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Tag No.: A0068
1. Based on record review and staff interview, it was determined that the Governing Body failed to ensure that the attending physician exercised oversight responsibility to effectively monitor and direct the total care and management of one (1) patient with significant co-morbidities and limited mobility, as evidence by: failure of the attending physician to clinically re-assess and/or ensure that on-going, comprehensive total body system re-assessments, inclusive of the skin/integumentary system, were being performed by the medical team, for the patient at risk for developing pressure ulcers; and failure to provide and/or ensure that early intervention and management of a hospital-acquired deep tissue injury and pressure ulcer were initiated in a timely manner. Patient # N1.
The findings included:
The Bylaws of the Medical and Dental Staff of the hospital, approved and adopted by the Board of Directors on March 10, 2011, included the following declaration statement under Section 1.1, ' The Purposes of the Medical and Dental Staff ' : " 1.1, To make certain that all patients admitted to or treated in any of the facilities, departments, or services of the Hospital receive high quality care in an efficient and effective manner. "
Under the Medical and Dental Staff Rules and Regulations the following directives were stipulated and included under Section 1, ' Admission and Discharge of Patients ' and Section 2, ' Medical Records ' , respectively: Section 1.3, ' Practitioner Responsibilities ' : " A member of the Medical and Dental Staff shall be responsible for the care and treatment of each patient in the hospital. Each practitioner shall be responsible for the accuracy and prompt completion of the patient ' s medical record, for necessary special instructions, and for transmitting report of the condition of the patient to the referring practitioner and to the relatives of the patient " ; Section 2.4, ' Progress Notes ' : " Pertinent timely progress notes shall be recorded sufficient to permit continuity of care. Each of the patient ' s clinical problems and test results should be clearly identified in the progress notes and correlated with specific treatment plans. Progress notes shall be written at least daily. Additional progress notes shall be recorded at the time of the observation sufficient to permit continuity of care. "
Patient # N1 was transferred from an outside acute care hospital on April 15, 2011 after presenting with symptoms of fever, abdominal pain and diarrhea. He/she subsequently developed Atrial Fibrillation with Rapid Ventricular Response (A-fib w/ RVR) complicated by Non-ST Segment Elevation Myocardial Infarction (NSTEMI), and Acute on Chronic Kidney Disease. Prior to this admission, the patient had undergone multiple hospitalizations for the management of recurrent Urosepsis.
The past medical history was extensive for the following significant co-morbidity diagnoses: Hypertension (HTN); Coronary Artery Disease (CAD); Acute Myocardial Infarction (AMI); Stage 4 Chronic Kidney Disease (CKD); Peripheral Vascular Disease (PVD); Type II Diabetes Mellitus; Cerebrovascular Accident (CVA); Parkinson ' s Disease; and Right Foot Gangrene with Left Above the Knee Amputation (AKA).
The transfer admitting diagnoses included the following: Acute Oliguric Renal Failure; Pneumonia; A-fib; status post NSTEMI; and Encephalopathy-Multifactorial.
Review of the nursing admission data base and the admission risk screen assessment, performed and completed on the evening of April 15, 2011, provided documented evidence that Patient # N1 had a Present on Admission (POA) Stage II Sacral Pressure Ulcer between the buttocks.
However, a concurrent review of the physician documentation revealed the following findings:
There was no documented evidence that an admission physical examination and/or inspection of Patient # N1 ' s skin /integumentary system was performed and completed by the physician team responsible for his/her care.
Review of the physician ' s admission History and Physical (H&P), performed on April 15, 2011 at 5:30 PM, and subsequent progress note, dated April 16, 2011 at 9:45 AM, revealed that the medical team of physicians failed to identify and include the patient ' s Stage II Sacral Pressure Ulcer as a POA clinical finding requiring active treatment and intervention.
Specific sections of the admission H&P designated for physician documentation of review of systems ' (ROS) information and assessment findings related to the physical examination of the patient ' s skin were left blank. Further evidence revealed that the anatomical body schematic, used as a visual identification and documentation of abnormal body assessment findings, was also left blank by the physicians.
Additionally, the medical team failed to identify or include the patient ' s POA pressure ulcers and other compromised skin integrity, as secondary diagnoses requiring on-going medical treatment. The diagnoses were not included or recorded on either the H&P or on the admission physician ' s order diagnoses. As a result, the medical team of physicians failed to provide necessary clinical oversight and initiate wound care treatment orders to manage the patient ' s identified pressure wounds.
Continued review of the medical record revealed that the patient developed an extensive area of painful, deep tissue excoriation to his/her buttock, labia and inner thigh areas which began approximately two to three days after admission. Nursing progress note entries documented that the excoriated areas of the patient ' s perineum were exacerbated by frequent episodes of incontinence with urine and stool.
However, review of physician documentation confirmed that seven (7) days after nursing personnel first identified and documented evidence of the patient ' s skin deterioration and pressure wounds: there was still no documented acknowledgment or assessment of skin and wound compromise entered by the physician team. Nor had there been any wound care treatment orders initiated and written by either the attending physician or the team of hospital physicians responsible for Patient # N1 ' s total care.
Furthermore, there was no documented evidence that the attending physician consistently monitored and/or performed comprehensive physical re-assessment exams of Patient # N1, with documented findings and a continued plan of care regimen inclusive of his/her skin/integumentary system.
A face-to-face interview was conducted with the Unit Nursing Director on May 16, 2011 at approximately 10:52 AM. After discussion and review of the medical record, he/she acknowledged and verified the aforementioned findings related to the physician ' s failure to provide appropriate oversight for the management and timely treatment of Patient # N1.
Record review was completed on May 16, 2011.
2. Based on record review and staff interview, it was determined that the Governing Body failed to ensure that the clinical staff consistently and accurately assessed one (1) patient for effective pain management; and intervened timely and appropriately with an effective treatment plan. Patient # N1.
The findings included:
Patient # N1 was transferred from an outside acute care hospital on April 15, 2011 after presenting with symptoms of fever, abdominal pain and diarrhea. He/she subsequently developed Atrial Fibrillation with Rapid Ventricular Response (A-fib w/ RVR) complicated by Non-ST Segment Elevation Myocardial Infarction (NSTEMI), and Acute on Chronic Kidney Disease. Prior to this admission, the patient had undergone multiple hospitalizations for the management of recurrent Urosepsis.
The past medical history was extensive for the following significant co-morbidity diagnoses: Hypertension (HTN); Coronary Artery Disease (CAD); Acute Myocardial Infarction (AMI); Stage 4 Chronic Kidney Disease (CKD); Peripheral Vascular Disease (PVD); Type II Diabetes Mellitus; Cerebrovascular Accident (CVA); Parkinson ' s Disease; and Right Foot Gangrene with Left Above the Knee Amputation (AKA).
The transfer admitting diagnoses included the following: Acute Oliguric Renal Failure; Pneumonia; A-fib; status post NSTEMI; and Encephalopathy-Multifactorial.
Review of the nursing admission data base and the admission risk screen assessment, performed and completed on the evening of April 15, 2011, provided documented evidence that Patient # N1 had a Present on Admission (POA) Stage II Sacral Pressure Ulcer between the buttocks.
Continued review of the medical record revealed that the patient developed an extensive area of painful, deep tissue excoriation to his/her buttock, labia and inner thigh areas which began approximately two to three days after admission. Progress note entries documented that the excoriated areas of the patient ' s perineum were exacerbated by frequent episodes of incontinence with urine and stool; and, was further aggravated by staff ' s continual application of diapers on the patient.
Documentation review of the wound care team progress notes revealed that on May 2, 2011, the patient ' s Stage II sacral pressure ulcer further declined and worsened to a Stage III pressure wound. The wound measurement dimensions were documented as: " 12.0 cm X 13.0 cm X 0 cm " . Documentation was also present to confirm that the deep tissue excoriation in the patient ' s perineal area had also worsened and now encompassed and further exacerbated his/her worsening sacral wound.
Evidence was present in the medical record documentation to indicate that Patient # N1 consistently experienced high levels of pain, as a result of his/her skin and wound condition.
Review of the nursing Adult Ongoing Assessment-Text and the nursing Progress Note-Texts were done for the time period of April 15, 2011 through May 12, 2011 to assess documentation entries related to patient ' s pain levels and staff ' s subsequent management thereof.
Daily documentation was present in the record to confirm that staff was aware that Patient # N1 was experiencing high levels of pain related to the extensive area of deep tissue excoriation surrounding and involving his/her perineum and sacral pressure ulcer. Daily pain score ranges of 8 to 9 on a scale of 10 were frequently documented throughout the adult ongoing assessment text and the progress note texts by nursing personnel. On the 10-scale range: zero (0) represented no pain and ten (10) represented the worst pain ever experienced.
Staff documentation, demonstrating awareness of patient ' s continual pain issues, included the following entries:
April 16, 2011 @08:57AM, Adult Ongoing Assessment-Text, Integumentary Description Assessment: " Full thickness, Tenderness around wound, Tenderness within wound " ; April 17, 2011 @ 09:43AM, Progress Note-Text: " P: 9/10; Oncoming nurse notified of need to medicate prior to cleaning patient " ; April 17, 2011 @ 11:40 AM, Progress Note-Text: " Pain 8/10 buttocks; Patient given PRN IV (give as necessary by intravenous injection) Morphine per order " ; April 19, 2011 @ 07:57AM, Progress Note-Text: " Medicated with Tylenol for moaning and yelling with repositioning " ; April 24, 2011 @ 09:21AM, Progress Note-Text: " Patient uncomfortable during cleaning of sacrum, cries out during cleaning " ; and, April 24, 2011 @ 06:15PM, Progress Note-Text: " Patient complaining generalized pain when turning and cleaning, at rest patient has no complaints pain ".
Concurrent reviews of physician documentation entries revealed that the attending physician and the medical team failed to acknowledge or address the on-going problem of pain experienced by
Patient # N1. Despite documented evidence of persistent pain and high pain scores, the physicians continually failed to implement an effective, on-going treatment plan for pain management.
Further evidence of inadequate and ineffectual pain management for Patient # N1 was corroborated through surveyor observation on May 12, 2011. At approximately 11:25 AM, the surveyor was present during a wound care dressing change for Patient # N1, secondary to bowel incontinence. The patient was observed to have extensive, partial thickness excoriation of the skin encompassing the entire buttock area. The excoriation extended forward to include the patient ' s labia and inner thigh areas. There was also soft tissue swelling involving the patient ' s labia. The entire perineal and buttock areas were reddened and appeared extremely tender to touch. This was evidenced by patient grimacing, squirming and crying out loudly with the removal of old dressing and cleansing. Additionally, old adhesive taping was noted sticking to the exposed areas of the patient ' s raw, excoriated skin.
Immediate inquiry of the registered nurse (RN) performing the dressing change and wound cleaning revealed that Patient # N1 had not been pre-medicated with any pain medication. Further discussion and inquiry with the RN confirmed that the patient had also not been placed on maintenance analgesia for effective pain control.
Subsequently, the RN was requested to temporarily discontinue the dressing change and request an evaluation for medication administration from the physician for the relief of pain and provision of comfort for Patient # N1. The nurse agreed with the surveyor observation. The patient was immediately assessed by the medical resident responsible for his/her care; and an order for pain medication was obtained and provided.
A face-to-face interview was conducted with the Unit Nursing Director on May 12, 2011 at approximately 11:40 AM. After discussion and review of the medical record, he/she acknowledged and verified the aforementioned findings.
Record review was subsequently completed on May 16, 2011.
Tag No.: A0131
Based on record review and staff interview, it was determined that the hospital staff failed to comply with federal and state regulations regarding the patient or the patient representatives ' right to be informed of his/her health status, as evidenced by the following: the hospital failed to give timely notification to the family representative of one (1) patient and inform them of a significant change in the patient ' s clinical status in the development of a complex hospital-acquired deep tissue injury and sacral pressure ulcer. Patient # N1.
The findings included:
Patient # N1 was transferred from an outside acute care hospital on April 15, 2011 after presenting with symptoms of fever, abdominal pain and diarrhea. He/she subsequently developed Atrial Fibrillation with Rapid Ventricular Response (A-fib w/ RVR) complicated by Non-ST Segment Elevation Myocardial Infarction (NSTEMI), and Acute on Chronic Kidney Disease. Prior to this admission, the patient had undergone multiple hospitalizations for the management of recurrent Urosepsis.
The past medical history was extensive for the following significant co-morbidity diagnoses: Hypertension (HTN); Coronary Artery Disease (CAD); Acute Myocardial Infarction (AMI); Stage 4 Chronic Kidney Disease (CKD); Peripheral Vascular Disease (PVD); Type II Diabetes Mellitus; Cerebrovascular Accident (CVA); Parkinson ' s Disease; and Right Foot Gangrene with Left Above the Knee Amputation (AKA).
The transfer admitting diagnoses included the following: Acute Oliguric Renal Failure; Pneumonia; A-fib; status post NSTEMI; and Encephalopathy-Multifactorial.
Review of the nursing admission data base and the admission risk screen assessment, performed and completed on the evening of April 15, 2011, provided documented evidence that Patient # N1 had a Present on Admission (POA) Stage II Sacral Pressure Ulcer between the buttocks.
Continued review of the medical record revealed that the patient developed an extensive area of painful, deep tissue excoriation to his/her buttock, labia and inner thigh areas which began approximately two to three days after admission. Progress note entries documented that the excoriated areas of the patient ' s perineum were exacerbated by frequent episodes of incontinence with urine and stool; and, was further aggravated by staff ' s continual application of diapers on the patient.
According to a telephone interview conducted with the patient ' s family on June 15, 2011 at 2:30 PM, the family was not aware of Patient # N1 ' s initial pressure ulcer nor had they been informed or made aware of the development and progressive worsening of Patient # N1 ' s deep tissue excoriation of the perineum area.
According to the family, even though they had visited daily with the patient during the hospitalization phase, they insisted that no one from the hospital staff had ever informed them that the patient had developed skin and pressure wounds and that the wounds were progressively worsening.
The family ' s awareness of the extent and seriousness of the patient ' s wounds were incidentally discovered during a hospital visit on the evening of May 4, 2011. According to the family, hospital staff was in process of repositioning and performing an incontinence change for the patient, when a family member entered the room and witnessed the patient ' s skin and wound condition.
Subsequent record review and investigative interviews with the hospital staff were conducted to determine the validity of the family ' s allegation related to the failure of hospital staff to inform them of significant changes in the patient ' s health condition.
Review of the medical record, to include the interdisciplinary care conferences, lacked documented evidence that the family was made aware of or counseled concerning the patient ' s declining skin and wound condition, prior to the incidental discovery made on May 4, 2011.
An investigative interview was conducted with a Patient Care Technician (PCT) on May 12, 2011 at approximately 10:35 AM. The PCT was queried concerning his/her contact with Patient # N1 ' s family and his/her knowledge concerning the family ' s awareness of the skin integrity and wound changes in the patient ' s condition.
The PCT stated that from his/her encounters with the family, they seemed unaware of the development and extent of the patient ' s wounds. The PCT cited a specific incident in which the patient ' s relative arrived during the personal care of Patient # N1 and was visibly shaken at the sight of the patient ' s wounds and perineum area.
Other staff interviews corroborated the above testimony, in that no one had direct knowledge if the family was informed or had been made aware of the condition of the patient ' s skin and integumentary system.
The record review was completed on May 16, 2011.
Tag No.: A0395
Based on record review and staff interview, it was determined that the nursing staff failed to effectively monitor and provide consistent, on-going nursing comprehensive assessments to evaluate changes in one (1) patient ' s skin and integumentary system; failed to timely implement the ' Pressure Ulcer Prevention and Treatment Protocol ' ; and, failed to ensure that the subsequent development of a hospital-acquired deep tissue injury and sacral pressure ulcer was effectively communicated to the medical team, in order to initiate timely and appropriate treatment orders to promote effective healing and prevent worsening. Patient # N1.
The findings included:
According to the Division of Nursing Policy # 500.217 entitled ' Wound Care ' , effective date January 2003, the following policy statements and directives were included: " The nurse will perform daily skin assessment of high pressure areas on all inpatients and document on the flow sheet; the nurse will conduct pressure ulcer risk assessment (Braden Scale) upon the patient ' s admission and on a weekly basis (each Wednesday) and document on the flow sheet; when the nurse discovers a wound, the wound will be evaluated according to appearance of the wound base, depth and amount of exudate and documented on the flowsheet; the nurse will complete a written assessment on the nursing flow sheet daily; the nurse will notify the medical staff of the presence of a wound by placing the " Wound Care Notification " sticker in the progress note; the nurse will notify the Wound Care Team ...; the Wound Care Team will evaluate wounds within 48 hours ... " .
In addition, the Department of Nursing Protocol entitled ' Pressure Ulcer Prevention and Treatment Protocol ' , no effective date documented, included the following statement guidelines and directives: " Implement protocol for patients at risk with total Braden Score less than or equal to 18 or any subcategory less than 2 (two). Enter a nursing order stating " Implement Pressure Ulcer Prevention and Treatment Protocol " on the Nursing Kardex and create an individualized plan of care based on patient assessment using protocol interventions below; Measure and document wound dimensions using length X (times) width X depth in centimeters (cm) on admission, transfer, on Wednesday, and at discharge; Hospital acquired pressure ulcers are entered into the Occurrence Reporting System upon initial identification and with advancement in stage. "
Patient # N1 was transferred from an outside acute care hospital on April 15, 2011 after presenting with symptoms of fever, abdominal pain and diarrhea. He/she subsequently developed Atrial Fibrillation with Rapid Ventricular Response (A-fib w/ RVR) complicated by Non-ST Segment Elevation Myocardial Infarction (NSTEMI), and Acute on Chronic Kidney Disease. Prior to this admission, the patient had undergone multiple hospitalizations for the management of recurrent Urosepsis.
The past medical history was extensive for the following significant co-morbidity diagnoses: Hypertension (HTN); Coronary Artery Disease (CAD); Acute Myocardial Infarction (AMI); Stage 4 Chronic Kidney Disease (CKD); Peripheral Vascular Disease (PVD); Type II Diabetes Mellitus; Cerebrovascular Accident (CVA); Parkinson ' s Disease; and Right Foot Gangrene with Left Above the Knee Amputation (AKA).
The transfer admitting diagnoses included the following: Acute Oliguric Renal Failure; Pneumonia; A-fib; status post NSTEMI; and Encephalopathy-Multifactorial.
Review of the nursing admission data base and the admission risk screen assessment, performed and completed on the evening of April 15, 2011, provided documented evidence that Patient # N1 had a Present on Admission (POA) Stage II Sacral Pressure Ulcer between the buttocks.
However, the record review revealed that the nursing staff failed to document, with the required specificity, initial comprehensive wound assessment findings, to include accurate and detailed descriptions of the POA Stage II sacral pressure wound, with the initial wound measurements and dimensions; and, failed to document and include all compromised skin integrity findings that were present at the time of admission, to include Patient # N1 ' s right foot gangrene, later described as " bogginess " .
Furthermore, there was documented evidence of inaccurate and inconsistent scoring on the admission ' s Braden scale (12 and 15, respectively) performed on April 15, 2011. This was an assessment tool utilized to predict the patient ' s risk for the development of pressure ulcers.
The patient ' s significant medical history and presenting clinical condition placed him/her at high risk for the development and progression of worsening pressure ulcers and skin compromise. In addition, the record review revealed that Patient # N1 had experienced several episodes of loose stools and diarrhea prior to and continuing after his/her hospital transfer. The patient had been empirically treated for Clostridium Difficile (C-diff). These significant risk factors were not accurately captured in the Braden scoring.
According to the current wound care policy, an accurately scored Braden scale, in conjunction with identified high-risk assessment findings, should have prompted the nursing staff to request an immediate evaluation of the patient by the Wound Care Team; and, discussion with the medical team to obtain a written order and prescribed treatment plan for the management of the patient ' s wound and skin issues.
Subsequent documentation was present which verified that the wound care team was not consulted for wound assessment and wound treatment recommendations until April 22, 2011, seven (7) days after the patient was admitted with an identified pressure ulcer. Record review confirmed that the April 22, 2011 date was the first documented order by the health care team requesting evaluation by the wound department.
Review of the nursing documentation entries also lacked evidence that the staff completed the required MD/LIP Notification sticker and placed it in the physician orders section of the medical record for physician notification and signature. Placement of the MD/LIP notification sticker was an administrative policy requirement for all patients with identified present on admission pressure ulcers and skin integrity issues.
Additional review of the ' Adult Ongoing Assessment-Text ' provided documented evidence that the nursing staff failed to adhere to the hospital ' s standard of practice related to the management and prevention of pressure ulcers. This was evidenced by a failure of the staff to consistently perform and document daily skin and wound assessment findings, with measurements (when required) for Patient # N1.
Continued review of the medical record revealed that the patient developed an extensive area of painful, deep tissue excoriation to his/her buttock, labia and inner thigh areas which began approximately two to three days after admission. Progress note entries documented that the excoriated areas of the patient ' s perineum were exacerbated by frequent episodes of incontinence with urine and stool; and, was further aggravated by staff ' s continual application of diapers on the patient.
Documentation by the wound care team provided the corroborating evidence that episodes of repeated diaper application contributed to the development of the patient ' s " incontinence-associated dermatitis and perineal excoriation " .
Documentation review also revealed that the nursing staff failed to timely notify the physician team when Patient # N1 ' s pressure wound and skin integrity began to deteriorate and became further compromised. Furthermore, there was no documented evidence that the nursing staff requested specific wound care treatment orders from the physicians to manage the compromised changes and decline in the patient ' s integumentary system.
There was, however, evidence present in the medical record which demonstrated that the nursing staff continually treated Patient # N1 ' s worsening wound and skin condition, for one (1) week without obtaining a physician ' s order or collaborating with the medical team concerning an appropriate and approved treatment plan.
A face-to-face interview was conducted with the Clinical Care Facilitator (CCF) on May 16, 2011 at approximately 11:15 AM. After discussion and review of the medical record, the CCF verified the aforementioned findings.
The record review was completed on May 16, 2011.