN-D stated the registered nurses always administered the medications for moderate (conscious) sedation in accordance with the physician's orders at the start of the procedure. RN-D explained if the patient required more medication during the surgery, the RN would consult with the physician prior to administering any subsequent doses.
During an interview on 12/7/16, the administrator acknowledged that the sedation policy read as though the physician was required to administer the moderate sedation medications. The administrator verified the policy had not been reviewed on an annual basis. The administrator was not aware of what the actual expectation or practice was and explained the policy and procedure for sedation would have to be reviewed by the medical staff.




32601



INFORMED CONSENT
SP1 was seen at the CAH on 12/6/16, and underwent a colonoscopy. SP1's Informed Consent to Undergo Colonoscopy was signed and dated 12/6/16, however lacked the time the informed consent was obtained.
SP2 was seen at the CAH on 11/15/16, and underwent a colonoscopy. SP2's Informed Consent to Undergo Colonoscopy was signed and dated 11/15/16, however lacked the time the informed consent was obtained.
Consents Required for Procedures or Treatments policy dated 5/31/16, indicated colonoscopy procedures required a written informed consent.

Based on interview and document review, the critical access hospital (CAH) failed to ensure at least 10% of the active and closed records had been reviewed as part of the CAH's annual evaluation. This had the potential to affect all current and future patients of the CAH.

Findings include:

The CAH's Annual Program Evaluation Report dated 5/24 and 5/25/16, did not identify whether any open or closed records had been reviewed.

On 12/8/16, at 10:00 a.m. the administrator stated she did not know which records had been reviewed and could not identify which open and closed records were reviewed as part of the annual CAH evaluation. The administrator provided a power point which included statistical data related to the CAH's utilization of services and stated "obviously there had to have been record review completed to get the statistical data" however, she could not identify which patient records, including open and closed records had been reviewed.

As a result, the administrator stated she was unable to verify whether the CAH had met the requirement for a minimum 10% review of active and closed records.

Although requested, no policy related to annual CAH evaluation was provided.

Based on interview and document review, the critical access hospital (CAH) failed to ensure CAH policy review and revision had been included as part of the annual CAH evaluation. This had the potential to affect all current and future patients of the CAH.

Findings include:

The CAH's Annual Program Evaluation Report dated 5/24-5/25/16, lacked consistent identification of policy review, revision, and development with the departmental reports included in the annual CAH evaluation.

On 12/8/16, at 9:30 a.m. the administrator confirmed the annual CAH evaluation lacked a complete listing of policies which had been developed, reviewed and/or revised. The AD stated the policy review was not standardized and verified the policy review for the 5/24-5/25/16, annual CAH evaluation was not completed.

The CAH's policy and procedure for CAH Policy Review last reviewed/revised October 2010 included, "To ensure that recommended review and revisions of department policies and Medical Staff Bylaws with a group of professionals are implemented." The policy indicated all health care policies would be reviewed annually at Medical Staffing meetings.

Based on interview and document review, the facility failed to ensure the CAH had a system to identify nosocomial infections and medication therapy. This had the potential to affect all current and future patients of the CAH.

Findings include:

During interview regarding the CAH's infection control practices, on 12/7/16 from 9:00-11:00 a.m., registered nurse (RN)-C stated she was responsible for the CAH's infection control program. RN-C stated she'd been newly assigned the responsiblity. RN-C further stated the facility did not have an infection control committee. RN-C stated there was limited information shared regarding infections in the hospital at the facility's monthly quality assurance (QA) meetings. RN-C supplied monthly meeting documentation from December 2015- December 2016 which indicated there were no nosocomial infections that occurred for any inpatient during this timeframe. However, RN-C also stated the CAH had no current system, or historical data, to show how the CAH tracked cultures, catheter use, need for patients on isolation precautions, or hospital acquired infections.

RN-C was asked to supply the last 12 months of infection control logs for CAH inpatients. RN-C stated that she had no infection control logs to provide for any of the months requested, but had initiated an inpatient infection tracking log earlier that morning. RN-C also stated the CAH currently had two patients on the nursing unit in isolation precautions for C-difficile and pneumonia. When RN-C was asked to provide the CAH's policy related to caring for patients with C-difficile, RN-C stated the facility did not have policies/procedures for caring for patients with C-difficile.

The CAH's infection control policy and procedures were reviewed with RN-C. The CAH infection control policy and procedure 3125-IC-F1 dated 4/1/14, identified: A total house surveillance will be done on all Hospital and Care Center positive cultures to monitor for nosocomial infections. The procedure directed the infection control officer to complete a chart review of each patient who had a positve culture to determine community acquired versus nosocomial infection, and each chart logged on the Report of Infection Control Data Sheet where quarterly the infections would be evaluated and summarized and negative trends would be communicated. Further review of CAH policies revealed the CAH infection control program had not developed or implemented any antibiotic stewardship policies or procedures.

Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure they had an arrangement with an outside entity to review the quality and appropriateness of diagnosis and treatment furnished by the CAH physician's. In addition, the CAH had no evidence peer review had been completed for 9 of 9 active Medical Staff and 73 CAH physicians including consulting medical staff, and Medical Staff that provided telemedicine. This practice had the potential to affect all current and future patients of the CAH.

Findings include:

On 12/8/16, at 10:00 a.m. registered nurse (RN)-C established she was the staff person in charge of the quality assurance process improvement (QAPI) activities for the CAH. RN-C verified the CAH did not have an arrangement with an outside entity to provide peer review for the quality and appropriateness of diagnosis and treatment furnished by all 9 of 9 active Medical Staff and 73 CAH physicians including consulting medical staff physicians, and those that provided telemedicine. In addition RN-C stated stated she was unaware of any peer review conducted for any of the aforementioned active, courtesy, of telemedicine Medical Staff.

Review of the Continuous Quality Improvement Peer Review Committee Plan revised 3/31/16, indicated the following under Objectives A. Medical Staff : 1. The Medical Staff shall have a written Continuous Quality Improvement/Peer Review Program (CQI/PR) which evaluates medical services provided at NORTH SHORE HEALTH. CQI/PR activities must be in place for the review and assessment of the following Medical Staff functions: blood utilization, emergency room services, key indicator review/patient care evaluations, medical record review, pharmacy and therapeutics, utilization review, trauma case review. The CQI/PR plan had not identified how Medical Staff peer review would be conducted, how often, or criteria for the selection of patient cases that would require peer review.

Review of the Medical Staff By-Laws dated as last revised August 2012 indicated active and courtesy staff would actively participate in professional practice evaluation and performance improvement process.

A review of all of the current CAH agreements revealed the CAH did not have an agreement with an outside agency to provide professional peer review services for the purpose of quality assurance.

A review of all of the CQI/PR meeting minutes from 1/15-12/16, revealed Medical Staff peer review had not been completed. On 12/7/16 at 2:30 p.m. the credentialing files for 6 of 9 active Medical Staff, 1 courtesy Medical Staff, and 1 telemedicine Medical Staff were reviewed, peer review was not found in any of the aforementioned Medical Staff credentialing files.

The Medical Director was interviewed on 12/8/16, at 11:45 a.m. and stated that peer review is done during the medical staff meeting every month where they look at all of the obstetric cases, patients with prolonged length of stay, return admissions (unknown time frame) and cases that may have complications. The medical director stated that minutes of these discussions are not recorded, and there is no documentation to support what patient cases were reviewed, how many were discussed, the discussion which took place and the outcome of the discussion or what process or procedure changes occurred as a result of the patient case review.

On 12/8/16, at 11:00 a.m. the administrator verified the CAH did not have an agreement with an outside agency to perform peer review for the CAH's active Medical Staff, consulting Medical Staff, and Medical Staff that provided telemedicine services.