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Tag No.: A0397
Based on record reviews and interviews, the Hospital failed to ensure the assignment of nursing personnel for patient care services was done in accordance with nursing personnel competence. This deficient practice was evidenced by failure of the Hospital to ensure annual competency evaluations for IV Conscious Sedation administration were documented for 2 (S11RN, S16RN) of 3 (S4RN, S11RN, S16RN) personnel reviewed for IV Conscious Sedation competency evaluations.
Findings:
Review of the hospital policy titled, "Competency of Associates", last reviewed 12/30/2019, revealed the following, in part: Associates, contract/agency personnel and volunteers must be competent and qualified to meet performance expectations and/or to provide quality patient care to the specific age patients they serve. As such, they will be assessed initially and as appropriate to ensure continuing competency.
1. Defined competencies: a. competency is defined as the minimum basic job knowledge, including skills, ability, and/or behaviors required to safely fulfill the responsibility of a job or assignment. b competencies will be identified and defined by individual position or department. c. competencies that require special attention are those that are considered high risk, low frequency, or are identified as problem prone by the department or service line leadership.
2. Assessment methods: Techniques used to evaluate competencies may include a wide variety of assessment methods. Methods used may include, but are not limited to: a. skill performance activities, c. computer based education, f. proficiency exams, g. return demonstrations.
3.Competency must be assessed by a qualified individual. Qualified individuals have equivalent or higher level of skill or competency.
4. Frequency of competency assessment: a. Competency assessment is assessed initially upon hire or prior to completion of the introductory period and whenever management deems it appropriate. b. components of initial competency assessment may include: iv. Completion of self-assessment, skills checklist, and validation by a qualified individual based on objective criteria. c. requirements for competency assessments and documentation include, but are not limited to: ii. Annual education modules, iii. Ongoing performance assessments, iv. Ongoing competency assessments.
A review of the LSBN (Louisiana State Board of Nursing) revealed in part: The Louisiana State Board of Nursing (LSBN) defined the scope of authorized practice for registered nurses regarding intravenous conscious/procedural sedation in September 1990 (npop 90.20) and determined the administration of intravenous conscious/procedural sedation was within the realm of practice of a registered nurse (RN) as delineated by the Board's specific criteria. Intravenous conscious/procedural sedation was defined as a state of mild to moderate sedation, permitting patient cooperation and tolerance of diagnostic and therapeutic medical procedures.
A. The RN (non-CRNA) shall have documented education and competency to include:
Knowledge of sedative drugs and reversal agents, their dosing, onset, duration, potential adverse reactions, drug compatibility, contraindications, and physiologic effects.
Advanced Cardiac Life Support
Skill in establishing an open airway, head-tilt, chin lift, use of bag-valve-mask device, oral and nasal airways, and emergency procedures. This includes rescuing a patient that may progress beyond deep sedation.
Demonstration of the acquired knowledge of anatomy, physiology, pharmacology, and basic cardiac arrhythmia recognition; the ability to recognize complications of undesired outcomes related to sedation/analgesia; appropriate interventions in compliance with standards of practice, emergency protocols or guidelines.
Demonstration of the knowledge of age specific considerations in regard to assessment parameters, potential complications, and appropriate interventions according to institutional protocol or guidelines.
Possession of the requisite knowledge and skills to perform and evaluate pre-procedure baseline, intra-procedure, and post-procedure clinical assessment of the patient undergoing sedation/analgesia.
Demonstration of the ability to use oxygen delivery devices, applying the principles of oxygen delivery and respiratory physiology.
Demonstration of the knowledge of the standards of practice and licensure related to the sedation/analgesia.
Application of the principles of accurate documentation in providing a comprehensive description of patient responses and outcomes.
B. Competencies will be measured initially during orientation and at least on an annual basis.
On 01/28/2021 an observation beginning at 1:00 p.m. was conducted of the Left Heart Catheterization for Patient #4. During the observation S4RN was observed administering Versed and Sublimaze/Fentanyl via PIV.
Review of S4RN's personnel record revealed competencies for administering Moderate Sedation/Analgesia were still being assessed by a preceptor, S11RN, as he was in orientation.
On 01/28/2021 from 1:35 p.m. - 1:57 p.m. an observation was made of Patient #3's left heart catheterization procedure being performed in Cath Lab Suite #2. During the observation S16RN was observed administering I.V. medications during the procedure.
Review of the procedural nursing notes for Patient #3's left heart catheterization revealed S16RN administered
1 mg Versed and 1ml Fentanyl via PIV at 1:43 p.m. and again administered 1 mg Versed and 1 ml Fentanyl via PIV at 1:57 p.m.
Review of S16RN's initial and annual skills competencies for Cath Lab revealed no documented evidence of demonstrated skills competency evaluations for administration of IV conscious sedation.
On 01/28/2021 from 2:15 p.m. to 2:35 p.m. an observation was made of Patient #5's left heart catheterization procedure performed in Cath Lab Suite #1. During the observation S4RN was observed administering IV medications during the procedure.
Review of the procedural nursing notes for Patient #5's left heart catheterization revealed S4RN administered
1 mg Versed and 1 ml Fentanyl via PIV at 2:29 p.m. on 01/28/2021.
Review of S4RN's personnel record revealed competencies for administering Moderate Sedation/Analgesia were still being assessed by a preceptor, S11RN, as he was in orientation.
In an interview on 01/29/2021 at 10: 00 a.m. with S2Dir and S13QA, they verified there were no demonstrated skills competency evaluations for administration of IV conscious sedation specific to the administration of Versed and Fentanyl for S11RN and S16RN.
Tag No.: A0749
Based on AORN guideline and hospital policy review, observation, and interview, the hospital's infection prevention and control program failed to ensure methods were employed for preventing and controlling the transmission of infections within the hospital. This deficient practice was evidenced by:
1) failure to ensure EVS staff performed disinfection of the hospital's heart catheterization labs per AORN guidelines for perioperative practice and according to EVS policies for cleaning/disinfection of sterile procedure rooms; and
2) failure to ensure breaches in hand hygiene did not occur when staff in the heart cath lab procedure room were performing procedures.
Findings:
1) Failure to ensure EVS staff performed disinfection of the hospital's heart catheterization labs per AORN guidelines for perioperative practice and according to EVS policies for cleaning/disinfection of sterile procedure rooms
Review of the AORN Guidelines for Perioperative Practice (2018 Edition) revealed the following, in part, Under Aseptic Practice, Environmental Cleaning, in part: Recommendation I- A multidisciplinary team should establish cleaning procedures and frequencies in the perioperative practice setting.
Recommendation II: The patient should be provided with a clean, safe environment. ..IIa. The perioperative RN should assess the perioperative environment frequently for cleanliness and take action to implement cleaning and disinfection procedures. ..II.b. All horizontal surfaces in the OR (e.g., furniture, surgical lights, booms, equip,etc.) should be damp dusted before the first scheduled surgical or other invasive procedure of the day. Dust is known to contain human skin and hair, fabric fibers, pollens, mold, fungi, insect parts, glove powder, and paper fibers, among other components.
Review of the hospital's contracted EVS policy revealed in part: Purpose: To clean and disinfect the sterile areas in sterile procedure rooms (for example surgery, cath lab procedure rooms, and C-section rooms) in accordance with industry (AORN) standards and CDC recommendations.
Policy: Sterile procedure rooms are where patients undergo invasive surgery procedures and these areas include Cath lab procedure rooms. When we are cleaning these areas of the hospital, remember why it is so vital to keep them clean and disinfected properly. Open wounds are very susceptible to harmful bacteria, so patients in the surgery rooms are extremely vulnerable to infection. The last thing we want is for our patients to get a healthcare associated infection while we are responsible for keeping these surgical rooms clean.
Terminal cleaning and disinfection of operating and invasive procedure rooms should be done after scheduled procedures are completed for the day.
Equipment and supplies: When you perform cleaning of sterile areas you'll want to make sure you have an ample supply of lint free or microfiber cleaning cloths. Lint free/micro fiber cloths help reduce bacteria carrying dust particles in these areas where patients are at their most vulnerable.
Special notes about equipment for cleaning sterile areas: Do not use spray bottles to apply disinfectants to environmental surfaces in sterile procedure rooms or areas. Disinfectants, when sprayed, may produce aerosols that contaminate sterile supplies or equipment in the sterile field.
Applying disinfectant with proper dwell time: When cleaning any space, always work from the cleanest to the most contaminated area. In this case, applying solution at the perimeter of the room, and mop towards the center of the room, which will usually be around the operating room table.
Review of the EPA information for Virex revealed the following: Cleaning procedures: Blood and body fluids must be cleaned from surfaces and objects before application of Virex. Contact time: Allow surface to remain wet for 1minute to kill HIV-1, 5 minutes to kill HBV and HCV, and for 10 minutes to kill all other organisms cited on the label.
On 01/28/2021 at 1:30 p.m. in Cath Lab procedure room #2, S15HK was observed using a disinfectant spray bottle, spraying the procedure table, the clear board on table, and the pump. S15HK was not concentrating the spray in direct, close proximity to the surface being disinfected. Further observation revealed S15HK was wiping the top section of the exam table with a cloth. She then wiped the lead cables and placed them on the dirty lower half of the table. She then wiped the top of a metal table in the back of the room, wiped one swipe on a wedge on the bottom shelf and the side of bottom shelf.
On 01/28/2021 at 2:05 p.m. in Cath Lab procedure room #1, S15HK was observed using a disinfectant spray bottle, not concentrating the spray in direct, close proximity to the surface being disinfected. She sprayed the procedure table, the clear board on the procedure table, and the pump. She was observed wiping down the board approximately one minute after spraying the board. Further observation revealed she was wiping down the C-Arm X-ray machine in spots, not covering the entire surface. S15HK was observed mopping around the procedure table in spots, not covering the entire area.
In an interview on 01/28/2021 at 3:45 p.m. with S12EvsSup, he indicated the solution being used for disinfecting the Cath labs was Oxycide. He reported the solution has a 3 minute dwell time.
On 01/29/2021 at 10:00 a.m. an observation was made of the cloths being used for wiping down surfaces in the heart cath lab. The cloths were loosely woven 12 inch x12 inch cotton wash cloths. The loose weave of the fibers of the wash cloth could result in shedding of fibers in the Cath lab environment.
In an interview on 01/29/2021 at 10:05 a.m. with S12EvsSup, he confirmed the cloths being used for wiping down surfaces in the Cath lab were the 12 inch x 12 inch 100 % cotton wash cloths he had provided for the surveyor to observe. He indicated they had been in talks regarding obtaining micro fiber towels since November/December of 2020. He confirmed they are not currently using lint-free or micro-fiber cleaning cloths. S12EvsSup reported their company policy is that no disinfectant should be sprayed. He indicated staff should be using flip top capped bottles and pouring the disinfectants and not spraying. He reported Virex is to be used on mattresses and for cleaning floors. He indicated the staff should be using Oxycide to disinfect the Cath lab and reported he thinks staff is using Virex because it "smells better than Oxycide."
In an interview on 01/29/2021 at 11:00 a.m. with S2Dir, he confirmed their EVS company provided a contracted service. He indicated he had not been observing the process for disinfecting the Cath lab rooms. S2Dir reported there is no checklist and there is no evaluation in place to ensure proper performance of disinfection of the Cath lab by the contracted EVS staff. S2Dir indicated evaluating proper performance of disinfection of the Cath lab by the contracted EVS staff would not be the hospital's responsibility. He indicated that would be the responsibility of S12EvsSup as it is his staff and he should be monitoring for proper job performance by his staff.
2) Failure to ensure breaches in hand hygiene did not occur when staff in the heart Cath lab procedure room were performing procedures.
Review of the hospital policy titled," Hand Hygiene" Policy Number: 3.410, revealed in part: VI: Procedures: A. Perform hand hygiene: 3. Before and after contact with a patient's environment, 6. After contact with inanimate objects in the immediate vicintiy of the patient. 7. If hands are moving from a contaminated body site to a clean body site.
On 01/28/2021 observations were conducted of procedures being performed in Cath lab procedure rooms #1 and #2 from 1:15 p.m. - 3:00 p.m. The following breaches in hand hygiene were observed:
S9RT was observed taking off a non-hospital laundered fleece jacket, pulling up his pants, placing his hands in his pockets and failed to perform hand hygine. He was then observed touching equipment in the sterile procedural area, placing his hands back in his pockets, failing to perform hand hygiene, and was then observed spiking the contrast for the procedure. S9RT was observed moving the garbage can and he failed to perform hand hygiene after touching the garbage can. Further observation revealed S9RT pulled his surgical mask beneath his nose and failed to perform hand hygiene after touching the mask.
S10RT was observed touching the trash can to move it, failed to perform hand hygiene, and was then observed opening packages and dropping suppplies onto the sterile field.
In an interview on 01/29/2021 at 11:00 a.m. with S2Dir, he confirmed hand hygiene was to be performed when hands were potentially contaminated.
Tag No.: A0951
Based on record review, observation, and interviews, the hospital failed to ensure the heart catheter procedure room followed acceptable professional standards of practice . This deficient practice was evidenced by failing to ensure that staff in the heart catheter procedure room followed acceptable professional standards of practice by:
a) non-scrubbed heart cath lab staff wearing clothing not laundered by the hospital over their hospital laundered scrubs during a heart catheterization
b) observations of surgical personnel wearing skull caps (surgeon caps) that did not completely cover all their hair; and
c) failing to ensure that staff adhered to acceptable standards of professional practice for the wearing of surgical masks during a heart catheterization.
Findings:
Review of the AORN Guidelines for Perioperative Practice (2018 Edition) revealed the following, in part, Under Aseptic Practice, Guideline for Surgical Attire, under Surgical Attire:
"Recommendation III. Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair. III.a. A clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn.
Review of the AORN Guidelines for Perioperative Practice (2018 Edition) revealed the following, in part, : Under Aseptic Practice, Guideline for Surgical Attire,
"Recommendation I, Clean surgical attire should be worn in the semi-restricted and restricted areas of the perioperative setting...I.b.5 Personal clothing that cannot be contained within the scrub attire either should not be worn or should be laundered in a health care-accredited laundry facility after each daily use...I.c. When in the restricted areas, all nonscrubbed personnel should completely cover their arms with a long-sleeved scrub top or jacket... I.h.4. Surgical masks should not be worn hanging around the neck...
Recommendation II. All individuals who enter the semi-restricted areas should wear scrub attire that has been laundered at a health care-accredited laundry facility or disposable scrub attire provided by the facility and intended for use within the perioperative setting.
Recommendation III. Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair. III.a. A clean surgical head cover or hood that confines all hair and completely coverers the ears, scalp skin, sideburns, and nape of the neck should be worn.
Review of the hospital policy titled Cath Lab Specific Infection Control Policy - Attire revealed in part:
Purpose: To maintain appropriate standards and promote a safe environment for all surgical or procedural area patients by minimizing external sources of contamination.
Policy: All personnel entering the restricted procedural areas of the cath lab will wear appropriate apparel.
Hair Covering: All possible head and facial hair should be covered when in restricted areas using disposable bouffant or hood-style head coverings.
Personal head covering may be used, but must be covered by a disposable bouffant/hood-style cap.
Masks: All persons entering any areas where a sterile field exists will wear a mask.
Masks will cover the mouth and nose and conform closely to the face.
Gloves: Hand hygiene should occur after removing gloves.
a. Clothing not laundered by the hospital wore over hospital laundered scrubs during a heart catheterization.
An observation was conducted on 01/28/2021 at 1:30 p.m. of S9RT wearing a fleece zip front jacket on the outside of his laundered hospital scrubs while in the procedure room during a left heart catheterization procedure on Patient #3.
An observation was conducted on 01/28/2021 at 2:15 p.m. of S14RT wearing a jacket on the outside of her laundered hospital scrubs while in the procedure room during a left heart catheterization procedure on Patient #5.
An interview was conducted with S2Dir on 01/29/2021 at 10:00 a.m. He reported the heart catheterization lab staff should not wear clothing items not laundered by the hospital over their hospital laundered scrubs.
b. observations of surgical personnel wearing skull caps (surgeon caps) that did not completely cover all their hair
An observation was conducted on 01/28/2021 at 1:00 p.m. during the left heart catheterization of Patient #4 while the patient was on the table with the sterile field in place. S4RN was observed wearing a skull cap with the sides rolled up leaving hair exposed on the sides and back of his neck. S6MD was observed wearing a bouffant cap with hair hanging out of the sides and back and S7STech was observed wearing a skull cap with hair hanging out of the back of the skull cap.
On 01/28/2021 at 1:15 p.m. S10RT was observed wearing a skull cap with hair hanging out of the back, while Patient #3 was on the procedure table in the cardiac cath lab.
On 01/28/2021 at 1:40 p.m. S8MD was observed wearing a skull cap with hair hanging out of the back, while performing the heart catheterization on Patient #3.
On 01/28/2021 at 2:08 p.m. S11RN was observed without a cap, leaving his hair exposed, while at Patient #5's side when he was on the procedure table in the cardiac cath lab.
An observation was conducted on 01/28/2021 at 2:35 p.m. during the left heart catheterization of Patient #5 while the patient was on the table with the sterile field in place. S6MD was observed wearing a bouffant cap with hair hanging out of the sides and back.
An interview was conducted with S3RN on 01/28/2021 at 2:25 p.m. She verified if a patient was in the cardiac catheterization room, the staff entering the room should be wearing hats and masks. She also stated the skull caps or bouffant caps should cover the hair and the beards should be covered.
c. failing to ensure that staff adhered to acceptable standards of professional practice for the wearing of surgical masks during a heart catheterization.
An observation was conducted on 01/28/2021 at 1:00 p.m. during the left heart catheterization of Patient #4 while the patient was on the table with the sterile field in place. S5RN was observed not having his beard covered on the sides.
An observation was conducted on 01/28/2021 at 1:30 p.m. of S10RT wearing a face mask with the bottom tie loosely secured so there was a gap in the mask around the chin and mouth area. This observation occurred during a heart catheterization of Patient #3 while S10RT was putting supplies on the sterile field in the procedure room.
An observation was conducted on 01/28/2021 at 1:35 p.m. of S17RN wearing a facemask that did not completely cover his facial hair. This observation was conducted during a heart catheterization of Patient #3.
An observation was conducted of on 01/28/2021 from 1:35 p.m. - 2:00 p.m. of S9RT wearing a facemask below his nose. This observation occurred during a heart catheterization of Patient #3.
An observation was conducted on 01/28/2021 at 2:10 p.m. of S4RN wearing a face mask with the bottom tie loosely secured so there was a gap in the mask around the chin and mouth area. This observation occurred during a heart catheterization of Patient #5 while S4RN was in the procedure room.
An observation was conducted on 01/28/2021 at 2:35 p.m. of S5RN wearing a facemask that did not completely cover his facial hair. This observation was conducted during a heart catheterization of Patient #5.
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