HospitalInspections.org

A. Based on review of the Critical Access Hospital's (CAH) list of contracted services, Quality Improvement Plan, and staff interview, it was determined, that for 2010 and 2011, the CAH failed to established an agreement with a network Hospital, QIO, equivalent entity, or another State approved qualified entity for services providing credentialing and quality assurance.

Findings include:

1. On 7/18/11 at 11:00 AM, the CAH's list of contracted services was reviewed. The list lacked the name of a network Hospital, QIO, equivalent entity, or another State approved qualified entity for providing credentialing and quality assurance services.

2. On 7/19/11 at 10:00 AM, the Hospital's Quality Improvement Plan was reviewed. The plan did not address credentialing, quality assurance, or reference to an agreement with an outside entity to provide any type of credentialing or quality assurance services.

3. On 7/19/11 at 1:30 PM, an interview was conducted with the Chief Nursing Officer (CNO). The CNO stated that she was not aware of an outside agreement to provide consultation or support for quality assurance or credentialing services. The CNO confirmed the findings during the interview on 7/19/11 at 1:30 PM.

Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Critical Access Hospital Re-Certification Survey conducted on August 1-2, 2011, the surveyors find that the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see C231.

Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Critical Access Hospital Re-Certification Survey conducted on August 1-2, 2011 the surveyors find that the facility does not comply with the applicable provisions of the 2000 Edition of the NFPA 101 Life Safety Code.
See the Life Safety Code deficiencies identified with K-Tags on the HCFA/CMS Form 2567, dated 8/2/11.

A. Based on review of Pharmacy contracts, Pharmacy and Therapeutics (P & T) Committee meeting minutes, pharmacist's work hours, Continuous Quality Improvement (CQI) meeting minutes, Critical Access Hospital (CAH) policies, Infection Control Plan, Infection Control Committee meeting minutes, observation, biological indicator log review, and staff interview, it was determined, the CAH failed to ensure that the requirements for providing services were met.

Findings include:

1. The CAH failed to ensure, that for 2011, Pharmacy services were supervised and coordinated to ensure medication safety. (C-276 A)

2. The CAH failed to ensure, that for 2 of 2 medication refrigerators (MSR #1 & 2), outdated medications were not available for patient use. (C-276 B)

3. The CAH failed to ensure, that for 2010 and 2011, a comprehensive Infection Control Plan was in place. (C-278 A)

4. The CAH failed to ensure, that for 9 of 73 biological indicator tests in 2011, biological indicator testing was completed and documented each day the autoclaves were used. (C-278 B)

5. The CAH failed to ensure, that 17 of 17 cans of enteral tube feeding, outdated nutritional supplements were not available for patient use. (C-279)

The cumulative effect of these systemic practices resulted in the CAH's inability to meet requirement for providing services. The condition of Provision of Services was not met.

B. Based on review of Critical Access Hospital (CAH) policies, observation, and staff interview, it was determined, that for 2 of 2 medication storage refrigerators (MSR #1 and #2), observed on the Medical Surgical Unit and in the Emergency Department, the CAH failed to ensure that outdated medications were not available for patient use.

Findings included:

1. The CAH policy entitled, "Surveillance of Outdated Materials/Biologicals", was reviewed on 7/18/11 at approximately 11:00 AM and required, "...All outdated materials shall be discarded and replaced accordingly..."

2. The CAH policy entitled, "Beyond Use Dating - Multi Dose Containers", was reviewed on 7/18/11 at approximately 11:00 AM and required "...2. Label the container with the beyond use dating based on 28 days from opening date or the manufacturer's expiration date whichever is shorter... 7. Discard the container twenty-eight (28) days after opening..."

3. An observational tour of the Medical Surgical Unit was conducted on 7/18/11 between 12:15 PM and 12:40 PM. The medication storage refrigerator for this unit (MSR #1) contained the following outdated medications:

- One vial of Novolin R Insulin was labeled with a sticker that indicated the vial was opened on 5/31/11 and would expire 28 days after opening (per Hospital policy).

- 9 vials of Influenza vaccine 0.5 milliliter (ml) that indicated expiration dates of 6/30/11.

4. An observational tour of the Emergency Department was conducted on 7/18/11 between 12:45 PM and 1:15 PM. The medication storage refrigerator for this unit (MSR #2) contained the following outdated medications:

- One opened vial of Novolin R Insulin was not labeled with the open date.

- 2 vials of Influenza vaccine 0.5 ml contained expiration dates of 6/30/11.

5. The above findings were confirmed with Chief Nursing Officer during an interview on 7/18/11 at approximately 3:00 PM.



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A. Based on review of Pharmacy contracts, Pharmacy and Therapeutics (P & T) Committee minutes, pharmacist's work hours, Continuous Quality Improvement (CQI) meeting, and staff interview, it was determined, that for 2011, the Critical Access Hospital (CAH) failed to ensure Pharmacy services were supervised and coordinated to ensure medication safety.

Findings include:

1. On 7/18/11 at 1:00 PM, a Contract for Pharmacy Service was reviewed. An agreement with Comprehensive Pharmacy Services, Inc (CPS) was entered into with Midwest Medical Center on 3/1/07. The agreement included, "Intent and Purpose... It is the intent and purpose of the parties that CPS shall exclusively furnish the professional capability and personnel to supervise and perform all Pharmacy services, as required by Hospital and its Medical Staff, and to provide such additional services as are set forth herein in order that the Department shall be operated in an effective and efficient manner...

2.3... CPS shall participate... in the Pharmacy and Therapeutics Committee...

2.6... In the event of a vacancy in the Director of Pharmacy Position or other positions... CPS will provide a consultant pharmacist to manage the daily operations of the Department... In no event shall the Department be without a pharmacist licensed in the State of Illinois for an unreasonable period of time...

2.8. CPS... shall furnish such general and administrative support services to Hospital... Such support services shall include, but not be limited to...

f. Monthly inspections of areas where pharmaceuticals are stored...

i. Continuous Performance Improvement Programs.

j. Participation in medication use evaluations, patient therapy reviews, and antibiotic surveys or audits...

l. Continuous Drug Interaction Monitoring and Adverse Drug Reaction Program..."

2. On 7/20/11 at 12:10 PM, the Pharmacy and Therapeutics (P & T) Committee minutes for 2010 and 2011 were reviewed. A P & T Committee meetings were held on 2/16/10, 6/8/10, and 8/10/10. No subsequent P & T meetings were held in 2010 or 2011, for 11 months. The Policy did not indicate how frequently the P & T Committee was required to meet. Meetings were attended by a Physician, Chief Nursing Officer, and Pharmacist. There was no documentation in the P & T minutes regarding participation in medication use, evaluations, patient therapy reviews, and antibiotic surveys or audits.

3. On 7/20/11 at 12:15 PM, the schedules of the CPS Pharmacist and the Director of Pharmacy (part time) were reviewed. From 1/1/11 to survey date 7/18/11, the CPS Pharmacist spent a total of 34 hours (4/28/11, 4/29/11, 5/31/11, 6/27/11, 6/28/11, & 7/6/11) in the Hospital.

4. The Director of Pharmacy worked approximately 2 days per week in 2010, until she resigned on 12/2/10. No other Pharmacist, except the CPS Consultant Pharmacist, worked in the CAH in 2011 until 7/1/11, on which date another Director of Pharmacy (part time) began work in the CAH. Twenty four hour, seven day per week Pharmacy off-site coverage was provided by Remote Solutions, through contractual agreement.

5. There is no documentation that CPS provided a consultant Pharmacist for almost 7 months during a vacancy from 12/2/10 to 7/1/11, to manage the daily operations of the Department.

6. On 7/20/11 at 1:30 PM, the Continuous Quality Improvement (CQI) monthly meeting minutes for the past 12 months (July 2010 to June 2011) were reviewed. There was no documentation of any discussion regarding pharmacy issues including:

- Periodic review and salutation of the implementation of pharmaceutical policies and procedures by staff.

- Monthly inspections of areas where pharmaceuticals are stored.

- Continuous Performance Improvement Programs.

- Continuous Drug Interaction Monitoring and Adverse Drug Reaction Program.

7. An interview was conducted with the Chief Nursing Officer (CNO) on 7/20/11 at 10:20 AM. The CNO stated that CPS had not fulfilled their responsibilities and a local Pharmacy was being considered to replace CPS in October 2011, the beginning of the new fiscal year. The CNO stated that she had taken on responsibilities of ordering, stocking, and supervision of medication when a Pharmacist was not available. The CNO stated that the new part time Pharmacist just received his Illinois license and began work in July 2011.

8. The personnel file of the CNO was reviewed on 7/19/11 at 11:00 AM. The file did not contain documentation of Pharmacy training.

9. The CNO confirmed the findings during the interview on 7/20/11 at 10:20 AM.

A. Based on review of Critical Access Hospital (CAH) Infection Control Plan, Infection Control Committee minutes, and staff interview, it was determined, that for 2010 and 2011, the CAH failed to ensure a comprehensive Infection Control Plan was in place.

Findings include:

1. The CAH's Infection Control Plan was reviewed on 7/21/11 at 8:30 AM. The Plan required, "To coordinate the infection control activities, infection control management functions are delegated to the Infection Control Officer/ Infection Control Committee to investigate and follow-up on clinical issues... Infection control at Midwest Medical Center allows for a systematic, coordinated and continuous approach... Infection control activities include the following... Monitoring and evaluation of key performance aspects of infection control surveillance, prevention and management... Continuously collecting and/or screening data to identify isolated incidents or potential infectious outbreaks... Participation in an organizational proactive education program, in an effort to reduce and control spread of infection and/or colonization... Facilitating a multidisciplinary approach to the prevention and control of infections..."

2. On 7/20/11 at 2:00 PM, the 2010 and 2011 Infection Control Committee minutes were reviewed. The only Infection Control Committee meeting in 2010, on 4/20/10, included discussion of CAH's Influenza and H1N1 vaccine supply, isolation cases in the 4th quarter of 2009 and 1st quarter of 2011, and the purchase of an instrument to be used in the Emergency Room. Although staff hand hygiene was selected as the focus for the Facility's 2010's Infection Control Surveillance activity, there was no documentation or discussion on staff hand hygiene. No subsequent Infection Control Committee meetings were held.

3. An interview was conducted with the Chief Nursing Officer/Infection Control Officer (CNO/ICO) on 7/21/11 9:00 AM. The CNO/ICO stated that due to budget constraints, the CAH eliminated the ICO from the budget and assigned the ICO duties to the CNO. The CNO stated that staff hand washing hygiene surveillance had not been done in 2010 or 2011 and remains the surveillance focus in 2011.

4. The CNO/ICO stated that post operative infections have not been reported in 2010 and 2011. However, the CNO/ICO stated that the CAH does not have a mechanism to survey post operative infections and expects the surgeon to inform the CAH if infections occur, even though the surgeons have not been notified to do so.

5. The CNO/ICO confirmed the findings during the interview on 7/21/11 at 9:00 AM.

B. Based on review of Critical Access Hospital (CAH) policy, biological indicator log review, and staff interview, it was determined, that for 4 of 49 days (1/4/11, 1/10/11, 5/26/11, and 6/6/11) for Autoclave #1 and 5 of 24 days (1/3/11, 3/10/11, 5/17/11, 6/16/11, & 6/17/11) for Autoclave #2, the CAH failed to ensure biological indicator testing was completed and documented each day the autoclaves were used.

Findings include:

1. CAH policy titled, "Maintenance of Autoclaves" was reviewed on 7/19/11 at 8:40 AM. The policy required, "A. Biological indicators shall be run on each autoclave every day that the autoclave will be used..."

2. On 7/19/11 at 8:30 AM, the Biological Indicator Logs for 2011 were reviewed. The Biological Indicator Log for Autoclave #1 included 4 days (1/4/11, 1/10/11, 5/26/11, and 6/6/11) of 49 days in 2011, when the Autoclave was used. However, the results for the biological indicator test and/or control test were not recorded in the log.

3. The Biological Indicator Log for Autoclave #2 included 5 days (1/3/11, 3/10/11, 5/17/11, 6/16/11, & 6/17/11) of 24 days in 2011, when Autoclave #2 was used. However, the results for the biological indicator test and/or control test were not recorded in the log.

4. These findings were confirmed by the OR Manager during an interview on 7/19/11 at 8:45 AM. The findings were discussed with the Chief Nursing Officer on 7/19/11 at 9:30 AM.

A. Based on review of Critical Access Hospital (CAH) policies, observation and staff interview, it was determined that for 17 of 17 cans of enteral tube feeding (8 cans of Glucerna and 9 cans of Jevity) observed in the Medical Surgical unit's nutrition room, the CAH failed to ensure that outdated nutritional supplements were not available for patient use.

Findings include:

1. The CAH policy entitled, "Enteral Tube Feeding", was reviewed on 7/18/11 at approximately 11:00 AM and required "...Compare physician's order with the formula label of accuracy and expiration date..."

2. The CAH policy entitled, "Surveillance of Outdated Materials/Biologicals", was reviewed on 7/18/11 at approximately 11:00 AM and required, "...All outdated materials shall be discarded and replaced accordingly.

3. An observational tour of the Medical Surgical Unit was conducted on 7/18/11 between 12:15 PM and 12:40 PM. The nutrition room contained 17 cans of enteral tube feeding (8 cans of Glucerna and 9 cans of Jevity) that were marked with a manufacturer's expiration date of 5/1/11.

3. The findings were confirmed with the Chief Nursing Officer during an interview on 7/18/11 at approximately 3:00 PM.

A. Based on review of Critical Access Hospital (CAH) policy, medical record, and staff interview, it was determined that in 1 of 1 (Pt #4) medical record reviewed of an isolation patient, the CAH failed to ensure isolation precautions were initiated and maintained.

Findings include:

1. The CAH policy entitled "Infection Control and Standard/Isolation Precautions," reviewed on 7/20/11 at approximately 11:45 AM required, "Policy:..2. In addition to Standard Precautions, isolation precautions shall be instituted for patients documented or suspected to be infected with ...Clostridium Difficile... Appendix A - Type and Duration of Precautions Recommended... C difficile - Contact..."

2. The clinical record of Pt # 4 was reviewed on 7/20/11 at approximately 10:00 AM. Pt #4 was an 88 year old male admitted on 5/9/11 with a diagnosis of Dehydration. The clinical record contained a physician's order dated 5/9/11 that required, "Stool for C-diff". The clinical record lacked documentation that Pt #4 was placed in contact precautions, as required.

3. The findings were confirmed by the Chief Nursing Officer during an interview on 7/20/11 between 10:00 AM and 10:45 AM.

A. Based on reviews of Critical Access Hospital (CAH) policies, clinical records, and staff interview, it was determined that for 2 of 17 (Pts. #2 and 3) inpatient clinical records reviewed, the CAH failed to ensure patient care plans were current and accurate.

Findings include:

1. CAH policy entitled, "Initial Nursing Assessment Data Base Form/Nursing Diagnosis Care Plan List," was reviewed on 7/20/11 at approximately 10:45 AM and required, "...Procedure: 1) The Initial Nursing Assessment Data Base shall be completed promptly upon the patient's arrival to the Inpatient Department... Procedure... 12. Complete the Nursing Diagnosis Care Plan list if indicated."

2. CAH policy entitled, "Documentation of the Nursing Process/PIE Protocol," was reviewed on 7/20/11 at approximately 11:00 AM and required, "...2. Nursing Diagnosis... e. The Nursing Diagnosis/Problem List shall be reviewed each shift for necessary revisions..."

3. The clinical record of Pt #2 was reviewed on 7/20/11 at approximately 10:00 AM. Pt #2 was a 92 year old female, admitted on 6/8/11, with diagnoses of Anemia and Diabetes Mellitus (DM). The record contained a Care Plan initiated 6/8/11 that lacked updates to include Pt #2's blood transfusion on 6/9/11, administration of oxygen on 6/9/11, and DM control and monitoring.

4. The clinical record of Pt #3 was reviewed on 7/20/11 at approximately 10:15 AM. Pt #3 was a 62 year old male, admitted on 6/30/11, with diagnoses of Super-therapeutic INR, Congestive Heart Failure, and Diabetes Mellitus Type II. The record contained a Care Plan initiated 6/30/11 that lacked an update to include Pt #3's Congestive Heart Failure and bilateral leg edema.

5. The findings were confirmed by the Chief Nursing Officer during an interview on 7/20/11 between 10:00 AM and 10:45 AM.

A. Based on reviews of Critical Access Hospital (CAH) policies, medical records, and staff interview, it was determined that for 3 of 26 (Pt's. #2, 3, and 4) medical records reviewed, the CAH failed to ensure clinical record documentation was complete, as required by policy.

Findings include:

1. The CAH policy entitled, Inpatient/Emergency Department Nursing/Pharmacy," was reviewed on 7/20/11 at approximately 9:45 AM and required, "...12. When administering injectable medications:.. 13. Document procedure in MAR (Medical Administration Record) including injection site."

2. CAH policy entitled "Withholding Resuscitative Measures," was reviewed on 7/20/11 at approximately 11:30 AM and required, "...9. Even if a Living Will or POA for Health Care is available, the physician shall be contacted for a DNR order for resuscitation efforts to be withheld... 12. Do Not Resuscitate orders shall be re-written with each re-admission to the facility..."

3. The clinical record of Pt #2 was reviewed on 7/20/11 at approximately 10:00 AM. Pt #2 was a 92 year old female, admitted on 6/8/11, with diagnoses of Anemia and Diabetes Mellitus (DM). The clinical record contained a physician's order dated 6/8/11, that required the usage of sliding scale insulin coverage for blood sugar checks four times a day. The clinical record contained Medication Administration Record (MAR) documentation that included the administration of insulin as ordered on 6/8/11, 6/9/11, 6/10/11 and 6/11/11 as ordered. However, the clinical record lacked documentation of the injection site.

4. The clinical record of Pt #3 was reviewed on 7/20/11 at approximately 10:15 AM. Pt #3 was a 62 year old male, admitted on 6/30/11 with diagnoses of Super-therapeutic INR, Congestive Heart Failure, and DM Type II. The clinical record contained a physician's order dated 6/30/11, that required: "Levemir 35 units SQ (subcutaneous) daily". The clinical record contained MAR documentation that included administration of Levemir on 7/1/11, 7/2/11, and 7/3/11 as ordered. However, the clinical record lacked documentation of the injection site.

5. Pt. #3's physician's order dated 6/30/11, required the administration of Novalog insulin 4 units SQ with each meal and a subsequent order change dated 7/2/11 that required the increase to 8 units SQ with each meal. Pt. #3's clinical record contained MAR documentation that included administration of the insulin on 6/30/11, 7/1/11, 7/2/11, and 7/3/11 as ordered. However, the clinical record lacked documentation of the injection site.

6. The clinical record of Pt # 4 was reviewed on 7/20/11 at approximately 10:00 AM. Pt #4 was an 88 year old male, admitted on 5/9/11, with a diagnosis of Dehydration, and expired on 5/12/11. The clinical record contained a physician's order dated 5/9/11, that required the usage of sliding scale insulin coverage and blood sugar checks after meals and before bed. The clinical record contained MAR documentation that included administration of the insulin on 5/9/11, 5/10/11, and 5/11/11 as ordered. However, the clinical record lacked documentation of the injection site.

7. Pt. #4's clinical record included an Illinois Department of Public Health Uniform Do-Not-Resuscitate (DNR) Advance Directive which had been signed, witnessed, and dated on 2/11/11. However, there was no physician's order that required Pt #4 become a DNR patient.

8. The findings were confirmed by the Chief Nursing Officer, during an interview, on 7/20/11 between 10:00 AM and 10:45 AM.

A. Based on review of the Critical Access Hospital's (CAH) Quality Improvement Plan, Continuous Quality Improvement (CQI) meeting minutes, and staff interview, it was determined, that in 2010 and 2011, the CAH failed to ensure medical records were sent for peer review, to determined if diagnoses and treatment were appropriate.

Findings include:

1. On 7/19/11 at 10:00 AM, the CAH's Quality Improvement Plan was reviewed. The Plan did not include reference to an agreement with an outside entity to provide medical record review.

2. On 7/20/11 at 1:20 PM, the Continuous Quality Improvement (CQI) monthly minutes for the past 12 months (July 2010 to June 2011) were reviewed. None of the monthly meetings included discussion of medical records sent for peer review to determined if diagnoses and treatment were appropriate.

3. On 7/19/11 at 1:30 PM, an interview was conducted with the Chief Nursing Officer (CNO). The CNO stated that she was not aware of an outside agreement to provide medical record review to determine if diagnosis and treatment were appropriate. The CNO confirmed the finding during the interview on 7/19/11 at 1:30 PM.