HospitalInspections.org

Based on document review and staff interview, it was determined that the hospital failed to protect and promote the rights of each patient. The facility failed to ensure that each patient and/or the responsible party was informed of their rights prior to receiving care or prior to discharge (see A 0117), failed to ensure that patients and/or the responsible party was informed of whom to contact in order to file a grievance (see A 0118), failed to obtain patients' informed consent before administering blood transfusions (see A 0131), failed to ensure evidence that less restrictive interventions were determined ineffective prior to implementation of a restraint (see A 0164), failed to ensure modifications were made to the patients care plan after an episode of seclusion (see A 0166), failed to ensure a restraint order was obtained for the use of a physical restraint (see A 0168), failed to ensure an order for seclusion was time limited (see A0171), failed to ensure a patient placed in seclusion was monitored (see A0175), failed to ensure a 1-hour face-to-face was conducted after implementation of a seclusion order (see A 0178), failed to ensure staff were trained in the application of restraints (see A 0196) and failed to ensure that unlicensed direct care staff who may restrain patients had training in first aid techniques and certification in the use of cardiopulmonary resuscitation (see A 0206).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the protection and promotion of the patient rights.

Based on document review and staff interview, it was determined that the hospital failed to track medical errors and adverse patient (reportable) events (see A 0286) and failed to ensure that the Quality Assessment/Performance Improvement program included all hospital departments and services, including those services furnished under contract or arrangement (see A 0308).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure maintenance and demonstrated evidence of a Quality Assessment and Performance Improvement program.

Based on Life Safety Code (LSC) survey, Saint Catherine Regional Hospital 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 19, Existing Health Care Occupancies.

This three story hospital was determined to be of Type II (222) construction with a basement and partially sprinkled. The basement kitchen, dining room, and old bathroom; the first floor physical therapy room, the gift shop, and the third floor hyperbaric chamber room were sprinklered. The facility has a fire alarm system with smoke detection in the corridors and in spaces open to the corridors. The facility has a capacity of 47 and had a census of 27 at the time of this survey.

Based on LSC survey and deficiencies found (see CMS 2567L), it was determined that the facility failed to ensure 6 of 200 corridor doors latched into the door frames and would resist the passage of smoke and failed to ensure 4 of 200 doors protecting corridor openings did not have an impediment to closing (see K 018), failed to maintain the vertical opening protection for 2 of 4 basement exit stairwells (see K 020), failed to ensure 2 of 3 basement sets of smoke barrier doors and 1 of 9 third floor sets of smoke barrier doors would restrict the movement of smoke for at least 20 minutes (see K 027), failed to ensure the corridor doors to 1 of 10 third floor and 2 of 6 basement hazardous areas, such as an area exceeding 50 square feet and storing combustible materials, and 1 of 1 gas fired equipment rooms were provided with self closing devices which would cause the doors to automatically close and latch into the door frames (see K 029), failed to ensure 2 of 2 battery operated emergency lights in the Physical Therapy addition were maintained and functioned (see K 046), failed to ensure fire drills were held at unexpected times, at least quarterly on 1 of 3 shifts during the past year (see K 050), failed to ensure 42 of 67 smoke detectors tested for sensitivity were either cleaned and recalibrated, or replaced and failed to ensure 3 of 67 smoke detectors in the facility connected to the fire alarm system were properly separated from an air supply or return vent (see K 051), failed to ensure 3 of 3 sprinkler system gauges were replaced or recalibrated every 5 years (see K 062), failed to ensure a policy and procedure was available for the operation 1 of 1 space heaters to ensure the unit was equipped with a heating element which would not exceed 212 degrees Fahrenheit (F) (see K 070), failed to ensure the means of egress was continuously maintained free of impediments to full instant use in the case of fire or other emergency for 1 of 3 exits (see K 072), failed to ensure 1 of 10 inspection certificates was current to ensure the water heater was in safe operating condition (see K 130), failed to ensure 1 of 1 emergency generators was provided with an alarm annunciator in a location readily observed by operating personnel at a regular work station such as a nursing station and failed to ensure 1 of 1 emergency generators was equipped with a remote manual stop (see K 144) and failed to ensure flexible cord electrical wiring used in the business office was in accordance with NFPA 70 (see K 147).

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.

Based on document review & interview, the facility failed to ensure that each patient and/or the responsible party was informed of their rights prior to receiving care or prior to discharge for 5 of 5 medical records (MR) reviewed (Patient #1, 2, 6, 7 & 9).

Findings include:

1. Review of the Registration Consent Form indicated the following:
"Patient Information: As an adult patient (18 years or older or an emancipated minor) receiving services for Acute care, Behavioral Health services, Emergency services, Observation and/or Outpatient surgery, I have received the information/forms listed below, the information has been fully explained to me and I have had the opportunity to have questions answered.
- Patient Rights/patient Grievance Procedures
- Patient Responsibilities
- Advance Directives Information/Your Right to Decide
- Organ Donation"

2. On 06-05-14 at 0942 hours, staff #50, registration clerk, confirmed that when patients are registering and consenting for treatment, no copies of the Patient Rights/Patient Grievance Procedures, Patient Responsibilities, Advance Directives Information/Your Right to Decide, Organ Donation are given.

3. Review of patient #1, 2, 6, 7 & 9's MR indicated that each was a Medicare patient and each MR lacked documentation of receiving the "Important Message From Medicare" on admission & prior to discharge.

4. On 06-05-14 at 1030 hours, staff #51, registration manager, confirmed that the Important Message From Medicare notice is not given to patients.

5. On 06-05-14 at 1040 hours, staff #52, case manager, confirmed that the Important Message From Medicare notice is not given to patients.

Based on document review, interview & observation, the facility failed to ensure that patients and/or the responsible party was informed of whom to contact in order to file a grievance.

Findings include:

1. Review of policy/procedure Patient Rights & Responsibilities indicated the following:
"- the patient, or when appropriate, the patient's representative has the right to file a verbal or written dispute, grievance or conflict by contacting any employee, administrative staff member, or by contacting the Director of Quality Management at 256-7660."

2. Review of the Registration Consent Form indicated the following:
"Patient Information: As an adult patient (18 years or older or an emancipated minor) receiving services for Acute care, Behavioral Health services, Emergency services, Observation and/or Outpatient surgery, I have received the information/forms listed below, the information has been fully explained to me and I have had the opportunity to have questions answered.
- Patient Rights/patient Grievance Procedures
- Patient Responsibilities
- Advance Directives Information/Your Right to Decide
- Organ Donation"

3. On 06-05-14 at 0942 hours, staff #50, registration clerk, confirmed that when patients are registering and consenting for treatment, no copies of the Patient Rights/Patient Grievance Procedures, Patient Responsibilities, Advance Directives Information/Your Right to Decide, Organ Donation are given.

4. On 06-05-14 at 0940 hours, by the registration area, a poster was hanging labeled as "Patient Rights & Responsibilities". The poster lacked documentation that a grievance may be lodged with the state agency including the contact information of the state agency.

Based on blood transfusion policy reviews, transfusion document chart reviews and staff interview, the hospital failed to obtain patients' informed consent before administering blood transfusions in accordance with approved medical staff policies and procedures for three (Patient #9, #17 and #18 ) of twenty patients.

Findings include:

1. On 6/03/14 at 1:40 p.m., review of the laboratory policy, "Blood and Blood Product Administration", revised 3/12, read:
"Each person must initial or sign appropriate forms assuring that all identifiers match and are acceptable."

2. On 6/04/14 at 2:00 p.m., review of twenty patients receiving blood units indicated six of these received-units did not have signed consent, per policy, including:

Patient #9
Unit administered on 10/10/13 at 0725 and Unit administered on
10/10/14 at 0820 had been administered without benefit of a signed patient consent.

Patient #17
Unit administered on 6/28/13 at 1630 had been administered with no documentation of a signed patient consent.
Unit administered on 6/28/13 at 2038 had also been administered with no documentation of a signed patient consent.

Patient #18
Unit administered on 5/23/13 at 1025 and Unit administered on
5/23/13 at 1351 had each been administered without benefit of a signed patient consent.

3. On 6/03/14 at 4:30 p.m., staff member #5 (registered nurse) acknowledged that missing signed consents for the above-listed patient blood units was not available for review.

Based on document review and staff interview, the facility failed to ensure evidence that less restrictive interventions were determined ineffective prior to implementation of a restraint in 1 (patient #26) of 1 instance of a physical restraint.

Findings include:

1. Review of patient #26 (med/surg patient) medical record indicated the following:
(A) Nurse notes document at 0025 and amended at 0035 on 4/25/14 indicated the patient had been physically held down by two (2) male staff members after he/she was physically and verbally "violent"
(B) The medical record lacked evidence that less restrictive interventions were attempted prior to the implementation of the physical restraint.

2 Facility policy titled "Restraint Use- Medical and Behavioral" last reviewed/revised 4/14 stated on page 3: "10. Documentation: The following will be documented in the medical record whenever a behavioral restraint is applied:................The less restrictive alternative(s) to restraint considered....."

3. Staff member #AA1, Director of Medical Records, verified the medical record information at 12:15 p.m. on 6/5/14.

Based on document review and staff interview, the facility failed to ensure modifications were made to the patients care plan after an episode of seclusion in 1 instance (patient #23).

Findings include:

1. Review of patient #23 medical record indicated the following:
(A) An order was written for seclusion at 0057 on 12/10/13 and the patient was placed in seclusion.
(B) The medical record lacked evidence that the care plan was modified after the episode of seclusion.

2. Facility policy titled "RESTRAINT & SECLUSION" last reviewed/revised 12/09 stated on page 8: "The use of restraints, (both physical and drugs used as a restraint)/seclusion is done in accordance with a written modification to the patient's plan of care......"

2. Staff member #AA1, Director of Medical Records, verified the medical record information at 12:15 p.m. on 6/5/14.

Based on document review and staff interview, the facility failed to ensure a restraint order was obtained in 1 instance of a physical restraint (patient #26).

Findings include:

1. Review of patient #26 (med/surg patient) medical record indicated the following:
(A) Nurse notes document at 0025 and amended at 0035 on 4/25/14 indicated the patient had been physically held down by two (2) male staff members.
(B) There was no order in the medical record for a restraint.

2. Review of facility incident reports indicated an incident report was completed on 4/24/14 at 2248 indicating the following:
(A) RN #1 responded to a code black (security issue) at "approx 2210" on 4/24/14 and upon arrival to the room of patient #26, RN #2 was attempting to restrain patient #26 "as he was swinging arms and attempting to come out of bed."
(B) RN #1 assisted RN #2 in holding the patient's arms and torso to the bed.
(C) The document indicated the patient wanted to leave to go home and get his/her pain medication.
(D) The patient was physically restrained 2 additional times during the code black episode.

3. Facility policy titled "Restraint Use- Medical and Behavioral" last reviewed/revised 4/14 stated on page 2: "5. Orders: Restraints will be initiated or continued upon the order of a treating physician with current privileges at this institution.....................6. Initiation without orders: If a physician is not available, a registered nurse may initiate restraint.........without the prior order of a physician. If restraint was necessary due to a significant change in the patient's condition, the physician will be notified immediately for an order. Otherwise, the physician must be notified and a restraint order requested within 8 hours of its initiatation."

3. Staff member #AA1, Director of Medical Records, verified the medical record information at 12:15 p.m. on 6/5/14.

Based on document review and staff interview, the facility failed to ensure an order for seclusion was time limited in 1 instance (patient #23).

Findings include:

1. Review of patient #23 medical record indicated the following:
(A) An order was written for seclusion at 0057 on 12/10/13 and the patient was placed in seclusion from 12:30 a.m. to 2:45 a.m.. The order was not time limited.

2. Staff member #AA1, Director of Medical Records, verified the medical record information at 12:15 p.m. on 6/5/14.

Based on document review and staff interview, the facility failed to ensure a patient placed in seclusion was monitored per policy in 1 instance (patient #23).

Findings include:

1. Review of patient #23 medical record indicated the following:
(A) An order was written for seclusion at 0057 on 12/10/13 and the patient was placed in seclusion from 12:30 a.m. to 2:45 a.m..
(B) The medical record lacked evidence that the patient was continuously monitored per policy during the seclusion episode. The record contained evidence of every 15 minute checks.

2. Facility policy titled "RESTRAINT & SECLUSION" last reviewed/revised 12/09 stated on page 7: "Reassessment of the patient in restraint/seclusion for a behavior management reason includes items listed above, as well as monitoring the patient on a continuous basis."

2. Staff member #AA1, Director of Medical Records, verified the medical record information at 12:15 p.m. on 6/5/14.

Based on document review and staff interview, the facility failed to ensure a 1-hour face-to-face was conducted after implementation of a seclusion order in 1 instance (patient #23).

Findings include:

1. Review of patient #23 medical record indicated the following:
(A) An order was written for seclusion at 0057 on 12/10/13 and the patient was placed in seclusion from 12:30 a.m. to 2:45 a.m..
(B) The medical record lacked evidence that a face-to-face was conducted within 1 hour of the initiation of seclusion.

2. Facility policy titled "RESTRAINT & SECLUSION" last reviewed/revised 12/09 indicated the face-to-face is to be performed by a physician within 1 hour.

2. Staff member #AA1, Director of Medical Records, verified the medical record information at 12:15 p.m. on 6/5/14.

Based on document review and staff interview, the facility failed to ensure staff were trained in the application of restraints for 2 of 2 Registered Nurses (RN #1 and RN #2) involved in a restraint episode for 1 patient (patient #26).

Findings include:

1. Review of patient #26 (med/surg patient) medical record indicated the following:
(A) Nurse notes document at 0025 and amended at 0035 on 4/25/14 indicated the patient had been physically held down by two (2) male staff members.

2. Review of facility incident reports indicated an incident report was completed on 4/24/14 at 2248 indicating the following:
(A) A code black (security issue) was called and RN #1 assisted RN #2 in holding the arms and torso of patient #26 to the bed.
(B) The patient was physically restrained 2 additional times during the code black episode.

3. Facility policy titled "Restraint Use- Medical and Behavioral" last reviewed/revised 4/14 stated on page 7: "A. In order to minimize the use of restraint, all direct care staff as well as any other staff involved in the use of restraint receive ongoing training.............."

4. Personnel files for RN #1 and RN #2 lacked evidence of training in the use of restraints.

5. Staff member #AA1, Director of Medical Records, verified at 2:00 p.m. on 6/5/14 that the personnel files for RN #1 and RN #2 lacked evidence of training in the use of restraints.

Based on document review and staff interview, the facility failed to ensure that unlicensed direct care staff who may restrain patients had training in first aid techniques and certification in the use of cardiopulmonary resuscitation for 2 of 2 Behavioral Health Certified Nursing Assistants (CNA) (Staff # N19 & N21) involved in a restraint episode.

Findings include:

1. Review of staff #19 & 21's personnel files lacked documentation of training in first aid techniques and certification in the use of cardiopulmonary resuscitation. Staff #19 & 21's personnel files indicated each worked on the inpatient Behavioral Health unit.

2. On 06-04-14 at 1520 hours, staff #44, manager of Behavioral Health inpatient unit, confirmed the staff may use lap belts as restraints and 4 way soft restraints.

3. On 06-05-14 at 1150 hours, staff #41 confirmed that staff #19 & 21's personnel file lacked documentation of training in first aid techniques and certification in the use of cardiopulmonary resuscitation.

Based on document review and interview, the facility failed to track medical errors and adverse patient (reportable) events as part of its Quality Assessment/Performance Improvement (QAPI) program.

Findings:

1. Review of the facility's QAPI program indicated it did not track medical errors and adverse patient (reportable) events.

2. In interview, on 6-5-14 at 10:30 am, employee #A9, Quality Assurance Leader, confirmed the above and no other documentation was provided prior to exit.

Based on document review and interview, the hospital's governing body failed to ensure that the Quality Assessment/Performance Improvement (QAPI) program included all hospital departments and services, including those services furnished under contract or arrangement for 6 (discharge planning, infusion therapy, medical records, physical therapy, respiratory care, and sleep lab) directly-provided services and 8 (blood bank, dietician, reference laboratory, medical records, magnetic resonance imaging, teleradiology, speech pathology, and transcription) contracted services.

Findings:

1. Review of the hospital's QAPI program indicated it did not include the directly-provided services of discharge planning, infusion therapy, medical records, physical therapy, respiratory care, and sleep lab.

2. Review of the hospital's QAPI program indicated it did not include the contracted services of blood bank, dietician, reference laboratory, medical records, magnetic resonance imaging, teleradiology, speech pathology, and transcription.

3. In interview, on 6-5-14 at 10:30 am, employee #A9, Quality Assurance Leader, confirmed the above and no other documentation was provided prior to exit.

Based on document review, a registered nurse failed to adequately supervise the care provided for 1 of 5 patients with orders for pain medication (patient #26).

Findings include:

1. Patient #26 was physically restrained on 4/24/14 because he/she was attempting to leave the hospital to go home and get his/her pain medication. It could not be determined that an RN supervised the care and assessed the patients need for the medication prior to physically restraining the patient.

2. Review of patient #26 medical record indicated the following:
(A) The patient presented to the hospital via ambulance at 1300 on 4/24/14 with complaint of chest pain.
(B) A list containing medications taken at home included, but was not limited to, Dilaudid 4 mg (pain medication) three (3) times a day and Neurontin 300 mg (anti-convulsant used at times for pain) 3 times a day.
(C) An order was written at 1608 on 4/24/14 for Dilaudid 4 mg prn (as needed) and Neurontin 300 mg tid (three times a day).
(D) The medical record lacked evidence that the patient was assessed for pain prior to the patient becoming upset at 2230 on 4/24/14 and leaving the facility.
(E) The medical record indicated the patient was physically held down by two (2) male staff members beginning at 2230 on 4/24/14 and prior to leaving the facility.

3. Review of facility incident reports indicated an incident report was completed on 4/24/14 at 2248 indicating the following:
(A) RN #1 responded to a code black (security issue) at "approx 2210" on 4/24/14 and upon arrival to the room of patient #26, RN #2 was attempting to restrain patient #26 "as he was swinging arms and attempting to come out of bed."
(B) RN #1 assisted RN #2 in holding the patients arms and torso to the bed.
(C) The document indicated the patient wanted to leave to go home and get his/her pain medication.
(D) The patient was physically restrained 2 additional times during the code black episode and prior to the patient leaving the facility.

4. Staff member #AA1, Director of Medical Records, verified the medical record information at 12:15 p.m. on 6/5/14.

Based on document review and staff interview, the nursing staff failed to develop a complete nursing care plan for 4 of 7 patients (patients 1, 8, 10, and 11) and failed to review the care plan per policy for 4 of 7 patients (patients 1, 8, 9, 10 ).

Findings include:

1. Review of patient #1 medical record indicated the following:
(A) The care plan did not include interventions to reach the documented goal. Nursing staff documented the patients current behavior in the intervention section instead of what interventions were to be used to reach the stated goal.
(B) The complete care plan was not reviewed per policy for > 24 hours on 4/7/14-4/8/14.

2. Review of patient #8 medical record indicated the following:
(A) The care plan did not include interventions to reach the documented goal. Nursing staff documented a goal in the intervention section instead of an intervention.
(B) The complete care plan was not reviewed per policy for > 24 hours on 6/1/14-6/2/14.

3. Review of patient #9 medical record indicated the following:
(A) The care plan was not reviewed per policy for > 24 hours on 6/1/4-6/2/14.

4. Review of patient #10 medical record indicated the following:
(A) The care plan did not include interventions to reach the documented goal. Nursing staff documented a goal in the intervention section instead of an intervention.
(B) The complete care plan was not documented as reviewed 5/28/14-6/2/14.

5. Review of patient #11 medical record indicated the following:
(A) The care plan did not include interventions to reach the documented goal. Nursing staff documented the patients current behavior in the intervention section instead of what interventions were to be used to reach the stated goal.

6. Facility policy titled "ASSESSMENT, RE-ASSESSMENT, & DATA COLLECTION" last reviewed/revised 7/13 stated on page 3: "1..................An RN will review the plan of care at least once every 24 hours......"

7. Staff member #N3, Director of Emergency Department, verified the medical record information for patient #1 beginning at 11:00 a.m. on 6/3/14.

8. Staff member #N2, Medical/Surgical Staff Nurse, verified the medical record information for patients #8 and 9 beginning at 2:55 p.m. on 6/3/14.

9. Staff member #N16, Behavior health Unit Licensed Practical Nurse, verified the medical record information for patients 10 and 11 beginning at 11:40 a.m. on 6/4/14.

Based on document review & interview the facility failed to ensure that nursing personnel completed unit specific competencies on the inpatient Behavioral Health unit for 7 of 15 personnel files reviewed (Staff #N1, N7, N9, N11, N16, N17 & N20).

Findings include:

1. Review of the Job Descriptions for a registered nurse (RN) and a licensed practical nurse (LPN) on the Med Surg (Medical Surgical) / BHS (Behavorial Health) unit indicated the following:
"9. Sucessfully complete facility conducted orientation of specialized dementia unit as appropriate."

2. Review of staff #N1, N7, N9, N11, N16, N17 & N20's personnel files indicated each was either a RN or LPN and worked on the BHS unit. Each file lacked documentation completing the facility conducted orientation of specialized dementia unit.

3. On 06-05-14 at 1150 hours, the facility conducted orientation of specialized dementia unit documentation was requested from staff #41. No documentation was provided prior to exit.

Based on document review and staff interview, the facility failed to ensure medications were administered in accordance with physician order for 1 of 5 patients with pain medication orders (patient #26).

Findings include:

1. Review of patient #26 medical record indicated the following:
(A) The patient presented to the hospital via ambulance at 1300 on 4/24/14 with complaint of chest pain.
(B) An order was written at 1608 on 4/24/14 for Neurontin 300 mg tid (three times a day).
(D) The medical record lacked evidence that the Neurontin was administered on 4/24/14.

2. Staff member #AA1, Director of Medical Records, verified the medical record information at 12:15 p.m. on 6/5/14.

Based on blood transfusion policy reviews, transfusion document chart reviews and staff interview, the hospital failed to administer blood transfusions in accordance with approved medical staff policies and procedures for fourteen (Patient #1-3, 6-7, 9-10, 13-15 and 17-20) of twenty patients.

Findings include:

1. On 6/03/14 at 1:40 p.m., review of the laboratory policy, "Blood and Blood Product Administration", revised 3/12, read:
"Each person must initial or sign appropriate forms assuring that all identifiers match and are acceptable."

2. On 6/03/14 at 1:50 p.m., review of the nursing policy, "Blood and Blood Product Administration", reviewed 11/07, read:
"Blood and Blood products will be administered upon a physician's order.
Nursing personnel will obtain a blood/blood product consent form.
Laboratory technologist and person picking up the blood shall sign and date blood request and blood bank ledger.
Whole blood and Packed Cells must be initiated within 30 minutes of obtaining the blood from the laboratory and must infuse within 4 hours of leaving the blood bank refrigerator.
Patients shall be frequently monitored for signs of adverse reactions, such as: chills or fever (temperature observation of 2 degree or more).
Vital signs including temperature, pulse, respirations and blood pressure, and visual checks of the patient will be as follows: 15 minutes after the start of the infusion
Whole blood and Packed Cells must be initiated within 30 minutes of obtaining the blood from the laboratory and must infuse within 4 hours of leaving the blood bank refrigerator.
Lab personnel and nursing personnel will review the transfusion record and sign post transfusion data under section 3 of the transfusion record."

3. On 6/04/14 at 2:00 p.m., review of twenty patients receiving blood units indicated fourteen of these received-units did not have complete documentation, per policy, on the Transfusion Record form including:

Patient #1
Unit administered on 4/24/14 at 2100: The unit was started at 2100; however, the 30 minute vitals were documented at 2130 in lieu of at 15 minutes (2115).
Patient #2
Unit administered on 2/04/14 at 2130: The unit was released from the blood bank at 2000; however, it was administered at 1 hour and 30 minutes in lieu of within 30 minutes (2030).
Patient #3
Unit administered on 1/24/14 at 2015: The unit was started at 2015
and the 15 minutes vitals were documented at 2027 which was 12 minutes; the unit was released from the blood bank at 1739 and completed at 2300 which was 5 hours and 21 minutes in lieu of within 4 hours (2139).
Unit administered on 1/24/14 at 1755: The unit was started at 1755 and the 15 minute vitals were documented at 1710 which was prior to the start time on 1755.
Patient #6
Unit administered on 12/05/13 at 2115: The transfusion record form was missing the tech signature signing time.
Patient #7
Unit administered on 11/009/13 at 1800: The 15 minute vital temperature was 93.1 Fahrenheit (F) at 1816 and the vital temperature at completion at 1936 was 98.3 F (a rise of 5.2 degrees F). No adverse reaction had been documented for this temperature rise above 2 degrees F.
Patient #9
Unit administered on 10/10/13 at 0725 and Unit administered on
10/10/14 at 0820 had been administered without benefit of a signed patient consent.
Patient #10
Unit administered on 10/2/13 at 1515: The time the unit had been released from the blood bank had not been documented.
Patient #13
Unit administered on 8/24/13 at 1235: The transfusion record form was missing the amount of blood transfused and the signature of the laboratory tech responsible for verifying the post transfusion data. The blood bank log was missing the time the unit had been cross matched.
Unit administered on 8/24/13 at 1418: The pretransfusion vital temperature as 98.0 F and the 15 minute vital temperature was 98.7 F (a rise of 0.7 degrees F) however no adverse reaction documentation was available for review.
The transfusion record form was missing the amount of blood transfused and both the signature of the Registered Nurse (RN) and laboratory tech responsible for verifying the post transfusion data. The blood bank log was missing the time the unit had been cross matched.
Patient #14
Unit administered on 8/13/13 at 2015: The unit was released from the blood bank at 1940 and started at 2015 which was greater than 30 minutes (35 minutes)
Patient #15
Unit administered on 7/17/13 at 2140 and Unit administered on
7/17/13 at 2332 had each been administered without benefit of a
physician's order.
Patient #17
Unit administered on 6/28/13 at 1630 had been administered with no documentation of a signed patient consent.
Unit administered on 6/28/13 at 2038: The unit was started at 2038 and the 15 minute vitals documented at 2048 which was 10 minutes in lieu of 15 minutes; This unit had also been administered with no documentation of a signed patient consent.
Patient #18
Unit administered on 5/23/13 at 1025 and Unit administered on
5/23/13 at 1351 had each been administered without benefit of a signed patient consent.
Patient #19
Unit administered on 5/09/13 at 2330 and Unit administered on
5/09/13 at 1645 had each been administered without benefit of a physician's order.
Patient #20
Unit administered on 4/28/13 at 0350: The unit was started on 4/28/13 at 0350 and the 15 minute vitals documented at 0410 which was at 20 minutes in lieu of within 15 minutes.

4. On 6/03/14 at 4:30 p.m., staff member #5 (registered nurse) acknowledged that missing documentation for the above-listed patient blood units was not available for review.

Based on observation, the facility failed to properly store medical records in a location where they were protected from fire in 1 instance.

Findings:

1. On 6-4-14 at 10:00 am, in the presence of employee #A3, Chief Executive Officer and employee #A6, Facility Director, it was observed in the medical record storage area, some of the paper records were stored on 7 shelves that were open on at least 2 sides (front and back). It was also observed the area did not have an automatic sprinkler system. If a fire occurred in that area, the records on those shelves were unprotected.

Based on observation, the facility failed to maintain the hospital's environment to assure the well-being of patients in 3 instances.

Findings:

1. On 6-4-14 at 10:25 am, in the presence of employee #A3, CEO, and employee #A6, Facility Director, it was observed in the mammography area there was a considerable amount of dust on the equipment.

2. On 6-4-14 at 10:30 am, in the presence of employee #A3, Chief Executive Officer, and employee #A6, Facility Director, it was observed in the computerized tomography scan area, there was a large amount of dust on the equipment.

3. On 6-4-14 at 10:45 am, in the presence of employee #A3, Chief Executive Officer, and employee #A6, Facility Director, it was observed in the radiology area, there was a large amount of dust on the lockers.

4. On 6-4-14 at 11:10 am, in the presence of employee #A3, Chief Executive Officer, and employee #A6, Facility Director, it was observed in the housekeeping storage area, there was a large amount of dust on the employee lockers.

Based on observation, facility documentation and interview, the facility failed to ensure 6 of 200 corridor doors latched into the door frames and would resist the passage of smoke and failed to ensure 4 of 200 doors protecting corridor openings did not have an impediment to closing, failed to maintain the vertical opening protection for 2 of 4 basement exit stairwells, failed to ensure 2 of 3 basement sets of smoke barrier doors and 1 of 9 third floor sets of smoke barrier doors would restrict the movement of smoke for at least 20 minutes, failed to ensure the corridor doors to 1 of 10 third floor and 2 of 6 basement hazardous areas, such as an area exceeding 50 square feet and storing combustible materials, and 1 of 1 gas fired equipment rooms were provided with self closing devices which would cause the doors to automatically close and latch into the door frames, failed to ensure 2 of 2 battery operated emergency lights in the Physical Therapy addition were maintained and functioned, failed to ensure fire drills were held at unexpected times, at least quarterly on 1 of 3 shifts during the past year, failed to ensure 42 of 67 smoke detectors tested for sensitivity were either cleaned and recalibrated, or replaced and failed to ensure 3 of 67 smoke detectors in the facility connected to the fire alarm system were properly separated from an air supply or return vent, failed to ensure 3 of 3 sprinkler system gauges were replaced or recalibrated every 5 years, failed to ensure a policy and procedure was available for the operation 1 of 1 space heaters to ensure the unit was equipped with a heating element which would not exceed 212 degrees Fahrenheit (F), failed to ensure the means of egress was continuously maintained free of impediments to full instant use in the case of fire or other emergency for 1 of 3 exits, failed to ensure 1 of 10 inspection certificates was current to ensure the water heater was in safe operating condition, failed to ensure 1 of 1 emergency generators was provided with an alarm annunciator in a location readily observed by operating personnel at a regular work station such as a nursing station and failed to ensure 1 of 1 emergency generators was equipped with a remote manual stop and failed to ensure flexible cord electrical wiring used in the business office was in accordance with NFPA 70.

Findings:
1. In observations with POF1, HVAC-Plant Operations staff, POF2, Tech-Plant Operations staff and POF3, Director of Facilities from 10:30 a.m. to 1:30 p.m. on 06/03/14, the following was noted:
a. The door to room 367 did not latch into the frame.
b. The door to room 217 did not latch into the frame.
c. The door to the basement sterilizer room had a two inch gap along the latching side of the door in the closed position.
d. The door to the basement housekeeping storage room had two, one half inch circular holes through the door next to the door knob.
e. The double doors to the hyperbaric chamber room failed to positively latch into the door frame and had a manual slide bolt latch at the top of each door.
f. The door to room 246 failed to latch into the door frame on several attempts and left a one inch gap when closed.

2. This was verified by POF1 and POF2 at the time of observations and acknowledged by POF4, Executive Director at the exit conference on 06/03/14 at 2:45 p.m.

3. In observations with POF1 and POF2 from 10:00 a.m. to 2:45 p.m. on 06/03/14, the following was noted:
a. The door to room 350 (office) was propped open with a wooden wedge under the door.
b. The door to the Behavioral Health Services office was propped open with a wooden wedge under the door.
c. The door to the first floor ER Treatment room was propped open with a wooden wedge under the door.
d. The door to room 310 was propped open with a wooden chair.

4. This was verified by POF1 and POF2 at the time of observation, and acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

5. In observations on 06/03/14 during a tour of the basement with POF3 from 10:00 a.m. to 2:45 p.m., it was noted the kitchen stairway door and the canteen area stairway door each failed to self close and latch into the door frame, leaving a one inch gap along the latching side of the doors.

6. This was verified by POF3 at the time of observations and acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

7. In observations with POF3 on 06/03/14 during a tour of the basement from 10:00 a.m. to 2:45 p.m., it was noted the set of smoke barrier doors by the pharmacy and the set of smoke barrier doors by the linen room failed to close completely, leaving a one inch gap where each set of doors came together.

8. In observation with POF1 and POF2 at 10:30 a.m. on 06/03/14, it was noted a door closer on one of the third floor sets of smoke barrier doors in the corridor near room 363 was disconnected and would not self close to form a smoke resistive barrier.

9. The basement pharmacy, basement linen room and near room 363 on the third floor sets of smoke barrier doors not closing completely was verified by POF3, POF1 and POF2 at the time of observations and acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

10. In observations on 06/03/14 during a tour of the third floor with POF1 and POF2 on 06/03/14 at 10:30 a.m., it was noted the third floor Respiratory Therapy Storage room (Room #375) door lacked a self closing device. This room exceeded 50 square feet and was used for storage of respiratory supplies wrapped in plastic and stored in cardboard boxes (hazardous areas are such as an area exceeding 50 square feet and storing combustible materials).

11. In observation with POF3 during a tour of the basement from 10:00 a.m. to 2:45 p.m., it was noted the basement's gas fired boiler room set of doors failed to self close and latch into the door frame on three separate attempts. The one hundred and forty square foot pharmacy storage room where twenty two cardboard boxes of pharmacy supplies were stored, and the sixty square foot copy machine room where eighteen plastic copy machines and six cardboard boxes filled with printer cartridges were stored each lacked self closing devices on the doors (hazardous areas are such as an area exceeding 50 square feet and storing combustible materials, and gas fired equipment rooms).

12. This was verified by POF1, POF2 and POF3 at the time of observations and acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

13. In observation with POF1 and POF2 from 10:30 a.m. to 1:30 p.m. on 06/03/14, it was noted the two battery operated emergency lights in the Physical Therapy addition did not function when tested.

14. In interview at the time of observation, POF1 and POF2 verified the aforementioned battery operated emergency lights did not function when tested. This was acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

15. Review of the Fire Drill Evacuation/Fire Report Checklist with POF3 on 06/03/14 at 10:15 a.m. revealed fire drills conducted on the third shift were held at the following similar times: on 01/24/14 at 6:15 a.m., on 04/10/14 at 6:30 a.m., and on 07/09/13 at 6:30 a.m.

16. In interview with POF3 on 06/03/14 at 10:30 a.m., the third shift starts at 11:00 p.m. and ends at 7:00 a.m. The third shift fire drills being held at similar times was verified by POF3 at the time of record review and acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

17. Review of Fire & Security Detector Sensitivity Test Reports dated 09/17/12 and 09/25/12 with POF3 on 06/03/14 at 10:30 a.m. revealed the reports listed fifty seven smoke detectors which failed sensitivity testing.

18. Review of the Fire & Security Service Work Order report dated 07/14/13 indicated POF2 replaced 15 smoke detectors, but the report was not specific as to which smoke detectors had been replaced.

19. In interview with POF3 on 06/03/14 at 10:40 a.m., it was stated the facility is replacing the failed smoke detectors over time because of the cost involved with replacement.

20. The forty two failed smoke detectors not being replaced or recalibrated was verified by POF3 at the time of record review, and acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

21. In observations with POF1 and POF2 from 10:30 a.m. to 1:30 p.m. on 06/03/14, the following was noted:
a. A smoke detector located in the third floor TV room was situated between a supply air vent and a make up air vent and was one foot away from either vent.
b. A smoke detector located in the third floor soiled linen room was one foot from an air supply vent.
c. A smoke detector located in the third floor personal laundry room was two feet from an air supply vent.

22. In interview at the time of observation,POF1 and POF2 verified the distances between the vents, and agreed the air flow could interfere with smoke detector function. This was acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

23. Review of Quarterly Sprinkler System Inspection Reports from 03/17/14 through 01/03/13 with POF3 on 06/03/14 at 10:40 a.m. indicated there was no record the three sprinkler system gauges having been replaced over the past five years.

24. In observation of the sprinkler riser, located in the basement boiler room on 06/03/14 at 10:45 a.m. with POF3, it was noted there were three gauges on the sprinkler riser with a manufacturer date of 2008 on two gauges and no manufacturer date on the one gauge.

25. The lack of the three sprinkler system gauges being replaced every five years was verified by POF3 at the time of observation of the sprinkler system riser and acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

26. Based on observation with POF1 and POF2 from 10:30 a.m. to 1:30 p.m. on 06/03/14, it was noted a portable space heater was plugged into an electrical outlet and appeared to be in use in the medical staff office.

27. POF1 and POF2 stated at the time of observation, they were unaware there was a space heater in the facility. They were unaware of a policy and procedure for the use of space heaters to identify where they might be used and any restrictions related to their use in the facility. This was acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

28. In observation with POF1 and POF2 from 10:30 a.m. to 1:30 p.m. on 06/03/14, the bushes outside the south exit were overgrown and protruding into the exit discharge path, covering half of the sidewalk.

29. In interview at the time of observation, POF1 and POF2 verified the means of egress was not continuously maintained free of impediments at the south exit. This was acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

30. Review of the ten boiler/hot water heater inspection certificates with POF3 on 06/03/14 at 11:05 a.m. indicated the inspection certificate for the Lochnivar model hot water heater with the Indiana Registration #281834 had an expiration date of 03/14/13.

31. Observation on 06/03/14 with POF3 of the Lochnivar model water heater located in the basement boiler room indicated there was no current inspection certificate in the boiler room.

32. The lack of a current inspection certificate for the Lochnivar model hot water heater was verified by POF3 at the time of record review and acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

33. In observation on 06/03/14 at 12:10 p.m. during a tour of the facility with POF1 and POF2, it was noted there was no remote alarm annunciator for the emergency generator in a location readily observed by operating personnel at a regular work station such as a nursing station. The only remote alarm annunciator for the generator was located in the Business Office which was not occupied at all times.

34. This was verified by POF1 and POF2 at the time of observation who confirmed the Business Office was not occupied at all times, and acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

35. In observations on 06/03/14 between 10:30 a.m. and 2:00 p.m. during a tour of the facility with POF1 and POF2, a remote shut off device for the generator was not found.

36. In interview at 12:22 p.m., while at the generator, POF1 said the generator was over 150 horsepower and verified there was no remote shut off device for the generator. This was acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

37. In observation on 06/03/14 during a tour of the facility from 10:30 a.m. to 1:30 p.m. with POF1 and POF2, it was noted that there was 15 foot length of orange electrical cord that was plugged into an electrical outlet in the Business Office and went up the wall, under the lay-in ceiling tile and was spliced into an electrical cord with a switch that was attached to a light at the top of a curio cabinet built into the first floor main corridor wall.

38. In interview at the time of observation, POF1 and POF2 acknowledged the orange electrical cord in the Business Office. This was acknowledged by POF4 at the exit conference on 06/03/14 at 2:45 p.m.

Based on review of the manufacturer's instrument manual, patient test results, observation and staff interview, the laboratory did not demonstrate that it could obtain performance specifications comparable to those established by the manufacturer in the upper linear test reportable range indices (complete blood count-CBC) for one of six specialities (Hematology) and the facility failed to store a piece of equipment in a manner to ensure an acceptable level of safety in 1 instance and failed to maintain 2 pieces of equipment.

Findings included:

1. On 6/05/14 at 10:15 a.m., review of the manufacturer's operator's manual for the LH 500 analyzer, used for CBC testing which included white blood count (WBC), red blood count (RBC), Hemoglobin (Hgb), and Platelet (Plt), approved 9/14/12, read:

Parameter Linearity Range Achieved upper limit-Units
WBC 0.0-200.0 Not Available cells/uL
RBC 0.00-7.00 Not Available cells/uL
Hemoglobin 0.00-25.0 Not Available g/dL
Plt 0 - 2000 Not Available cells/uL
Legends:
K/uL (thousand per microliter)
g/dL (gram per deciliter)"

2. On 6/05/14 at 10:00 a.m., staff member #8 (laboratorian) acknowledged that, through interview and upon request, the above-listed documentation of the upper performance limitations of each CBC indices listed by the manufacturer had not been documented and achieved by the LH 500 analyzer in Hematology


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3. On 6-4-14 at 10:10 am, in the presence of employee #A3, Chief Executive Officer, and employee #A6, Facility Director, it was observed in the cardiopulmonary storage area that there was a large compressed gas tank cylinder stored upright on the floor that was not secured by chain or holder. If the tank was knocked over and broke the head off the compressed cylinder, it could result in harm to people and/or property.

4. On 6-4-14 at 10:15 am, in the presence of employee #A3, Chief Executive Officer, and employee #A6, Facility Director, it was observed in the physical therapy area that there were parallel bars and wooden stairstep equipment. Employee #A3, CEO was requested to provide documentation of a periodical maintenance program for the equipment.

5. In interview, on 6-5-14 at 3:00 pm, employee #A6, Facility Director, indicated there was no documentation of a periodical maintenance program for the above-stated equipment and no further documentation was provided prior to exit.