Deficiency Index

Every finding on record at Izen Healthcare Services Inc

Richardson, Texas · CCN 747770

4 findings across 1 survey, in the inspector's own words.

The inspector’s own words from form CMS-2567, unedited, including CMS’s own spacing. Names and some dates are redacted by CMS.

Survey of October 18, 2024

4 findings
E0000

A recertification survey was conducted on 10/10/2024. The census was: LCHHS: 314 (Licensed and Certified Home Health Services) PAS: 0 (Personal Assistance Services) No deficiencies were cited.

G0000

A recertification survey and complaint investigation (336090, 337147, 353125, 366388, 368678, 379526, 382746, 521676) was conducted on 10/10/2024. The census was: LCHHS: 314 (Licensed and Certified Home Health Services) PAS: 0 (Personal Assistance Services) Abbreviations: > = greater than 3Xwk = three times a week Adm = Administrator AM - Ante meridiem APS = adult protective services BM = bowel movement CCC = Clinical Care Coordinator cg = caregiver COTA = Certified Occupational Therapy Assistant DON = director of nursing/supervising nurse Dsg = dressing EMS = emergency medical services HHA = home health agency HF = hydrofera HHS = Health and Human Services HHSC = Health and Human Services Commission Implantable port = a central line implanted under the skin used for medication administration IV = intravenous LVN = licensed vocational nurse M/W/F = Monday Wednesday Friday ML = milliliter NP = nurse practitioner NS = normal saline PICC = A peripherally inserted central catheter (a type of long catheter that is inserted through a peripheral vein, often in the arm, into a larger vein in the body, used when IV treatment is required over a long period; PICC lines can have 1-3 lumens/tubes/lines, which allow medications to be attached and flow through the line. Blood draws for lab purposes can also be extracted from a lumen) POC = plan of care PM = Post meridiem Prn = as needed pt = patient SN = skilled nurse RN = registered nurse s/s = signs and symptoms Temp = temperature TPN = total parenteral nutrition TX = Texas W = week wc = wound care Y = yes

G0430

Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a patient's right to be free from neglect by the agency's employees for one of one patient (Patient 1) with a Stage 4 decubitus ulcer (the most serious type of pressure ulcer that extends below the fat layer into the deep tissues, including muscle, tendons, and ligaments and sometimes as far down as the cartilage or bone. There’s a high risk of infection at this stage.) in that the agency nurses (RN A, LVN A and LVN B) failed to follow wound care orders and to perform wound assessments. This failure resulted in Client 1 being harmed and hospitalized with a diagnosis of sepsis (a life-threatening medical emergency that occurs when an infection triggers a chain reaction throughout the body) and placed all clients at risk of poor care and a deteriorating health status. Record review of the Texas Unified Licensing Information Portal included a self-reported incident (Intake 521676) in which the DON reported to the HHSC Complaint and Incident Intake on 07/31/2024. The report included an allegation of Neglect of Patient 1 by RN A, LVN A and LVN B. Record review of the Texas Unified Licensing Information Portal included the agency’s Provider Investigation Report signed and dated by the DON on 07/31/2024 regarding Patient 1. The report read in part, “… Incident Category Neglect… Diagnosis and pertinent history Pressure ulcer of sacral region, stage 4; Quadriplegia (the condition in which both the arms and legs are paralyzed and lose normal function)… Staff Name [RN A] [LVN A] [LVN B]… This patient has multiple wounds, including a stage 4 pressure ulcer on the coccyx (a small triangular bone at the base of the spinal column; also known as the tailbone). Upon reviewing the case, it was found that the previous attending clinicians failed to document accurately. On July 31, 2024, [LVN C]… sent a picture of the wound to [LVN D/CCC], before transferring the patient to the hospital… Upon investigating further, the clinical leadership team unanimously agreed that this incident should be reported to TX HHS and APS…” Record review of the Agency's complaint log revealed a Self-Report to the Texas Department of Family and Protective Services regarding Patient 1 submitted by LVN D/CCC on 07/31/2024. The report read in part, “… What are your concerns? Lack of medical care… What medical care is not being provided? Patient’s wound has deteriorated tremendously…” Record review of Patient 1’s electronic health record included a plan of care dated 05/30/2024-07/28/2024 with a start of care date of 05/30/2024 that was digitally signed by RN A on 05/30/2024 and a recertification plan of care dated 07/29/2024-09/26/2024 that was digitally signed by RN A on 07/24/2024. The plan of care included a diagnosis of quadriplegia and a stage 4 pressure ulcer to the sacral region (five fused vertebrae bones that form the sacrum) and a nursing frequency of one visit a week for nine weeks. The plan of care read in part, “… SN to assess/evaluate wound(s) at each dressing change and PRN for signs/symptoms of infection. Report to physician increased temp >100.5, chills, increased (sic) in drainage, foul odor, redness, unrelieved pain, and any other significant changes. Using universal precautions and clean technique, wound care to coccyx as follows: remove old dressings, cleanse with NS pat dry and apply calcium alginate (a wound dressing used for moderate to heavy draining wounds)… dry dressings and secure with tape wound care to be done 3xwk and as needed for saturation/dislodgement. SN may instruct CG on wound care to be performed on non-nursing days…” The record included Patient 1 was hospitalized at Hospital YY with a urinary tract infection from 06/04/2024-06/14/2024, transferred to Hospital ZZ on 06/14/2024 and discharged home on 07/05/2024. The record included discharge orders from Hospital ZZ signed and dated by NP on 07/03/2024 that read in part, “… Patient remains on aggressive wound care… coccyx unstageable pressure wound – cleanse with NS moise (sic) gauze, pat dry, apply Medihoney (wound gel made from honey) to wound base, HF blue (a dressing that provides wound protection and addresses bacteria and yeast in a moist wound environment) secured (sic) with foam dressing, change M/W/F and as needed is (sic) loose or soiled…” The record included a resumption of care visit conducted by RN A on 07/06/2024 that read in part, “… WOUND… Location: coccyx… Pressure Injury - Stage: 4… Treatment: cleanse area with wound cleanser and pat dry apply duodenum (sic)… Family has been instructed and verified… Plan for Next Visit: assess and teach family on wound care… wound care to coccyx as follows: remove old dressings, cleanse with NS pat dry and apply calcium alginate…dry dressing and secure with tape… wound care to be done 3xwk and as needed for saturation/dislodgement. SN may instruct CG on wound care to be performed on non-nursing days…” The visit note did not include the wound care ordered by NP on the discharge orders dated 07/03/2024. There was no evidence RN A trained the caregiver to perform the wound care ordered by the NP on the discharge orders dated 07/03/2024 for the 3rd wound care for the week. The record included a resumption of care order signed and dated by RN A on 07/06/2024 that read in part, “… Update to plan of care as follows: SN frequency: 1w1 2w3 with 2-3 PRN visits for falls and wound care… Goals Added… Wound(s) will heal without complication by: 7/20/2024… Interventions Added… SN to assess/evaluate wound(s) at each dressing change and PRN for signs/symptoms of infection. Report to physician increased temp >100.5, chills, increased in drainage, foul odor, redness, unrelieved pain, and any other significant changes…” There was no evidence that the RN updated the POC to include 3 visits for wound care according to NP orders. There was no evidence that the RN updated the POC to include the wound care ordered by NP on the discharge orders dated 07/03/2024. The week of 07/07/24-07/13/2024, two nursing visits were made . The record included a nursing visit note dated 07/11/2024 by LVN A that read in part, “… WOUND…Location: coccyx… Pressure Injury, Stage: 4… Treatment: cleansed area with wound cleanser, patted dry, applied duodenum (sic) and change as needed… Family has been instructed and verified… Patient has multiple wounds… Provided wound care as ordered. ” The visit note did not include the wound care ordered by the NP on the discharge orders dated 07/03/2024. There was no evidence the LVN trained the caregiver to perform the wound care ordered by the NP on the discharge orders dated 07/03/2024. There was no evidence the caregiver performed wound care for the 3rd wound care for the week. The record a nursing visit note dated 07/13/2024 by LVN A that read in part, “… Family has performed wound care prior to SN arrival…” There was no evidence wound care was performed or a wound assessment was done by LVN A. Wound care and assessment were not performed three times a week as ordered by the NP on the discharge orders dated 07/03/2024. The week of 07/14/24-07/20/2024, two nursing visits were made: The record included a nursing visit note dated 07/15/2025 but electronically signed by LVN B on 07/16/2024 that read in part, “… Patient has multiple wounds per physician orders that are maintained by patient’s family stating wounds are changed daily…” There was no evidence wound care and assessment were performed by LVN B. There was no evidence the LVN trained the caregiver to perform the wound care ordered by the NP on the discharge orders dated 07/03/2024. The record included a nursing visit note conducted on 07/17/2025 by LVN B that read in part, “…WOUND…Location: coccyx… Pressure Injury, Stage: 4… Treatment: cleansed area with wound cleanser, patted dry, applied duodenum (sic) and change as needed… Family has been instructed and verified…Patient/Caregiver need further instruction on wound management… ” There was no evidence the LVN trained the caregiver to perform the wound care ordered by the NP on the discharge orders dated 07/03/2024. The visit note did not include the wound care ordered by NP on the discharge orders dated 07/03/2024. Wound care and assessment were not performed three times a week as ordered by the NP on the discharge orders dated 07/03/2024. There was no evidence the agency trained the cg to provide the wound care for the 3rd visit as ordered by the NP. The week of 07/21/2024-07/27/2024, two nursing visits were made: The record included a nursing visit note conducted on 07/22/2024 by LVN B that read in part, “…WOUND…Location: coccyx… Pressure Injury, Stage: 4… Treatment: cleansed area with wound cleanser, patted dry, applied duodenum (sic) and change as needed… Family has been instructed and verified… Instruction provided on wound care. Caregiver instruction on wound is effective… ” There was no evidence the LVN trained the caregiver to perform the wound care ordered by the NP on the discharge orders dated 07/03/2024. The record included a recertification visit conducted by RN A on 07/24/2024 that read in part, “… WOUND… Location: coccyx… Pressure Injury - Stage: 4… Surrounding Tissue: Erythema (red of the skin), Excoriated (skin injury)… collagen dressing ( a dressing that stimulates new tissue growth) provided family as niece told SN after they clean him to apply the dry dressing… wound care to coccyx as follows: remove old dressings, cleanse with NS pat dry and apply calcium alginate… dry dressings and secure with tape Wound care to be done 3xwk and as needed for saturation/dislodgement… Plan for Next Visit: to assess ulcers and provide wound care…” The two visit notes (07/22/2024 and 07/24/2024) did not include the wound care ordered by NP on the discharge orders dated 07/03/2024. The record included a visit note conducted on 07/29/2024 by COTA that read in part, “… “…Strong Oder noted coming from patient due to poor hygiene…” The record included a nursing visit note conducted on 07/31/2024 by LVN C that read in part, “… pt is lying in feces and excessing [sic] wound drainage from the coccyx wound that has soaked through the bed sheets and is all over the patients arms, groin , sides and legs… Pt room and wounds have a very foul odor… SN then cleasned (sic) pt arms and legs and back from all the excessing wound drainage and noted pt has stool as well. SN cleansed pt BM then cleansed coccyx wound with NS and patted dry with gauze due to the severe state of the pt, SN had the patient’s niece call 911 for patient to be transported by ambulance to hospital due to concerns or possible sepsis due to pt condition. SN unable to assess wound sizes due to EMS arriving quickly. Office notified of pt condition and photo sent of coccyx wound prior to transport to [Hospital YY]. No wound care performed aside from cleaning the patient up…” The record included a communication note signed and dated by LVN D/CCC on 07/31/2024 that read in part, “… I received a call from [LVN C] to report the condition that this patient was found in upon her arrival for scheduled home health visit. She reports that the patient was found lying in bed, soiled with feces, his coccyx wound had drained so much from the dressing change the night before that it had soaked through the bedding and underpads and had an extremely foul odor. She also noted that the wounds had degraded to the point of eschar [a dark crusty area of dead tissue that covers a wound], maceration [skin that has softened and broken down due to excess moisture] and exposed bones. 911 called and patient immediately transported by ambulance to [Hospital YY]… DON & Clinical Care Manager notified and provided with picture of coccyx wound…” The electronic record did not include any pictures of the coccyx wound. The complaint manual included a counseling form signed and dated by the DON on 08/06/2024 that read in part, “… [RN A]… Identified Area Needing Improvement/and or Incident/Problem Area… This patient has multiple wounds including a stage 4 pressure ulcer on the coccyx. Upon reviewing the case it was found that the previous attending clinicians failed to document accurately and report the condition of the wounds to the clinical team and to their supervisor. On July 31, 2024, [LVN C] sent a picture of the wound to [LVN D/CCC], before transferring the patient to the hospital. [LVN D/CCC] then brought this matter to the attention of our DON… Subsequently, the DON… convened a clinical team meeting with… [LVN D/CCC]. Upon investigating further, the clinical leadership team unanimously agreed that this incident should be reported to TX HHS and APS. People involved: [Patient 1]; [RN A]; [LVN A]; [LVN B]…[LVN D/CCC]…DON; Adm… Recommended plan… the management team has decided to terminate this nurse effective immediately… meeting with [RN A] on 8/6/24… [RN A] refused to sign…” The complaint manual included a counseling form signed and dated by the DON on 08/08/2024 that read in part, “… [LVN A]… Identified Area Needing Improvement/and or Incident/Problem Area… This patient has multiple wounds including a stage 4 pressure ulcer on the coccyx. Upon reviewing the case it was found that the previous attending clinicians failed to document accurately and report the condition of the wounds to the clinical team and to their supervisor. On July 31, 2024, [LVN C] sent a picture of the wound to [LVN D/CCC], before transferring the patient to the hospital. [LVN D/CCC] then brought this matter to the attention of our DON… Subsequently, the DON… convened a clinical team meeting with… [LVN D/CCC]. Upon investigating further, the clinical leadership team unanimously agreed that this incident should be reported to TX HHS and APS. People involved: [Patient 1]; [RN A]; [LVN A]; [LVN B]…[LVN D/CCC]…DON; Adm… Undesirable behavior may lead to termination of employment… Employee Signature… Refused to sign…” The complaint manual included a counseling form signed and dated by the DON and LVN B on 08/08/2024 that read in part, “… [LVN B]… Identified Area Needing Improvement/and or Incident/Problem Area… This patient has multiple wounds including a stage 4 pressure ulcer on the coccyx. Upon reviewing the case it was found that the previous attending clinicians failed to document accurately and report the condition of the wounds to the clinical team and to their supervisor. On July 31, 2024, [LVN C] sent a picture of the wound to [LVN D/CCC], before transferring the patient to the hospital. [LVN D/CCC] then brought this matter to the attention of our DON… Subsequently, the DON… convened a clinical team meeting with… [LVN D/CCC]. Upon investigating further, the clinical leadership team unanimously agreed that this incident should be reported to TX HHS and APS. People involved: [Patient 1]; [RN A]; [LVN A]; [LVN B]…[LVN D/CCC]…DON; Adm… Employee input: [LVN B] family refused SN to observe all wounds this time stating wc was completed prior to SN arrival. My second visit I completed wounds and measurements/pictures. No coccyx wound observed per family request…” RN A and LVN A were no longer employed by the agency and were not interviewed. During an interview with Patient 1’s emergency contact, the Family Member reported: Patient 1 went back to the hospital because his bottom [coccyx] wound had gotten much larger and infected. The home health nurses taught Family Member how to do the wound care so it could be done when the nurse s were not there, but the wound got bigger and Patient 1 developed new wounds. The Family Member did not remember what the wound care was. Agency nurses were doing wound care twice a week for a few weeks but after that only one time a week. During an interview with LVN D/CCC on 10/17/2024 at 6:45 PM, LVN D/CCC stated: Following LVN C’s nursing visit on 07/31/2024, LVN C reported to LVN D/CCC the horrible condition of the coccyx wound including the odor and her concern Patient 1 wasn’t being cared for appropriately by the agency nurses or family. LVN D/CCC reviewed the prior nursing notes since the start of care and she stated it did not make sense and nothing was adding up and nothing had been documented by the nurses about the wound. LVN C stated she was concerned Patient 1 had signs and symptoms of sepsis. LVN D/CCC stated she notified the DON of the lack of documentation issues in the nursing notes and the general lack of care the agency nurses provided. She further stated that the agency was culpable because of the lack of care provided. LVN D also stated that LVN A and RN A did not take the concerns seriously but LVN B was remorseful and took direction on how to better handle things in the future. The surveyor asked where the coccyx wound picture was located since it was not included in the electronic record. LVN D/CCC stated the picture should be in the electronic record but she would find it and email the picture to the surveyor. The surveyor received the wound care picture via email from LVN DD/CCC on 10/17/2024 at 6:59 PM. During an interview with the DON on 10/18/2024 beginning at 1:56 PM, the surveyor asked who was responsible for determining if visit frequencies were appropriate based on patient needs. The DON stated the clinicians and then the clinical team that included the DON, ADON, and LVN D/CCC. The surveyor asked why nursing visits were ordered one time a week on the plans of care when wound care was ordered three times a week and who did the wound care when the agency nurses did not do it. The DON stated it did not make sense and it must have been a scheduling error. She stated the agency had some issues with RN A. The DON stated she interviewed RN A on 08/06/2024: RN A stated to the DON the stage 4 coccyx wound was not as bad at the start of care visit on 05/30/2024 as it was leading up to Patient 1’s hospitalization on 07/31/2024. The DON asked RN A why nursing visits were ordered once a week on the plan of care. RN A stated to the DON the stage 4 decubitus ulcer was not that bad at the start of care and the caregiver would perform the wound care when the nurse was not there. The surveyor asked the DON if she could show the surveyor where a family member was taught and demonstrated competency to perform the wound care. The DON stated RN A told the DON the family member had been doing the wound care and was competent but she did not see it documented in the electronic record. The surveyor reviewed the ordered wound care from the discharge orders from Hospital ZZ signed and dated by NP on 07/03/2024 that read in part, “… Patient remains on aggressive wound care… coccyx unstageable pressure wound – cleanse with NS moise (sic) gauze, pat dry, apply Medihoney to wound base, HF blue secured with foam dressing, change M/W/F and as needed is (sic) loose or soiled…” and asked why RN A documented the wrong wound care to the stage 4 coccyx wound on the 07/06/2024 resumption of care visit [WOUND… Location: coccyx… Pressure Injury - Stage: 4… Treatment: cleanse area with wound cleanser and pat dry apply duodenum (sic)… Plan for Next Visit: assess and teach family on wound care… wound care to coccyx as follows: remove old dressings, cleanse with alginate…dry dressing and secure with tape]. The DON stated she thought the wound care prior to the hospitalization automatically carried forward to the resumption of care visit note. The surveyor asked why wound care orders weren’t followed on the 07/11/2024, 07/17/2024, 07/22/2024 and 07/24/2024 nursing visits. The DON stated the wound care carried forward from prior visits and the nurses should have checked to make sure it was correct on the visit notes. During an interview with LVN B on 10/17/2024 at 6:15 PM, the surveyor asked why wound care was not done as ordered on the 07/17/2024 and 07/22/2024 nursing visits. LVN B stated she did not see the new wound care orders on the post-hospital order. She stated that agency office staff were supposed to email the nurses with order changes but she was not notified of new orders. She stated that wound care was not done and the coccyx wound was not assessed on the 07/17/2024 and 07/22/2024 visits because the family had already done the wound care. The surveyor asked why her supervisor wasn’t notified the wounds were not assessed and wound care was not done. LVN B stated she had only seen the patient two times and she always documented the family had already done the wound care and refused care. The LVN stated that she did not observe an odor, signs/symptoms of a wound infection or that Patient 1 was unkept on her 07/22/2024 visit. During an interview with the DON on 10/18/2024 beginning at 2:22 PM, the surveyor asked if LVN B notified her the wounds were not observed and wound care was not done on the 07/17/2024 and 07/22/2024 visits. The DON stated LVN B completed the wound section of the nursing notes so it appeared she had changed the dressing but LVN B did not notify the office staff the wound care was not done. The surveyor asked if the agency had the ability to meet the needs of Patient 1 and why Patient 1’s needs were not met. The DON stated the agency had the ability to meet Patient 1’s needs, they were doing much better now than they were then and the agency had learned from errors made by the nurses. She stated that Patient 1 was affected because he did not receive the care he needed and that the agency depended on their clinicians and the care they provided. The surveyor asked what the agency could have done differently to avoid Patient 1’s outcome. The DON stated continuous teaching with the clinicians to improve their documentation and build rapport between the clinicians and the clinical team. The surveyor asked if the patient was neglected by the nurses. The DON stated, “Yes.” The surveyor asked how the DON provided oversight to ensure care and services were implemented based on the patient’s identified needs in their plan of care. The DON stated she believed if the clinicians had wound measurements and weekly wound pictures, the wounds could be better monitored. The surveyor asked who was responsible for monitoring the delivery of care. The DON stated “the clinical team.” During an interview with COTA on 10/18/2024 at 12:10 PM, the surveyor asked if COTA reported the strong odor coming from the patient during her 07/29/2024 visit. The COTA stated “no,” she only documented it because she thought the odor was due to a lack of personal hygiene. Her visits did not include observation of the wounds. Agency policy titled, “TX.3 Abuse, Neglect and Exploitation” with a revision date of 010121 read in part, “Purpose… To protect and promote a patient’s right, which include the right to be free from… neglect… from an agency employee… Definitions… I. "Adult Neglect" means the failure to provide for one's self the goods or services, including medical services, which are necessary to avoid physical or emotional harm or pain or the failure of a caretaker to provide such goods or services…” Agency policy titled, “RI.1 Patient Bill of Rights and Responsibilities/ Right of the Elderly” with a revision date of 070121 read in part, “Purpose To ensure all patients/patient representative (if any)/legal guardians and Agency staff acknowledge, understand, observe and implement the patient's rights and responsibilities to protect and promote the patient’s rights… Procedure… D. A patient has the right to be free from abuse, neglect, and exploitation by an agency employee, volunteer, or contractor…”

G0574

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included all supplies required, all medications and treatments, safety measures to protect against injury, patient and caregiver education and training, patient-specific interventions and measurable goals in three of thirteen records reviewed (Patient 2, 3 and 4) in that: In one of thirteen records reviewed (Patient 2), where the patient had a PICC line the plan of care did not include measurable outcomes and goals; the location of the PICC line; safety measures for the PICC line; the number of PICC line lumens ; orders for the nurse to assess the PICC line site for signs of infection/complications; a complete medication list to include medications used to treat adverse reactions to the IV medications and frequency of administration; instructions to educate the patient/caregiver on measures to take if an adverse reaction to the IV medication occurred; PICC supplies and equipment; the type of dressing change for the SN to perform when changing the PICC dressing and orders for the nurse to draw blood from the PICC line. In one of thirteen records reviewed (Patient 3) where the patient had an implantable port, the plan of care did not include orders for the nurse to administer IV medications; the location of the central line; safety measures for the central line; for the nurse to assess the central line site for signs and symptoms of infection and complications; orders and frequency for the nurse to remove/change the needle, draw blood and change the dressing from the central line site; how the from the central line medication was to be infused; the rate of infusion; a complete medication list to include medications used to treat adverse reactions to the central line medications the frequency of administration and the central line supplies and equipment. In one of thirteen records reviewed (Patient 4) where the patient had a PICC line, the plan of care did not include orders for the nurse to administer IV medications; the location of the PICC line; the number of PICC line lumens; orders for the nurse to assess the PICC line site for signs of infection/complications; how the PICC line medication was to be infused and the rate of infusion; a complete medication list to include medications used to treat adverse reactions to the IV medications and frequency of administration; instructions to educate the patient/caregiver on measures to take if an adverse reaction to the IV medication occurred and PICC supplies and equipment. These failures placed patients at risk of harm from agency staff who could not address the patient's risk factors and type of services needed for appropriate care; at risk of a declining health status, complications, receiving inappropriate care, omission of care and the need for hospitalizations. Findings include: According to: https://www.mayoclinic.org/tests-procedures/picc-line/about/pac-20468748 PICC line safety measures: don't lift heavy objects and don't have blood pressure readings taken on the affected arm; avoiding jarring activities with your arm, such as throwing a ball; avoid submerging the PICC line in water, such as might happen with swimming or using a hot tub; cover your PICC line when you take a shower, as the area shouldn't get wet. PICC line care: checking the area daily for signs of infection and flushing the line with solution weekly to keep it clear from clogs. It's easier if you have someone to help you with PICC line care. If you need help, you might consider hiring a home healthcare provider. https://medlineplus.gov/ency/patientinstructions/000159.htm A PICC line needs to be flushed after every use to keep the catheter clean. It also prevents blood clots from blocking the catheter. https://www.oncolink.org/cancer-treatment/hospital-helpers/central-lines-and-care/picc-line#:~:text=A%20PICC%20line%20may%20have%201%20to%203,to%20give%20different%20things%20at%20the%20same%20time. A PICC line may have 1 to 3 lumens to connect to. They may also be called single, double, or triple lumen catheters. Each lumen can be used to give different things at the same time. Patient 2: Record review of the medical record included a plan of care signed by RN B on 08/07/2024 and dated 08/09/2024 to 10/07/2024 with a start of care date of 04/11/2024. The plan of care included a diagnosis of pancreatic cancer and management of a PICC line. The plan of care did not include measurable outcomes and goals; the location of the PICC line; safety measures for the PICC line; the number of PICC line lumens; orders for the nurse to assess the PICC line site for signs of infection/complications; a complete medication list to include medications used to treat adverse reactions to the IV medications and frequency of administration; instructions to educate the patient/caregiver on measures to take if an adverse reaction to the IV medication occurred; PICC supplies and equipment; the type of dressing change for the nurse to perform when changing the PICC dressing and orders for the nurse to draw blood from the PICC line. The record included nurse visit notes dated 08/09/2024, 08/13/2024, 08/22/2024, 08/27/2024, 09/03/2024 and 09/17/2024 by LVN D that read in part, “… Seen today to obtain blood for labs, tolerated well and blood obtained for ordered labs. Transported to lab…Plans for Next Visit: PICC dressing change and blood draw…” The record included a nurse visit note dated 09/10/2024 by LVN D that read in part, “… Patient seen today for PICC line dressing change and labs, patient unable to sit up, she has projectile vomiting and increased temp and distended abdomen. She is complaining of abdominal pain with little relief from medications. Daughter is taking patient to the ER for evaluation.… Plans for Next Visit: PICC dressing change and blood draw…” The record included a nurse visit note dated 09/12/2024 by LVN D that read in part, “… Seen today for PRN visit to obtain blood for labs, tolerated well and blood obtained for ordered labs. Transported to lab…Plans for Next Visit: PICC dressing change and blood draw…” The record included nurse visit notes dated 09/24/2024 and 10/02/2024 by LVN D that read in part, “… Seen today for PICC line dressing change and to obtain blood for labs, tolerated well and blood obtained for ordered labs. Transported to lab…” The record included a recertification nurse visit note dated 10/03/2024 by RN B that read in part, “…SN is needed for… PICC line dressing changes, labs…” During an interview with RN B on 10/17/2024 beginning at 3:23 PM, the surveyor reviewed the survey findings and asked why the items were not included in the plan of care. RN B stated orders were included on the start of care plan of care dated 04/11/2024 but they were not carried forward on the subsequent plan of care; the plan of cares were to be updated with each episode. The nurses were following the first plan of care since it had not been changed by the doctor. Since Patient 2 was not a new agency patient, the missing information was known by the nurses because it was included in the nursing notes. RN B did not know why goals were not included in the plan of care. RN B stated the patient and nurses flushed the PICC line. The nurse obtained blood from the PICC line and flushed the PICC line during visits. During an interview with LVN D on 10/17/2024 beginning at 3:55 PM, LVN D stated: LVN D flushed the PICC line when she obtained blood from the PICC line but she forgot to document it on her notes. During an interview with the Adm during the entrance conference on 10/10/2024 at 11:15 AM, the surveyor asked who was responsible for ensuring the plan of care included all required elements. The Adm stated the DON and RN case manager. During an interview with the DON on 10/18/2024 at 1:30 PM, the surveyor asked why the items were not included in the plan of care. The DON stated the agency had trouble getting goals to show up in plans of care. The DON acknowledged the other items were not included in the plan of care and stated that was something the quality assurance team should catch and send back to the clinician to review. The DON stated if the patient had a PICC line, the nurses used the PICC line to obtain blood. Patient 3: Record review of the medical record included a plan of care signed by RN C on 08/08/2024 and dated 08/13/2024 to 10/11/2024 with a start of care date of 06/14/2024. The plan of care included a diagnosis of stomach cancer. The plan of care did not include orders for the nurse to administer central line medications; the location of the central line; safety measures for the central line; for the nurse to assess the central line site for signs and symptoms of infection and complications; orders and frequency for the nurse to remove/change the needle, draw blood and change the dressing from the central line site; how the central line medication was to be infused; the rate of infusion; a complete medication list to include medications used to treat adverse reactions to the central line medications the frequency of administration and the central line supplies and equipment. The record included a supplemental order dated 06/14/2024 from the prior start of care episode that read in part, “…Implanted PORT (central line) care and maintenance per agency's policy/procedure. Chlorhexadine (sic) patch (type of dressing) to catheter exit site. Change patch dressing every 7 days and as needed per agency's policy/procedure… Sodium chloride (an IV medication)… 10 ML IV push as flush before and after medication administration and 10-20 ML as needed for catheter maintenance and labwork… Heparin (an IV medication)…5 ML IV push as final flush after medication administration once daily and as needed for port maintenance. Flush unused port once monthly for maintenance… Labs: HHA to obtain… 6/17/24. Prior to lab draw… hold TPN (IV nutrition) for 15 minutes, then flush line access with 20 ml of Sodium Chloride… “ The orders were not included in the plan of care for the episode beginning 08/13/2024. The record included a supplemental order dated 08/14/2024 that read in part, “… HHA to obtain [labs] once weekly on Mondays. Prior to lab draw… hold TPN for 15 minutes, then flush line access with Sodium Chloride…Patient Requires Portable TPN Pump Daily… TPN Administration Kit Daily…TPN Supply Kit Daily…” The record included nursing visit notes dated 08/20/2024, 09/05/2024, 09/10/2024 by LVN E that read in part, “… SN change pt port needle and dressing. SN performed hand hygiene, then removed old needed (sic)… SN cleaned Mediport location, attached hub to tubing, primed tubing. palpated and held mediport (a type of port) in place, inserted needle into mediport. Blood return achieved. Mediport flushed, biopatch placed at site of insertion and covered by occlusive dressing… Blood was collected… during the procedure…” The record included a nursing visit note dated 09/26/2024 by LVN E that read in part, “… venipuncture was performed…” During an interview with RN C on 10/18/2024 at 1:08 PM, the surveyor reviewed the survey findings and asked why the items were not included in the plan of care. RN C stated he did not find a way to include all the information when he inputted the medications. RN C stated he may have missed some parts of the plan of care but the agency had a QA department that reviewed the plan of cares to ensure everything was included. During an interview with LVN E on 10/17/2024 at 2:50 PM, the surveyor asked where the orders were to change the port needle including the size of needle to use. LVN E stated when labs are ordered, LVN E understood the port needle had to be changed. LVN E did not think there was an order. During an interview with the Adm during the entrance conference on 10/10/2024 at 11:15 AM, the surveyor asked who was responsible for ensuring the plan of care included all required elements. The Adm stated the DON and RN case manager. During an interview with the DON on 10/18/2024 at 11:35 AM, the surveyor asked why the items were not included in the plan of care. The DON stated she did not see them in the plan of care, she only saw some orders from the start of care episode dated 06/14/2024. The DON stated the items should have been included in the plan of care for the current episode. Patient 4: Record review of the medical record included a plan of care signed by RN E on 06/04/2024 and dated 06/04/2022 to 08/02/2022 with a start of care date of 06/04/2024. The plan of care included a diagnosis of a right arm infection, a wound to the right leg and management of PICC line. The plan of care did not include orders for the nurse to administer IV medications; the location of the PICC line; the number of PICC line lumens; orders for the nurse to assess the PICC line site for signs of infection/complications; how the PICC line medication was to be infused and the rate of infusion; a complete medication list to include medications used to treat adverse reactions to the IV medications and frequency of administration; instructions to educate the patient/caregiver on measures to take if an adverse reaction to the IV medication occurred and PICC supplies and equipment. The record included a supplemental order dated 06/02/2022 that read in part, “…Home IV Antibiotic… Ceftriaxone (antibiotic) 2gm daily Stop date 06/20/2022 Weekly [labs] every Monday while on antibiotic…” The record included a start of care nursing visit completed on 06/04/2022 by RN E. The visit note read in part, “…Therapies the patient receives at home… Intravenous or infusion therapy… Does patient have IV access… Y… Type: PICC Date of Insertion: 06/02/2022 Date of Last Dressing Change: 06/02/2022… Using sterile technique, flush PICC lines with normal saline, administer Ceftriaxone… IV over 5 minutes, flush with NS again and last with Heparin daily and change PICC line dressing once weekly with sterile technique…” The record included a communication noted signed and dated on 06/15/2022 by LVN G that read in part, “… Pt. called and reported "the SN was here, and she did not look at my PICC dsg. and it is damp and needs to be changed." Called and spoke with SN and she reported the pt. may have taken a shower. Telephone MD for PRN order; and MD gave order for dsg change on 06/16/2022…” RN E and LVN G were former employees and not interviewed. During an interview with the DON on 10/18/2024 at 2:45 PM, the surveyor asked why LVN G did not assess the PICC line site. The DON stated the clinician should have assessed the site and documented their assessment. The record included a nursing visit note dated 06/16/2022 by RN F that read in part, “… with aseptic technique labs… drawn and taken to Lab…” The record included a nursing visit note dated 06/20/2022 by CCC that read in part, “… Using aseptic technique SN obtained labs, labs taken to nearby Lab…” RN F and CCC were former employees and not interviewed. During an interview with the DON on 10/18/2024 at 2:45 PM, the surveyor asked why RN F and CCC did not flush the PICC line after the lab draw. The DON stated she believed they did flush the line but did not document it. Agency policy titled, “TX.6 Plan of Care” with a revision date of 070121 read in part, “… Purpose To develop an individualized Plan of Care which specifies the care and services necessary to meet the patient specific needs and according to state and federal regulations… Procedure… C. The individualized Plan of Care will specify the care and services necessary to meet the patient specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the Agency anticipates will occur as a result of implementing and coordinating the plan of care. The POC will contain the following elements… The types of services, supplies, and equipment required… All medications and treatments… Safety measures to protect against injury… Patient and caregiver education and training to facilitate timely discharge… Patient-specific interventions and education… Measurable outcomes and goals identified by the Agency and the patient…” Agency policy titled, “IVT.1 Assessment for Intravenous Therapy” with a revision date of 070121 read in part, “… Purpose… To insure that prescribed intravenous therapy care is administered safely… Policy… B. IV infusions may be administered or disconnected by the RN or a LVN… Accurately and completely report and document: patient status, nursing care rendered, physician or allowed practitioner orders, administration of medications and treatments… I… Measures will be implemented prior to and during all intravenous therapy to minimize the risk of anaphylaxis (a life-threatening reaction to an allergen)… or other adverse reactions… Procedure… Patient/caregiver will be educated on medication, side effects, possible adverse reactions, s/s to report, procedures for administering drug, possible complications of IV therapy…” Agency policy titled, “IVT.2 Adverse Drug Reactions” with a revision date of 070121 read in part, “… Purpose Establish guidelines for SN’s administering home infusion therapy and response to adverse drug reactions encountered and to ensure optimal care and patient safety… Policy A. SN will react in an efficient and timely manner if an adverse drug reaction occurs in the home. B. RN will identify and classify the reaction appropriately… Anaphylactic drug reaction Procedure A. In a non-life threatening, non-acute systemic reaction, such as: itching, rash, nausea, vomiting… the SN will… Administer (per order) Diphenhydramine (medication to relieve allergy symptoms; sometimes known as Benadryl) 50mg orally or Diphenhydramine hydrochloride IV push... Agency should obtain a written order for an adverse drug reaction prior to administering infusion therapy… B. In case of a significant adverse drug reaction/anaphylactic reaction, such as: hives on face or chest, feeling of warmth with erythema (redness) with or without itching, wheezing, dyspnea (shortness of breath), respiratory distress, swelling of face, eyes, lips, tongue, throat, hands, or feet, severe abdominal cramping… the following will be initiated… Administer emergency medications (injectable Epinephrine (medicine to relieve anaphylactic symptoms)… Call ambulance… Maintain patent airway… Start CPR if needed until EMS arrives and… Monitor pulse, respiration’s and blood pressure every 15-30 minutes until emergency medical team arrives… C. Adverse drug reaction when nurse is not in the home, caregiver will have received instructions to… Stop infusion if in progress… Call 911 or emergency ambulance number… Implement measures per written orders… Start CPR if necessary, if trained in CPR… Stay with patient until ambulance arrives, and transportation has occurred… Notify physician and home care agency of reaction and patient status…”

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