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5165 MCCARTY LN

LAFAYETTE, IN 47905

QAPI GOVERNING BODY, STANDARD TAG

Tag No.: A0308

Based on document review and staff interview, the facility failed to ensure 9 of 9 services provided by contractors were part of its comprehensive quality assessment and improvement (QA&I) program.

Findings included:

1. The 2014 Quality and Patient Safety Plan indicated all services with direct or indirect impact on patient care quality shall be reviewed under the quality improvement program.

2. Review of the facility's Performance Improvement Plan and 2014 Arnett Quality Panel indicated it did not include contracted services: Biohazard Waste Hauler, Blood Bank, Laundry, Dietary, Renal Dialysis, Bioengineering, Tele-Radiology, Mobil Positron Emission Tomography, and Extracorporeal Shock Wave Lithotripsy.

3. At 11:00 AM on 10/15/2016, staff member #2 (Director Clinical Excellence) confirmed contracted services: Biohazard Waste Hauler, Blood Bank, Laundry, Dietary, Renal Dialysis, Bioengineering, Tele-Radiology, Mobil Positron Emission Tomography, and Extracorporeal Shock Wave Lithotripsy were not part of the hospital's QA&I program.

MEDICAL STAFF PERIODIC APPRAISALS

Tag No.: A0340

Based on document review and staff interview, the hospital failed to ensure 1 of 6 non-physician practitioners (AH1) files reviewed had an annual competence/skill assessment evaluation by the Medical Staff as defined in the Medical Staff Bylaws.

Findings included:

1. Medical Staff Bylaws (last approved January 28, 2014) Article XI section 11.2 indicated appointments to the Allied Health Care Providers staff shall constitute the provider's agreement that he or she will: sponsoring relationship with at least one physician sponsor; work under the direction of a medical staff member who was credentialed and has privileges at the hospital; annual competence/skill assessment evaluation; shall comply with State of Indiana laws as it relates to Allied Health Care Providers.

2. Review of staff member AH1's (CRNA) credential file indicated AH1 did not have evidence an annual performance evaluation.

3. At 2:15 PM on 10/14/2014, staff member #2 (Director of Clinical Excellence) confirmed that staff member AH1 (CRNA) did not have documentation in the staff member's credential file of a performance evaluation.

MEDICAL STAFF CREDENTIALING

Tag No.: A0341

Based on document review and staff interview, the hospital failed to ensure 1 of 6 non-physician practitioners (AH1) files reviewed was credentialed by the Medical Staff as defined in the Medical Staff Bylaws.

Findings included:

1. Medical Staff Bylaws (last approved January 28, 2014) Article XI section 11.2 indicated appointments to the Allied Health Care Providers staff shall constitute the provider's agreement that he or she will: sponsoring relationship with at least one physician sponsor; work under the direction of a medical staff member who was credentialed and has privileges at the hospital; annual competence/skill assessment evaluation; shall comply with State of Indiana laws as it relates to Allied Health Care Providers.

2. Review of staff member AH1's (CRNA) credential file indicated AH1 was re-appointed by the Medical Staff in April 2014. The staff member's credential file did not have evidence an annual performance evaluation nor a collaborative agreement with a member of the medical staff.

3. At 2:15 PM on 10/14/2014, staff member #2 (Director of Clinical Excellence) confirmed that staff member AH1 (CRNA) did not have documentation in the staff member's credential file of a performance evaluation nor documentation of physician(s) that supervise staff member AH1 and lacked a medical staff category requested privileges form. The staff member indicated the CRNA does administer anesthesia during surgeries.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on policy and procedure review, medical record review and interview, the facility failed to ensure the nursing staff followed physician orders and policy and procedure for 2 of 2 pediatric patients under the age of two (N1 and N3).

Findings included:

1. The facility policy "Routine Maternal/Child Health Nursing Assessment, Care Planning, and Documentation Standards", effective July 2014, indicated, "d) Upon admission to Pediatrics: a. Nursing Admission Assessment: The goal is to complete the Nursing Admission Assessment within two (2) hours of admission to the nursing care unit and includes: i. Admission, mode of admission, gender, age, height, weight, OFC [Occipital Frontal Circumference] for patients two (2) and under, marital status, Advance Directive status, legal guardian for consents."

2. The medical record for patient N1, a twelve-month old admitted 05/22/14 and discharged 05/24/14, lacked documentation of any measurement of the head circumference. Admission physician orders from 05/22/14 indicated, "Admit Weight, Length, OFC and Allergies".

3. The medical record for patient N3, a twenty-three-month old admitted 08/10/14 and discharged 08/13/14, lacked documentation of an admission assessment head circumference measurement. Admission physician orders from 08/10/14 indicated, "Admit Weight, Length, OFC and Allergies".

4. At 10:50 AM on 10/17/14, the manager of the Pediatric Unit, staff member A20, confirmed the head circumference measurements were not documented according to the unit protocol and physician orders.

CONTENT OF RECORD: DISCHARGE SUMMARY

Tag No.: A0468

Based on policy and procedure review, medical record review and interview, the facility failed to ensure all patients had discharge summaries completed according to policy for 4 of 15 closed medical records reviewed (N3, N6, N13, and N15).

Findings included:

1. The facility policy "Content of Medical Records", last reviewed September 2014, indicated, "10. Discharge Summary: a. The discharge summary is the responsibility of the attending physician, although the responsibility may be delegated to a resident or credentialed non-physician provider. The discharge summary shall be completed upon discharge of the patient from the hospital, not to exceed 7 days."

2. The medical record for patient N3, admitted 08/10/14 and discharged 08/13/14, lacked documentation of a physician discharge summary.

3. The medical record for patient N6, admitted 05/17/14 and discharged 05/18/14, lacked documentation of a physician discharge summary or final discharge progress note.

4. The medical record for patient N13, admitted 05/22/14 and discharged 05/24/14, indicated a physician discharge summary dictated 07/15/14 and signed 07/28/14.

5. The medical record for patient N15, admitted 08/21/14 and discharged 08/25/14, lacked documentation of a physician discharge summary.

6. At 12:15 PM on 10/17/14, the Clinical Informatics Coordinator, staff member A40, who navigated the EMR (Electronic Medical Record), confirmed the four records were missing a discharge summary performed according to policy.

PHARMACY ADMINISTRATION

Tag No.: A0491

Based on policy and procedure review, observation and interview, the facility failed to ensure all drugs were labeled and stored according to policy and all storage areas were maintained according to policy.

Findings included:

1. The facility policy "Drug Storage Guidelines ", last reviewed 11/20/11, indicated, "A. Proper environmental control, cleanliness and light must be maintained to ensure the integrity of the medication storage areas. Staff members in each medication storage area, in conjunction with Hospital Facilities, are responsible for documenting refrigerator temperatures daily and maintaining proper drug storage conditions."

2. The facility policy "Single and Multi-Dose Vials: Storage and Use", last approved May 2013, indicated, "B. Multi-dose vials: 1. Multi-dose vials (i.e. those which contain a preservative) should be discarded 28 days from the date the vial is opened or upon suspected contamination or loss of integrity of the vial. When opening a multidose vial, label with the expiration date of 28 days from the date of opening."

3. The facility policy "Labeling Medications", effective October 2013, indicated, "2. Label all syringes unless medication is immediately and completely administered. a) Syringes must be labeled with : i) Patient name and identifier , if for a specific patient. ii) Name and amounts/concentrations of drug. iii) Names or initials of the people who prepared and verified it. iv) The date and exact time of preparation."

4. During the tour of the 6th floor patient unit at 11:35 AM on 10/14/14, accompanied by A7, the Director of Nurse Practice and Quality, and A18, the unit charge nurse, intravenous antibiotics were observed stored in a free-standing refrigerator in the medication room. No thermometer was observed within or attached to the refrigerator and no temperature monitoring logs were available.

5. During the tour of the Obstetrical Unit at 2:50 PM on 10/14/14, accompanied by A3, the Administrative Director of In-Patients, A7, the Director of Nurse Practice and Quality, and A21, the unit charge nurse, the following items were observed in the drawer of a locked epidural cart:
A. An open, but not dated, multi-dose vial of Xylocaine 2% with Epinephrine.
B. A syringe of clear fluid, wrapped with a preprinted sticker that read "Xylocaine".
C. A syringe of clear fluid, wrapped with a preprinted sticker that read "Epinephrine".
D. A syringe of clear fluid with no labeling.

6. At 1:00 PM on 10/14/14, staff member A7 confirmed the temperature of the refrigerator containing the antibiotics was not being monitored. He/she indicated most of the pharmacy refrigerators were remotely monitored, but that was one that was missed. He/she also confirmed the multi-dose vial and the syringes of medication were not dated or labeled according to policy.

SECURE STORAGE

Tag No.: A0502

Based on policy and procedure review, observation and interview, the facility failed to ensure all medications were secured and protected from unauthorized access.

Findings included:

1. The facility policy "Drug Storage Guidelines", last reviewed 11/20/11, indicated, "B. Medications must be accessible to and under the control of authorized personnel only. Storage guidelines ensure that medications: ...4. Medication carts must be locked or located in a locked room if used for drug storage when not attended by authorized personnel."

2. During the tour of the Pediatric Unit at 2:25 PM on 10/14/14, accompanied by A3, the Administrative Director of In-Patients, A7, the Director of Nurse Practice and Quality, and A20, the Manager of the Pediatric Unit, an unlocked and unattended medication cart was observed at the nurses' station.

3. At 2:30 PM on 10/14/14, staff member A20 confirmed the cart contained medications and should be kept locked.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on Life Safety Code (LSC) survey, Indiana University Health Arnett Hospital is comprised of the main hospital in Lafayette, IN (Building 01), the ambulatory surgery center in Lafayette, IN (Building 02), the Sleep Center in Lafayette, IN (Building 03) and the Cancer Center in Lafayette, IN (Building 04). Building 01 was found not in compliance with Requirements for Participation in Medicare/Medicaid, 42 CFR Subpart 482.41(b), Life Safety from Fire and the 2000 Edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC) Chapter 18, New Health Occupancies; Building 02 was found not in compliance with Requirements for Participation in Medicare/Medicaid, 42 CFR Subpart 482.41(b), Life Safety from Fire and the 2000 Edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC) Chapter 20, New Ambulatory Health Care Occupancies; Building 03 was found in compliance with Requirements for Participation in Medicare/Medicaid, 42 CFR Subpart 482.41(b), Life Safety from Fire and the 2000 Edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC) Chapter 38, New Business Occupancies; and Building 04 was found not in compliance with Requirements for Participation in Medicare/Medicaid, 42 CFR Subpart 482.41(b), Life Safety from Fire and the 2000 Edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC) Chapter 38, New Business Occupancies.

Building 01 is a seven story fully sprinklered building of Type I (332) construction and has a fire alarm system with smoke detection in the corridors, patient rooms and spaces open to the corridors. Building 01 provides overnight care. Building 01 has a capacity of 191 beds and had a census of 157 at the time of this survey.

Indiana University Health Arnett Hospital has elected to utilize the Categorical Life Safety Code waiver pertaining to multiple doors in the same means of egress equipped with delayed egress devices on floors 3 and 4.

Building 02 is a one story fully sprinklered building of Type II (000) construction and has a fire alarm system with smoke detection in the corridors and spaces open to the corridors. Building 02 provides ambulatory surgical services with no overnight stays.

Building 03 is located on the first floor of a two story fully sprinklered building of Type II (111) construction and has a fire alarm system with smoke detection in the corridor. Building 03 provides services during overnight hours.

Building 04 is located in a one story fully sprinklered building of Type II (000) construction and has a fire alarm system with smoke detection in the corridor. Building 04 provides services during regular business hours.

Based on LSC survey and deficiencies found (see CMS 2567L), it was determined that the facility failed to ensure 100 percent of corridor doors positively latched into the door frame (see K 018), failed to ensure 100 percent of battery operated emergency lighting was tested in accordance with LSC 7.9 (see K 046), failed to ensure a complete automatic sprinkler system was installed in accordance with NFPA 13, 1999 Standard for the Installation of Sprinkler Systems, to provide complete coverage for 5 of 5 elevator machine rooms (see K 056), failed to ensure 1 of 1 sprinkler systems was continuously maintained in reliable operating condition and inspected and tested periodically (see K 062), failed to exercise 2 of 2 generators to meet the requirements of NFPA 110, the Standard for Emergency and Standby Powers Systems, chapter 6-4.2 and failed to ensure 2 of 2 emergency generators were equipped with remote manual stops (see K 144), Building 01. The facility failed to ensure documentation of a fire drill for the day shift for 1 of 4 calendar quarters (see K 050), failed to electronically supervise 1 of 1 Post Indicator Valves (PIV) (see K 061), failed to regulate the use of portable space heaters in 1 of 1 Central Supply Room (see K 070) and failed to exercise 1 of 1 generators to meet the requirements of NFPA 110, the Standard for Emergency and Standby Powers Systems, chapter 6-4.2 (see K 144), Building 02. The facility failed to ensure 100 percent of battery operated emergency lighting was tested in accordance with LSC 7.9 (see K 046), Building 04.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure that all locations from which it provides services are constructed, arranged and maintained to ensure the provision of quality health care in a safe environment.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on document review, observation and staff interview, the hospital failed to maintain the eyewash stations located in the Cancer Center, Power Plant, Biohazard Room and failed to conduct preventive maintenance inspections on the industrial automatic floor scrubbers and the rehab wooden steps.

Findings included:

1. Risk Assessment for Safety and the Environmental of Care policy (last approved May 2014) indicated the hospital maintains a safe environment; the hospital conducts environmental tours to identify environmental deficiencies, hazards, and unsafe practices; and the hospital shall comply with Occupational Safety & Health Administration (OSHA) and Life Safety Code (LSC).

2. The 2014 Medical Equipment Management Plan indicated all patient care equipment shall be assessed for proper preventive maintenance inspections.

3. OSHA general standard at 1910.151 applies. When necessary, facilities for drenching or flushing the eyes "shall be provided within the work area for immediate emergency use". In applying these general terms, OSHA would consider the guidelines set by such sources as American National Standards Institute (ANSI) Z358.1 -1998, Emergency Eyewash and Shower Equipment, which states, at section 7.4.4, that "eyewash facilities are to be located to require no more than 10 seconds to reach but that where a strong acid or caustic is used, the unit should be immediately adjacent to the hazard". Proper maintenance and weekly testing is necessary to ensure that Emergency Drench Showers and Eyewash Stations are functioning safely and properly. Weekly testing helps clear the supply lines of sediment and bacteria build-up that is caused from stagnant water. The ANSI standard states that plumbed flushing equipment, "shall be activated weekly for a period long enough to verify operation and ensure that flushing fluid is available".

4. The following was observed during tour of the facility which began 10:30 AM on 10/16/2014:
(A) At 10:30 AM, the offsite Cancer Center was toured with staff member #33 (Practice Op Manager). The eyewash station tag recorded weekly observation checks; however, the last weekly tag was observed with a recorded date of 9/8/2014. The tag was absent for at least the previous 4 weeks of observation checks.
(B) At 10:45 AM, the Power Plant was toured with staff member #36 (maintenance staff member). The eyewash station tag recorded monthly observation checks and not the required weekly observation checks.
(C) At 1:30 PM, the Biohazard Room AG274 was toured with staff member #36 (maintenance staff member). The room was observed with four battery operated floor scrubbers. One of the floor scrubbers was observed with the batteries being charged on a battery charger. The room's battery charging station was observed without a eye washing station in case of acid splash into the operator's eyes.

5. The preventive maintenance documents were inspected on assorted clinical and non-clinical equipment and lacked documentation that preventive maintenance inspections were conducted on the automatic floor scrubbers and the patient care equipment, rehab wooden steps.

6. At 11:30 AM on 10/17/2014, staff member #2 (Director Clinical Excellence) indicated Clinical Engineering Department and the Maintenance Department has not conducted preventive maintenance inspections on the automatic floor scrubbers and the rehab wooden steps.

LIFE SAFETY FROM FIRE

Tag No.: A0709

Based on observation, record review and interview, the facility failed to ensure 100 percent of corridor doors positively latched into the door frame, failed to ensure 100 percent of battery operated emergency lighting was tested in accordance with LSC 7.9, failed to ensure a complete automatic sprinkler system was installed in accordance with NFPA 13, 1999 Standard for the Installation of Sprinkler Systems, to provide complete coverage for 5 of 5 elevator machine rooms, failed to ensure 1 of 1 sprinkler systems was continuously maintained in reliable operating condition and inspected and tested periodically, failed to exercise 2 of 2 generators to meet the requirements of NFPA 110, the Standard for Emergency and Standby Powers Systems, chapter 6-4.2 and failed to ensure 2 of 2 emergency generators were equipped with remote manual stops, Building 01. The facility failed to ensure documentation of a fire drill for the day shift for 1 of 4 calendar quarters, failed to electronically supervise 1 of 1 Post Indicator Valves (PIV), failed to regulate the use of portable space heaters in 1 of 1 Central Supply Room and failed to exercise 1 of 1 generators to meet the requirements of NFPA 110, the Standard for Emergency and Standby Powers Systems, chapter 6-4.2, Building 02. The facility failed to ensure 100 percent of battery operated emergency lighting was tested in accordance with LSC 7.9, Building 04.

Findings:

1. Building 01: Observation on 10/15/14 with DO1, Director of Operations and FA1, Facilities Administration during the tour from 9:00 a.m. to 12:00 p.m.ndicated the corridor door to the patient soiled utility pass through area for the patient rooms on the 2nd, 3rd, 4th and 5th floors failed to latch into the frames.

2. In interview at the time of observations, DO1 and FA1 acknowledged the corridor doors for the patient room soiled pass through were not latching into the door frames.

3. Observations with ILFM1 during the tour on 10/15/14 from 9:00 a.m. to 12:00 p.m. noted the facility has at least fifteen emergency lights with battery back-up located in the the power house generator room, five operating rooms and in various electrical rooms spread out throughout the hospital.

4. Interview with ILFM1 during record review on 10/14/14 at 3:00 p.m. indicated there was no written record of a monthly function test or an annual test regarding the battery-operated emergency lights in the hospital available for review.

5. In observation with DO1 and FA1 on 10/15/14 at 8:45 a.m., it was noted that all five of the hospital elevator equipment rooms lacked sprinkler coverage or protection from an automatic extinguishing system.

6. In interview with DO1 and FA1 on 10/15/14 at 8:45 a.m., it was acknowledged that all five of the hospital elevator equipment rooms lacked sprinkler coverage or protection from an automatic extinguishing system.

7. Observation with ILFM1 from 9:00 a.m. to 9:45 a.m. on 10/15/14 noted the sprinkler system located in the fire pump room had at least nine pressure gauges with years of manufacture ranging from 2006 to 2008. Sprinkler risers in the south mechanical room (AG230) and north mechanical room (AG104) had at least twelve pressure gauges with years of manufacture also ranging from 2006 to 2008.

8. In interview during the time of observation, ILFM1 was unaware of the requirement for gauges to be replaced or tested every 5 years and acknowledged sprinkler pressure gauges throughout the hospital had not been tested or replaced since installation of the sprinkler system.

9. Review of the "Planned Maintenance Checklist-Monthly" for the two hospital emergency generators with ILFM1 on 10/14/14 at 3:30 p.m., indicated Line J(2)j of the generator checklist which was intended to show the load percentage in kilowatts was consistently recorded with amperage/voltage or left blank.

10. In interview at the time of review, ILFM1 indicated the two generators operate at more than 30 percent of the EPS nameplate rating when tested but acknowledged the documentation was lacking to demonstrate compliance.

11. Observation of the power house generator room on 10/15/14 at 9:05 a.m. during a tour of the facility with ILFM1 noted emergency stop buttons were provided on the generators but the generators were not equipped with remote manual stop stations.

12. In interview at the time of observation, ILFM1 acknowledged remote shut off devices for either generator were not provided.

13. Building 02: Review of "Code Red Drill Evaluation Reports" documentation with DON1, the Director of Nursing during record review at 2:30 p.m. on 10/15/14 noted documentation of a fire drill conducted for the day shift in the third quarter (July, August, September) of 2014 was not available for review.

14. In interview on 10/15/14 at 2:30 p.m., DON1 acknowledged the facility held an inservice instead of a fire drill for the day shift in the third quarter of 2014.

15. Observation with ILFM1, DO1 and FA1 on 10/15/14 at 1:10 p.m. noted the Post Indicator Valve (PIV) outside the Ambulatory Surgical Center (ASC) was padlocked but lacked electronic supervision.

16. In interview at the time of observation, ILFM1, DO1 and FA1 acknowledged the sprinkler PIV lacked electronic supervision.

17. Observation with ILFM1, DO1 and FA1 on 10/15/10 at 1:30 p.m. indicated a portable space heater was located in the ASC Central Supply room office.

18. In interview at the time of observation, DO1 and FA1 acknowledged space heaters were not allowed anywhere within the health facility locations.

19. Review of the "Planned Maintenance Checklist-Monthly" for the ASC emergency
generator with ILFM1 on 10/14/14 at 3:30 p.m. indicated Line J(2)j of the generator checklist which was intended to show the load percentage in kilowatts was consistently recorded with amperage/voltage or left blank.

20. In interview at the time of review, ILFM1 indicated the ambulatory surgical center generator does not operate at more than 30 percent of the EPS nameplate rating when tested and indicated the most recent load bank test was conducted more than a year ago on 06/29/13.

21. Building 04: Observations with DO1 and FA1 during the tour of the Cancer Center on 10/15/14 at 3:30 p.m. noted the facility had at least twenty emergency lights with battery back-up spread out throughout the Cancer Center.

22. In interview with OLFM1, the Outpatient Lead Facilities Maintenance person during record review on 10/16/14 at 9:00 a.m. confirmed there was no written record of a monthly function test or an annual test regarding the battery-operated emergency lights available for review.

VENTILATION, LIGHT, TEMPERATURE CONTROLS

Tag No.: A0726

Based on observation, manufacturer's labeling directions, and interview, the facility failed to ensure nutritional supplements were stored under appropriate conditions.

Findings included:

1. During the tour of the 6th floor patient unit at 11:35 AM on 10/14/14, accompanied by A7, the Director of Nurse Practice and Quality and A18, the unit charge nurse, two containers of Jevity 1.5 Cal tube feedings were observed on the counter in the well-lit pantry.

2. Between 1:30 PM and 1:50 PM on 10/14/14, accompanied by A9, the COO and A48, the dietician, numerous containers of Jevity 1.2 Cal, Jevity 2 Cal, and Nepro Carb Steady tube feedings were observed in a well-lit storage room near the kitchen.

3. During the tour of the Medical Progressive Unit at 1:55 PM on 10/14/14, accompanied by A3, the Administrative Director of In-Patients, A7, the Director of Nurse Practice and Quality, and A19, the Unit Manager, a container of TwoCal and two containers of Jevity tube feedings were observed on the counter in the well-lit pantry.

4. The manufacturer's label on all of the tube feeding containers indicated the solution contained light sensitive nutrients and needed to be stored accordingly.

5. At 1:45 PM on 10/14/14, staff member A48 indicated nurses returned the tube feedings from the units to the storage room, but confirmed the room was dietary's responsibility.

6. At 2:00 PM on 10/14/14, staff member A7 confirmed the containers of tube feedings were not stored to protect the integrity of the solutions.