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Based on record review and interview, the facility failed to ensure that written grievance resolution letters contained the investigation completion date, in 1 of 1 patient complaints reviewed (Patient #31). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

The 3/16/16 record review of Patient #31's written compliant of emergency room care was received on 3/1/16. Attached to this complaint was a written notice provided by Quality Vice President Y on 3/2/16. Review of the hospital response letter revealed no information of when the investigation was completed.

During interview with Quality Vice President Y on 3/16/16 at 10:40 a.m. , Y stated "The completion date is not documented".

Based on record review and interview the facility failed to update the plan of care to reflect the use of restraints in 3 of 3 restrained patients reviewed (Patient #30, Patient #31, Patient #32). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

The 3/16/16 record review of facility policy "Restraint or Seclusion" dated 8/20/2014 states in part: "12. Plan of Care: a. Use of restraints must be reflected in the nursing notes and restraint monitoring documentation must be added to the nursing interventions. Use of restraints must be specifically addressed each shift in the daily goals and in the shift summary."

1) The 3/16/16 record review revealed Patient #30 received inpatient services from 1/5/2016 through 1/6/2016. Patient #30 was restrained at the facility for 4 hours from 1/5/2016 at 9:30 PM to 1/6/2016 at 1:30 AM. Patient #30's care plan is not updated to include the use of restraints, daily goals are not specific to restraints.

2) The 3/16/16 record review revealed Patient #31 received inpatient services from 9/18/2015 through 9/24/2015. Patient #31 was restrained at the facility for approximately 45 hours from 9/21/2015 at 10:30 AM through 9/23/2015 at 7:36 AM. Patient #31's care plan is not updated to include the use of restraints, daily goals are not specific to restraints.

3) The 3/16/16 record review revealed Patient #32 received inpatient services from 12/3/2015 through 12/8/2015. Patient #32 was restrained at the facility for at least 11 hours from 12/6/2015 at 3:10 PM through 12/7/2015 at 2:00 AM. Patient #32's care plan is not updated to include the use of restraints, daily goals are not specific to restraints.

During an interview on 3/16/2016 at 10:30 AM, Director Z stated the restraint flowsheet auto-populates and serves as a care plan intervention. Director Z stated there are no goals related to the restraints and the intervention is not linked to any type of nursing diagnosis.

Based on record review and interview, the facility failed to ensure restraints are ordered by a qualified physician in 1 of 3 patient records reviewed (Patient #31). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

The 3/16/16 record review of facility policy "Restraint or Seclusion" dated 8/20/2014 states in part: "6. Ordering of Restraints/Requirements for Orders: a. Only a physician or licensed independent practitioner may order restraints."

The 3/16/16 record review revealed Patient #31 was admitted to the facility on 9/18/2015. Patient #31's medical record contains an order dated 9/22/2015 at 9:15 AM for "Restraints PER PROTOCOL" entered by an RN. The order is not signed by the physician. The order states "No signature is necessary."

During interview on 3/16/2016 at 10:10 AM, Director Z stated "The RN put the order in and if the order is per protocol an MD signature isn't required."

Based on record review and interview, the facility failed to ensure restraint orders are not standing orders per policy for 3 of 3 restrained patients reviewed (Patient #30, Patient #31, Patient #32). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

The 3/16/16 record review of facility policy "Restraint or Seclusion" dated 8/20/2014 states in part: "6. Ordering of Restraints/Requirements for Orders: ...b. Standing and PRN orders are NOT acceptable."

1) The 3/16/16 record review reveals Patient #30 was admitted to the facility on 1/5/2016. Per Patient #30's restraint flowsheet, restraints are initiated on 1/5/2016 at 9:30 PM. Patient #30's medical record contains an order dated 1/5/2016 at 10:50 PM for "Restraints PER PROTOCOL."

2) The 3/16/16 record review reveals Patient #31 was admitted to the facility on 9/18/2015. Per Patient #31's Restraint Assessment flowsheet, restraints were initiated on 9/21/2015 at 10:30 AM due to "harm to self." Patient #31's medical record contains an order dated 9/22/2015 at 9:15 AM for "Restraints PER PROTOCOL" almost 24 hours after the initiation of restraints. On 9/22/2015 at 5:00 PM, the restraint flowsheet documents: "Order Discontinued...restraints d/c'd (discontinued)." On 9/22/2015 at 8:30 PM restraints are re-initiated. There are no orders in the medical record for the re-initiation of restraints.

3) The 3/16/16 record review reveals Patient #32 was admitted to the facility on 12/3/2015. Patient #32's medical record contains an order dated 12/6/2015 at 3:10 PM for "Restraints PER PROTOCOL."

During an interview on 3/16/2016 at 10:30 AM, Director Z there is no "restraint protocol" but the electronic health record is set up "like that so that the restraint nursing assessment attaches" in the medical record.

Based on record review and interview, the facility failed to ensure restraint orders have a stop time and that restraints are discontinued as early as possible, for 3 of 3 restrained patients reviewed (Patient #30, Patient #31, Patient #32). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

The 3/16/16 record review of facility policy "Restraint or Seclusion" dated 8/20/2014 states in part: "4. Restraint will be discontinued at the earliest possible time...6. Ordering of Restraints/Requirements for Orders: ...c. Each order for restraint must be time limited...".

1) The 3/16/16 record review revealed Patient #30 was admitted to the facility on 1/5/2016. Patient #30's medical record contains an order dated 1/5/2016 at 10:50 PM for "Restraints PER PROTOCOL." The order does not include a time limit. Per Patient #30's Restraint Assessment flowsheet, restraints were initiated on 1/5/2016 at 9:30 PM through 1/6/2016 at 1:30 AM. Documentation at 10:50 PM, 12:00 AM and 1:00 AM states: "restraints continued due to agitation to protect IV (intravenous) line, for patient's safety and staff safety." Documentation at 1:30 AM states: "Restraints removed as they were making patient more agitated."

2) The 3/16/16 record review revealed Patient #31 was admitted to the facility on 9/18/2015. Patient #31's medical record contains an order dated 9/22/2015 at 9:15 AM for "Restraints PER PROTOCOL." Text within the order states "D/C (discontinue) as soon as possible." The order does not include a time limit. Patient #31 was in restraints from 9/21/2016 at 10:30 AM through 9/23/2016 at 7:36 AM.

3) The 3/16/16 record review revealed Patient #32 was admitted to the facility on 12/3/2015. Patient #32's medical record contains an order dated 12/6/2015 at 3:10 PM for "Restraints PER PROTOCOL." The order does not include a time limit. Per Patient #32's Restraint Assessment flowsheet, restraints were initiated on 12/6/2015 at 3:10 PM. There is no documentation in the chart as to when the restraints were discontinued. Patient #32 was discharged from the facility on 12/8/2016.

During an interview on 3/16/2016 at 10:30 AM, Director Z stated there is no protocol to discontinue restraints and the orders do not include a time limit or stop time.

Based on record review and interview, the facility failed to establish assessment frequency guidelines for 3 of 3 restrained patients (Patient #30, Patient #31, Patient #32). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

The 3/16/16 record review of facility policy "Restraint or Seclusion" dated 8/20/2014 states in part: "10. Documentation: a. These tools include areas to document a specific description of the patient's behavior, the intervention used and the less restrictive alternatives. The patient's condition that warranted use, patient's response, and the rationale for the continued use of the intervention. b. ...The selection of an intervention and determination of the necessary frequency of assessment and monitoring should be individualized..."

1) The 3/16/16 record review revealed Patient #30 was admitted to the facility on 1/5/2016. Per Patient #30's Restraint Assessment flowsheet, restraints were initiated on 1/5/2016 at 9:30 PM due to "harm to self." Documentation states: "Behavior Modifications: Medication, Verbal Intervention. Actions Taken: Non-Physical Intervention." The patient is reassessed on 1/5/2016 at 10:00 PM and 11:00 PM, on 1/6/2016 at 12:00 AM, 1:00 AM. The restraints are documented as discontinued on 1/6/2016 at 1:30 AM. The assessments do not include the patient's response and do not describe the "non-physical interventions" used.

2) The 3/16/16 record review revealed Patient #31 was admitted to the facility on 9/18/2015. Per Patient #31's Restraint Assessment flowsheet, restraints were initiated on 9/21/2015 at 10:30 AM due to "harm to self." Reassessment is performed on 9/21/2015 at 12:00 PM, 2:00 PM, 4:00 PM. There is no documentation of the restraints being discontinued, the next assessment is documented on 9/22/2015 at 1:00 AM, 6:00 AM, 8:00 AM, 10:00 AM, 11:00 AM, 12:00 PM, 4:00 PM, 5:00 PM. On 9/22/2015 at 5:00 PM, the restraint flowsheet documents: "Order Discontinued...restraints d/c'd (discontinued)." On 9/22/2015 at 8:30 PM restraints are re-initiated with follow up assessments at 10:00 PM, 11:00 PM and on 9/23/2015 at 12:00 AM, 1:00 AM, 2:00 AM, 3:00 AM. There is no additional documentation until 9/23/2015 at 7:36 AM, when the restraints are discontinued. None of the assessments include documentation of interventions used and less restrictive alternatives. The assessments are not performed at regular intervals.

3) The 3/16/16 record review revealed Patient #32 was admitted to the facility on 12/3/2015. Per Patient #32's Restraint Assessment flowsheet, restraints were initiated on 12/6/2015 at 3:10 PM for "harm to self." A restraint assessment is not performed again until 12/6/2015 at 8:00 PM, more than 4 hours after the initiation of restraints. Reassessments are then performed on 12/6/2015 at 9:00 PM, 10:00 PM, 11:00 PM and on 12/7/2015 at 12:00 AM and 2:07 AM. There are no further assessments and no documentation when the restraints were discontinued. The assessments do not include interventions and less restrictive alternatives used. The assessments are not performed at regular intervals.

During an interview on 3/16/2016 at 10:30 AM, Director Z stated "we are aware that there are some inconsistencies, we have a lot to work on."

Based on record review and interview, the facility failed to ensure nursing care plans had individualized development based on nursing/ medical needs and were reviewed/revised when needed, for 6 of 30 patients reviewed (Patient's 8, 16, 24, 25, 27, 28). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

The 3/16/16 record review of hospital policy; "Care Planning" dated 07/06/2015 states "The nursing process of assessment, diagnosis (critical thinking), planning, implementation, and evaluation is used to determine the patient's nursing care needs...1. The care planning process includes reviewing physician orders and progress notes, patient assessments, goal setting, interventions, evaluation of patient responses to treatments, referrals to other health care professionals, and continuous review and revision of care and treatment in order to meet the patient's needs. ...4. Identified patient goals may be entered in the EMR (electronic medical record), with appropriate documentation of goal attainment."

1) Pt. (Patient ) #16 was admitted on 03/14/2016 for symptomatic treatment of cancer. Patient #16 had a nursing care plan which consisted solely of goals related to using the call light appropriately. Per review of #16's medical record on 03/16/16 at 10:00 AM, the care plan did not include nursing diagnoses or evaluation of progress towards goals. Care plan evaluation consisted of documentation that stated "ongoing" with no further determination by the nursing staff.

2) Pt. (Patient ) #24 was admitted on 03/14/2016 for knee replacement surgery. Patient #24 had a nursing care plan which consisted solely of goals related to rating pain at 5 or less, and using the call light. Per review of #24's medical record on 03/16/16 at 10:30 AM, the care plan did not include nursing diagnoses or evaluation of progress towards goals. Care plan evaluation consisted of documentation that stated "ongoing" with no further determination by the nursing staff.

3) Patient #25 was admitted on 03/14/2016 for knee replacement surgery, #25 had a nursing care plan which consisted solely of goals related to rating pain at 5 or less, using the call light and tolerating an advanced diet. Per review of #25's medical record on 03/16/16 at 11:00 AM, the care plan did not include; nursing diagnoses or evaluation of progress towards goals. Care plan evaluation consisted of documentation that stated "ongoing" with no further determination by the nursing staff.

4) Patient #27 was admitted on 03/15/2016 for complaints of pain and shortness of breath, #27 had a nursing care plan which consisted solely of goals related to maintaining an oxygen saturation of greater than 94%. Per review of #27's medical record on 03/16/16 at 11:30 AM, the care plan did not include nursing diagnoses or evaluation of progress towards goals. Care plan evaluation consisted of documentation that stated "ongoing" with no further determination by the nursing staff.

5) Patient #28 was admitted on 03/15/2016 for laproscopic bowel resection, #28 had a nursing care plan which consisted solely of goals related to voiding by 2:00 PM, ambulating at least 4 times a day, tolerating an advanced diet reporting discomfort. Per review of #28's medical record on 03/16/16 at 12:00 PM, the care plan did not include nursing diagnoses or evaluation of progress towards goals. Care plan evaluation consisted of documentation that stated "ongoing" with no further determination by the nursing staff.

During interview with Registered Nurse (RN) CC on 03/16/2016 at 10:24 AM, RN CC confirmed there were no care plans, only goals.



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6) The 3/16/16 record review reveals Patient #8 was admitted to the facility on 3/13/2016 for labor and delivery. On 3/13/2016 at 9:19 PM, #8 gave birth via cesarean section. Due to respiratory distress, #8's newborn was transferred to another facility for higher level care within 3 hours of delivery. Patient #8's care plan includes a problem of "Ineffective bonding related to baby being transferred." The nursing assessment on 3/15/2016 at 12:00 AM states "Maternal Child Interaction: Skin to skin; Assist with NB (newborn) Care; Interested in Learning; Hold/Interact with NB WNL (within normal limits)."

During an interview at the time of the review on 3/15/2016 at 10:00 AM, Registered Nurse U stated the information documented for maternal child interaction is not accurate as the newborn is not at the facility.

During an interview on 3/16/2016 at 8:35 AM, Patient Care Vice President X stated "we don't use nursing diagnoses as part of our care plan. Interventions are auto-populated based on the physician's orders and the medical diagnosis."

During interview with Director Z on 3/16/2016 at 9:30 AM, Z stated "the patient's should have goals relevant to their problems and the interventions should help the patients meet their goals."

Based on record review and interview, the facility failed to obtain patient consent for treatment, in 2 of 2 obstetric patients reviewed (Patient #8, Patient #10). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

The 3/16/16 record review of the facility policy "Consent Forms" dated 7/19/2012 states: "All consent forms should be signed by the patients (age 18 and older) whenever possible... We obtain a signed consent form annually for all clinical (day) procedures, surgical procedures, and inpatient visits."

1) The 3/16/16 record review revealed Patient #8 was admitted to the facility as an inpatient on 3/13/2016. Per medical record review on 3/15/2016 at 10:00 AM, Patient #8's medical record did not contain any signed consent for treatment.

2) The 3/16/16 record review revealed Patient #10 was admitted to the facility as an inpatient on 3/10/2016. Per medical record review on 3/15/2016 at 10:40 AM, Patient #10's medical record did not contain a signed consent form for treatment.

During an interview on 3/15/2016 at 10:50 AM, Unit Secretary V stated "if there's one [signed consent] within a year we don't have to have one signed again."

Per review of the registration forms with Unit Secretary V at 10:50 AM, Patient #8 had no record on file of a signed consent form. Patient #10's record documents "Admission Consent Form Last Signed: 11/4/2013."

During an interview on 3/16/2016 at 8:45 AM, Director AA stated Patient #8 and Patient #10 "should have consents." Per AA, the facility requires 1 signed consent per year for outpatients and 1 signed consent for inpatients per each inpatient visit.

Based on observation, record review and interview, the facility failed to ensure medications and biologicals were safe for patient use, in 3 of 10 hospital areas observed (Rehabilitation clinic, Surgery and Obstetrics). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

The 3/16/16 record review of facility policy "Outdated Pharmaceuticals" dated 02/06/2015, states "All medication storage areas will be checked at least bi-monthly for outdates... 3. Multidose vials are good until the manufacturer's expiration date provided the vial is is stored appropriately...They shall be dispensed as patient-specific and should not be shared by multiple patients...".

The 3/16/16 record review of facility policy "Administration of Medications" dated 2/27/2014 states in part: "8. Use of Injectable...Multidose Vial Medications...b. Multidose vials are good until the manufacturer's expiration date provided the vial is stored appropriately, and a visual check is performed. They shall be dispensed as patient-specific and should not be shared by multiple patients...e. For medications that are on the [Facility] Pharmacy Department's shortage list, anesthesia may continue to use multidose vials for multiple patients The list will be maintained by pharmacy and communicated to anesthesia anytime there are changes."

The 3/16/16 record review of "The United States Pharmacopoeia (USP) General Chapter 797 [16 ] recommends the following for multi-dose vials of sterile pharmaceuticals: ...If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial."

Off-site rehabilitation clinic
During a tour of the clinic with clinic manager EE on 03/15/16 at 10:45 AM, the following observations were made:

1) In the base cabinet of the therapy gym area, there were approximately forty 0.9 gram packets of Bacitracin Zinc ointment dated 09/2015 and a 10 ml. syringe of saline dated 06/2013.

During interview with clinic manager EE, at the time of the above observation, EE stated that staff "should be keeping an eye on these".



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Surgical Services unit
2) On 3/14/2016 at 1:35 PM, the anesthesia cart in Endoscopy procedure room #1 contained a bottle of Flumazenil with an expiration date of 2/2016.

3) On 3/14/2016 at 2:40 PM, Operating Room #3 contained an open, undated multidose vial of Neostigmine and a vial of Bupivicaine with an expiration date of 7/2015.

4) On 3/14/2016 at 2:45 PM, Operating Room #4 contained an open, undated multidose vial of Flumazenil and a vial of Bupivicaine with an expiration date of 7/2015.

During an interview on 3/14/2016 at 3:40 PM, Director L stated multidose vials are used by the anesthesia department if the medications are identified as a "short supply" medication. Per Director L, pharmacy monitors the medications in the anesthesia medication carts for expired medications "every Monday and Thursday" but the short-supply, multidose vials are not changed out of the cart. Director L stated the open multidose vials "should be" dated.

Obstetrics unit
5) Observations on 3/15/2016 at 9:20 AM revealed the Obstetrics Operating Room anesthesia medication cart contained 6 vials of Propofol expired 3/1/2016, and 1 vial of Sevoflurane Inhalant anesthetic expired 10/2015.

6) Observations on 3/15/2016 at 9:50 AM revealed the crash cart on the Obstetrics nursing unit contained 2 bags of Normal Saline expired 7/2015 and 1 bag of Normal Saline with Dextrose expired 7/2015.

During interview on 3/15/2016 at 9:50 AM, CRNA (Nurse Anesthetist) W stated at the time of the observations that the expired medications "should not" be in the cart.

Based on observations, interviews and record reviews, the facility failed to ensure that cold and hot foods were maintained at a safe temperature, in 1 of 10 food preparation areas observed (main kitchen); and failed to ensure that foods were appropriately labeled and dated, in 2 of 10 food preparation areas observed (main kitchen and obstetric unit kitchenette); and failed to ensure that cookware was stored and/or maintained in a sanitary manner, in 1 of 10 areas observed (main kitchen). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

FOOD TEMPERATURES
The 3/16/16 record review of the 2013 Food and Drug Administration Food Code revealed "bacterial growth and/or toxin production can occur if time/temperature control for safety food remains in the temperature 'Danger Zone' of 41 degrees Fahrenheit to 135 degrees Fahrenheit too long."

The 3/15/2016 record review of the following facility policies and procedures revealed:
"Infection Prevention and Control, Version #:6, Revision Date: 04/09/2015. Section j. Nutrition Services, Café and any other area where food is prepared for patient/customer consumption... ii. Food Preparation 1. b. ...Hot food shall be held at a temperature of greater or equal to 135o F or more, and cold foods at 41o F or less."

1) Observations on 3/14/2016 at 12:23 PM of the main kitchen with Director of Nutrition Services A (DNS-A) revealed patient's meal trays sitting on worktable. On meal trays were glasses containing white milk and chocolate milk. Culinary Aide B (CA-B) announced trays were ready to be sent to rooms. CA-B was asked for temperatures of the white milk and chocolate milk. The temperature of the white milk was 46.9 degrees Fahrenheit and the chocolate milk was 52.5 degrees Fahrenheit.

2) During observations on 3/14/2016 at 12:30 PM of the salad bar, used for preparation of patient's foods, outside the main kitchen area, Director of Nutrition Services A (DNS-A) was asked for temperatures of food items on/ in salad bar. The wheat berry salad temperature measured at 45.6 degrees Fahrenheit. Interview with DNS-A revealed salad bar temperatures are not being recorded.

FOOD ITEMS NOT LABELED
The 3/16/16 record review of the 2013 Federal Food and Drug Administration Food Code reveals "food prepared and held in a food establishment shall be clearly marked to indicate the date or day by which the food shall be consumed, sold or discarded, when held at a temperature of 41o Fahrenheit or less for a maximum of 7 days".

The 3/15/16 at 10:59 AM record review of facility policy "Infection Prevention and Control, Version #:6, Revision Date: 04/09/2015" stated under " j. Nutrition Services, Café and any other area where food is prepared for patient/customer consumption" that "2. d) All perishable food shall be refrigerated at the appropriate temperature, packaged in a sanitary manner and labeled with the appropriate date. e) Refrigerated juices shall be discarded after 7 days of opening."

3) Observations on 3/14/2016 at 11:45 AM of the walk-in cooler in the main kitchen, while accompanied by Director of Nutrition Services A (DNS-A), revealed a small round cardboard container with no label containing pineapple chunks.

4) Observations on 3/14/2016 at 3:40 PM of the Obstetrics Unit kitchenette, while accompanied by Director of Nutrition Services A (DNS-A) revealed in the refrigerator three opened undated cartons of "Rejuv" grape, cranberry and Apple juice.

During interview with DNS-A on 3/14/2016 at 3:40 PM, A stated "when nursing opens a carton of juice, it must be labeled with a discard date identified on container".

SANITARY STORAGE/ CONDITIONS
The 3/16/16 record review of the 2013 Federal Food and Drug Administration Food Code reveals that "food items and equipment must be properly stored to prevent transmission of foodborne pathogens or contamination".

The 3/16/16 record review of the ServSafe, 6th Edition Coursebook states: "Once utensils, tableware, and equipment have been cleaned and sanitized, they must be stored in a way that will protect them from contamination."

Record review on 3/15/2016 of facility policy "Ware Washing, Version #:3, Revision Date: 02/22/2016" and "Infection Prevention and Control, Version #:6, Revision Date: 04/09/2015" revealed no documented information regarding storage of cooking/ serving utensils and equipment.

During interview on 3/14/2016 at 3:30 PM to 4:15 PM, Director of Nutrition Services A (DNS-A) stated " the hospital uses the following professional standards of practice for food safety: Federal Food and Drug Administration Food Code, Wisconsin Food Code and ServSafe.

5) Observations on 3/14/2016 of main kitchen, with Director of Nutrition Services A (DNS-A), at 11:40 AM through 12:23 PM, revealed all of facility's pots, pans, and cooking/serving utensils were hanging from the ceiling and walls exposing their food contact surfaces to potential contamination.

6) Observations on 3/14/2016 of the main kitchen, with Director of Nutrition Services A (DNS-A) from 11:40 AM to 12:23 PM, revealed the entire edge of the oven hood located above the griddle was dusty.

During interview with DNS-A on 3/14/2016 at 11:40 AM through 12:23 PM A stated "maintenance comes in every two weeks to clean oven hood, we will need to change cleaning schedule".

A standard Validation Survey for Life Safety Code compliance was conducted by the Wisconsin Division of Quality Assurance on March 14-17, 2016. Sauk Prairie Hospital was found to be NOT in compliance with the following applicable regulations for hospital participation in Medicare-Medicaid:

42 CFR 482.41 Condition of Participation: Physical Environment was NOT MET
42 CFR 482.41(b) Standard: Safety from Fire was NOT MET
NFPA 101 (2000 edition)-Life Safety Code (Chapter 18-New Healthcare and Chapter 38-New Business) was NOT MET

Sauk Prairie Hospital is a 1-story structure built in 2013, with Type II (0,0,0) construction. The building also had a business occupancy that was attached to the health care occupancy but it is separated with 2-hour rated construction. The facility was fully sprinkled. The facility had an emergency generator that provided power to the emergency loads. The facility contained thirteen smoke compartments. Sauk Prairie Hospital is licensed for 35 beds, with a census of 25, 25, and 26 inpatients at the time of the survey. Sixteen (16) federal deficiencies of the Life Safety Code were cited for this building. In addition, there are a total of three medical office buildings that were surveyed.

The facility was found to contain the following deficiencies.
K 17 areas open to the corridor
K 29 hazardous rooms without sealed wall penetrations.
K 30 hazardous gift shop without proper rated walls
K 38 egress paths had obstructions
K 46 emergency illumination of the interior means of egress was dark
K 48 staff trained not properly trained on extinguishment of fires.
K 50: Fire drills not done correctly.
K 56: sprinkler system was not compliant to NFPA 13 minimum standards
K 62 sprinkler system was not properly maintained
K 64 portable fire extinguishers were not fully visible
K 67 ventilation system not in accordance with NFPA 90A and neutral airflow between the corridor and rooms.
K 73 egress path that was free of non-combustible decorations
K 75 proper storage and handling of rubbish and soiled materials
K 77 medical gas piping as required by NFPA 99 with compliant medical gas piping,
K 103 The facility did not provide interior walls and partitions made of noncombustible or limited-combustible materials.
K 130 (At the Outpatient buildings) exiting, exit signage,sprinklers.
K 144 Transfer Switches were not inspected or tested in accordance with NFPA 110

Please refer to the full description and findings within the specific K-tag deficiencies for the appropriate building found later in this report.

The cumulative effect of these deficiencies has the potential to affect the safety of all patients receiving services at the hospital.

A standard Validation Survey for Life Safety Code compliance was conducted by the Wisconsin Division of Quality Assurance on March 14-17, 2016. Sauk Prairie Hospital was found to be NOT in compliance with the following applicable regulations for hospital participation in Medicare-Medicaid:

42 CFR 482.41 Condition of Participation: Physical Environment was NOT MET
42 CFR 482.41(b) Standard: Safety from Fire was NOT MET
NFPA 101 (2000 edition)-Life Safety Code (Chapter 18-New Healthcare and Chapter 38-New Business) was NOT MET

Sauk Prairie Hospital is a 1-story structure built in 2013, with Type II (0,0,0) construction. The building also had a business occupancy that was attached to the health care occupancy but it is separated with 2-hour rated construction. The facility was fully sprinkled. The facility had an emergency generator that provided power to the emergency loads. The facility contained thirteen smoke compartments. Sauk Prairie Hospital is licensed for 35 beds, with a census of 25, 25, and 26 inpatients at the time of the survey. Sixteen (16) federal deficiencies of the Life Safety Code were cited for this building. In addition, there are a total of three medical office buildings that were surveyed.

The facility was found to contain the following deficiencies.
K 17 areas open to the corridor
K 29 hazardous rooms without sealed wall penetrations.
K 30 hazardous gift shop without proper rated walls
K 38 egress paths had obstructions
K 46 emergency illumination of the interior means of egress was dark
K 48 staff trained not properly trained on extinguishment of fires.
K 50: Fire drills not done correctly.
K 56: sprinkler system was not compliant to NFPA 13 minimum standards
K 62 sprinkler system was not properly maintained
K 64 portable fire extinguishers were not fully visible
K 67 ventilation system not in accordance with NFPA 90A and neutral airflow between the corridor and rooms.
K 73 egress path that was free of non-combustible decorations
K 75 proper storage and handling of rubbish and soiled materials
K 77 medical gas piping as required by NFPA 99 with compliant medical gas piping,
K 103 The facility did not provide interior walls and partitions made of noncombustible or limited-combustible materials.
K 130 (At the Outpatient buildings) exiting, exit signage,sprinklers.
K 144 Transfer Switches were not inspected or tested in accordance with NFPA 110

Please refer to the full description and findings within the specific K-tag deficiencies for the appropriate building found later in this report.

The cumulative effect of these deficiencies has the potential to affect the safety of all patients receiving services at the hospital.

Based on observation and staff interviews, the facility did not construct, install and maintain a proper ventilation, filtration and temperature control system in central supply, sleep lab of the medical office building, and corridors of the hospital. The facility did not have a ventilation system that was installed and maintained in accordance with state regulations and manufacturer recommendations. This deficiency occurred in 2 of the 8 smoke compartments, and had the potential to affect all inpatients, outpatients, staff and visitors within these smoke compartments.

FINDINGS INCLUDE:

1. On 03/15/2016 at 10:15 am, observation and interview revealed on the 1st floor central supply room, that the ventilation to the space could not be confirmed to be compliant with accepted standards. The clean storage room had negative ventilation. The air flow was from the dirty loading dock into the clean supply room, This was not compliant with FGI Guidelines and ASHRAE 170. This observed situation was not compliant with 42 CFR 482.41(c)(4). This condition was confirmed at the time of discovery by a concurrent observation and interview with staff C (Director of Maintenance), staff F (Maintenance)and staff G (Maintenance).

2. On 03/14/2016 at 5:10 PM, observation and interview revealed on the main entrance lobby, that the ventilation to the space could not be confirmed to be compliant with accepted standards. Air from the Medical Office Building is entering the hospital. This air has not been filtered per FGI Guidelines and ASHRAE 170. This observed situation was not compliant with 42 CFR 482.41(c)(4). This condition was confirmed at the time of discovery by a concurrent observation and interview with staff C (Director of Maintenance).


3. On 03/15/2016 at 10:55 am, observation and interview revealed on the main entrance lobby, that the boilers for heating the hospital could not be confirmed to be compliant with accepted standards. The reserve boilers for space heating and the reserve boiler for the hot water heating did not have the ability to use propane as a source of fuel for the pilot light when the boiler was on fuel oil. The normal fuel is natural gas for both the boiler and its pilot light. Without the propane pilot light, the boilers will not fire when natural gas is not available. This is not compliant, per FGI Guidelines and ASHRAE 170. This observed situation was not compliant with 42 CFR 482.41(c)(4). This condition was confirmed at the time of discovery by a concurrent observation and interview with staff C (Director of Maintenance) and staff I (Maintenance).

4. On 03/15/2016 at 10:55 am, interview revealed at the medical office building at 250 26th street, Prairie du Sac {where the sleep lab is located} that the required outside airflow was reduced to zero when the fire alarm of the hospital (different building) was activated. This is not compliant, per FGI Guidelines and ASHRAE 170. This observed situation was not compliant with 42 CFR 482.41(c)(4). This condition was confirmed at the time of discovery by interview with staff C (Director of Maintenance).

Based on observation, record review and interview, the facility failed to perform hand hygiene per policy, in 2 of 6 patient care observations (Patient #18 and Patient #17); and failed to follow manufacturer's recommendations for equipment and supplies handling, in 2 of 2 reprocessing departments observed (sterile and endoscope). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

HAND HYGIENE
The 3/16/16 record review of facility policy "Hand Hygiene, reviewed 1/21/2016" states in part: "2. Hand hygiene is always indicated before and after patient care: ...b. Before performing invasive procedures. ...e. After situations during which microbial contamination of hands is likely to occur, especially those involving contact with mucous membranes, blood or body fluids, secretions, or excretions. ...i. When you remove gloves. ...6. Glove Use: ...f. Gloves will not be worn outside of immediate patient care areas, even if clean."

1) Surgical suite observations on 3/15/2016 at 8:50 AM revealed CRNA (Nurse Anesthetist) W performed an epidural injection on Patient #18. After the procedure, CRNA W removed sterile gloves and donned a pair of clean gloves without performing hand hygiene to clean up the used supplies. CRNA W then changed gloves without performing hand hygiene to set up the epidural injection pump. CRNA W removed the gloves and charted using the bedside computer without performing hand hygiene. CRNA W left the patient room and went down the hallway without performing hand hygiene.

During interview, when asked about performing hand hygiene post procedure, CRNA W stated on 3/15/2016 at 9:20 AM, "I usually do."

2) Surgical suite observations during a pre-operative preparation on Patient #17 on 2/15/2016 at 2:00 PM revealed that CRNA (Nurse Anesthetist) M changed gloves without performing hand hygiene, left Patient #17's pre-operative room while wearing gloves to retrieve an ultrasound machine, and returned to the patient's room wearing the gloves. CRNA N donned gloves at 2:10 PM to insert Patient #17's IV (intravenous line) without performing hand hygiene. At 2:12 PM CRNA O did not perform hand hygiene prior to donning sterile gloves to perform a femoral nerve block on Patient #17.

During an interview on 3/15/2016 at 5:00 PM, Director L stated "I would expect them [the CRNA staff] to know what there are supposed to do" regarding hand hygiene.

During an interview on 3/16/2016 at 11:40 AM, Infection Control Preventionist DD stated "We haven't worked with the CRNA group specifically, we need to do some (infection control) audit rounding."

STERILE REPROCESSING
The 3/16/16 record review of the manufacturer's directions for use for the facility's general surgical instrument cleaning brushes, dated 2/2016, states "Disinfection: General instrument cleaning brushes can be cleaned using ultrasonic and automatic washers and disinfectors."

During interviews on 3/14/2016 at 3:10 PM, Sterile Processing Technicians P and Q stated that the facility uses reusable cleaning brushes. P and Q stated the brushes are cleaned daily by either putting through the washer or soaking in alcohol. Sterile Processing Technician P went on to state, "I prefer to put them through the washer but some people soak in the alcohol."

During interview with Director S, the manufacturer's directions were reviewed, on 3/14/2016 at 3:55 PM. S stated the directions do not include using alcohol as a disinfection agent, and "we will have to change our process" to meet manufacturer's recommendations.

ENDOSCOPE REPROCESSING
During observation of endoscope reprocessing in the GI (gastrointestinal) clinic on 3/14/2016 at 1:45 PM, GI Technician R used Rapicide PA High-Level Disinfectant Test Strips to verify adequate levels of chemical disinfectant. The test strip bottle was open and undated. Per R, the test strips are good for 4 months after opening.

During an interview on 3/14/2016 at 3:55 PM, Director S stated "staff are expected to date [the testing strips] when opened."

Based on record review and interview, the facility failed to ensure that a organ procurement representative or a designated requestor approached the deceased patient's representative about organ donation, in 2 of 2 patient death records reviewed (Patient's 19 and 20). This had the potential to affect the current in-patient and out-patient census of 36 patients.

Findings include:

The 3/16/16 record review of hospital policy "Organ and Tissue Donation, reviewed 12/28/2015" stated "...d. If the patient has been determined to be suitable for donation by the OPO (organ procurement organization), tissue bank or eye bank, the opportunity for donation must be made by a designated requestor from the OPO."

1) The 3/16/16 record review of Patient #19's "record of death" dated 8/16/2014 revealed "the person providing education/requesting donation from family" was Coroner II.

During interview with Patient Care Vice President X on 3/16/16 at 2:45 p.m., X stated that "there is no evidence that the coroner is a designated requestor, that is not our policy".

2) The 3/16/16 record review of Patient #20's "record of death" dated 10/2/15 revealed "the person providing education/requesting donation from family" was Registered Nurse (RN) JJ.

During interview with Patient Care Vice President X on 3/16/16 at 2:45 p.m., X stated that "we do not have trained designated donor requestors on our staff, RN JJ is not a designated requestor".