Initial Comments:
Based on the findings of an onsite unannounced recertification survey conducted on April 1, 2024, through April 4, 2024, Upper Darby Dialysis (DaVita), was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced recertification survey conducted on April 1, 2024, through April 4, 2024, Upper Darby Dialysis (DaVita), was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.30(a)(1) STANDARD IC-WEAR GLOVES/HAND HYGIENE Name - Component - 00 Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.
Observations:
Based on observations, review of agency policy and procedures, and interview with the facility administrator, it was determined that the facility staff did not practice proper hand hygiene during central venous catheter (CVC) exit site care and initiation of dialysis treatments, for one (1) of ten (10) observations. (Observation #2)
Findings include:
Reviewed facility ' s policies and procedures on April 2, 2024 from 9:10AM until approximately 9:30AM.
Procedure 1-04-02B titled "Central Venous Catheter (CVC) with ClearGuard HD Antimicrobial End Caps Procedure" states, " ...1. Perform hygiene per procedure ...4. Remove old dressing and discard ....7. Remove gloves and discard. Perform hand hygiene per procedure and re-glove. 8. ..using aseptic technique, clean exit site ...wait 60 seconds for air dry time...10. Remove gloves and discard, perform hand hygiene per procedure and re-glove ...12. Place sterile 2x2 gauze over the catheter exit site ...Seal edges of gauze with tape ...14. Remove gloves and discard, perform hand hygiene per procedure and re-glove ...16. Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds ...17. Attach sterile 10ml syringes to the arterial and venous limbs ... "
Observation tour of treatment area was conducted on April 1, 2024 from approximately 9:30AM until approximately 1:15PM revealed:
Observation #2: At approximately 11:04AM, PCT2 was observed performing central venous catheter (CVC) exit site care for a patient at station #4. PCT2 performed hand hygiene, donned clean gloves, and performed central venous catheter exit site care using proper technique. After PCT2 applied the sterile dressing to the CVC exit site, PCT2 did not remove gloves, perform hand hygiene or don clean gloves prior to initiation of dialysis treatment. PCT2 used the same gloved hands to close the catheter clamps, and disinfect CVC hubs. PCT2 then removed gloves, performed hand hygiene, donned new gloves and connected the sterile syringes to the hubs.
An interview with the agency facility administrator, regional director, and clinical services director on April 4, 2024 at approximately 1:35PM confirmed the above the findings.
Plan of Correction:V113
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 04/08/24. Surveyor observations were reviewed. Education included but was not limited to a review of Procedure 1-04-02B "Central Venous Catheter (CVC) with Cleargaurd HD Antimicrobrial End Caps Procedure" with emphasis on but not limited to: 1) Step 1: Perform hand hygiene per procedure. Put on PPE... 2) Step 4: Remove old dressing and discard. 3) Step 7: Remove gloves and discard. Perform hand hygiene per procedure and re-glove. 4) Step 8: Holding catheter with the nondominant hand and using aseptic technique, clean exit site ... wait 60 seconds for air dry time... 5) Step 10: Remove gloves and discard, perform hand hygiene per procedure and re-glove. 6) Steps 12: Place sterile 2x2 gauze over the catheter exit site ... Seal edges of gauze with tape. 7) Step 14: Remove gloves and discard, perform hand hygiene per procedure and re-glove. 8) Step 16: Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds... 9) Step 17: Attach sterile 10 ml syringes to the arterial and venous limbs. Verification of attendance for the in-service was evidenced by teammate's signature on an attendace sheet. The Facility Administrator or designee will conduct CVC procedure audits to verify teammates perform proper hand hygiene during CVC exit site care and treatment initiation: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed, until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.150(c)(2)(i) STANDARD MD RESP-ENSURE ALL ADHERE TO P&P Name - Component - 00 The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on review of facility policy, medical records (MR), dialysis treatment documentation (flowsheets), and interview with the facility administrator, it was determined that the medical director failed to ensure that all policies and procedures relative to patient care and safety, were adhered to by all individuals who treat patients in the facility for three (3) of seven (7) in-center hemodialysis medical records reviewed (MR2, MR5, and MR7).
Findings Included:
Policy 1-03-08, titled " Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment " states, " ...Pre-Treatment Data Collection/Assessment - 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse ...If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis ....6. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis ...Intradialytic Data Collection/Assessment - ...11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately ...The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient ' s medical record ...Blood Pressure (BP) Pre-Dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg, Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. Blood Pressure Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg, Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg ...Blood Pressure Post-Treatment: ...Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg. Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg ... Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg. Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg ...Pre/Intra/Post Patient Reports/Complaints and/or Teammate Observations of: Pain, chest pain ...Weakness or numbness ...Cramping ...Changes in level of consciousness, ability to communicate ... "
Reviewed medical records (MR) on April 2, 2024 from 11:55AM until approximately 2:50PM and April 3, 2024 from approximately 9:30AM until approximately 12:30PM. Reviewed dialysis treatment documentation (flowsheets) on April 2, 2023 from approximately 6:00PM until approximately 7:00PM and April 3, 2024 from approximately 9:00AM until approximately 9:30AM.
MR2. Admission Date: 10/14/2022. DOB: 12/18/1958. Dialysis Treatment Order Date: 3/7/2024; Frequency: Three (3) days per week; Treatment Duration: 4 hours.
Treatment Record for 3/25/2024: Pre-Treatment Blood Pressure (BP) sitting 182/97, documented by PCT. 9:28AM BP 175/98 "Patient access cannulated without difficulty; Normal saline prime given; Treatment started without complications; Patient reports SOB; Heart skipping beat this morning before treatment. RN notified" documented by PCT. 9:31AM Update " BP elevated " documented by PCT. 9:31AM BP 180/103 " Patient awake; Alert; States no complaints at this time " documented by PCT. 10:01AM BP 173/98 " Patient awake; States no complaints at this time " documented by RN. 10:31AM BP 178/105 " Patient awake; Alert; States no complaints at this time; Patient BP trending high; Patient on phone " documented by RN. 11:01AM BP 176/96 " Patient awake; Alert; States no complaints at this time; Patient on phone " documented by PCT. 11:31AM BP 171/99 " Patient awake; Alert; State no complaints at this time; Patient BP trending high; RN notified " documented by PCT. 12:01PM BP 174/102 " Patient awake; Alert; States no complaints at this time; Patient talking on phone " documented by PCT. 12:31PM BP 172/111 " Patient awake; Alert; States no complaints at this time; Patient BP trending high " documented by PCT. 12:33PM BP 172/103 " Patient awake; Alert; States no complaints at this time " documented by PCT. 1:01PM BP 176/98 " Patient reports cramping in left leg; UF paused " documented by PCT. 1:10PM Manual Entry " Patient reports cramping worsening; 100ml NSS given " documented by PCT. 1:28PM BP 175/98 " Patient blood returned without complications; Treatment terminated; Patient reports cramp is gone " documented by PCT. Post-Treatment sitting B/P 180/98, standing B/P 170/94, documented by PCT.
No evidence documented that RN was notified during the last two (2) hours of treatment of BP readings out of facility parameters and that patient complained of cramping. No evidence documented that physician was notified.
MR5. Admission Date: 8/30/2022. DOB: 4/9/1956. Dialysis Treatment Order Date: 11/15/2023; Frequency: Three (3) days per week; Treatment Duration: 4 hours and forty-five (.75) minutes.
Treatment Record for 3/28/2024: Pre-Treatment Blood Pressure (BP) sitting 128/60, documented by PCT. 6:55AM BP 118/51 "Treatment started without complications" documented by PCT. 7:02AM BP 112/55 " Patient awake; Alert; States no complaints at this time " documented by PCT. 7:32AM BP 107/47 " Patient awake; States no complaints at this time " documented by PCT. 7:41AM BP 101/49 " Patient states no complaints at this time; BP recheck; Patient monitored " documented by PCT. 8:08AM BP 77/47 " BP recheck; Patient alert and states no complaints " documented by PCT. 8:09AM BP 90/42 " Cuff adjusted; RN notified; Patient will remain monitored " documented by PCT. 8:23AM BP 105/44 " BP rechecked; Patient monitored " documented by PCT. 8:32AM BP 86/35 " Patient blood pressure low " documented by PCT. (9:04AM Update " UF turned off " documented by PCT.) 8:51AM BP 96/83 " Patient states no complaints at this time; BP recheck " documented by PCT. 9:02AM BP 83/38 " Patient blood pressure low; Patient monitored eyes closed; Patient resting " documented by PCT. 9:32AM BP 50/40 " Patient blood pressure low " documented by PCT. 9:39AM BP 103/67 " BP recheck; Patient monitored " documented by PCT. 10:05AM BP 126/96 " Patient monitored eyes closed; Patient resting " documented by PCT. 10:32AM BP 81/31 " Patient monitored eyes closed; Patient resting " documented by PCT. 10:49AM BP 95/45 " Treatment terminated " documented by PCT. Post-Treatment sitting B/P 100/69, documented by PCT.
No evidence documented that RN was notified during the last three (3) hours of treatment of BP readings out of facility parameters, and that physician was notified.
MR7. Admission Date: 11/22/2022. DOB: 12/31/1959. Dialysis Treatment Order Date: 12/19/2023; Frequency: Three (3) days per week; Treatment Duration: 3 hours and thirty (30) minutes.
Treatment Record for 3/29/2024: Pre-Treatment Blood Pressure (BP) sitting 162/88, documented by PCT. 11:00AM BP 177/76 "Treatment started without complications" documented by PCT. 11:02AM BP 154/82 " Patient awake; Alert; States no complaints at this time " documented by PCT. 11:32AM BP 183/84 " Patient monitored; Watching TV no complications " documented by PCT. 12:02PM BP 138/106 " Patient monitored; Watching TV no complications " documented by PCT. 12:33PM BP 191/89 " Patient reports cramping; UF turned off " documented by PCT. 13:02PM BP 180/155 " Patient monitored; Watching TV no complications " documented by PCT. 13:32PM BP 194/120 " Patient monitored; Watching TV no complications " documented by PCT. 14:02PM BP 163/76 " Patient monitored; Watching TV no complications " documented by PCT. 14:32PM BP 177/85 " Patient monitored; Watching TV no complications " documented by PCT. 14:34AM Updated " Treatment terminated " documented by PCT. Post-Treatment sitting B/P 169/87, documented by PCT.
No evidence documented that RN was notified of BP readings out of facility parameters and that patient complained of cramping. No evidence documented that physician was notified.
An interview with the agency facility administrator, regional director, and clinical services director on April 4, 2024 at approximately 1:35PM confirmed the above the findings.
Plan of Correction:V715
A Governing Body meeting with the Medical Director, Facility Administrator, Nursing Manager and Regional Operations Director was held 04/08/24 to review the results of the survey ending on 04/04/24. The Governing Body reviewed the document Medical Director Qualifications and Responsibilities Policy COMP-DD-017 section 4.2.1. (C) Oversight of policies and procedures relative to patient admissions, patient care, infection control and safety are adhered to by all individuals who treat patients in the center, including attending physicians and non-physician providers. The Medical Director acknowledges that he/she is responsible to ensure the facility teammates are trained, follow policy and procedure, and deficiencies identified need to be corrected timely with the support of the facility team. Plans of correction have been developed and initiated to correct identified deficiencies and to sustain compliance. The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 4/08/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: A. [Pre-treatment data collection]: 1) Patient data will be obtained and documented by the patient care technician or licensed nurse. Data collection includes: Measurement of blood pressure, sitting and standing and intradialytic BP in the sitting/reclined or supine position... 2) Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse ... If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 3) The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis. B. [Intradialytic monitoring]: 1) Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately... The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 2) The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 3) All findings, interventions and patient response will be documented in the patient's medical record. C. [Post treatment]: 1) The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre dialysis findings. 2) If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 3) Licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility. D. [Abnormal findings]: Blood pressure - Pre dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg. Blood Pressure-Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. Blood Pressure Post Treatment if the patient can stand: Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg; Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg. Sitting BP for patient's that cannot stand: Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg; Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg. Pre/Intra/Post Patient Reports/ Complaints and/or teammate observation of: Pain, chest pain... Weakness or numbness... Cramping... Changes in level of consciousness, ability to communicate... The Facility Administrator or designee will conduct flow sheet audits to verify proper documentation of data collection, with timely notification of abnormal findings to nurse and appropriate response / intervention as needed, by nurse: on twenty five percent (25%) of the treatment records daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately The Medical Director will review progress of teammate education, results of all audits, and adherence to this plan of correction during monthly Quality Assessment Performance Improvement meetings known as the Facility Health Meeting. The Facility Administrator will report progress, as well as any barriers to maintaining compliance, with supporting documentation included in the meeting minutes. Action plans will be evaluated for effectiveness, new plans developed as applicable to achieve compliance with teammate adherence to policy and procedure. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this plan of correction.
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