Bringing transparency to federal inspections
Tag No.: A0449
Based on review of 42 CFR (Code of Federal Regulations) 412.25, Medicare Benefit Policy - Chapter 2 - Inpatient Psychiatric Hospital (IPF) Services, Medicare General Information - Eligibility and Entitlement Chapter 4, Medical Staff Bylaws, Policies, and Rules and Regulations and medical records and interview with facility staff, it was determined the facility failed ensure patients admitted to the Prospective Payment System (PPS) Psychiatric unit were certified and recertified for admission regardless of the patient's payor source. This affected 4 of 4 records reviewed of patients admitted to the PPS Psychiatric unit, including Patient Identifier (PI) #s 34, 38, 39 and 40 and had the potential to affect all patients admitted to the PPS Psychiatric unit.
Findings include:
1. 42 CFR 412.25 Excluded hospital units: Common requirements.
(a) Basis for exclusion. In order to be excluded from the prospective payment systems as specified in 412.1(a)(1) and be paid under the inpatient psychiatric facility prospective payment system as specified in 412.1(a)(2) or the inpatient rehabilitation facility prospective payment system as specified in 412.1(a)(3), a psychiatric or rehabilitation unit must meet the following requirements.
(1) Be part of an institution that: (i) Has in effect an agreement under part 489 of this chapter to participate as a hospital;
(ii) Is not excluded in its entirety from the prospective payment systems; and (iii) Has enough beds that are not excluded from the prospective payment systems to permit the provision of adequate cost information, as required by 413.24(c) of this chapter.
(2) Have written admission criteria that are applied uniformly to both Medicare and non-Medicare patients.
2. Medicare Benefit Policy - Chapter 2
20 - Admission Requirements
For all IPFs, according to 42 CFR (Code of Federal Regulations) 412.27 (a) and 42 CFR 482.61, distinct part psychiatric units of acute care hospitals and CAHs (Critical Access Hospitals) are required to admit only those patients whose admission to the unit is required for active treatment, of an intensity that can be provided appropriately only in an inpatient hospital setting, of a psychiatric principal diagnosis that is listed in the Fourth Edition, Text Revision of the American Psychiatric Association's Diagnostic and Statistical Manual, or in Chapter Five of the International Classification of Diseases, applicable to the service date. Psychiatric hospitals are required to be primarily engaged in providing, by or under the supervision of a psychiatrist, psychiatric services for the diagnosis and treatment of mentally ill persons, according to 42 CFR 412.23(a)...
... 30.2.1- Certification and Recertification Requirements
30.2.1.1 - Certification
The certification that a physician must provide with respect to IPF services is required to include a statement that the services furnished can reasonably be expected to improve the patient's condition or for diagnostic study. The certification is required at the time of admission or as soon thereafter that is reasonable and practical...
30.2.1.2 - Recertification
If the patient continues to require active inpatient psychiatric treatment, then a physician must recertify as of the 12th day of hospitalization (with subsequent recertifications required at intervals established by the IPF's Utilization Review committee on a case-by-case basis, but no less than every 30 days) that the services were and continue to be required for treatment that could reasonably be expected to improve the patient's condition, or for diagnostic study, and that the patient continues to need, on a daily basis, active treatment furnished directly by or requiring the supervision of inpatient psychiatric facility personnel. In addition, the hospital records should show that services furnished were intensive treatment services, admission or related services, or equivalent services...
3. Medicare General Information - Eligibility and Entitlement Chapter 4
10.9 - Inpatient Psychiatric Facility Services Certification and Recertification
The requirements for physician certification and recertification for inpatient psychiatric facility services are similar to the requirements for certification and recertification for inpatient hospital services. However, there is an additional certification requirement. In accordance with 42 CFR 424.14, all IPFs (distinct part units of acute care hospitals, CAHs, and psychiatric hospitals) are required to meet the following certification and recertification requirements.
At the time of admission or as soon thereafter as is reasonable and practicable, a physician (the admitting physician or a medical staff member with knowledge of the case) must certify the medical necessity for inpatient psychiatric hospital services. The first recertification is required as of the 12th day of hospitalization. Subsequent recertifications will be required at intervals established by the hospital's utilization review committee (on a case-by-case basis), but no less frequently than every 30 days.
There is also a difference in the content of the certification and recertification statements. The required physician's statement should certify that the inpatient psychiatric facility admission was medically necessary for either (1) treatment which could reasonably be expected to improve the patient's condition, or (2) diagnostic study.
The physician's recertification should state:
1. That inpatient psychiatric hospital services furnished since the previous certification or recertification were, and continue to be, medically necessary for either:
a. Treatment which could reasonably be expected to improve the patient's condition;
b. Diagnostic study;
2. The hospital records indicated that the services furnished were either intensive treatment services, admission and related services necessary for diagnostic study, or equivalent services, and
3. Effective July 1, 2006, physicians will also be required to include a statement recertifying that the patient continues to need, on a daily basis, active treatment furnished directly by or requiring the supervision of inpatient psychiatric facility personnel.
For convenience, the period covered by the physician's certification and recertification is referred to a period during which the patient was receiving active treatment. If the patient remains in the hospital but the period of "active treatment" ends (e.g. because the treatment cannot reasonably be expected to improve the patient's condition, or because intensive treatment services are not being furnished), program payment can no longer be made even though the patient had not exhausted his/her benefits. Where the period of "active treatment" ends, the physician is to indicated the ending date in making his recertification. If "active treatment" thereafter resumes, the physician should indicate, in making his recertification, the date on which it resumed...
4. Medical Staff Bylaws, Policies, and Rules and Regulations
Adopted by: The Medical Executive Committee, February 13, 2015
Approved by: The Board, March 9, 2015
Article III
Medical Records
3.3 Content of Record:
(a) Medical records will contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient's progress and response to medication and services...
Medical Record Reviews:
1. Patient Identifier (PI) # 34 was admitted to the facility on 3/30/15 with diagnosis of Dementia with Dyscontrol. Review of the medical record revealed the document entitled, "Physician Certification & Re-Certification". There was no documentation this document was signed and/or dated by the physician to certify that the patient inpatient psychiatric facility admission was medically necessary.
2. PI # 38 was admitted to the facility on 3/31/15 with diagnosis of Suicidal Ideation. Review of PI # 38's medical record revealed no documentation of an initial certification and recertification.
An interview was conducted on 4/22/15 at 10:20 AM with Employee Identifier (EI) # 17, Clinical Nurse Manager of the PPS Psychiatric Unit, who verified there was no documentation of a certification and/or recertification for PI # 38.
3. PI # 39 was admitted to the facility on 3/19/15 with diagnosis of Dementia with Behavioral Disturbances. Review of PI # 39's medical record revealed no documentation of an initial certification and recertification.
An interview was conducted on 4/22/15 at 10:21 AM with EI # 5, Executive Director of Nurses, who verified there was no documentation of a certification and/or recertification for PI # 39.
4. PI # 40 was admitted to the facility on 4/7/15 with diagnosis of Dementia with Behavioral Disturbances. Review of PI # 40's medical record revealed no documentation of an initial certification and recertification.
An interview was conducted on 4/22/15 at 11:01 AM with EI # 18, Case Manager, who stated the only patients that are certified are "Traditional Medicare patients".
Tag No.: A0467
Based on record review and interview it was determined the facility failed to ensure the nurses:
1. Assessed wounds to include measurements on admission and weekly.
2. Followed physician orders for dressing changes.
3. Documented complete entries for care provided.
This affected 4 of 4 patients reviewed with decubitus ulcers, including PI (Patient Identifier) # 6, # 7, # 44, and # 46, and had the potential to negatively affect all patients receiving care for decubitus ulcers.
Findings include:
1. PI # 6 was admitted to the facility on 4/8/15.
During the medical record review on 4/22/15, with Employee Identifier (EI) # 11, Registered Nurse, Quality Management, the following physician orders for wound care were documented:
4/8/15 at 4:42 PM: "Daily - cleanse wound to lower gluteal cleft area with sns (sterile normal saline), 4x4, cover with Viscopaste daily / prn (as needed) if soiled." The order was canceled 4/10/15 at 6:36 AM.
4/8/15 4:42 PM: "Cover area on sacral with double strip of Viscopaste and cover with dry gauze - do each shift and as needed." This order was discontinued 4/10/15 at 6:36 AM.
Review of nursing notes dated 4/8/15 through 4/10/15 revealed no wound care for the sacral/gluteal area was documented.
The above findings were verified on 4/22/15 with Employee Identifier (EI) # 11, during the medical record review.
2. PI # 7 was admitted to the facility on 4/17/15.
During the medical record review 4/21/15, with EI # 6, Manager, Neurological Intensive Care Unit, Physician orders for wound care were documented:
4/18/15 9:21 AM: "Clean and dress wound with Santyl and Silver alginate with bordered foam to wound daily." No site was documented.
4/20/15 10:45 AM: "Sacrum: Cleanse with saline. Dry. No sting skin prep to surrounding skin. Apply Aquacel AG to wound bed. Cover with large Biatain foam island dressing. Perform daily and prn."
Review of the nursing notes dated 4/18/15 through 4/20/15 revealed no wound care documented on 4/18/15. Wound care was performed as ordered on 4/19/15. On nursing note dated 4/20/15 7:30 PM, the following documentation was found: "Wound care done to sacral wound..." There was no documentation for specific wound care performed.
The above findings were verified on 4/21/15 with EI # 6, Manager of Neurological Intensive Care Unit (NICU) during the record review.
3. PI # 44 was admitted to the facility on 4/2/15.
A medical record review was conducted 4/22/15 with EI # 11, with the following findings verified:
4/2/15, physician's order: "Daily and prn, cleanse right hip and sacrum with saline, apply skin prep around the wound, apply 1/4 strength Dakin's moistened 4x4, cover with Biotain foam island dressing."
Review of the nursing notes dated 4/3/15 through 4/21/15 revealed no specific wound care documented:
4/3/15: "Wound care completed to hip and buttocks."
4/5/15: "Wound care to sacral area performed using established protocol - Dakin's wet to dry - Biotain dressing applied to sacral area." No documentation was found that wound care was performed to the right hip.
4/7/15: "Wound care and dressing change to sacrum and right hip as ordered. Pt (patient) tolerated well."
4/8/15: "Wound care and dressing change to sacrum and right hip as ordered. Pt (patient) tolerated well."
4/9/15: "Wound care giving as ordered, position for comfort, pt tolerated well."
4/10/15: "Wound care performed by student nurse and instructor as ordered. Pt tol (tolerated) well."
4/11/15: "Wound care to sacrum performed, patient tolerated well. Will continue to monitor."
4/13/15: "Wound care performed on patients rt (right) hip and sacral. Patient tolerated well and no distress noted."
4/14/15: "Changes dressing on right hip and sacrum per doctors orders pt tolerated well will continue to monitor."
4/15/15: Pt lying on left side respiration even non labor changes dressing on right hip and sacrum per doctors orders will continue to monitor."
4/18/15: "Wound care completed."
4/20/15: "Changes dressing on right hip and sacrum per doctors orders pt tolerated well will continue to monitor."
4/21/15: Changes dressing on right hip and saccum (sacrum) per doctors orders will continue to monitor."
On the following dates, no wound care was documented in the nurses notes: 4/4/15, 4/6/15, 4/12/15, 4/16/15, 4/17/15, and 4/19/15.
The above findings were verified during the record review on 4/22/15 with EI # 11.
4. PI # 46 was admitted to the facility on 3/31/15 with diagnoses including a history of Sacral Decubitus Ulcers.
A medical record review was conducted 4/22/15 with EI # 11, and the following physician's orders were documented:
4/1/15 12:14 PM: "Every 12 hours. Clean wound with saline. Pack loosely with 1/4 strength Dakins (moistened gauze/Kerlix), cover with 4x4 gauze, ABD (abdominal) pad, secure with roll gauze, paper tape. Wound dressing change 2 x daily / prn. Wound locations: Sacral wound. This order was canceled 4/14/15 at 10:20 AM.
4/14/15 10:20 AM: " Interval: Every 12 hours. Cleanse wound with saline, pack loosely with 1/4 strength Dakins (moistened gauze/Kerlex), cover with 4x4 gauze, ABD pad, secure with roll gauze, paper tape, wound dressing change: 2 x daily / prn. Wound locations: sacral wound, and bilateral ischial wounds.
4/14/15 10:22 AM: "Please note changes to wound care protocol, new small wounds to bilateral ischial areas also.
Review of the nursing notes dated 4/2/15 through 4/22/15 revealed:
4/2/15 9:19 PM: "Cleaned patient's wound and changed dressing at 2100 (9:00 PM)."
4/3/15 4:28 AM: "Cleaned, redressed wound and changed colostomy bag at 0425 (4:25 AM)."
4/3/15 9:03 PM: "Wound care performed as ordered."
4/5/15 5:00 AM: "Dressing to lumbar area removed. Moderate amount of yellowish tan drainage noted. Dakens (Dakins) soaked kerlex (Kerlix) applied to wound bed. Area covered with 4x4 gauze, the ABD pad. Dressing secured with paper tape..."
4/6/15 5:00 AM: "Dressing to lumbar area removed. Moderate amount of yellowish tan drainage noted on dressing. Wound packed with Dakins soaked Kerlix, then covered with 4x4 gauze, the ABD pad. Dressing secured with paper tape..."
4/6/15 2:36 PM: "Late entry 1213 wet to dry Dakins dressing change done. Bone exposed. Site has odor present..."
4/7/15 2:33 PM: "...wocn (Wound, Ostomy and Continence Nurse) redressed wound with Dakins moist gauze dressing, 4x4, abd, tape..."
4/8/15 7:24 AM: "Dressing change done this morning to patients lower back and sacrum per orders..."
4/8/15 11:32 AM: "Dressing change to sacrum completed per orders."
4/8/15 5:13 PM: "Wound care performed per orders..."
4/9/15 3:00 AM: "Dressing change just completed to patient lower back/sacral area..."
4/9/15 7:09 PM: "Wound care performed as ordered."
On 4/10/15 the patient underwent wound debridement.
On 4/11/15 12:25 PM a physician's order was found documenting: "Hold dressing changes until Dr. Profit reorders."
4/11/15 4:50 PM nursing note: "Dressing change to buttocks and ischial area due to contamination with stool. Dressing change per last order. Check with MD (physician) in AM. If ordered needs changing. Current Dankin's (Dakin's) solution 4x4 abd..."
4/12/15 3:32 AM: "Change dressing as per order..."
4/12/15 12:55 PM: "Wet to dry Dakins dressing change done to lower back wound..."
4/12/15 6:02 PM: "...Wound care done as ordered."
4/13/15 7:27 PM: "Dressing change to sacrum and ostomy bag / care."
4/13/15 8:10 PM: "Late entry - 1800 (6:00 PM) ... Dressing change done to back and buttocks at 1500 hrs (3:00 PM) today..."
4/14/15 5:07 AM: "Sacral / back and right upper leg dressing changed..."
4/14/15 9:48 AM: "...wocn performed wound care to left ischial with moist Dakins gauze dressing, 4x4, paper tape; sacral wound...was cleaned with SNS (sterile normal saline), 4x4, redressed with Dakins moist gauze dressing, 4x4, ABD / tape..."
4/17/15 2:04 PM: "...wocn performed wound care to bilateral ischial wounds and sacral wound with Dakins moist gauze dressing, 4x4, abd / tape...Sacral...wound packed at 3, 6, and 9 o'clock areas with moist gauze into pockets, then entire wound covered with moist Dakins gauze, covered with 4x4, abd, tape..."
4/17/15 2:30 PM: "Dressing change done per wound care nurse."
4/18/15 5:27 PM: "Dressing change done per orders..."
4/20/15 4:08 PM: "Dressing change per orders..."
4/21/15 11:01 AM: "...wocn changed out dressings this am, right ischial wound no change...left ischial wound...sacral wound was cleaned and redressed with moist Dakins gauze dressing, 4x4, abd pad..."
4/22/15 3:37 AM: "Just completed sacral dressing change..."
4/22/15 9:33 AM: "...Wound care performed per orders..."
During the record review on 4/22/15, EI # 11 verified that dressing changes were not completed as ordered, were not documented completely, and wound care was performed from 4/11/15 through 4/14/15 (5:07 AM) with no orders in the record.
Tag No.: A0700
Based on observations during facility tour with hospital staff by the Fire Safety Compliance Officer and staff interviews, it was determined that the facility was not constructed, arranged and maintained to ensure patient safety.
Findings Include:
Refer to Life Safety Code citations.
Tag No.: A0724
Based on review of the Cold Pack Unit Monitor logs and the Hydrocollator Monitor logs it was determined the facility failed to follow the directions on the individual logs which require staff to record daily temperatures.
This had the potential to negatively affect all patients served by the Rehabilitation Unit.
Findings include
A tour was conducted on 4/21/15 at 2:00 PM of the Rehabilitation Unit specifically the exercise area with Employee Identifier (EI) # 13 Physical Therapist, Manager. During the tour the surveyor was taken to an area where the cold pack unit and the hydrocollator unit were stored for use.
Review of the 2015 Daily Cold Pack Unit Monitor Log and the Daily Hydrocollator Monitor Log revealed no documentation of daily temperatures on either log from January 1, 2015 to January 12, 2015.
Review of the 2015 logs revealed no documentation of daily temperatures on the Daily Cold Pack Unit Monitor Log for the dates of 3/12/15, 3/23/15, 3/31/15, and 4/19/15 and no documentation of daily temperatures on the Daily Hydrocollator Monitor Log for the dates of 2/20/15, 3/12/15, 3/23/15 and 4/19/15.
An interview was conducted on 4/21/15 at 2:30 PM with EI # 13 who confirmed the above mentioned findings and stated the temperatures are to be recorded daily.
Tag No.: A0748
Based on review of facility policies and observations it was determined the facility failed to follow their policy for Point of Care Glucose Testing, Urinary Catheter Care and Hand Hygiene. This deficient practice affected Patient Identifier (PI) # 59, 60, 61, # 37 and had the potential to negatively affect all patients requiring urinary catheters and point of care testing for blood glucose.
Findings include
Policy: Point-of-Care Blood Glucose Testing
Policy Review Date: 5/21/13
Purpose:
To establish a process for point-of-care blood glucose testing.
Policy:
As ordered by the physician point-of-care blood glucose testing is preformed at the bedside. Frequency should be indicated by a physician's order...
Procedure:
4. Clean exterior of the glucometer with approved disinfecting agent.
Policy:
General Departmental Infection Control Policy
Policy Review Date: 11/11/13
Purpose:
To provide guidelines for all departments and employees for the prevention and control of infections
1. Overall Policy
A. Purpose: To provide guidelines for all departments and employees for the prevention and control of infection
B. Role
1. Employees shall adhere to general and department specific infection control policies.
C. Important Points
1. The most important infection control practice is hand hygiene.
II. Hand Hygiene
Hand washing is the most effective technique for preventing the spread of infection. Employees, physicians, and volunteers should follow established policies for hand-hygiene.
A. Infirmary Health system follows the Center for Disease Control (CDC) handwashing guidelines and recommendations including:
1. Indications for hand washing and hand antisepsis:
b. If hands are not visibly soiled, use an alcohol based hand rub for routine decontamination of hands...
c. Decontaminate hands before having direct contact with patients.
g. Decontaminate hands if moving from a contaminated body site to a clean body site during patient care.
h. Decontaminate hands after contact with inanimate objects, (including medical equipment), in the immediate vicinity of the patient.
i. Decontaminate hands after removing gloves.
Facility Policy: Urinary Catheter Care
Approval date: 12/23/2014
Purpose:
To establish guidelines for care of urinary catheters to prevent or reduce catheter urinary tract infection.
Policy:
Urinary catheter care should be provided each shift, after bowel movement, and as indicated by patient condition by the RN/LPN (Registered Nurse/Licensed Practical Nurse) and Nursing Assistant.
Procedure:
... 5. Female Patient:
... b. Urinary Catheter Care:
... 2. RN/LPN:a. Stabilize urinary catheter with gloved hand just below meatus. Using fresh chlorhexidine wipe, cleanse external surface of catheter using a downward motion (patient to tubing).
b. Use another chlorhexidine wipe for the tubing and entire bag...
6. Male Patient:
... b. Urinary Catheter Care:
... 2. RN/LPN:
a. Stabilize urinary catheter with gloved hand just below meatus. Using fresh chlorhexidine wipe, cleanse external surface of catheter using a downward motion (patient to tubing)...
On 4/21/15 at 9:30 AM, the surveyor observed Employee Identifier (EI) # 12, Registered Nurse (RN) perform catheter care for Patient Identifier (PI) # 59. During the catheter care, EI # 12 used Chlorhexidine 2% wipes to clean the catheter using a down and back motion from the meatus to the end of the catheter.
EI # 12 failed to follow the facility's policy by using a down and back motion, instead of downward motion from patient to tubing.
On 4/21/15 at 11:15 AM, the surveyor observed EI # 15, Psychiatric Aide perform blood glucose point of care testing for PI # 60 with gloved hands. Once testing was completed, EI # 15 took the blood glucose machine to begin testing for PI # 61. EI # 15 failed to clean the machine, remove gloves or perform hand hygiene. EI # 15 was unable to test PI # 61's blood glucose at that time due to unable to scan the patient's arm band. EI # 15 placed the blood glucose machine on the charger at the nurse's station and removed gloves. EI # 15 failed to perform hand hygiene after gloves were removed. EI # 15 obtained a new arm band for PI # 61. EI # 15 obtained the blood glucose testing machine and clean gloves. EI # 15 donned gloves, tested PI # 61's blood glucose. EI # 15 removed gloves and returned the blood glucose machine to the charger at the nurse's station. EI # 15 failed to perform hand hygiene or sanitize the blood glucose machine after use.
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During a tour of the Post Surgical Intensive Care Unit on 4/21/15 at 2:30 PM. EI # 8 performed Foley catheter care for PI # 37. EI # 8 stabilized the urinary catheter of the female patient at the Labia Majora. A Chlorhexidine wipe was obtained and used to cleanse the Foley catheter from the Labia Majora down to the connection to the urinary catheter drainage bag tubing and back up toward the Labia Majora. The facility policy was not followed by EI # 8 for providing Foley catheter care to a female patient.
An interview was conducted 4/21/15 at 3:00 PM with EI # 9, Manager of Post Surgical Intensive Care Unit, who verified the Foley catheter care was not per facility policy.
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On 4/21/15 at 11:30 AM the surveyor observed EI # 14, Certified Nursing Assistant (CNA) on the 3 West area perform Point of Care Blood Glucose Testing for an unsampled patient. The CNA sanitized hands and donned clean gloves prior to the scanning of the patient's bracelet and obtaining a blood sample for the glucometer strip. After the glucose testing was completed, the CNA removed gloves and donned a clean pair of gloves without performing hand hygiene prior to donning the clean gloves.
An interview conducted on 4/21/15 at 11:45 AM with EI # 16, 3 West Nurse Manager, confirmed the above findings.
Tag No.: A0955
Based on review of medical records (MR) facility policies and staff interviews, it was determined the hospital failed to document a properly executed informed consent form in the MR prior to surgery or invasive procedures. This affected 8 of 51 medical patient records reviewed, including Patient Identifier (PI) # 6, 11, 12, 13, 37, 36, 27 and 25 and had the potential to negatively affect all patients receiving surgical or Peripherally Inserted Central Catheter (PICC) procedures in this facility.
Findings include:
Policy: Informed Consent
Approval date: 9/16/2013
Absent emergency or extraordinary circumstances, no medical or surgical procedures will be performed upon a patient unless the patient has had the opportunity to confer with a physician and the patient has given his or her informed consent for and surgical procedures and for any and all surgical procedures where necessary.
...
Alabama law specifics that the physician has the duty to obtain and document the patient's informed consent...Any patient has the right to consent, refuse or withhold consent. The informed consent of every competent adult patient should be obtained and documented by the physician prior to the procedure.
... Informed consent documentation will be required, absent emergency or extraordinary circumstances for all surgical and invasive treatments and/or procedures and all procedures involving anesthesia or IV (intravenous)moderate sedation. Invasive treatments and/or procedures involving puncture, incision of the skin, insertion of an instrument or foreign material into the body that requires the expertise of a physician credentialed and privileged through the medical staff process.
A physician may use a procedure specific informed consent form or a generic informed consent form tailored to the patient's specific care, treatment or services for their patient to sign which becomes part of the medical record. A member of the hospital staff may witness a patient's, the legal representative's or next of kin's signature but it is the physician's responsibility to inform, obtain and document the informed consent".
Universal Protocol Policy
Appendix A
" Universal Protocol is required for operative and invasive procedures that expose patients to more than minimal risk...
High-risk invasive procedure is any procedure that is known to expose a patient to the risk of serious harm or permanent loss of function or injury. Generally, this includes procedures requiring consent by the patient.
List of Invasive, High-Risk or Non-Surgical Procedures
Any procedure involving skin incision
Any procedures including general or regional anesthesia, monitored anesthesia care, or conscious sedation
Injections of any substances into a joint space or body cavity
Percutaneous aspiration of body fluids or air through the skin (e.g. , arthrocentesis, bone marrow aspiration, lumbar puncture, paracentesis, thoracentesis, suprapubic catheterization, chest tube)
Biopsy (e.g., bone marrow, breast, liver, muscle, kidney, genitourinary, prostate, bladder, skin)
Cardiac procedures (e.g., cardiac catheterization, cardiac pacemaker implantation, angioplasty, stent-implantation, intra-aortic balloon catheter insertion, elective cardioversion)
Endoscopy (e.g., colonoscopy, bronchoscopy, esophagogastric Endoscopy, Cystoscopy, percutaneous endoscopic Gastrostomy, J-tube placement, nephrology tube placements)
Invasive radiological procedures (e.g., hagiography, angioplasty, percutaneous biopsy)
Dermatology procedures (biopsy, excision and deep cryotherapy for malignant lesions-excluding cryotherapy for benign lesions)
Invasive Opthalmic procedures including miscellaneous procedures involving implants
Oral procedures including tooth extraction gingival biopsy
Podiatric invasive procedures (e.g., removal of ingrown toenail)
Skin or wound debridement
Electroconvulsive therapy
Radiation oncology procedures
Central line placements or PICC (Peripherial Inserted Central Catheter)
Kidney stone lithotripsy
Colposcopy and/or endometrial biopsy..."
1. PI # 6 was admitted to the facility on 4/16/15 with diagnoses including status post Rupture of Transverse Colon.
Review of the MR on 4/21/15 revealed the patient was admitted to receive an open colostomy reversal surgical procedure. Further review of the MR revealed no documentation of a signed consent form for the aforementioned surgical procedure.
During the chart review on 4/21/15 Employee Identifier (EI) #
2, Chief Nursing Officer, stated only certain procedures require a written informed consent at this facility, including bronchoscopy, cardiac catheterization, gastrointestinal procedures, and circumcision.
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2. PI # 11 was admitted to the facility on 4/18/15 with diagnoses including Altered Mental Status, Fever, History of Diabetes Mellitus (DM) and Peripherial Vascular Disease (PVD) with Right Below the Knee Amputation (BKA).
Review of the MR revealed the patient had an Incision and Drainage (I&D) on 4/20/15 of an abscess to the right flank area. There was no signed consent form for the procedure in the MR.
A tour of the Neuro Intensive Care Unit (NICU) was conducted on 4/21/15. An observation of a Peripherally Inserted Central Catheter (PICC) procedure was conducted. Review of PI # 11's MR revealed no documentation of a signed consent for the PICC to be inserted.
An interview was conducted on 4/21/15 at 10:25 AM with EI # 6, Registered Nurse Manager of NICU, EI # 7, Registered Nurse Team Leader of NICU and EI # 3, Registered Nurse, Executive Director of Nursing, stated the aforementioned procedures did not require a signed consent form.
3. PI # 12 was admitted to the facility on 4/15/15 with diagnoses including
Altered Mental Status and Thrombocytopenia.
Review of the MR revealed the patient had a PICC inserted on 4/15/15. Further review of the MR revealed there was no documentation of a signed consent for the invasive procedure to be performed.
An interview was conducted on 4/22/15 at 9:25 AM with EI # 3, stated this invasive procedure did not require a signed consent form.
4. PI # 13 was admitted to the facility on 4/15/15 with diagnoses including a Right Hip Fracture requiring surgery to the right hip. Review of the MR revealed no documentation of a signed consent form for the surgical procedure or for the administration of anesthesia.
An interview was conducted on 4/22/15 at 1:25 PM with EI # 10, RN, Manager of Medical Intensive Care Unit and EI # 3, who stated this invasive procedure did not require a signed consent form.
5. PI #37 was admitted to the facility on 4/1/15 with diagnoses including Abdominal Pain and Acute Cholecystitis.
Review of the MR revealed the patient had an open Cholecysectomy. Further review of the MR revealed no documentation of written consent form for the surgical procedure or for the administration of anesthesia.
An interview was conducted on 4/21/15 at 2:30 PM with EI # 9, RN, Manager of Post Surgical Intensive Care Unit (SICU), and EI # 3, who stated no surgical consent or anesthesia consent was needed for this surgical procedure.
6. PI #36 was admitted to the facility on 4/1/15 with diagnoses including Cancer of the Liver.
Review of the MR revealed during the hospital stay the patient had a liver resection. Further review of the MR revealed no documentation of written consent form for the surgical procedure or for the administration of anesthesia.
An interview was conducted on 4/21/15 at 2:30 PM with EI # 9, RN, Manager of Post SICU, and EI # 3, who stated no surgical consent or anesthesia consent was needed for this surgical procedure.
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7. PI # 25 was admitted to the facility on 4/21/2015 for medical and surgical health screening due to history of Gastroesophageal Reflux Disease.
Review of the medical record on 4/20/15 revealed the patient was scheduled for Colonoscopy. Further review of the MR revealed no documentation informed consent for the above mention surgical procedure was obtained with patient's signature and appropriately witnessed.
An interview was conducted on 4/22/15 at 2:30 PM with EI # 19, System Vice President, Surgical Services and EI # 20, Quality Assessment and Educator, Surgical Services agreed with the above mentioned findings.
8. PI # 27 was admitted to the facility on 4/21/15 with the diagnosis of Morbid Obesity and Body Mass Index 42.
Review of the medical record on 4/20/15 revealed the patient was scheduled for Lapaproscopy. Further review of the MR revealed there was no documentation informed consent for the above mention surgical procedure was obtained.
An interview was conducted on 4/22/15 at 2: 45 PM with EI # 19, System Vice President, Surgical Services and EI # 20, Quality Assessment and Educator, Surgical Services agreed with the above mentioned findings.
EI # 19, System Vice President, Surgical Services further stated that some of the surgical physician have their patients signed informed consents at their office that has all of the elements of informed consents including the actual surgical procedure, signed by the patient and witnessed by the physician. There was no documentation in the facility's medical record of these informed consents.