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Based on observation, staff interview, personnel file review and facility policy and procedure review it was determined the facility failed to ensure a registered nurse supervised and evaluated the nursing care for each patient (A 395), failed to ensure nursing staff developed, and kept current, a nursing care plan for each patient (A 396) and failed to ensure drugs and biological's were prepared and administered in accordance with Federal and State laws (A 405) and failed to ensure blood transfusions and intravenous medications were administered in accordance with State law and approved medical staff policies and procedures (A 409). The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on medical record review, hospital policies and procedures, and staff interview, the facility failed to ensure the registered nurse documented required assessments, initiated interventions, or followed hospital policy and procedures for the care of patients. This finding affected five of 10 patients reviewed receiving nursing services. (Patients #2, #4, #5, #6 and #7) The hospital census was 155.

Findings include:

Review of the hospital's policy and procedure, titled Patient Assessment and Re-Assessment with a most recent review date of 03/01/16 directed that all patients receiving inpatient, outpatient, observation, ambulatory surgery or emergency services will have an initial assessment and appropriate follow-up assessments based upon their individual needs including physical, psychological spiritual, educational, environmental, self-care deficits, social/cultural status and discharge planning. The goal of the assessment/reassessment process is to provide a framework for the delivery of care that ensures comprehensive planning and timely evaluation through the continuum of care. All assessments provided by health-care professional will include: data collected to assess the needs of the patient, data analyzed to create information necessary to develop a plan to meet the patient's care or treatment needs, and decisions made regarding patient care and treatment are prioritized based on analysis of the information collected.

The hospital policy and procedure titled Pressure Ulcer Prevention with a date of 03/2016 directed that all assessments and interventions will be documented in the appropriate sections of the electronic medical record (EMR). Skin and wound assessment performed on admission by the Registered Nurse (RN), assess the wound (if known) as well as the age of the wound and treatment history. History of previous wounds or skin conditions should be obtained from patient and documented. Ongoing Assessments will be assessed each shift (hospital has two twelve hours shifts), with documentation in skin assessment section of the EMR which included depth of tissue destruction, location, measurements, color of wound bed, exudates type and amount, and peri-wound. Item 2.2.3 wound documentation, including assessment of any reddened or broken areas in the skin will be documented upon admission in the appropriate wound section. All patients with pressure ulcers or have a history of pressure ulcers are to be considered "at risk: for pressure ulcers regardless of the their Braden Scale for Predicting Pressure Ulcer Risk Score. The Braden score must be calculated to assist in developing an optimal individualized plan of care for pressure ulcer prevention. A sub-scale score of 2 or less in any category required consistent off loading of heels considered and universal heel pillows must be applied for all at risk patients. Universal Interventions for all Patients directed staff to use heel protection or heel suspension devices, turn and reposition every 2 hours or more frequently or use a 30 degree side lying position, for patients at risk, and to limit seated time to one to two hours.

The facility policy titled Wound Care and Irrigation (Perry and Potter, 8th Edition) directed under procedural guidelines 38-1 on page 925 that routine wound assessments provided valuable information regarding the status of the wound. This clinical reference further directed that the following parameters were included in a wound assessment, the location, the type of wound, extent of tissue involvement, type and percentage of tissue in wound base, wound size (included length, width, and depth), wound exudates, presence of odor, peri-wound area and pain. The directive further directed staff to examine the last (previous) wound assessment to use as a comparison for assessments and to determine wound healing.

1. Review of the medical record revealed Patient #5 presented at the hospital on 06/24/16 for the treatment of dehydration and a fall which resulted in the patient being down in the home for some time (one to four days) and exposed to urine and stool for extended time prior to hospitalization. The initial nursing assessment dated 6/24/16 at 1:30 AM which included the initial skin assessment documented Patient #5 as having excoriated bilateral groins that were reddened, an excoriated sacrum (large triangular shaped bone at the base of the spine) with pink red tissue, the assessment documented the patient with a reddened belly button, bruising to the left hip, rib cage which was assessed as purple, the peri area (area between genitals and anus) was assessed as reddened, and overall dry skin. The assessment documentation lacked any measurements of any wounds. The first Braden score was dated as 06/24/16 at 10:05 AM and scored the patient as 2 in the areas of mobility, friction and shear and sensory perception ( at risk per facility policy). The facility was unable to provide documentation of any consistent pressure reduction interventions or repositioning every two hours per the facility policy. One nursing documentation entry dated 06/24/16 at 10:05 AM recorded the patient as in bed on left side with both heels elevated.

The nursing documentation dated 6/25/16 at various times assessed the skin condition as excoriated bilateral groins (anterior leg folds), reddened sacrum, reddened peri area, and purple bruising to the left side and ribs. The documentation timed at 6:00 PM documented the placement of Mepilex to the buttocks (a foam bordered occlusive dressing used to minimize pain and absorb and retain exudates and treat a variety of wounds). The facility provided documentation for one of the two required Braden Risk Scores which was dated 06/25/16 at 8:00 PM and scored the patient as bedfast, and scores of 2 each for mobility, sensory perception and friction or shear ( at risk). The facility was unable to provide consistent documentation the patient was turned and repositioned every two hours or heels elevated per policy and procedure for at risk patients. The facility was unable to provide documentation of skin assessments or interventions other than the patient was ambulating with assistance on 06/25/16 at 8:00 PM.

The facility was unable to provide skin assessments or Braden scoring performed by nursing on 06/26/16. The documentation dated 06/26/16 at 8:00 AM, 12:00 PM and 4:00 PM documented the patient in a supine (laying on back) position with heel and elbow protectors in place. The patient was documented as positioned on right side at 8:00 PM with both bilateral heel and elbow protectors in place.

The nursing documentation dated 06/27/16 at 12:00 AM (midnight) documented a Braden Score of 14 (moderate risk for pressure ulcers per industry standards) and that the patient was positioned on the right side with bilateral heel pads on, the facility was unable to provide documentation of a skin assessment. The nursing documentation dated 06/27/16 revealed the nurse assessed the patient at 8:00 AM but recorded the documentation at 10:49 AM. The documentation again revealed a Braden Score of 14 (moderate risk) and interventions of patient resting on right side with bilateral heel pads. The facility was unable to provide documentation of a skin assessment.

Review of the occupational therapy notes dated 06/24/16 at 11:00 AM revealed the therapist visited Patient #5 at this time, the patient complained of painful knees bilaterally. The therapist documentation revealed several abrasions and areas of skin breakdown. Blood noted on the patient's sheets near peri area (buttocks) and that nursing was notified. The documentation revealed the patient was returned to bed following the therapy session due to the nurses' need to assess wounds. The occupational therapist's assessment documented the patient would benefit from a wound consult.

Review of the physical therapist's progress note dated 06/27/16 at 11:05 AM documented the nurse was called in when the patient stood because the patient was bleeding from a wound on the buttocks. The wound care nurse was called in to assess. The patient has multiple wounds on her backside, legs, and lower abdomen.

Review of Patient #5's physician orders revealed a wound consult was ordered on 06/27/16 at 11:49 AM. The wound nurse documented an assessment on 06/27/16 at 12:07 PM and documented the patient's physician was notified at 12:02 PM of the findings. Review of the patient's medical orders dated 06/26/16 and 06/27/16 revealed the patient had a complete metabolic panel on each day (these test included tests for albumin and total protein) ordered.

Review of the wound consultant notes dated 06/27/16 revealed the reason for the consultation was for heel and buttocks ulcers. Patient #5's wound appearances were documented as follows: wound #1 right heel measured 3 centimeters (about 1.2 inches) length by 2 centimeters(cm) width or (3/4 inch) and characterized as a deep tissue injury pressure ulcer. Wound #2 left heel measured 2.5 cm by 2.5 cm (about 1 inch by 1 inch) also characterized as deep tissue injury pressure ulcer. Wound #3 was located on the right buttocks and measured 10 cm in length by 3 cm width (or about 4 inches by 1 inch) and described as full thickness with necrotic (dead) tissue, granulation and a small amount of bloody drainage with reddened periwound (surrounding area). The documentation also revealed the wound over the buttocks was over fatty tissue, was necrotic and from perianal dermatitis with ulceration related to incontinence and moisture. The right and left heels are purplish bluish discoloration and these may have been previous absorbed blisters. Total protein was 5.2 grams per dilution (normal was 6.4 to 8.2 gm/dL) and the albumin level was 2.2 gm/dL (normal was 3.2 -4.6 gm/dl). These laboratory values are indicators of possible protein malnutrition and overall nutritional status. The wound consultant's plan directed staff to apply Santyl (topical debriding medication to remove dead tissue) and to cover with Mepilex every day, apply skin prep and sage boots to bilateral feet (skin prep was a protective barrier wipe and sage boots used to protect and offload heel pressure to aid in healing).

The National Pressure Ulcer Advisory Panel classified wounds as follows: A full thickness wound may expose fatty tissue but not bone, tendon or muscle and have undermining or tunneling. Suspected deep tissue injury was documented as purple or maroon localized area of discolored intact skin or blood filled blister due to damage of underlying soft tissue from pressure, shear or friction. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue

Review of the dietician's consult dated 06/28/16 at 4:17 PM revealed the consultation was from the wound nurse secondary to Patient #5's bilateral heel deep tissue wounds and a full ulcer to the buttocks. The nutritional diagnoses documented the patient with increased nutrient needs secondary to increased demand for nutrients as evidence of multiple areas of skin breakdown. The consultant interventions for the patient included healthy diet, encourage intakes of greater than 50% an order for Prostat (high protein supplement) one ounce (at lunch), monitor weights, and provide patient or caregiver with diet education.

Interview with nursing Staff F on 09/07/16 at 7:57 AM revealed she was consulted to see Patient #5 on 06/27/16 at which time the patient's heels were documented to have deep tissue injury bilaterally and additionally, a right buttocks wound that was full thickness over fatty tissue that was secondary to perianal dermatitis related to incontinence but was not a pressure ulcer as it was not over bony tissue but rather fatty tissue. Staff F verbalized Patient #5's bilateral heels were described as suspected deep tissue injuries.

Interview with administrative Staff E and W on 09/06/16 at 8:36 AM verbalized Patient #5's buttock wound was not a pressure ulcer as it was not over a bony prominence. Staff W verbalized that the bilateral heel wounds were deep tissue injuries. A request was made for the facility's policy and procedure for the assessment of wounds. Staff W responded that nursing staff used the Braden Scale for Predicting Pressure Sore Risk. A separate request was made for the facility's policy and procedure for the assessment of non-pressure sore wounds and the expected components of a non-pressure ulcer wound assessment. Staff W verbalized that when the hospital failed to have specific clinical policy and procedures the accepted clinical reference used was the Clinical Skills and Techniques by Perry and Potter and the hospital currently used the 8th Edition with a copyright date of 2014 of this reference book. (See policy and procedure above). Staff W verbalized that assessments were performed according to medical unit and patient admission status. Patients in observational status received focused assessments which included Braden Scale for risk of pressure ulcers and skin was always assessed. Staff W verbalized, complete nursing assessments were to be completed at the time of admission and once between the hours of 7:00 AM and 7 PM and once between the hours of 7:01 PM and 6:59 AM thereafter. Staff E verbalized the facility provided hourly comfort care that was documented on the Patient Hourly Rounding sheets, however these rounding sheets were not part of the patient record and were only audit tools, and as such these were reviewed and then destroyed.

Interview with nursing staff G on 09/07/16 at 12:16 PM verbalized the expectation of staff nurses was that skin was always assessed and documented.

Interview with Medical Staff Member D on 09/07/16 at 2:37 PM revealed Patient #5 was admitted with history of fall and dehydration as well as being on hard floor for unknown amount of time of one to three or four days. The average elderly 80 year old women as a rule has multiple co-morbid diagnoses and some degree of protein malnutrition as a general rule. Patient #5 was at risk at time of hospitalization. It was not unusual in cases similar to this of injuries manifesting days after hospitalization, "these type deep tissue wounds evolve from the inside out often days after the occurrence of the injury." Per the description documented by the wound consult these wounds occurred prior to hospitalization and evolved during the patient's stay. A second interview with Medical Staff D on 09/09/16 at 3:35 PM confirmed, "we could have done better on assessments and documentation, I'll give you that; But these types injuries don't appear for often days after the injury occurred."


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2. Review of Patient #2's electronic medical record revealed the following discrepancies in nursing shift assessments and reassessments. Per the admission assessment completed 09/02/16 at 22:00, Patient #2 had a "skin tear" to his left forearm and scratches to his "bilateral lower extremities." His gait was described as "swaying" and he was admitted for a fall at home.

Shift reassessments on 09/03/16 at 00:00 and 04:00 both noted "Agree with Previous Assessment: Y." The remaining sections of the assessments were blank.

On 09/03/16 at 07:45AM the RN completed a shift assessment and documented she was "unable to assess" Patient #2's gait under the Musculoskeletal section, but she also documented no "gait instability" under the Fall Risk Injury section. Under the same Fall Risk Injury section the RN documented "N" (no) for recent falls, but on a Nurse Note she wrote at 08:09 on 09/03/16 Patient #2 was "admitted after falling at home in the attic."

Under the Integumentary section of the assessment, the RN documented Patient #2's skin was intact, but on a Nurse Note at 09:56AM she documented he had "abrasions on both lower legs."

On 09/03/16 at 11:34AM the RN documented Patient #2's skin was "warm & dry, no redness, discolor or break in integrity" despite the previously noted "abrasions." The RN also documented no recent falls under the Fall Risk Injury section.

Another shift assessment was completed on 09/03/16 at 3:25PM. The RN documented Patient #2 had a skin tear on his left forearm but made no mention of the "abrasions" on his bilateral lower legs. The same RN also documented she was "unable to assess" the patient's gait, but she also documented no "gait instability" under the Fall Risk Injury section.

At 7:40PM on 09/03/16 Patient #2 was transferred from the CCU (critical care unit) to 3 South. The RN started a shift assessment but failed to complete the Fall Injury Risk section. In a Nurse Note she documented Patient #2 had an IV (intravenous device) infusing at 125 cc/hr.

On 09/04/16 at 12:02AM the same RN documented a shift reassessment and failed to complete the Fall Risk Injury section. At 8:19AM a shift assessment was completed with the RN noting Patient #2 had a skin tear on his left forearm and abrasions to his bilateral lower extremities. The RN also documented Patient #2 had a "saline lock", meaning no IV fluids were infusing.

A shift reassessment was documented at 4:08 PM with the RN noting under Integumentary "abrasions" to bilateral lower extremities. There was no documentation regarding the left forearm. The Fall Injury Risk section was also incomplete.

On 09/06/16 at 8:30PM the RN completed a shift assessment and documented a skin tear on left forearm and abrasions on bilateral lower extremities. A shift assessment was then completed on 08/07/16 at 9:15AM and the RN documented Patient #2's skin was "warm & dry, no redness, discolor or break in integrity."

Staff A was made aware of and confirmed these findings on 09/08/16 at 1:10 PM.

3. Review of Patient #4's electronic medical record revealed the following discrepancies in nursing documentation. A history and physical completed by the NP (nurse practitioner) on 08/24/16 noted "wound care for coccyx ulcers present on admission."

Review of the corresponding nursing admission assessment completed on 08/24/16 at 12:15AM noted the following integumentary (skin) concerns:

a. abrasion on right ankles measuring 2 cm by 3 cm
b. redness on bilateral heels
c. red, dry, flaky skin on bilateral lower legs
d. abrasion, excoriated right sacrum
e. scab on right thigh
f. scab on right knee

The wound care nurse then completed an assessment of Patient #4 on 08/24/16 per physician's order. The wound nurse documented Patient #4 had a "right ankle partial-thickness abrasion" and ordered Medihoney to be applied every two days. There was no documented evidence the wound nurse addressed the "coccyx ulcers" identified by the NP or the other skin issues identified by the admitting nurse.

The medical record contained one documented instance where the Medihoney was applied, on 08/26/16 at 6:21PM, but the order was still active as of 09/07/16.

During the most recent skin assessment completed on 09/07/16 at 8:00 AM, the RN documented Patient #4 had "multiple" generalized abrasions and abrasions to his "bilateral heels."

Staff A was made aware of and confirmed these findings on 09/08/16 at 2:20 PM.

4. Patient #6 was admitted to the facility on 09/03/16. Per the history and physical dated 09/03/16, a wound consult was ordered due to "excoriation to the left block with blanching per nursing." The reason for the physician order for wound care consult was noted as "medical excoriation on sacrum."

A shift assessment by the RN on 09/06/16 at 20:30 documented Patient #6 had "excoriation" on his buttocks, "excoriation" on his left buttock, and an "abrasion" on his sacrum.

The medical record lacked evidence a wound consult was completed. Staff A was made aware of and confirmed these findings on 09/08/16 at 2:47 PM. At that time Staff A confirmed Patient #6 was discharged on 09/07/16 without a completed wound consult.

5. Review of Patient #7's electronic medical record revealed a 09/06/16 order to "apply Aquacel silver to the wound on right foot after complete MRI, cover with Meplex. change daily." There was no documented evidence this dressing was applied.

Staff A was made aware of and confirmed this finding on 09/08/16 at 1:10 PM.

Based on medical record review, hospital policy and procedure review and staff interview the facility failed to maintain a current plan of care based on nursing assessment for one patient (#1) of 10 patients reviewed for current plans of care. The facility census was 155.

Findings include:

Review of the hospital's policy and procedure titled Standards of Care with a revision date of 03/2016 directed the standards of practice are congruent with hospital nursing practice and reflect benchmarked and evidence based practice. The Standards of practice reflect nursing care plans and interventions related to disease specific management. The facility's policy and procedure titled Patient and Re-assessment with a most recent revision date of 03/01/16 directed that data was collected and analyzed to assess the needs of the patient and to create the information necessary to develop a plan to meet the patient's care or treatment needs.

Patient #1 was admitted to the facility on 08/31/16 with diagnoses which included myocardial infarction (heart attack) congestive heart failure, and history of an elevated D-Dimer (test for risk of blood clots). Review of the medical record revealed the patient had a physician's order for Fentynl Duragesic patch (change every 72 hours) dated 09/05/16 for pain relief. The medical record documented the patient had complained of right shoulder and left hip pain levels from 5 to 8 on a 10 point scale on 09/04/16 and 09/05/16. Review of the medication administration record revealed the patient was medicated with the Duragesic patch (Fentanyl) on 09/05/16 at 5:34 PM. Review of the nursing documentation dated 09/06/16 at 8:24 AM confirmed the Duragesic pain patch and further documented "continue the current plan of care." Review of the patient's plan of care on the afternoon of 09/06/16 revealed the patient did not have a plan of care for pain.

Interview with Staff V on 09/06/16 at 4:41 PM confirmed the medical record documented the patient experienced pain, was medicated for pain but was unable to provide documentation the patient's plan of care reflected a plan to address the patient's pain.

Based on observations, staff interview, and review of hospital policies and procedures the hospital failed to ensure nursing staff followed facility policy and procedure for two patients (#11 and #12) of seven patients observed for nurses compliance with medication administration and aseptic techniques. The facility census was 155.

Finding include:

1. Observation of medication administration for Patient #12 on 09/07/16 at 8:00 AM revealed Staff X was observed coming from one patient's room and instructed the surveyor to follow into Patient #12's room for medication administration observation. Staff X proceeded to reach into the lower front pocket of her nursing uniform and withdraw a small zippered plastic bag as well as a few loose medications in paper and plastic pouches from her lower front pocket of her nursing uniform. Staff X proceeded to prepare and administer Patient #12's medications. Staff X confirmed the medications were pre-pulled from the hospital's automatic medication dispenser earlier and that this process saved time.

Interview with supervisory nurse Staff W on 09/07/16 at 1:22 PM confirmed the facility has an unwritten policy that nurses are not to put medications into uniform pockets, "that's something nurses learn in nursing school. I spoke with our educators who also verbalized nurses are instructed not to do this."

Review of the hospital policies and procedures titled Aseptic Guidelines with a date of 11/01/13 and Hand Hygiene with a revision date of 12/2014 directed nursing staff as follows, aseptic technique used to reduce the risk of infection and minimize exposure of health care providers to potentially infectious microorganisms. It reduces the number of organisms and prevents their spread. Use aseptic technique for brief invasive procedures that may break the skin or mucous membranes or normally sterile parts of the body. The policy directed staff to use an aseptic technique when procedures involved small key sits, such open wounds, including insertion and puncture sites.

The hand hygiene policy procedure directed staff to wash hands or use an alcohol based hand sanitizer before and after direct patient contact, before invasive procedures, after removing gloves and after contact with objects located in the patient's environment. This policy further directed staff to wear gloves when it is reasonably anticipated that contact with blood or other potentially infectious materials, mucous membranes, and non intact skin will occur. The policy continued to direct staff to wash hands after removing gloves as pathogens can gain access through small defects in gloves or by contamination of hands during glove removal.

2. Observation on 09/07/16 at 9:12 AM revealed Staff Z entered Patient #11's room to obtain a blood glucose level prior to breakfast. Staff Z was observed to gather the glucometer from the nurses' station and approach Patient 11's room. Staff Z dropped a cotton ball off the floor, reached down with bare hands retrieved the item and disposed of it, then proceeded to the patient's bed side. Staff Z proceeded to cleanse Patient #11's third right finger with alcohol, apply the lancet to the finger, Staff Z applied light side pressure to the area of the puncture and proceeded to obtain enough blood for the blood glucose test. Staff Z wiped away the first drop of blood, placed the used cotton ball on the patient's bedside table, proceeded to obtain another drop of blood for the glucometer and obtained the patient's blood glucose level. Staff Z picked up the previously used cotton ball used to wipe away the first drop of blood and applied it to the patient's finger. Staff Z announced to the patient the need for insulin coverage based on the glucometer reading. Staff Z gathered the used cotton ball and glucmeter strip disposed of these items in the sharps container in Patient #11's room and then proceeded out of the room, walked in the hall with the potentially contaminated glucometer and proceeded to enter an empty room two rooms down from the patient's room, gather gloves and to clean the glucometer with an antibacterial disinfectant and store the machine. Staff Z removed her gloves, and proceeded to access the nursing unit's pyxis computer and floor stock medications.

Staff Z gathered a vial of insulin, cleansed the rubber septum and withdrew the correct amount of insulin for Patient #11. At no time during this process was Staff Z observed to perform hand hygiene or glove before or after contact with Patient #11's blood or environment. Staff Z then proceeded to place the floor stock vial of insulin used for all patient's housed on the unit into the front pocket of her nursing uniform and proceed back into the patient's room to administer Patient #11's morning insulin.

Interview with Staff Z on 09/07/16 9:21 AM confirmed this finding. A second interview with supervisory nursing Staff Y on the afternoon of 09/07/16 confirmed she had observed this finding as well.

Based on observation, staff interview, and policy and procedure review, the facility failed to ensure one of one blood transfusions observed was administered in accordance with policy and procedure. This affected Patient #3.The facility census was 155.

Findings include:

Facility Policy No. 400 - Blood Administration was reviewed. Per policy, "prior to administration of blood components, each unit must be checked by: two Registered Nurses or one Registered Nurse and a Physician or one Registered Nurse and a Licensed Practical Nurse."

The policy further specified at bullet point 10 the following must done before administration of a blood component:

10.1 Verification at bedside must occur
10.2 An RN and a second qualified staff member qualified staff member must perform the verification check.
10.3 Second qualified staff member can be :
10.3.1 RN
10.3.2 LPN
10.3.3 Physician
10.4 Physically compare patient name, patient birth-date, and medical record number on Electronic Tag, label on component bag and patient ID band.
10.5 Blood component and unit number must be identical on the Transfusion Identification Tag and blood component label.
10.6 Check unit for color, signs of hemolysis and expiration date.


1. At approximately 12:50 PM on 09/06/16 the process for administration of blood was observed with Staff B as the primary nurse and Staff C as "the second qualified staff member." Patient #3 was ordered to receive two units of packed red blood cells. Staff B and Staff C were preparing to administer the second unit.

There was no observation of Staff B and Staff C completing policy steps 10.1 through 10.6.

Staff W was present during the observation and confirmed policy and procedure was not followed and there was no physical verification of patient name, patient birth-date, and medical record number on Electronic Tag, label on component bag and patient ID band.