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Based on the review of medical records (MR), Lippincott Procedures, V.A.C. (vacuum assisted closure) Therapy Clinical Guidelines, the hospital's Wound Care Protocol, facility policies and procedures and interviews it was determined the facility failed to ensure the staff provided wound care according to completed physician orders and notified the physician of patients' wound deterioration/new wounds.

Findings include:

Refer to A 392 for findings.

Based on the review of medical records (MR), Lippincott Procedures, V.A.C. (vacuum assisted closure) Therapy Clinical Guidelines, facility policies and procedures and interviews it was determined the facility failed to ensure the staff:

1. Followed the physician's orders for wound care.

2. Wrote complete wound care orders for negative pressure wound therapy.

3. Notified the physician of new wounds or when wounds deteriorated.

4. Weighed patients as ordered by the physician.

5. Reevaluated the patient's pain treatment when needed.

This affected 4 of 4 wound care records reviewed with wound care orders, which included Patient Identifiers (PI) # 4, # 1, # 5, # 2 and had the potential to negatively affect all patients served by this facility.

Lippincott Procedures - Negative pressure wound therapy
Revised August 17, 2018

Implementation:

Verify the practitioner's order for the appropriate wound cleaning agent, frequency of dressing change, type of negative pressure unit, type of wound packing, and setting for the negative pressure device...

...Verify that the number of removed pieces correlates with the number documented in the patient's record.

Using foam packing:

...Count the number of foam pieces you use and document that number on the dressing and in the patient's medical record...

Completing the procedure:

... Turn on the negative pressure unit.

Document the procedure

Documentation:

Document the date and time; wound assessment, including signs and symptoms of infection; wound measurements; pain assessment and any interventions; patient's response. Record the weight of soiled dressing (if appropriate). Note the type and number of dressings you used and the setting for the negative pressure wound therapy unit. Record the verification of components you removed from the wound.

V.A.C. Therapy Clinical Guidelines
A Reference Source for Clinicians

V.A.C. Therapy Safety Information:

Important: As with any prescription medical device, failure to consult a physician...may lead to improper product performance and the potential for serious or fatal injury. Do not adjust therapy unit settings or perform therapy application without directions from/or supervision by the treating physician.

Points to Remember When Using V.A.C. Therapy

Always count the total number of pieces of foam used in the wound. Document the foam quantity and dressing change date on the drape or Foam Quantity Label if available, and in the patient's chart...

When dressing is removed, count the number of foam pieces removed, correlate the count with the number of foam pieces previously placed in the wound and verify the complete removal of all V.A.C. Foam dressing pieces.

Foam Placement:

...The V.A.C. White foam Dressing may be more appropriate for use with explored tunnels...Always count the total number of pieces of foam used in the wound. Document the foam quantity and dressing change date on the drape or foam quantity label if available, and in the patient's chart.

Foam Removal:

V.A.C. Foam Dressing are not bioabsorbable. Always count the total number of pieces of foam removed from the wound and ensure the same number of foam pieces are removed as were placed.

Continuous versus Intermittent/DPC (Dynamic Pressure Control) V.A.C. Therapy:

Continuous, rather than intermittent/DPC, V.A.C. Therapy is recommended over unstable structures, such as an unstable chest wall or non-intact fascia (is a band or sheet of connective tissue, primarily collagen, beneath the skin that attaches, stabilizes, encloses, and separates muscles and other internal organs), in order to help minimize movement and stabilize the wound bed. Continuous therapy is also generally recommended for patients at increase risk of bleeding, highly exudating wounds, fresh flaps and graphs and wounds with acute enteric fistulae.

Facility Policy: Pain Management
Effective Date: 7/27/18
Last Reviewed Date: 7/27/18
Policy #: 140

Purpose: The purpose of pain assessment and management of pain through an interdisciplinary approach that minimizes risk associated with pain management:

2. Promoting an optimal level of function, supporting the patient's ability to participate in rehabilitation.

Policy:

1. Assessment and Documentation:

7....
D. Result/effectiveness of interventions implemented.

Facility Policy: Wound Assessment, Prevention, and Documentation
Effective Date: 03/22/18
Last Reviewed Date: 07/27/18
Policy # 2

Purpose:

2. To ensure standard documentation related to the assessment of skin and wounds.
3. To facilitate both accuracy in wound assessment...

1. Assessment

All patients admitted to the hospital will be screened within 8 hours for risk of skin breakdown and for alterations in skin Intergrity by the registered nurse...

III. Documentation

B. Measurements: Stage 2 and greater pressure injuries, and other wounds as applicable will include the following documentation: Size: LENGTH, WIDTH, and DEPTH should be recorded in centimeters on admission or discovery, weekly and at discharge.

1. PI # 4 was admitted to the hospital on 12/1/19 at 1:50 AM with diagnoses including: Generalized muscle weakness, Pneumoperitoneum with fecal peritonitis, Prior left below the knee amputation, End Stage Renal Disease (ESRD), Type 2 Diabetes Mellitus, Hypertension, Anemia, Atrial Fibrillation, COPD (Chronic Obstructive Pulmonary Disease), and Pressure Injury Sacrum/Coccyx.

WOUNDS:

Review of the Incision/Wound documentation dated 12/1/18 at 2:46 AM revealed the following:

Wound # 1 - mid abd (abdomen) wound Other: Surgical wound = length (L) 24.5 cm (centimeters), x (by) width (W) 4.5 cm x depth (D) 3.8 with moderate serosanguineous drainage. There was no documentation of a dressing covering the wound.

Wound # 2 - coccyx Other: Unstageable = L - 12 cm and W - 15 cm.

Review of the Physician's Orders dated 12/1/18 at 5:05 AM revealed the following wound care: "BID (twice a day) dressing change to mid abdominal wound BID, until wound vac therapy. clean with ns (normal saline), apply wet to dry dsg (dressing),"

Review of the physician's Orders dated 12/1/18 at 8:27 PM revealed the following: clean abdominal incision with sterile saline, apply skin prep to peri wound, apply wound vac at 125 mmHg (millimeters of mercury) Negative Pressure every M, W, F (Monday, Wednesday, and Friday). There was no documentation of the color sponge the staff were to use nor if the negative pressure was continuous or intermittent.

Review of the physician's orders dated 12/1/18 at 8:29 PM revealed the following orders: Clean the wound to the sacral area with sterile saline, pat dry, apply skin prep to peri wound, apply Santyl ointment to necrotic tissue, and cover with dry dressing every night at bedtime (Q HS). Start on 12/2/18 at 8:00 PM.

Review of the wound care provided by the nurse to the mid abd. on 12/1/18 at 8:32 PM revealed the use of 2 pieces of black foam and no documentation what the setting was for the negative pressure. There was no documentation of wound care to the mid abd from the time the patient was admitted to the hospital on 12/1/18 at 1:50 AM to 12/1/18 at 8:32 PM.

Further review of the wound care documentation to the coccyx provided by the nurse on 12/1/18 at 8:32 PM revealed the following wound care: cleaned with sterile saline, Santyl ointment to necrotic tissue, and cover with dry dressing. There was no documentation of wound care to the coccyx from the time the patient was admitted to the hospital on 12/1/18 at 1:50 AM to 12/1/18 at 8:32 PM.

Review of the wound care to the coccyx provided by the nurse on 12/2/18 at 11:52 PM revealed no documentation the area was cleansed with sterile saline.

Review of the wound care provided by the nurse on 12/3/18 at 9:38 AM revealed the wound to the mid abd measured L - 23 cm, W - 3.5 cm and d - 4 cm. There was no documentation what the wound was cleansed with, how many pieces of foam were removed, how many pieces of foam were used, amount of negative pressure or if it was continuous or intermittent.

Review of the wound care to the mid abd provided by the nurse on 12/4/18 (Tuesday) at 1:00 AM revealed the wound was cleansed with sterile saline and negative pressure. There was no documentation why the wound vac needed to be changed, how many pieces of foam were removed, how many pieces of foam were used, amount of negative pressure or if it was continuous or intermittent.

Review of the wound care to the mid abd provided by nurse on 12/5/18 at 8:40 PM revealed the wound was cleansed with sterile saline. There was no documentation how many pieces of foam were removed, how many pieces of foam were used, if negative pressure was used, amount of negative pressure or if it was continuous or intermittent.

There was no documentation wound care was provided to the coccyx area on 12/6/18, 12/7/18, 12/8/18, or 12/9/18.

Review of the wound care to the mid abd provided by nurse on 12/7/18 at 1:23 PM revealed no documentation the wound was cleansed with sterile saline. There was no documentation how many pieces of foam were removed, how many pieces of foam were used, amount of negative pressure or if it was continuous or intermittent.

Review of the wound care to the mid abd provided by nurse on 12/10/18 at 3:33 AM revealed the wound was cleansed with sterile saline,. There was no documentation how many pieces of foam were removed, how many pieces of foam were used, amount of negative pressure or if it was continuous or intermittent.

Review of the wound care to the mid abd provided by nurse on 12/10/18 at 1:13 PM revealed no documentation the wound was cleansed with sterile saline. There e was no documentation how many pieces of foam were removed, how many pieces of foam were used, amount of negative pressure or if it was continuous or intermittent.

Review of the wound care to the mid abd provided by nurse on 12/12/18 at 3:18
PM revealed no documentation the wound was cleansed with sterile saline. There was no documentation how many pieces of foam were removed, how many pieces of foam were used, amount of negative pressure or if it was continuous or intermittent.

An interview was conducted with EI # 2, Chief Nursing Officer on 1/28/19 at 1:00 PM. EI # 2 confirmed the above findings.

PAIN

Review of the physician's order dated 12/3/18 at 11:13 AM revealed an order for Norco 7.5 mg (milligrams) -325 mg oral q 6 hours PRN for pain (scale 4-10).

Review of the Medication Administration Record (MAR) dated 12/4/18 at 6:46 AM revealed a pain level of 10 = worst pain and the nurse administered the Norco 7.5 mg.

Further review of the MAR dated 12/4/18 at 7:30 AM revealed the patient's pain level was at a 5 = Moderate pain. There was no documentation of a follow up for the patient's pain.

Review of the MAR dated 12/4/18 at 2:53 PM revealed a pain level of 10 = worst pain and the nurse administered the Norco 7.5 mg.

Further review of the MAR dated 12/4/18 at 3:15 PM revealed the patient's pain level was at a 9 = severe pain. There was no documentation of a follow up for the patient's pain.

There was no documentation of an intervention for the patient's pain until 9:32 PM on 12/4/18 when the nurse documented the administration of Norco 7.5 on the MAR, which included a pain level of 10 = worst pain.

Review of the MAR dated 12/10/18 at 11:53 AM revealed a pain level of 10 = worst pain and the nurse administered the Norco 7.5 mg.

Further review of the MAR dated 12/10/18 at 12:55 PM revealed the patient's pain level was still a 10 = worst pain. There was no documentation of a follow up for the patient's pain.

There was no documentation of an intervention for the patient's pain until 5:34 PM on 12/10/18 when the nurse documented the administration of Norco 7.5 on the MAR, which included a pain level of 8 = severe pain.

Review of the MAR dated 12/11/18 at 11:58 AM revealed a pain level of 8 = severe pain and the nurse administered the Norco 7.5 mg.

Further review of the MAR dated 12/11/18 at 12:28 PM revealed the patient's pain level was still a 5 = moderate pain. There was no documentation of a follow up for the patient's pain.

An interview was conducted with EI # 2, Chief Nursing Officer on 1/28/19 at 1:00 PM. EI # 2 confirmed the above findings.

2. PI # 1 was admitted to the facility on 11/30/18 with diagnoses including Gangrene of the right foot S/P (status post) right above the knee amputation (R AKA), Prior Left below the knee amputation (L BKA), ESRD, Hypertension, Type 2 Diabetes Mellitus, Peripheral Vascular Disease, and Anemia.

WOUNDS

Review of the Flowsheet dated 11/30/18 at 10:10 PM revealed the following documentation:

Wound # 1 - LBKA = had a dressing applied without documentation of what dressing was applied, cleansed with wound cleanser and no documentation of a measurement.

Wound # 2 - RAKA = cleansed with wound cleanser and xeroform dressing was applied. There was no documentation the wound was measured.

Review of the physician order dated 12/1/18 at 8:04 PM revealed wound care orders for the RAKA, which included clean with sterile saline, pat dry, and apply xeroform and dry dressing until healed QHS.

Review of the physician order dated 12/1/18 at 8:06 PM revealed wound care orders for the LBKA, which included clean with sterile saline, pat dry, and apply Santyl to necrotic tissue and cover with a dry gauze dressing QHS.

Review of the wound care documentation revealed no wound care was performed 12/1/18.

Review of the wound care documentation dated 12/2/18 at 6:50 PM revealed wound # 1 LBKA was cleansed with sterile saline, dressed with petroleum gauze and not the Santyl that was ordered. The nurse documented wound # 2 (documented as the R BKA instead of the RAKA) was dressed with collagens. There was no documentation of a physician's order for the collagens.

Further review of the wound care documentation dated 12/2/18 at 6:50 PM revealed a new pressure ulcer to the coccyx, wound # 3 . There was a large amount of purulent serosanguineous foul smelling drainage. The nurse documented cleansed with wound cleanser. There was no documentation the physician was notified.

Review of the physician's order dated 12/3/18 at 3:23 AM revealed orders for the nurse to cleanse the coccyx wound with wound cleanser and apply a foam dressing Q HS.

Review of the wound care documentation dated 12/3/18 at 8:10 PM revealed wound # 1 was cleansed with sterile saline, dressed with petroleum gauze and not the Santyl that was ordered. There was no documentation of an order for the petroleum gauze. The nurse documented the wound # 3 to the coccyx was cleansed with wound cleanser and dressed with a foam dressing. There was no documentation of wound measurements for any of the 3 wounds.

Review of the wound care documentation dated 12/4/18 at 8:10 PM revealed wound # 1 was cleansed with sterile saline, dressed with petroleum gauze and not the Santyl that was ordered. There was no documentation of an order for the petroleum gauze.

Further review of the wound care documentation dated 12/4/18 at 8:10 PM revealed the coccyx wound measured L - 1.5 cm, W - 4 cm, and D - 0.1 cm. There was no documentation of wound # 1 and 2.

Review of the wound care documentation dated 12/5/18 at 8:10 PM revealed no documentation wound care was performed to the RAKA or the coccyx.

Review of the wound care documentation dated 12/6/18 revealed the nurse applied collagen dressing to the LBKA. There was no documentation of a physician's order for the collagen dressing.

Review of the wound care documentation dated 12/7/18 at 8:20 PM and 12/8/18 at 7:04 PM revealed LBKA was cleansed with sterile saline, dressed with petroleum gauze and not the Santyl that was ordered. There was no documentation of an order for the petroleum gauze.

There was no documentation the nurse provided wound care to the RAKA or the coccyx wound on 12/8/18.

Review of the wound care documentation dated 12/10/18 at 8:08 PM revealed the nurse applied collagen dressing to the LBKA. There was no documentation of a physician's order for the collagen dressing.

Review of the wound care documentation dated 12/11/18 at 4:51 PM revealed no documentation the nurse applied xeroform to the RAKA.

Further review of the wound care documentation dated 12/11/18 at 4:51 PM revealed a new pressure ulcer to the R buttocks which measured L - 1 cm, W - 1.5 cm and D - 0.1 cm. There was no documentation the physician was notified of the new wound. The nurse documented the measurements to the coccyx wound as L - 3 cm, which increased in length since 12/4/18 at 8:10 PM where the coccyx wound measured L - 1.5 cm. There was no documentation the physician was notified of the increase in the coccyx wound length.

Review of the wound documentation dated 12/12/18 at 8:11 PM revealed no documentation of the dressing used to cover the coccyx wound.

There was no documentation of wound care being performed to the L BKA, R AKA, coccyx or the R buttocks on 12/13/18.

Review of the wound care documentation dated 12/14/18 at 3:57 AM revealed the nurse applied a petroleum dressing to the LBKA. There was no documentation of a physician's order for the petroleum dressing.

Review of the wound care documentation dated 12/14/18 at 7:22 PM, 12/15/18 at 7:54 PM, and 12/15/18 at 8:47 PM revealed the nurse applied collagen dressing to the LBKA. There was no documentation of a physician's order for the collagen dressing.

Review of the wound care documentation dated 12/17/18 at 2:54 PM revealed the nurse dressed the LBKA with a xeroform dressing and used Santyl on the RAKA. There was no documentation of a physician's order for the xeroform to the LBKA or Santyl to the RAKA.

Review of the nurses' documentation of the wound appearance revealed the following :

LBKA
12/2/18, 12/5/18, 12/11/18, and 12/17/18 = necrotic tissue and slough
12/4/18 and 12/7/18 = necrotic tissue, eschar and slough
12/6/18 and 12/14/18 = necrotic tissue and eschar
12/9/18 = ...dehisced, edges separated, necrotic tissue
12/10/18, 12/12/18 and 12/16/18 = edges separated...necrotic tissue, eschar
12/15/18 = edges separated...necrotic tissue

There was no documentation of a measurement of the LBKA from admission on 11/30/18 to 12/17/18 when the patient was discharged.

RAKA
12/2/18 to 12/14/18 = sutured
12/15/18 = edematous, edges separated, necrotic tissue, slough
12/16/18 = edematous, edges separated, gaping
12/17/18 = necrotic tissue, eschar, slough

There was no documentation of a measurement of the RAKA from admission on 11/30/18 to 12/17/18 when the patient was discharged. There was no documentation the physician was notified of the deterioration of the RAKA.

WEIGHTS

Review of the physicians order dated 12/5/18 revealed an order for the staff to weigh the patient daily. There was no documentation the patient was weighed on 12/5/18, 12/7/18, 12/8/18, 12/10/18, 12/11/18, 12/14/18, and 12/16/18.

An interview was conducted on 1/25/19 at 2:30 PM with EI # 2 who verified the above findings.

3. PI # 5 was admitted to the facility on 1/15/19 at 3:35 PM with diagnoses including Severe PAD (Peripheral artery disease) with gangrene S/P amputation of the right 1st, 2nd, and 4th toes, Atrial valve insufficiency S/P replacement, Hypertension, CAD (Coronary artery disease), Prior CVA (Cerebrovascular accident) and Prostate cancer.

Review of the wound care documentation dated 1/15/19 at 6:14 PM revealed the nurse applied negative pressure at 125 mmHg to the right foot partial toes amputation. The wound measured L - 10 cm, W - 3 cm and D - 2.5 cm. There was a small amount of serosanguineous and serous drainage. There was no documentation the wound was cleansed, type or number of sponges, if the negative pressure was continuous or intermittent.

Review of the physician's order dated 1/15/19 at 6:19 PM revealed the following: "black foam, continuous, q M, W, F". There was no documentation of a cleaning agent or the amount of negative pressure.

Review of the wound care documentation dated 1/18/19 at 3:47 PM, 1/21/18 at 10:06 AM and 1/23/19 at 3:13 PM revealed the nurse applied negative pressure to the right foot partial toes amputation. There was a small amount of serosanguineous drainage. There was no documentation the wound was cleansed, type or number of sponges, amount of negative pressure or if it was continuous or intermittent.

An interview was conducted on 1/25/19 at 2:10 PM with EI # 2 who verified the above findings.

4. PI # 2 was admitted to the facility on 12/7/18 with diagnoses including Osteomyelitis of the left heel, Type II Diabetes Mellitus, Hypertension, Anemia, and ESRD.

Review of the physician's orders dated 12/7/18 revealed the following wound care orders:

Left heel surgical debridement site = cleanse with sterile saline, apply Santyl to the slough areas, cover with 1/4 strength Dakins solution, dress with xeroform gauze and dress Q HS.

Pressure area to buttocks = Cleanse with wound cleanser and cover with foam dressing M, W, F.

Review of the wound care documentation revealed no documentation of wound care to the left heel on 12/8/18.

Review of the wound care documentation dated 12/9/18 at 9:00 PM and 12/11/18 at 8: 43 PM revealed no documentation the nurse dressed the left heel wound with xeroform.

Review of the physician's order dated 12/12/18 revealed orders for wound care to the top of the left foot as follows: cleanse with sterile saline and cover with xeroform gauze and dry dressing Q HS.

Review of the wound care documentation revealed no documentation wound care was provided to any wounds on 12/13/18 and 12/15/18.

Review of the wound care documentation dated 12/14/18 (Friday) at 8:00 PM revealed no documentation wound care was provided to the top of the left foot or the buttocks. Further review of the wound care documentation dated 12/14/18 (Friday) at 8:00 PM revealed no documentation of the wound care provided to the left heel.

Review of the wound care documentation dated 12/16/18 at 8:40 PM revealed no documentation the nurse dressed the wound to the left heel with xeroform gauze.

An interview was conducted on 1/25/19 at 1:45 PM with EI # 2 who verified the above findings.