The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

GLENWOOD REGIONAL MEDICAL CENTER 503 MCMILLAN ROAD WEST MONROE, LA 71291 May 29, 2015
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
Based on record review and interview, the governing body failed to ensure that the medical staff was accountable for the quality of care provided to patients as evidenced by the medical staff's failure to 1) recognize that the hospital was not identifying, tracking and trending hospital acquired wounds and 2) identify that the hospital had no established wound care protocols.

Findings:

1) Hospital was not identifying,tracking and trending hospital acquired wounds.


Review of the QAPI Program documentation revealed there was no system in place for identifying, tracking and trending of hospital acquired wounds.

Review of Medical Staff meeting minutes revealed no documented evidence of discussion of identification, tracking, and trending of hospital acquired wounds.

In an interview on 5/29/15 at 12:37 p.m. with S4QADirector, she confirmed the hospital had no system in place for identifying, tracking and trending of hospital acquired wounds. She also indicated the hospital was not gathering data related to community acquired versus hospital acquired wounds. S4QADirector indicated there was no in depth review of wounds nor were there any Performance Improvement indicators related to wounds.

2) Hospital had not established wound care protocols

Review of Medical Staff meeting minutes revealed no documented evidence of discussion of establishment of hospital wound care protocols.

In an interview on 5/29/15 at 10:42 a.m. with S3DON, she confirmed the hospital's medical staff had not established/approved wound care protocols for the hospital.

In an interview on 5/29/15 at 1:20 p.m. with S35MD, he indicated wound care consults did not always occur the next day after the consult was ordered. In the event consults had not occurred in a timely manner, the patient's physician would have to write interim wound care orders. S35MD agreed that having no established wound care protocols was an issue.
VIOLATION: PATIENT RIGHTS: PERSONAL PRIVACY Tag No: A0143
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the hospital failed to ensure patient's rights to privacy were protected as evidenced by having the presence of video surveillance monitoring in the patient's room for 1 of 1 patient (Patient # 14) reviewed for refusing video surveillance out of a total sample of 30. Findings

Review of the hospital's Policy titled " Patient Rights & Responsibilities" presented by S3RN/DON as being current (02/15) read in parts: Patient Rights: 19. Full consideration of privacy concerning your medical care program. Case discussion, consultation, examination, and treatment are confidential and should be conducted discretely. You have the right to be advised as to the reason for the presence of any individual.

Review of the medical record for Patient #14 revealed she had been admitted on [DATE] with the diagnosis of Cellulitis of face and discharged on [DATE]. Continued review of Patient #14's Nurses notes (discharge note) revealed she was discharged AMA (Against Medical Advice) after she discovered she was being monitored by the hospital's care view system (video surveillance).

Review of Patient #14's admission agreement and consent revealed she declined to have the use of Nurse View/Secure View.

Review of the hospital's complaint log revealed Patient #14 filed a complaint on 04/07/15 for an incident that occurred while in the hospital on [DATE]. Review of the complaint revealed Patient #14 complained about being monitored by the Hospital's monitoring system (careview). Patient #14 made a request to the staff to turn the monitor off and the request was denied despite her declination of monitoring upon admission.

Review of a response letter dated 04/13/15 to Patient #14 from Risk Management read in part: "We have identified some opportunities for process improvement, and have begun immediate staff re-education regarding use of the Careview monitoring system."

In an interview on 05/27/15 at 2:15 p.m., S15 confirmed that Patient #14 had declined Careview monitoring and the staff failed to protect her right to privacy.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of 2 of 2 (#1, #2) medical records for patients with pressure wounds from a total sample of 30, review of the Quality Assurance Performance Improvement (QAPI) data and interviews, the QAPI program failed to include data relative to the hospital's failure to have a system in place to track the progression of wounds.
Findings:

Patient #1
Review of Patient #1's medical record revealed he was admitted on [DATE] through the emergency department. Further review revealed the patient had the following admit diagnoses: Acute exacerbation of CHF( congestive heart failure), shortness of breath, Respiratory Distress, Chronic Atrial fibrillation, Chronic Obstructive Pulmonary Disease, (COPD), Diabetes Mellitus, Type II, and Heel and Sacral wounds.
Review of Patient #1's medical record revealed he had a wound consult ordered on [DATE].
Further review revealed a wound care consult was conducted on 5/26/15. The patient's wounds were described, by the wound care nurse (from the outpatient wound clinic) as follows: 1. Sacral Pressure Ulcer-unstageable, 2. Coccyx Pressure Ulcer- unstageable, 3. Left buttock-lateral:Stage II, 4. Left buttock medial: Stage II, 5. Left buttock inferior: Stage II, 6. Left buttock superior: Stage III, 7. Left heel- DFU( diabetic foot ulcer), 8. Left heel plantar-DFU. The patient's wounds were measured by the wound care nurse. Wound care recommendations were made. A recommendation was also made to consult the Podiatrist from the wound care clinic for care of the patient's foot/heel wounds.
Review of Patient #1's medical record revealed no documented evidence of assessments of the patient's wounds by nursing staff from 5/24/15 (admission) until the wound care nurse assessed the wounds on 5/26/15. Further review revealed no other documented evidence of assessments of Patient #1's wounds, by nursing staff, after the outpatient wound care nurse performed an assessment on 5/26/15. Patient #1's medical record was reviewed for wound documentation for the following dates: 5/24/15 (admission) - midday of 5/29/15 (survey team exited on 5/29/15).

Patient #2
Review of Patient # 2 ' s medical record revealed he was admitted on [DATE] with the following admission diagnoses: Bilateral Pulmonary Edema versus Pneumonia, Congestive Heart Failure (CHF)-systolic, Acute Renal Failure, severe Hyperkalemia, Chronic Anemia, Diabetic Foot Ulcer, and poorly controlled Diabetes Mellitus, Type II-insulin dependent.
Review of Patient #2 ' s nursing assessments revealed the following entries:
2/18/15, 9:00 p.m.: Skin Assessment: Skin breakdown: Yes; Activity: Chair fast; Friction/Shear: 2, potential problem; Generalized edema: mild; Mobility: Slightly limited; Pressure relief device: pillows; Coccyx: skin intact, Stage I; Right heel: dressing dry, intact; Skin risk score: 16 (15-18=mild risk).
2/18/15, 11:00 p.m.: Skin assessment: Skin breakdown: Yes; Coccyx: Stage II, partial thickness; Right heel: dressing dry, intact; Skin risk score: 16 (15-18=mild risk).
2/20/15 05:23 a.m.: wound care consult for sacral wound, redness, intact and wound to left plantar region post infected corn.
Further review revealed no documentation of assessment/measurement/treatment of Patient #2 ' s coccyx/sacral wound for the following dates: 2/19/15, 2/20/15 (except for a single entry at 05:30 a.m. on 2/20/15 regarding a wound care consult) and 2/21/15-2/26/15. .
Review of Patient #2 ' s medical record entries for incision/wound revealed no documentation of assessment/treatment of Patient #2 ' s sacral/coccyx wound from 2/20/15-2/26/15.
Review of Patient #2 ' s Physician Orders revealed the following entries:
2/20/15 05:21 a.m.: Wound Care Consult: Instruction: wound to left foot, diabetic, hypertensive, renal failure and sacral wound. Further review revealed no documented evidence of wound care assessment by the outpatient wound care nurse or treatment orders for the patient's Stage II Sacral Pressure Ulcer.
In an interview on 5/28/15 at 1:45 p.m. with S29RN, she confirmed there was no documented evidence of a wound care assessment by the outpatient wound care nurse, no treatment orders for the Stage II Sacral Pressure Ulcer, and no documented evidence of wound assessments and/or routine wound measurements with performance of wound care, by staff nurses, on Patient #2. She said wound assessment/wound care performance, provided by the unit nurses, should have been documented in the patient's records. S29RN said wound care assessment documentation, by nursing staff, was a problem and it needed to be addressed.

In an interview on 5/29/15 at 12:37 p.m. with S4QADirector, she confirmed the hospital had no system in place for identifying, tracking and trending of hospital acquired wounds. She also indicated the hospital was not gathering data related to community acquired versus hospital acquired wounds. S4QADirector indicated there were no in depth reviews of wounds nor were there any Performance Improvement indicators related to wounds.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview and record review, the hospital failed to meet the Condition of Participation for Nursing Services as evidenced by:

1) Failure of the Registered Nurse to evaluate the nursing care of patient #2 who had a Stage II Sacral Pressure Ulcer. There failed to be documentation by the Registered Nurse to indicate the wound was assessed and treated from 02/20/15 thru 02/26/15. (see findings at A0395)

2) Failure of the nursing staff to assess and document the presence of a Foley Catheter and Foley Catheter Care for 1 (#2) of 4 (#1,#2,#4,#5) patients reviewed for indwelling Foley catheters out of a total sample of 30. (see findings at A0395)

3) Failure of the Registered Nurse to assign the nursing care of each patient to nursing personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available as evidenced by assigning wound assessments and care to nursing staff who had not received hospital specific training in wound care and had no skills competency evaluations related to wound care performance for 2 of 2 (#1,#2) patients reviewed for wounds (see findings at A0397)
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the registered nurse failed to supervise and evaluate the nursing care provided to each patient as evidenced by:

1) failing to ensure a pressure wound was assessed and treated from 02/20/15 thru 02/26/15 for 1 (#2) of 2 (#1,#2) patients reviewed for pressure ulcers.

2) failing to ensure nursing staff trained in wound assessments were assessing patient wounds for 2 of 2 (#1,#2) patients reviewed for wounds.

3) failing to ensure nursing staff assessed and documented the presence of a Foley Catheter and Foley Catheter Care for 1 (#2) of 4 (#1,#2,#4,#5) patients reviewed for indwelling Foley catheters.

Findings:

1. Failing to ensure Patient #2's Stage II Sacral Pressure Wound was assessed and treated.

Patient #2
Review of Patient # 2's medical record revealed he was admitted on [DATE] with the following admission diagnoses: Bilateral Pulmonary Edema versus Pneumonia, Congestive Heart Failure (CHF)-systolic, Acute Renal Failure, severe Hyperkalemia, Chronic Anemia, Diabetic Foot Ulcer, and poorly controlled Diabetes Mellitus, Type II-insulin dependent.
Review of Patient #2's nursing assessments revealed the following entries:
2/18/15, 9:00 p.m.: Skin Assessment: Skin breakdown: Yes; Activity: Chair fast; Friction/Shear: 2, potential problem; Generalized edema: mild; Mobility: Slightly limited; Pressure relief device: pillows; Coccyx: skin intact, Stage I; Right heel: dressing dry, intact; Skin risk score: 16 (15-18=mild risk).
2/18/15, 11:00 p.m.: Skin assessment: Skin breakdown: Yes; Coccyx: Stage II, partial thickness; Right heel: dressing dry, intact; Skin risk score: 16 (15-18=mild risk).
2/20/15 05:23 a.m.: wound care consult for sacral wound, redness, intact and wound to left plantar region post infected corn.
Further review revealed no documentation of assessment/measurement/treatment of Patient #2's coccyx/sacral wound for the following dates: 2/19/15, 2/20/15 (except for a single entry at 05:30 a.m. on 2/20/15 regarding a wound care consult) and 2/21/15-2/26/15.
Review of Patient #2's medical record revealed no documentation of assessment/treatment of Patient #2's sacral/coccyx wound from 2/20/15-2/26/15.
.
Review of Patient #2 ' s Physician Orders revealed the following entries:
2/20/15 05:21 a.m.: Wound Care Consult: Instruction: wound to left foot, diabetic, hypertensive, renal failure and sacral wound. Further review revealed no documented evidence of wound care assessment by the outpatient wound care nurse or treatment orders for the patient's Stage II Sacral PressureUlcer.
In an interview on 5/28/15 at 1:45 p.m. with S29RN, she confirmed there was no documented evidence of a wound care assessment by the outpatient wound care nurse, no treatment orders for the Stage II Sacral Pressure Ulcer, and no documented evidence of wound assessments and/or routine wound measurements with performance of wound care, by staff nurses, on Patient #2. She said wound assessment/wound care performance, provided by the unit nurses, should have been documented in the patient's records. S29RN said wound care assessment documentation, by nursing staff, was a problem and it needed to be addressed.


2. Failing to ensure nursing staff trained in wound assessments were assessing wounds for 2 (#1,#2) of 2 (#1,#2) patients reviewed for wounds.


Patient #1
Review of Patient #1's medical record revealed he was admitted on [DATE] through the emergency department. Further review revealed the patient had the following admit diagnoses: Acute exacerbation of CHF (congestive heart failure), shortness of breath, Respiratory Distress, Chronic Atrial fibrillation, Chronic Obstructive Pulmonary Disease, (COPD), Diabetes Mellitus, Type II, and Heel and Sacral wounds.
Review of Patient #1's medical record revealed he had a wound consult ordered on [DATE].
Further review revealed a wound care consult was conducted on 5/26/15. The patient's wounds were described, by the wound care nurse as: 1. Sacral Pressure Ulcer-unstageable, 2. Coccyx Pressure Ulcer- unstageable, 3. Left buttock-lateral:Stage II, 4. Left buttock medial: Stage II, 5. Left buttock inferior: Stage II, 6. Left buttock superior: Stage III, 7. Left heel- DFU( diabetic foot ulcer), 8. Left heel plantar-DFU. The patient's wounds were measured by the wound care nurse. Wound care recommendations were made. A recommendation was also made to consult the Podiatrist from the wound care clinic for care of the patient's foot/heel wounds.
Review of Patient #1's medical record revealed no documented evidence of assessments of the patient's wounds by nursing staff from 5/24/15 (admission) until the wound care nurse assessed the wounds on 5/26/15. Further review revealed no other documented evidence of assessments of Patient #1's wounds, by nursing staff, after the outpatient wound care nurse performed an assessment on 5/26/15. Patient #1's medical record was reviewed for wound documentation for the following dates: 5/24/15 (admission) - midday of 5/29/15 (survey team exited on 5/29/15).

Patient #2
Review of Patient #2's nursing assessments revealed the following entries: 2/18/15, 9:00 p.m.: Skin Assessment: Skin breakdown: Yes; Activity: Chair fast; Friction/Shear: 2, potential problem; Generalized edema: mild; Mobility: Slightly limited; Pressure relief device: pillows; Coccyx: skin intact, Stage I; Right heel: dressing dry, intact; Skin risk score: 16 (15-18=mild risk).
2/18/15, 11:00 p.m.: Skin assessment: Skin breakdown: Yes; Coccyx: Stage II, partial thickness; Right heel: dressing dry, intact; Skin risk score: 16 (15-18=mild risk).
2/20/15 05:23 a.m.: wound care consult for sacral wound, redness, intact and wound to left plantar region post infected corn.
Further review revealed no documentation of assessment/measurement/treatment of Patient #2's coccyx/sacral wound for the following dates: 2/19/15, 2/20/15 (except for a single entry at 05:30 a.m. on 2/20/15 regarding a wound care consult) and 2/21/15-2/26/15. Additional review revealed dry, intact or per protocol was the only assessment documentation of Patient #2's right heel wound from 2/19/15-2/26/15.
Review of Patient #2's medical record revealed the following entries for incision/wound site management:
2/20/15 05:42 a.m.: Diabetic left foot - Length: 6 cm (centimeters) x (by) width: 3 cm, assessment: red, blistered, scaly area; Surrounding skin: WNL (within normal limits); wound dressing: dry, intact; cleansed povidine iodine; Wound Intervention: Dressing changed, dressing removed. Further review revealed no documentation of assessment of Patient #2 ' s sacral/coccyx wound. Additional review revealed no other documentation of assessment/measurement/treatment of Patient #2 ' s left foot wound or the patient ' s sacral/coccyx wound.
Review of Patient #2 ' s Admit Physician Orders, dated 2/18/15, revealed an order for a Podiatry consult.
Further review of Patient #2 ' s Physician Orders revealed the following entries:
2/20/15 05:21 a.m.: Wound Care Consult: Instruction: wound to left foot, diabetic, hypertensive, renal failure and sacral wound.
2/20/15 9:00 p.m.: Clean wound on foot with wound cleaner, apply Santyl and Gentamicin, Cover with gauze, wrap with Kerlix, Write time and date on dressing tape. Gentamicin ointment 0.1% to foot with Santyl BID (twice a day); Collagenase 250 units/gram ointment apply to foot wound BID with Gentamicin.
In an interview on 5/28/15 at 1:45 p.m. with S29RN, she confirmed the above referenced lack of documented evidence of wound assessments and/ or routine wound measurements with performance of wound care, by staff nurses, on Patient #1 and Patient #2. She indicated hospital nursing staff had no specialized training in wound care and no skills competency evaluations related to wound care performance.
In an interview on 5/28/15 at 4:25 p.m. with S37LPN, she confirmed that hospital staff nurses performed daily wound care after the patients had been evaluated by the wound care nurse. She also confirmed she had not received any type of wound care training. S37LPN said she had not had any skills competency evaluations related to wound care training during her employment with the hospital.
In an interview on 5/29/15 at 8:40 a.m. with S30UnitManager, she confirmed the staff nurses who performed daily wound care and wound assessments had not received any formal training related to assessing wounds/providing wound care. S30UnitManager also said they had not had any type of skills competency evaluations for wound care.
In an interview on 5/29/15 at 10:30 a.m. with S36RN Education, she confirmed the hospital had not provided any specialized wound care training or performed skills competency evaluations for unit nursing staff who were providing wound care. She said a very general presentation on wound assessments was proved to nursing staff which did not include a skills evaluation.
In an interview on 5/29/15 at 10:42 a.m. with S3DON, she confirmed the hospital had not provided any specialized wound care training or assessment of skills competency evaluations for unit nursing staff who were providing wound care.

In an interview on 5/29/15 at 1:00 p.m. with S31RN, she confirmed she had not received wound care training during her employment with the hospital. She said the wound care nurses from the outpatient wound care clinic were responsible for measuring patient wounds and they performed the initial assessments. S31RN said unit nursing staff assumed responsibility for assessment of wounds and wound care after the wound care nurse had completed her assessment.

3. Failing to ensure nursing staff assessed and documented the presence of a Foley Catheter and Foley Catheter Care

Patient #2
Review of Patient #2's medical record revealed no documented evidence of an order for Foley catheter insertion or for removal of Patient #2's Foley catheter.

Further review of Patient #2's medical record revealed the following physician consult order: 2/20/15, 05:00 a.m.: Consult Urology for continued pain to penis post Foley catheter, History of [DIAGNOSES REDACTED].

Review of Patient #2's medical record revealed the following Urology consult note, dated 2/23/15, completed by S33PA (physician's assistant) from Urology:
Treatment Note: [AGE] year old admitted secondary to CHF exacerbation, ARF (acute renal failure), history of Bladder Ca (Cancer). Now c/o (complains) of " urethra pain " , has Foley.
a. Bladder Ca, urethra pain
b. Pain secondary to Foley, may d/c (discontinue) Foley if ok with primary care physician; Pyridium 200mg TID

Review of Patient #2's medical record revealed no documented evidence of when the patient's Foley catheter had been inserted nor was there documented evidence of the name of the staff member who had catheterized the patient. Further review revealed no documented evidence of the presence of an indwelling Foley catheter or catheter care by hospital staff. Additional review revealed no documentation of removal of the patient's Foley catheter.

In an interview on 5/28/15 at 1:45 p.m. with S29RN, she indicated Patient #2's Foley catheter had been inserted somewhere between the 2/18/15 and 2/20/15. She confirmed, after review of the patient's medical record, that there was no documented evidence of when the patient's Foley catheter had been inserted nor was there documented of evidence of the name of the staff member who had catheterized the patient. She also confirmed there was no documented evidence of the presence of an indwelling Foley catheter or catheter care by hospital staff. S29RN also confirmed there was no documentation of removal of the patient's Foley catheter.

In an interview on 5/28/15 at 7:00 p.m. with Patient #2's family member, he confirmed Patient #2 had an indwelling Foley catheter. He said Patient #2 had requested a urology consult because his urologist had instructed him to avoid catheterization due to his history of [DIAGNOSES REDACTED].

In an interview on 5/29/15 at 11:00 a.m. with S33PA, she indicated if she documented, in her consult note, that the patient had an indwelling Foley catheter , then he had a Foley. S33PA also indicated patients who were treated for CHF or Renal Failure in the emergency department routinely had a catheter inserted for management of their disease process.

In an interview on 5/29/15 at 10:42 a.m. with S3DON, she confirmed, after review of the patient's medical record, that there was no documented evidence of when the patient's Foley catheter had been inserted nor was there documented of evidence of the name of the staff member who had catheterized the patient. She also confirmed there was no documented evidence of the presence of an indwelling Foley catheter or catheter care by hospital staff. S3DON also confirmed there was no documentation of removal of the patient's Foley catheter. S3DON indicated she had no explanation for the total lack of staff documentation related to the presence of/care of/insertion and removal of Patient #2's Foley catheter.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the hospital failed to ensure the nursing staff developed and kept current a nursing care plan for 4 (#1,#2,#3,#5) of 5 (#1-#5) records reviewed for care plans out of a total sample of 30.
Findings:

Patient #1
Review of Patient #1's medical record revealed he was admitted on [DATE] with the following admit diagnoses: Acute exacerbation of CHF(congestive heart failure), shortness of breath, Respiratory Distress, Chronic Atrial fibrillation, Chronic Obstructive Pulmonary Disease, (COPD), Diabetes Mellitus, Type II, and Heel and Sacral wounds. Review of Patient #1's care plan revealed Diabetes Mellitus, Type II was not addressed as one of the patient's problems in his plan of care.

Patient #2
Review of Patient # 2 ' s medical record revealed he was admitted on [DATE] with the following admit diagnoses: Bilateral Pulmonary Edema versus Pneumonia, Congestive Heart Failure (CHF)-systolic, Acute Renal Failure, severe Hyperkalemia, Chronic Anemia, Diabetic Foot Ulcer, and poorly controlled Diabetes Mellitus, Type II-insulin dependent. Further review revealed Patient #2 also developed a Stage II Sacral Pressure Ulcer and had an indwelling Foley Catheter. Review of Patient #2's care plan revealed the patient's Stage II Sacral Pressure Ulcer, Diabetes Mellitus, Type II (insulin dependent), Anemia, and indwelling Foley catheter were not addressed as problems in his plan of care.

Patient #3
Review of Patient #3's medical record revealed she was admitted on [DATE] with the following admit diagnoses: Acute exacerbation of CHF(congestive heart failure), Altered Mental Status, shortness of breath and Diabetes Mellitus, Type II- insulin dependent. Review of Patient #3's care plan revealed Diabetes Mellitus, Type II and Altered Mental Status were not addressed as problems in her plan of care.

Patient #5
Review of Patient #5's medical record revealed he was admitted on [DATE] with the following admit diagnoses: Intestinal Obstruction, Alcoholic with liver disease, Hypertension and Renal Failure. Review of Patient #5's care plan revealed Hypertension and Chemical Dependency (Alcoholism) were not addressed as problems in his plan of care.

In an interview on 5/27/15 at 10:00 a.m. with S29RN, she confirmed the above referenced care plans were not inclusive. She indicated the care plans should have been individualized to reflect each patient's status and agreed the above referenced care plans had not been individualized.
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the registered nurse failed to assign the nursing care of each patient to nursing personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available as evidenced by assigning wound assessments and care to nursing staff who had not received hospital specific training in wound care and had no skills competency evaluations related to wound care performance for 2 (#1,#2) of 2 (#1,#2) patients reviewed for wounds.
Findings:

Patient #1
Review of Patient #1's medical record revealed he was admitted on [DATE]. Further review revealed the patient had the following admit diagnoses: Acute exacerbation of CHF( congestive heart failure), shortness of breath, Respiratory Distress, Chronic Atrial fibrillation, Chronic Obstructive Pulmonary Disease, (COPD), Diabetes Mellitus, Type II, and Heel and Sacral wounds.
Review of Patient #1's medical record revealed he had a wound consult ordered on [DATE].
Further review revealed a wound care consult was conducted on 5/26/15. The patient's wounds were described as follows: 1.Sacral Pressure Ulcer-unstageable 2. Coccyx Pressure Ulcer- unstageable 3. Left buttock-lateral:Stage II 4. Left buttock medial: Stage II 5. Left buttock inferior: Stage II 6. Left buttock superior: Stage III 7. Left heel- DFU (diabetic foot ulcer) 8. Left heel plantar-DFU. The patient's wounds were measured by the wound care nurse. Wound care recommendations were made. A recommendation was also made to consult the Podiatrist from the wound care clinic for care of the patient's foot/heel wounds.
Review of Patient #1's medical record revealed no documented evidence of assessments of the patient's wounds by nursing staff from 5/24/15 (admission) until the wound care nurse assessed the wounds on 5/26/15. Further review revealed no other documented evidence of assessments of Patient #1's wounds, by nursing staff, after the outpatient wound care nurse performed an assessment on 5/26/15. Patient #1's medical record was reviewed for wound documentation for the following dates: 5/24/15 (admission) - midday of 5/29/15 (survey team exited on 5/29/15).


Patient #2
Review of Patient # 2's medical record revealed his point of entry for care was through the hospital's Emergency Department on 2/18/15. Further review revealed admission physician orders, dated 2/18/15, to admit Patient #2 to the ICU (Intensive Care Unit). Patient #2's admission diagnoses included the following: Bilateral Pulmonary Edema versus Pneumonia, Congestive Heart Failure (CHF)-systolic, Acute Renal Failure, severe Hyperkalemia, Chronic Anemia, Diabetic Foot Ulcer, and poorly controlled Diabetes Mellitus, Type II-insulin dependent.
Review of Patient #2's Admit Physician Orders, dated 2/18/15, revealed an order for a Podiatry consult. Further review of Patient #2's Physician Orders revealed the following entries:
2/20/15 05:21 a.m.: Wound Care Consult: Instruction: wound to left foot, diabetic, hypertensive, renal failure and sacral wound.
2/20/15 9:00 p.m.: Clean wound on foot with wound cleaner, apply Santyl and Gentamicin, Cover with gauze, wrap with Kerlix, Write time and date on dressing tape. Gentamicin ointment 0.1% to foot with Santyl BID (twice a day); Collagenase 250 units/gram ointment apply to foot wound BID with Gentamicin.
Review of Patient #2's nursing assessments revealed the following entries: 2/18/15, 9:00 p.m.: Skin Assessment: Skin breakdown: Yes; Activity: Chair fast; Friction/Shear: 2, potential problem; Generalized edema: mild; Mobility: Slightly limited; Pressure relief device: pillows; Coccyx: skin intact, Stage I; Right heel: dressing dry, intact; Skin risk score: 16 (15-18=mild risk).
2/18/15, 11:00 p.m.: Skin assessment: Skin breakdown: Yes; Coccyx: Stage II, partial thickness; Right heel: dressing dry, intact; Skin risk score: 16 (15-18=mild risk).
2/20/15 05:23 a.m.: wound care consult for sacral wound, redness, intact and wound to left plantar region post infected corn.
Further review revealed no documentation of assessment/measurement/treatment of Patient #2's coccyx/sacral wound for the following dates: 2/19/15, 2/20/15 (single entry at 05:30 a.m. on 2/20/15 regarding a wound care consult) and 2/21/15-2/26/15. Additional review revealed dry, intact or per protocol was the only assessment documentation of Patient #2's right heel wound from 2/19/15-2/26/15.
Review of Patient #2's medical record revealed the following entries for incision/wound site management:
2/20/15 05:42 a.m.: Diabetic left foot - Length: 6 cm (centimeters) x (by) width: 3 cm, assessment: red, blistered, scaly area; Surrounding skin: WNL (within normal limits); wound dressing: dry, intact; cleansed povidine iodine; Wound Intervention: Dressing changed, dressing removed. Further review revealed no documentation of assessment of Patient #2's sacral/coccyx wound. Additional review revealed no other documentation of assessment/measurement/treatment of Patient #2's left foot wound or the patient's sacral/coccyx wound.
In an interview on 5/28/15 at 1:45 p.m. with S29RN, she confirmed the above referenced lack of documented evidence of wound assessments and/ or routine wound measurements with performance of wound care, by staff nurses, on Patient #1 and Patient #2. She said wound assessment/wound care performance should have been documented in the patient's records. S29RN said wound care assessment documentation, by nursing staff, was a problem and it needed to be addressed. She indicated hospital nursing staff had no hospital training in wound care and no skills competency evaluations related to wound care performance.
In an interview on 5/28/15 at 4:25 p.m. with S37LPN, she confirmed that hospital staff nurses performed daily wound care after the patients had been evaluated by the wound care nurse. She also confirmed she had not received any type of wound care training. S37LPN said she had not had any skills competency evaluations related to wound care training during her employment with the hospital.

In an interview on 5/29/15 at 10: 30 a.m. with S36RN Education, she confirmed the hospital had not provided any wound care training or performed skills competency evaluations for nursing staff who were providing wound care. She said a very general presentation on wound assessments was proved to nursing staff.

In an interview on 5/29/15 at 10:42 a.m. with S3DON, she confirmed the hospital had not provided any specialized wound care training or performed skills competency evaluations for nursing staff who were providing wound care.

In an interview on 5/29/15 at 1:00 p.m. with S31RN, she confirmed she had not received wound care training during her employment with the hospital. She said the wound care nurses from the outpatient wound care clinic measured patient wounds.
VIOLATION: FORM AND RETENTION OF RECORDS Tag No: A0438
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews and interview, the hospital failed to ensure medical records were accurately written and promptly completed. This was evidenced by:

1) failure of the nursing staff to assess and document the presence of a Foley Catheter and Foley Catheter Care for 1 (#2) of 4 (#1,#2,#4,#5) patients reviewed for indwelling Foley catheters,

2) failure to accurately and consistently document in the patient record the location of foot ulcers for 2 of 2 (#1, #2) patients with wounds, and 3) failure to promptly complete medical records by having a total of 631 medical records that were more than 30 days delinquent.

Findings:

1) Failure to assess and document the presence of an indwelling Foley Catheter and catheter care:
Review of Patient #2's medical record revealed the following physician consult order: 2/20/15, 05:00 a.m.: Consult Urology for continued pain to penis post Foley catheter, History of [DIAGNOSES REDACTED].
Review of Patient #2's medical record revealed the following Urology consult note, dated 2/23/15, completed by S33PA (physician's assistant) from Urology:
Treatment Note: [AGE] year old admitted secondary to CHF exacerbation, ARF (Acute Renal Failure), history of Bladder Ca (Cancer). Now c/o (complains) of "urethra pain ", has Foley; Pain secondary to Foley, may d/c (discontinue) Foley if ok with primary care physician.
Review of Patient #2's medical record revealed no documented evidence of when the patient's Foley catheter had been inserted nor was there documented of evidence of the name of the staff member who had catheterized the patient. Further review revealed no documented evidence of the presence of an indwelling Foley catheter or catheter care by hospital staff. Additional review revealed no documentation of removal of the patient's Foley catheter.
In an interview on 5/28/15 at 1:45 p.m. with S29RN, she indicated Patient #2's Foley catheter had been inserted somewhere between the 2/18/15 and 2/20/15. She confirmed, after review of the patient's medical record, that there was no documented evidence of when the patient's Foley catheter had been inserted nor was there documented of evidence of the name of the staff member who had catheterized the patient. She also confirmed there was no documented evidence of the presence of an indwelling Foley catheter or catheter care by hospital staff. S29RN also confirmed there was no documentation of removal of the patient's Foley catheter.
In an interview on 5/28/15 at 7:00 p.m. with Patient #2's family member, he confirmed Patient #2 had an indwelling Foley catheter.
In an interview on 5/29/15 at 11:00 a.m. with S33PA, she indicated if she documented, in her consult note, that the patient had an indwelling Foley catheter, then he had a Foley.
In an interview on 5/29/15 at 10:42 a.m. with S3DON, she confirmed, after review of the patient's medical record, that there was no documented evidence of when the patient's Foley catheter had been inserted nor was there documented of evidence of the name of the staff member who had catheterized the patient. She also confirmed there was no documented evidence of the presence of an indwelling Foley catheter or catheter care by hospital staff. S3DON also confirmed there was no documentation of removal of the patient's Foley catheter. S3DON indicated she had no explanation for the total lack of staff documentation related to the presence of/care of/insertion and removal of Patient #2's Foley catheter. S3DON indicated patient medical records were not audited for accuracy of documented information and agreed ensuring medical record information was accurate should have been included in audits.
2) Failure to accurately and consistently document in the patient record the location of foot ulcers for 2 of 2 (#1, #2) patients with wounds.
Patient #1
Review of Patient #1's medical record revealed he was admitted on [DATE] with the following admit diagnoses: Acute exacerbation of CHF (congestive heart failure), shortness of breath, Respiratory Distress, Chronic Atrial fibrillation, Chronic Obstructive Pulmonary Disease, (COPD), Diabetes Mellitus, Type II, and Heel and Sacral wounds.
Further review revealed a wound care consult was conducted on 5/26/15. The patient's foot wounds were described as follows: 7. Left heel- DFU ( diabetic foot ulcer) 8. Left heel plantar-DFU. The patient's wounds were measured by the wound care nurse. Wound care recommendations were made. Further review of Patient #1 ' s wound care consult notes revealed that the patient ' s diabetic foot ulcers were described as being located on his right heel and his right heel plantar surface. The patient only had diabetic ulcers located on one foot.
Patient #2
Review of Patient #2 ' s nursing assessments revealed the following entries: 2/18/15, 9:00 p.m.: Skin Assessment: Skin breakdown: Yes; Right heel: dressing dry, intact.
2/18/15, 11:00 p.m.: Skin assessment: Skin breakdown: Yes; Right heel: dressing dry, intact.
2/20/15 05:23 a.m.: Wound care consult for sacral wound, redness, intact and wound to left plantar region post infected corn.
Review of Patient #2 ' s medical record revealed the following entries for incision/wound site management: 2/20/15 05:42 a.m.: Diabetic left foot - Length: 6 cm (centimeters) x (by) width: 3 cm, assessment: red, blistered, scaly area; Surrounding skin: WNL (within normal limits); wound dressing: dry, intact; cleansed povidine iodine; Wound Intervention: Dressing changed, dressing removed.
Review of Patient #2 ' s Physician Orders revealed the following entries: 2/20/15 05:21 a.m.: Wound Care Consult: Instruction: wound to left foot, diabetic, hypertensive, renal failure and sacral wound.
Review of Patient #2 ' s medical record revealed diabetic foot ulcer documentation by hospital staff referenced the ulcer as being on his right foot and on his left foot interchangeably. The patient only had an ulcer on one of his feet.
In an interview on 5/29/15 at 10:42 a.m. with S3DON, she indicated the above referenced patient wound documentation was not audited for accuracy and agreed ensuring medical record information was accurate should have been included in audits.

3) Review of the hospital's medical record delinquent log revealed the following:
>30 days-365; >60 days-76; >90 days-67; & >120 days-123.

Review of the hospital's Medical Bylaws read in parts:
1) Automatic suspension of a Practitioner's admitting privileges shall be imposed for failure to complete medical records as required by the Medical Staff Bylaws and Rules & Regulations. The suspension shall continue until such records are completed unless the Practitioner satisfies the Chief of Staff that he/she has a justifiable excuse for such omissions.
2) Medical Records Expulsion: Notwithstanding the provisions of Section 8.4(b)(1), any Medical Staff Member who accumulates forty-five (45) or more CONSECUTIVE days of automatic suspension under said subsection 8.4(c) shall automatically be expelled from the Medical Staff. Such expulsion shall be effective as of the first day after the forty-fifth (45th) consecutive day of such automatic suspension.
2.20.1 Incomplete medical records are delinquent thirty (30) calendar days after the day the patient is discharged .
2.20.2 Practitioners with delinquent medical records will receive written notification that all elective (non-emergency) privileges will be suspended. This includes privileges to admit patients and perform surgical and medical procedures. Written notification of suspension shall be sent at least fifteen (15) calendar days prior to the date of proposed suspension of elective privileges.
2.20.3 A Practitioner whose elective (non-emergency) privileges have been suspended for thirty (30) calendar days or more will also have all clinical privileges suspended automatically. During clinical privileges suspension, the suspended Practitioner must designate a Practitioner or Practitioners to fulfill all of his clinical responsibilities, including consultations. The Practitioner may continue to care for his patients already hospitalized at the time of the clinical privileges suspension.

Review of a document (memorandum) presented by S34 revealed a list of Practitioners (61) who were suspended as of 05/26/15 for delinquent medical records.

In an interview on 05/26/15 at 2:00 p.m., S34 indicated Practitioners with medical records delinquent for greater than 30 days are placed on suspension. S34 indicated Practitioners are notified in writing at least 15 (calendar) days prior to the date of proposed suspension of elective privileges. S34 indicated Practitioners are not allowed to admit and/or perform medical or surgical procedures during suspension. S34 confirmed the hospital had 123 medical records that were more than 120 days delinquent. S34 indicated the 123 medical records were delinquent records of Practitioner who were on courtesy staff and/or were no longer on staff at the hospital. S34 indicated the hospital had no system in place for completion of medical records for Practitioners who were no longer on staff and/or visit the hospital.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations, interviews and record reviews, the hospital failed to ensure the infection control officer maintained an effective system for identifying, reporting, investigating, and controlling of infections and communicable diseases of patients and personnel, as evidenced by:

1) failing to ensure that staff adhered to infection control practices for the cleaning/disinfecting of patient multi use handheld glucometers,

2) failing to ensure that a water leak in the wall of Operating Room # 4 was repaired,

3) failing to ensure that staff were not allowed to have soft drink containers on the supply cart in the Medication Room,

4) failing to ensure that surgical services were provided in accordance with acceptable professional standards of practice by failing to ensure that surgical instruments were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's routine use of IUSS (Immediate Use Steam Sterilization)(Flash Sterilization) of surgical instruments for surgical procedures,

5) failing to ensure that staff in the restricted surgical suite areas followed acceptable professional standards of practice by observations of staff wearing their surgical masks hanging down from the neck,

6) failing to ensure that staff in the surgical suite areas followed acceptable professional standards of practice by: a) observations of non-scrubbed surgical staff not wearing a long sleeved warm up jacket during surgical procedures, b) observations of surgical staff wearing undergarments that were not completely covered by their surgical attire, and c) observations of surgical personnel wearing skull caps (surgeon caps) that did not completely cover all their hair,

7) failing to ensure that staff adhered to acceptable standards of professional practice for instrument decontamination by not decontaminating all the surgical instruments that were opened on the sterile field after a surgical procedure was completed and before the instruments were sterile reprocessed for other patient surgical procedures, and for staff not adhering to acceptable infection control practices for the proper use of PPE (personal protective equipment) during instrument decontamination,

8) failing to have a functional workflow pattern in the decontamination rooms (surgery, emergency, endoscopy, and obstetrical areas) for processing surgical instruments after patient use to ensure the cleaning and processing of surgical instruments followed acceptable professional standards of practice, as evidenced by observations of the decontamination rooms with both soiled and cleaned work areas contained in the same area in the room, and

9) failing to ensure that sterile surgical supplies were not opened up in advance (pre-prepared) or opened up in advance (pre-prepared) in other locations in the surgical suite for patient surgical procedures as evidenced by the perfusion machine(s) used in cardiac heart surgery being sterilely set up (pre-prepared) in the cardiac heart surgical suite and in a sub-sterile room a day or more before a cardiac heart procedure was to be performed in the cardiac heart surgical suite.

Findings:
1) failing to ensure that staff adhered to infection control practices for the cleaning/disinfecting of patient multi use handheld glucometers

A review of the hospital policy titled, "Accu-Chek Inform II System- Policies and Procedures " , revised on 5/10/13 and provided by S5RN as the most current, revealed in part; Use a Clorox Germicidal Wipe to disinfect by gently wiping the surfaces of the meter three times vertically and horizontally. Allow the surfaces of the meter to remain damp with the disinfectant solution for one full minute. Dry the meter thoroughly with a soft cloth or gauze after cleaning.

An observation on 5/28/15 at 11:10 a.m. was made of S26RN performing an accu-chek on Patient R1. After performing the accu-chek, S26RN was not observed disinfecting the glucometer device before replacing it back into its case.

In an interview on 5/28/15 at 11:30 a.m. with S5RN, she was made aware of the observation of S26RN performing an accu-chek and failing to disinfect the glucometer device prior to replacing it into its case. S5RN indicated that the handheld multiple use glucometer devices should be cleaned/disinfected after each patient use according to hospital policy.

2) failing to ensure that a water leak in the wall of Operating Room # 4 was repaired,

An observation on 5/27/15 at 10:15 a.m. of Operating Room #4, in the presence of S5RN, S11RN, S15RN and S40ORT, revealed a patch of paint on the wall (6 inches by 24 inches) that was peeling off.

In an interview on 5/27/15 at 10:15 a.m. with S40ORT and S5RN, S40ORT indicated that the wall had a water leak in it about 2 years ago and maintenance had just " popped a hole " in the wall to let the water drain out and did not patch/repair the wall's damage caused by the water leak. S5RN indicated that the wall's damage caused by the water leak should have been repaired by maintenance at that time.

3) failing to ensure that staff were not allowed to have soft drink containers on the supply cart in the Medication Room.

An observation on 5/28/15 at 11:15 a.m. of S27's pharmacy supply cart in the Medication Room revealed a large soft drink on the pharmacy supply cart.

In an interview on 5/28/15 at 11:30 a.m. with S5RN, in the presence of S3RN, S5RN indicated that food and drink were not allowed in the nurse's Medication Room.

4) failing to ensure that surgical services were provided in accordance with acceptable professional standards of practice by failing to ensure that surgical instruments were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's routine use of IUSS (Immediate Use Steam Sterilization)(Flash Sterilization) of surgical instruments for surgical procedures,

A review of the AORN (Association of periOperative Registered Nurses) Perioperative Standards and Recommended Practices, 2013 edition - Recommended Practice for Sterilization revealed in part: IUSS should not be used as a substitute for sufficient instrument inventory in order to minimize the patient risk for SSI's (surgical site infections).

A review of the hospital policy titled, "Flash Sterilization ", with a revised date of 01/16/08, as provided by S11RN (Surgical Services Charge Nurse) as the most current, revealed that Flash (IUSS) sterilization will be limited to the following situations: There is immediate need for the item and there is insufficient time to process by the preferred sterilization method ....

A review of the hospital's Flash (IUSS) Sterilization Aggregate Data, as provided by S5RN (Infection Control Officer) that was collected by S12RN (Surgical Services Department Director) on the number of IUSS loads run by the Surgical Services Department from 2014 to present revealed the monthly percentages from January 2014 to April 2015 were:
January 2014 - 4.8% of 250 surgical cases,
February 2014 - 5.7% of 264 surgical cases,
March 2014 - 4.9% of 288 surgical cases,
April 2014 - 5.7% of 335 surgical cases,
May 2014 - 9.8% of 286 surgical cases,
June 2014 - 8.0% of 300 surgical cases,
July 2014 - 6.0% of 316 surgical cases,
August 2014 - 8.4% of 299 surgical cases,
September 2014 - 6.4% of 298 surgical cases,
October 2014 - 11.7% of 324 surgical cases,
November 2014 - 5.0% of 260 surgical cases,
December 2014 - 9.4% of 278 surgical cases,
January 2015 - No data was available,
February 2015 - Data was incomplete,
March 2015 - 7.3% of 303 surgical cases, and
April 2015 - 4.5% of 290 surgical cases.

In an interview on 5/29/15 at 9:20 a.m. with S5RN (Infection Control Officer) and S11RN (Operating Room Charge Nurse) the Flash (IUSS) Sterilization Aggregate Data from 2014 to present was reviewed. S5RN and S11RN indicated that the Corporate Benchmark was 10% or less for IUSS use each month. S5RN and S11RN indicated that S12RN collected the data from the monthly Flash (IUSS) Sterilization Logs for the Infection Control Committee and she (S12RN) was not available this week. S11RN indicated that unless the Surgical Services Department was over the Corporate Benchmark of 10% IUSS use each month, the Surgical Services Department did not really track or trend any IUSS usage in the Surgical Services Department. S5RN and S11RN indicated that the hospital's Surgical Services Department followed the AORN Perioperative Standards and Recommended Practices
.
5) failing to ensure that staff in the restricted surgical suite areas followed acceptable professional standards of practice by observations of staff wearing their surgical masks hanging down from the neck,

A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practice for Surgical Attire revealed in part: Surgical masks should not be worn hanging down from the neck. Surgical masks are intended to contain and filter droplets from the nasopharynx. The filter portion of the surgical mask harbors bacteria collected from the nasopharyngeal airway and should not be worn hanging from the neck. Surgical masks should be tied securely and discarded after each procedure or when soiled.

Observations of the semi-restricted and restricted areas of the surgical suites on 5/27/15, in the presence of S5RN, S11RN, and S15RN, from 10:00 a.m. to 1:00 p.m. revealed the following infection control breaches of staff (S15RN, S5RN, S11RN, S40ORT, S13MD, S14RN, S16RadTech, S17CRNA, S18CRNA, S19RN, S20InstruTech, S21ORT, S22RN) wearing their surgical masks hanging down from their necks:

In an interview on 5/27/15 at 1:30 p.m. with S5RN and S11RN they was made aware of the multiple infection control breaches of staff wearing their surgical masks hanging down from their necks. S11RN indicated that he was aware or the AORN Perioperative Standards and Recommended Practice for Surgical Attire that surgical masks should not be worn hanging down from the neck.

6) failing to ensure that staff in the surgical suite areas followed acceptable professional standards of practice by: a) observations of non-scrubbed surgical staff not wearing a long sleeved warm up jacket during surgical procedures, b) observations of surgical staff wearing undergarments that were not completely covered by their surgical attire, and c) observations of surgical personnel wearing skull caps (surgeon caps) that did not completely cover all their hair,

Observations on 5/27/15 from 10:00 a.m. to 1:00 p.m. of the surgical area, in the presence of S5RN, S11RN, S15RN, revealed the following: S5RN, S11RN, S17CRNA, S18CRNA wearing T-shirts underneath their surgical attire that were not completely covered by their surgical attire; S11RN, S13MD, S14RN, S18CRNA wearing skull caps (surgeon caps) that did not completely cover their sideburns, nape of neck, ears or facial hair; S14RN, S19RN, S22RN during a surgical procedure not wearing a long sleeved warm up jacket.
A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practice for Surgical Attire - Recommendation III revealed in part: When in the semi-restricted or restricted surgical areas, all non-scrubbed personnel should wear a freshly laundered or single use long sleeved warm up jacket snapped closed with the cuffs down to the wrists. Wearing the warm up jacket snapped closed prevents the edges of the front of the jacket from contaminating a skin prep area or the surgical sterile field. Long sleeved attire helps contain skin squames shed from bare arms. All personal clothing should be completely covered by the surgical attire. Undergarments such as T-shirts with a V-neck, which can be contained underneath the scrub top, may be worn; personal clothing that extends above the scrub top neckline or below the sleeve of the surgical attire should not be worn.
A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practice for Surgical Attire - Recommendation IV revealed in part: All personnel should cover head and facial hair, including the sideburns, the ears and the nape of the neck, when in semi-restricted and restricted areas. Human hair can be a site of pathogenic bacteria such as MRSA. Hair acts as a filter when it is uncovered and collects bacteria. A clean, low-lint surgical head covering or hood that confines all hair and covers scalp skin and ears should be worn. The head covering or hood should be designed to minimize microbial dispersal. Skull caps (surgeon caps) fail to contain the side hair above and in front of the ears and hair at the nape of the neck and the ears and should not be worn.
In an interview on 5/27/15 at 1:30 p.m. with S11RN, in the presence of S5RN, he was made aware of the above observations. S11RN indicated that he was not aware that surgical attire included a snapped up warm up jacket while circulating in surgical procedures. S11RN further indicated that he was not aware that undergarments should be completely covered by one's surgical attire and that all hair and ears, including facial hair needed to be completely covered by an appropriate head covering. S5RN indicated that she mostly depended upon the surgical department to monitor acceptable infection control practices in their department. S5RN and S11RN indicated that the hospital followed the AORN Perioperative Standards and Recommended Practices for Surgical Attire.
7) failing to ensure that staff adhered to acceptable standards of professional practice for instrument decontamination by not decontaminating all the surgical instruments that were opened on the sterile field after a surgical procedure was completed and before the instruments were sterile reprocessed for other patient surgical procedures, and for staff not adhering to acceptable infection control practices for the proper use of PPE (personal protective equipment) during instrument decontamination

A review of the AORN Perioperative Standards and Recommended Practices, 2013 Edition, Recommended Practice for Care of Instruments: Recommendation V revealed that all instruments opened in the operating room onto the sterile field should be decontaminated whether or not they have been used. All instruments opened during a surgical procedure are considered contaminated. Scrubbed persons (operating room technicians, operating physicians) may touch instruments without being aware of it. Unused instruments may also come in contact with used instruments.

A review of the hospital policy titled, " Instrument Cleaning and Processing", revised on 01/23/08, and provided by S11RN, as the most current, revealed in part: Instrument personnel will wash, disinfect and process all instruments, equipment and supplies brought to the decontamination area according to AORN Perioperative Standards and Recommended Practices. During decontamination, the instrument technician will wear PPE; an impervious gown, face mask, protective eyewear and gloves.

An observation was made of S21ORT on 5/27/15 at 12:00 p.m. in the surgery Decontamination Room. S21ORT was observed decontaminating only half of the surgical instruments that were opened on the sterile field prior to placing them in the washer sterilizer. S21ORT was not observed wearing a disposable gown while decontaminating the surgical instruments.

An observation was made of S23InstrTech on 5/27/15 at 1:40 p.m. in the endoscopy Decontamination Room. S23InstrTech was observed wearing a disposable gown that was not tied and where the disposable gown kept falling off his shoulders while he was decontaminating the endoscopic instruments.

In an interview on 5/27/15 at 2:15 p.m. with S11RN he was asked about the decontamination of all the surgical instruments opened on a sterile field in a surgical procedure and the use of PPE to include a disposable gown while decontaminating instruments. S11RN indicated that the instrument technicians only decontaminated the surgical instruments that were actually used in the surgical procedure and not all the surgical instruments that were opened on the sterile field. If the instruments were not used during the surgical procedure, they were not considered soiled. S11RN indicated that he was not aware that all surgical instruments from a sterile field had to be decontaminated prior to reprocessing. S11RN indicated that all instrument technicians were supposed to wear appropriate PPE, to include a disposable gown that was tied completely in the back when decontaminating surgical instruments. S11RN indicated that the Surgical Services Department followed AORN Perioperative Standards and Recommended Practice.

8) failing to have a functional workflow pattern in the decontamination rooms (surgery, emergency, endoscopy, and obstetrical areas) for processing surgical instruments after patient use to ensure the cleaning and processing of surgical instruments followed acceptable professional standards of practice, as evidenced by observations of the decontamination rooms with both soiled and cleaned work areas contained in the same area in the room,

A review of the AORN Perioperative Standards and Recommended Practices for Sterilization and Disinfection, 2013 Edition, - Recommended Practices for Sterilization: Recommendation III revealed that functional workflow patterns should be established to create and maintain physical separation between the decontamination and sterilization (processing) areas to aid in achieving environmental and microbial control. During manual cleaning (decontamination) of instruments, particulates, aerosolized matter, dust, and microbial counts are elevated. Physical separation minimizes potential contamination of cleaned items. A workflow pattern that begins in the decontamination area (dirty) and flows to the clean area prevents cleaned items from reentering a contaminated area where they can be re-contaminated.

An observation on 5/27/15 of the hospital's decontamination rooms (surgery, emergency, endoscopy and obstetrical areas) revealed that the "clean areas " were also located in the rooms labeled " Decontamination Room " and that the workflow patterns did not follow functional and acceptable professional standards of practice.

In an interview on 5/27/15 at 3:30 p.m. with S5RN she indicated that the decontamination rooms' workflow patterns were not optimal for acceptable infection controls practices. S5RN further indicated that the decontamination rooms' workflow patterns should be rearranged to be more functional. S5RN indicated that the hospital followed the AORN Perioperative Standards and Recommended Practices for Sterilization and Disinfection.

9) failing to ensure that sterile surgical supplies were not opened up in advance (pre-prepared) or opened up in advance (pre-prepared) in other locations in the surgical suite for patient surgical procedures as evidenced by the perfusion machine(s) used in cardiac heart surgery being sterilely set up (pre-prepared) in the cardiac heart surgical suite and in a sub-sterile room a day or more before a cardiac heart procedure was to be performed in the cardiac heart surgical suite.
A review of the AORN Perioperative Standards and Recommended Practices, 2013 Edition, - Recommended Practice for Sterile Technique: Recommendation V revealed: The sterile field and sterile supplies should be prepared as close as possible to the time of use. The sterile field and the sterile supplies should be prepared in the location where it will be used and should not be moved. Moving the sterile field and sterile supplies from one location to another or setting up the sterile field too early, increases the potential for contamination. The potential for bacterial growth and contamination increases with time because dust and other particles present in the ambient environment settle on horizontal surfaces. Particulate matter can be stirred up by personnel movement and can settle on opened sterile supplies. The sterility of an opened sterile field and sterile supplies is event related.
A review of the hospital policy titled, "Cleaning, Disinfection, and Sterilization of Equipment" , revised on 4/10/15, and provided by S5RN as the most current policy, revealed in part: Keep sterile packages intact until use. Do not "pre-prepare" any tables, carts, etc. by opening sterile trays, arranging them for use, or covering them with a sterile drape. These items are only to be opened just prior to use (within 1 hour, not hours from potential use).
An observation on 5/27/15 at 11:15 a.m., in the presence of S5RN, S11RN and S15RN, of the heart surgical suite and the sub-sterile room next to the heart surgical suite, each revealed a perfusion machine that was "pre-prepared" in advance with opened sterile supplies and covered with a sterile drape, where no surgical procedure was in progress and where no surgical procedure was scheduled for that day.
In an interview on 5/27/15 at 11:15 a.m. with S11RN, in the presence of S5RN and S15RN, he indicated that the Perfusionist opens the sterile supplies and sterilely "pre-prepare" the perfusion machines and leaves them sterilely set up and covered for future cardiac heart surgeries in the heart surgical suite. S11RN indicated that the operating room staff were not allowed to sterilely "pre-prepare" surgical rooms for future use and the operating room staff were expected to create their sterile field as close as possible to a patient's surgical procedure. S11RN indicated that the contract Perfusionist probably should not sterilely "pre-prepare" the perfusion machines with the sterile supplies in advance of a patient's surgical procedure. S11RN indicated that the Perfusionist should be expected to adhere to the AORN Perioperative Standards and Recommended Practices for Sterile Technique and to hospital policy.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on interviews, observations and record reviews, the hospital
1) failed to ensure that surgical services were provided in accordance with acceptable professional standards of practice by failing to ensure that surgical instruments were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's routine use of IUSS (Immediate Use Steam Sterilization)(Flash Sterilization) of surgical instruments for surgical procedures,
2) failed to ensure that staff in the restricted surgical suite areas followed acceptable professional standards of practice by observations of staff wearing their surgical masks hanging down from the neck,
3) failed to ensure that staff in the surgical suite areas followed acceptable professional standards of practice by: a) observations of non-scrubbed surgical staff not wearing a long sleeved warm up jacket during surgical procedures, b) observations of surgical staff wearing undergarments that were not completely covered by their surgical attire, and c) observations of surgical personnel wearing skull caps (surgeon caps) that did not completely cover all their hair,
4) failed to ensure that staff adhered to acceptable standards of professional practice for instrument decontamination by not decontaminating all the surgical instruments that were opened on the sterile field after a surgical procedure was completed and before the instruments were sterile reprocessed for other patient surgical procedures, and for staff not adhering to acceptable infection control practices for the proper use of PPE (personal protective equipment) during instrument decontamination,
5) failed to have a functional workflow pattern in the decontamination rooms (surgery, emergency, endoscopy, and obstetrical areas) for processing surgical instruments after patient use to ensure the cleaning and processing of surgical instruments followed acceptable professional standards of practice, as evidenced by observations of the decontamination rooms with both soiled and cleaned work areas contained in the same area in the room, and
6) failed to ensure that sterile surgical supplies were not opened up in advance (pre-prepared) or opened up in advance (pre-prepared) in other locations in the surgical suite for patient surgical procedures as evidenced by the perfusion machine(s) used in cardiac heart surgery being sterilely set up (pre-prepared) in the cardiac heart surgical suite and in a sub-sterile room a day or more before a cardiac heart procedure was to be performed in the cardiac heart surgical suite.
Findings:
1) failed to ensure that surgical services were provided in accordance with acceptable professional standards of practice by failing to ensure that surgical instruments were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's routine use of IUSS (Immediate Use Steam Sterilization)(Flash Sterilization) of surgical instruments for surgical procedures,

A review of the AORN (Association of periOperative Registered Nurses) Perioperative Standards and Recommended Practices, 2013 edition - Recommended Practice for Sterilization revealed in part: IUSS should not be used as a substitute for sufficient instrument inventory in order to minimize the patient risk for SSI's (surgical site infections).

A review of the hospital policy titled, "Flash Sterilization ", with a revised date of 01/16/08, as provided by S11RN (Surgical Services Charge Nurse) as the most current, revealed that Flash (IUSS) sterilization will be limited to the following situations: There is immediate need for the item and there is insufficient time to process by the preferred sterilization method ....

A review of the hospital's Flash (IUSS) Sterilization Aggregate Data, as provided by S5RN (Infection Control Officer) that was collected by S12RN (Surgical Services Department Director) on the number of IUSS loads run by the Surgical Services Department from 2014 to present revealed the monthly percentages from January 2014 to April 2015 were:
January 2014 - 4.8% of 250 surgical cases,
February 2014 - 5.7% of 264 surgical cases,
March 2014 - 4.9% of 288 surgical cases,
April 2014 - 5.7% of 335 surgical cases,
May 2014 - 9.8% of 286 surgical cases,
June 2014 - 8.0% of 300 surgical cases,
July 2014 - 6.0% of 316 surgical cases,
August 2014 - 8.4% of 299 surgical cases,
September 2014 - 6.4% of 298 surgical cases,
October 2014 - 11.7% of 324 surgical cases,
November 2014 - 5.0% of 260 surgical cases,
December 2014 - 9.4% of 278 surgical cases,
January 2015 - No data was available,
February 2015 - Data was incomplete,
March 2015 - 7.3% of 303 surgical cases, and
April 2015 - 4.5% of 290 surgical cases.

In an interview on 5/29/15 at 9:20 a.m. with S5RN (Infection Control Officer) and S11RN (Operating Room Charge Nurse) the Flash (IUSS) Sterilization Aggregate Data from 2014 to present was reviewed. S5RN and S11RN indicated that the Corporate Benchmark was 10% or less for IUSS use each month. S5RN and S11RN indicated that S12RN collected the data from the monthly Flash (IUSS) Sterilization Logs for the Infection Control Committee and she (S12RN) was not available this week. S11RN indicated that unless the Surgical Services Department was over the Corporate Benchmark of 10% IUSS use each month, the Surgical Services Department did not really track or trend any IUSS usage in the Surgical Services Department. S5RN and S11RN indicated that the hospital's Surgical Services Department followed the AORN Perioperative Standards and Recommended Practices
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2) failed to ensure that staff in the restricted surgical suite areas followed acceptable professional standards of practice by observations of staff wearing their surgical masks hanging down from the neck,

A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practice for Surgical Attire revealed in part: Surgical masks should not be worn hanging down from the neck. Surgical masks are intended to contain and filter droplets from the nasopharynx. The filter portion of the surgical mask harbors bacteria collected from the nasopharyngeal airway and should not be worn hanging from the neck. Surgical masks should be tied securely and discarded after each procedure or when soiled.

Observations of the semi-restricted and restricted areas of the surgical suites on 5/27/15, in the presence of S5RN, S11RN, and S15RN, from 10:00 a.m. to 1:00 p.m. revealed the following infection control breaches of staff (S15RN, S5RN, S11RN, S40ORT, S13MD, S14RN, S16RadTech, S17CRNA, S18CRNA, S19RN, S20InstruTech, S21ORT, S22RN) wearing their surgical masks hanging down from their necks:

In an interview on 5/27/15 at 1:30 p.m. with S5RN and S11RN they was made aware of the multiple infection control breaches of staff wearing their surgical masks hanging down from their necks. S11RN indicated that he was aware or the AORN Perioperative Standards and Recommended Practice for Surgical Attire that surgical masks should not be worn hanging down from the neck.

3) failed to ensure that staff in the surgical suite areas followed acceptable professional standards of practice by: a) observations of non-scrubbed surgical staff not wearing a long sleeved warm up jacket during surgical procedures, b) observations of surgical staff wearing undergarments that were not completely covered by their surgical attire, and c) observations of surgical personnel wearing skull caps (surgeon caps) that did not completely cover all their hair.

Observations on 5/27/15 from 10:00 a.m. to 1:00 p.m. of the surgical area, in the presence of S5RN, S11RN, S15RN, revealed the following: S5RN, S11RN, S17CRNA, S18CRNA wearing T-shirts underneath their surgical attire that were not completely covered by their surgical attire; S11RN, S13MD, S14RN, S18CRNA wearing skull caps (surgeon caps) that did not completely cover their sideburns, nape of neck, ears or facial hair; S14RN, S19RN, S22RN during a surgical procedure not wearing a long sleeved warm up jacket.
A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practice for Surgical Attire - Recommendation III revealed in part: When in the semi-restricted or restricted surgical areas, all non-scrubbed personnel should wear a freshly laundered or single use long sleeved warm up jacket snapped closed with the cuffs down to the wrists. Wearing the warm up jacket snapped closed prevents the edges of the front of the jacket from contaminating a skin prep area or the surgical sterile field. Long sleeved attire helps contain skin squames shed from bare arms. All personal clothing should be completely covered by the surgical attire. Undergarments such as T-shirts with a V-neck, which can be contained underneath the scrub top, may be worn; personal clothing that extends above the scrub top neckline or below the sleeve of the surgical attire should not be worn.
A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practice for Surgical Attire - Recommendation IV revealed in part: All personnel should cover head and facial hair, including the sideburns, the ears and the nape of the neck, when in semi-restricted and restricted areas. Human hair can be a site of pathogenic bacteria such as MRSA. Hair acts as a filter when it is uncovered and collects bacteria. A clean, low-lint surgical head covering or hood that confines all hair and covers scalp skin and ears should be worn. The head covering or hood should be designed to minimize microbial dispersal. Skull caps (surgeon caps) fail to contain the side hair above and in front of the ears and hair at the nape of the neck and the ears and should not be worn.
In an interview on 5/27/15 at 1:30 p.m. with S11RN, in the presence of S5RN, he was made aware of the above observations. S11RN indicated that he was not aware that surgical attire included a snapped up warm up jacket while circulating in surgical procedures. S11RN further indicated that he was not aware that undergarments should be completely covered by one's surgical attire and that all hair and ears, including facial hair needed to be completely covered by an appropriate head covering. S5RN indicated that she mostly depended upon the surgical department to monitor acceptable infection control practices in their department. S5RN and S11RN indicated that the hospital followed the AORN Perioperative Standards and Recommended Practices for Surgical Attire.
4) failed to ensure that staff adhered to acceptable standards of professional practice for instrument decontamination by not decontaminating all the surgical instruments that were opened on the sterile field after a surgical procedure was completed and before the instruments were sterile reprocessed for other patient surgical procedures, and for staff not adhering to acceptable infection control practices for the proper use of PPE (personal protective equipment) during instrument decontamination

A review of the AORN Perioperative Standards and Recommended Practices, 2013 Edition, Recommended Practice for Care of Instruments: Recommendation V revealed that all instruments opened in the operating room onto the sterile field should be decontaminated whether or not they have been used. All instruments opened during a surgical procedure are considered contaminated. Scrubbed persons (operating room technicians, operating physicians) may touch instruments without being aware of it. Unused instruments may also come in contact with used instruments.

A review of the hospital policy titled, " Instrument Cleaning and Processing", revised on 01/23/08, and provided by S11RN, as the most current, revealed in part: Instrument personnel will wash, disinfect and process all instruments, equipment and supplies brought to the decontamination area according to AORN Perioperative Standards and Recommended Practices. During decontamination, the instrument technician will wear PPE; an impervious gown, face mask, protective eyewear and gloves.

An observation was made of S21ORT on 5/27/15 at 12:00 p.m. in the surgery Decontamination Room. S21ORT was observed decontaminating only half of the surgical instruments that were opened on the sterile field prior to placing them in the washer sterilizer. S21ORT was not observed wearing a disposable gown while decontaminating the surgical instruments.

An observation was made of S23InstrTech on 5/27/15 at 1:40 p.m. in the endoscopy Decontamination Room. S23InstrTech was observed wearing a disposable gown that was not tied and where the disposable gown kept falling off his shoulders while he was decontaminating the endoscopic instruments.

In an interview on 5/27/15 at 2:15 p.m. with S11RN he was asked about the decontamination of all the surgical instruments opened on a sterile field in a surgical procedure and the use of PPE to include a disposable gown while decontaminating instruments. S11RN indicated that the instrument technicians only decontaminated the surgical instruments that were actually used in the surgical procedure and not all the surgical instruments that were opened on the sterile field. If the instruments were not used during the surgical procedure, they were not considered soiled. S11RN indicated that he was not aware that all surgical instruments from a sterile field had to be decontaminated prior to reprocessing. S11RN indicated that all instrument technicians were supposed to wear appropriate PPE, to include a disposable gown that was tied completely in the back when decontaminating surgical instruments. S11RN indicated that the Surgical Services Department followed AORN Perioperative Standards and Recommended Practice.

5) failed to have a functional workflow pattern in the decontamination rooms (surgery, emergency, endoscopy, and obstetrical areas) for processing surgical instruments after patient use to ensure the cleaning and processing of surgical instruments followed acceptable professional standards of practice, as evidenced by observations of the decontamination rooms with both soiled and cleaned work areas contained in the same area in the room,

A review of the AORN Perioperative Standards and Recommended Practices for Sterilization and Disinfection, 2013 Edition, - Recommended Practices for Sterilization: Recommendation III revealed that functional workflow patterns should be established to create and maintain physical separation between the decontamination and sterilization (processing) areas to aid in achieving environmental and microbial control. During manual cleaning (decontamination) of instruments, particulates, aerosolized matter, dust, and microbial counts are elevated. Physical separation minimizes potential contamination of cleaned items. A workflow pattern that begins in the decontamination area (dirty) and flows to the clean area prevents cleaned items from reentering a contaminated area where they can be re-contaminated.

An observation on 5/27/15 of the hospital's decontamination rooms (surgery, emergency, endoscopy and obstetrical areas) revealed that the "clean areas" were also located in the rooms labeled "Decontamination Room" and that the workflow patterns did not follow functional and acceptable professional standards of practice.

In an interview on 5/27/15 at 3:30 p.m. with S5RN she indicated that the decontamination rooms' workflow patterns were not optimal for acceptable infection controls practices. S5RN further indicated that the decontamination rooms workflow patterns should be rearranged to be more functional. S5RN indicated that the hospital followed the AORN Perioperative Standards and Recommended Practices for Sterilization and Disinfection.

6) failed to ensure that sterile surgical supplies were not opened up in advance (pre-prepared) or opened up in advance (pre-prepared) in other locations in the surgical suite for patient surgical procedures as evidenced by the perfusion machine(s) used in cardiac heart surgery being sterilely set up (pre-prepared) in the cardiac heart surgical suite and in a sub-sterile room a day or more before a cardiac heart procedure was to be performed in the cardiac heart surgical suite.
A review of the AORN Perioperative Standards and Recommended Practices, 2013 Edition, - Recommended Practice for Sterile Technique: Recommendation V revealed: The sterile field and sterile supplies should be prepared as close as possible to the time of use. The sterile field and the sterile supplies should be prepared in the location where it will be used and should not be moved. Moving the sterile field and sterile supplies from one location to another or setting up the sterile field too early, increases the potential for contamination. The potential for bacterial growth and contamination increases with time because dust and other particles present in the ambient environment settle on horizontal surfaces. Particulate matter can be stirred up by personnel movement and can settle on opened sterile supplies. The sterility of an opened sterile field and sterile supplies is event related.
A review of the hospital policy titled, "Cleaning, Disinfection, and Sterilization of Equipment", revised on 4/10/15, and provided by S5RN as the most current policy, revealed in part: Keep sterile packages intact until use. Do not "pre-prepare" any tables, carts, etc. by opening sterile trays, arranging them for use, or covering them with a sterile drape. These items are only to be opened just prior to use (within 1 hour, not hours from potential use).
An observation on 5/27/15 at 11:15 a.m., in the presence of S5RN, S11RN and S15RN, of the heart surgical suite and the sub-sterile room next to the heart surgical suite, each revealed a perfusion machine that was " pre-prepared " in advance with opened sterile supplies and covered with a sterile drape, where no surgical procedure was in progress and where no surgical procedure was scheduled for that day.
In an interview on 5/27/15 at 11:15 a.m. with S11RN, in the presence of S5RN and S15RN, he indicated that the Perfusionist opens the sterile supplies and sterilely "pre-prepare" the perfusion machines and leaves them sterilely set up and covered for future cardiac heart surgeries in the heart surgical suite. S11RN indicated that the operating room staff were not allowed to sterilely "pre-prepare" surgical rooms for future use and the operating room staff were expected to create their sterile field as close as possible to a patient's surgical procedure. S11RN indicated that the contract Perfusionist probably should not sterilely "pre-prepare" the perfusion machines with the sterile supplies in advance of a patient's surgical procedure. S11RN indicated that the Perfusionist should be expected to adhere to the AORN Perioperative Standards and Recommended Practices for Sterile Technique and to hospital policy.