Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on October 10, 2023 through October 12, 2023, Woodlyn Dialysis was identified to have the following standard level deficiency that was determined to be in substantial 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:
494.62(d)(1) STANDARD
ESRD EP Training Program
Name - Component - 00
§494.62(d)(1): Condition for Coverage:
(d)(1) Training program. The dialysis facility must do all of the following:
(i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
Staff training must:
(iii) Demonstrate staff knowledge of emergency procedures, including informing patients of-
(A) What to do;
(B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated;
(C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and
(D) How to disconnect themselves from the dialysis machine if an emergency occurs.
(iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and
(v) Properly train its nursing staff in the use of emergency equipment and emergency drugs.
(vi) Maintain documentation of the training.
(vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures.
Observations:
Based on a review of facility documentation, review of medical records (MR), facility policy, and an interview with the administrator and director of operations, the facility failed to follow policy regarding their fire and evacuation training and drills for for five (5) of seven (7) MRs. MR# 1, 3, 4, 5, and 7.
Findings include:
A review of facility policy, "Facility Emergency Management Plan (ICHD, Home) on October 11, 2023 at 1:30 PM states: "Fire safety drills: b. required on a QUARTERLY basis.
A review of MRs was conducted on October 11, 2023 at approximately 10:00 AM and on October 12, 2023 at approximately 9:30 AM.
MR# 1 admission date 2/25/22 did not contain documentation of fire and evacuation training and drills for quarters 1 and 2 of 2023 and none for 2022.
MR# 3 admission date 1/31/23 did not contain did not contain documentation of fire and evacuation training and drills for quarter 2 of 2023.
MR#4 admission date 1/21/2020 did not contain documentation of fire and evacuation training and drills for quarters 1 and 2 of 2023 and quarters 1, 3, and 4 for 2022.
MR#5 admission date 6/6/18 did not contain any documentation of fire and evacuation training and drills for 2022 and 2023.
MR#7 admission date 3/26/2020 did not contain any documentation of fire and evacuation training and drills for 2022 and 2023.
An interview with the administrator and operations director on October 12, 2023 at 12:30 PM confirmed the above findings stating that these findings were found in a facility internal audit and that drills were currently being completed for quarter 3 of 2023.
Plan of Correction:On 10/19/2023, the Governing Body met to review results of the survey ending 10/12/23. A plan of correction was developed and initiated to correct identified deficiencies and sustain compliance.
The Facility Administrator or designee will in-service all clinical teammates starting 10/17/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 4-07-01 "Facility Emergency Management Plan (EMP)" with emphasis on but not limited to: 1) The Facility Administrator or designee, is responsible to: Conduct and review quarterly fire safety and evacuation training and drills for compliance, identify additional training and education needs. 2) Fire safety drills: a. Required on a quarterly basis; one drill to be conducted for each shift of patients; b. Include patient emergency takeoff procedure, policy: Termination of Dialysis in an Emergency; c. Document training for both teammates and patients; d. Complete exercise evaluation and teammate attendance sheet; e. Document in Governing Body and maintain with facility EMP. Verification of attendance is evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee have scheduled drills through 2024. The Administrative Assistant (AA) or designee will assist by preparing documents for the patients to sign and by filing them promptly in the medical records upon completion.
The Facility Administrator or designee will audit fire drill documentation for three (3) quarters to verify compliance for all shifts of patients. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with the Medical Director during the monthly Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on October 10, 2023 through October 12, 2023, Woodlyn Dialysis 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 STANDARD
IC-SANITARY ENVIRONMENT
Name - Component - 00
The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.
Observations:
Based on an observational tour, facility policy and an interview with the administrator and director of operations, the facility did not maintain a sanitary environment for one (1) of one (1) observation. Observation #1.
Findings include:
A review of facility policy 1-05-01 "Infection Control For Dialysis Facilities" on October 12, 2023 at 1:30 PM states: "Facility Hygiene 16...Clean areas should be clearly separated from contaminated areas where used supplies and equipment is handled."
During the observational tour of the isolation room on October 10, 2023 at approximately 9:45 AM it was noted that the supply room contained unused plastic biohazard containers. These containers were not stored away from clean supplies
An interview with the administrator and operations director on October 12, 2023 at 12:30 PM confirmed that unused plastic biohazard containers should be stored separately and away from clean supplies.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 10/17/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with the emphasis on but not limited to: Facility Hygiene: 1) Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee arranged the stock room and verified clean areas were used for the storage of clean supplies and clearly separated from contaminated areas where used supplies and equipment are handled.
The Facility Administrator or designee will conduct infection control audits to verify clean and dirty areas are clearly separated and teammates perform tasks appropriately: daily for two (2) weeks, and 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 results of the audits with teammates during homeroom meetings and with Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this 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 a review of facility policy/procedure, treatment area observations, and an interview with the administrator and director of operations, the facility failed to ensure the staff followed infection control protocols, included but not limited to, performing hand hygiene/donning clean gloves for five(5) of eighteen (18) observations (Obs). Obs# 1, 2, 3, 4, and 5.
Findings include:
A review of facility policy 1-05-01 "Infection Control For Dialysis Facilities" on October 12, 2023 at 1:30 PM states: "Hand Hygiene 1. All teammates...will perform hand hygiene...b. prior to gloving and immediately after removal of gloves... d. after patient and dialysis delivery system contact...f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse... PPE (personal protective equipment) 5. Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces...a. Removed prior to leaving the treatment area. b. Removed as soon as possible if overtly contaminated...c. PPE is not to be worn in non-treatment areas..."
Observation of the treatment area was conducted on October 10, 2023 from 10:00 AM-1:00 PM and 2:10 PM-2:45 PM and on October 11, 2023 from 10:23 AM-11:00 AM.
Obs#1 station 2 PCT3 (patient care technician) removed gloves, did not perform hand hygiene prior to donning clean gloves prior to: placing a clean field under the CVC (central venous catheter) prior to disinfection of the CVC hubs, after connecting sterile syringes to each port prior to initiation of treatment. PCT 3 was observed not to remove gloves, perform hand hygiene, don clean gloves after removing the old catheter dressing. PCT3 observed cleaning small blood spill on floor, changing gloves without performing hand hygiene after treatment initiation was completed. PCT 3 was observed to consistently not perform hand hygiene prior to donning new gloves throughout the observation period. After treatment initiation observation, while performing machine preparation and other non patient related duties PCT 3's mask did not cover nose for a short period of time.
Obs#2 PCT2 was observed to be wearing a gown that was not buttoned at top and bottom.
Obs#3 PCT#6 did not wear a gown while in the isolation room completing computer documentation-note the room is not used for hepatitis patients or for isolation and the patient had already exited the room.
Obs#4 Another staff member was observed leaving the treatment floor to enter supply/water room area without removing PPE.
Obs#5 PCT1 was observed throughout the observation period of changing gloves without performing hand hygiene prior to donning clean gloves.
An interview with the administrator and operations director on October 12, 2023 at 12:30 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 10/17/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with the emphasis on but not limited to: A. Hand hygiene: 1) All teammates...will perform hand hygiene... b. prior to gloving and immediately after removal of gloves... d. after patient and dialysis delivery system contact... f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse... B. Personal Protective Equipment (PPE): 1) Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces... a. Removed prior to leaving the treatment area. b. Removed as soon as possible if overtly contaminated... c. PPE is not to be worn in non-treatment areas... Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct infection control audits to verify hand hygiene is performed and PPE is worn appropriately per policy: 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 results of the audits with teammates during homeroom meetings and with Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.30(a)(1)(i) STANDARD
IC-IF TO STATION=DISP/DEDICATE OR DISINFECT
Name - Component - 00
Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient.
-- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient.
-- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient's station should be used only for that patient and should not be returned to a common clean area or used on other patients.
Observations:
Based on observation of the treatment area, facility policy and an interview with the administrator and director of operations, the facility did not follow its policy for disinfection of non disposable equipment for two (2) of two (2 ) observations Obs. Obs # 5 and 6.
Findings include:
Observation of the treatment area was conducted on October 10, 2023 from 10:00 AM-1:00 PM and 2:10 PM-2:45 PM and on October 11, 2023 from 10:23 AM-11:00 AM.
A review of facility policy 1-05-01 "Infection Control For Dialysis Facilities" on October 12, 2023 at 1:30 PM states: 14a. Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach...
Obs#5 and #6 RN1 did not disinfect the stethoscope that was used to auscultate a patient's lungs prior to using stethoscope on the next patient at station 1 and again at station 8.
An interview with the administrator and operations director on October 12, 2023 at 12:30 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 10/17/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with emphasis on but not limited to: 1) Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. a. Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution... Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct infection control audits to verify stethoscopes are disinfected between uses, prior to removal from treatment area/station: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review results of the audits with teammates during homeroom meetings and with Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.30(a)(1)(i) STANDARD
IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES
Name - Component - 00
Isolation of HBV+ Patients
To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients.
Observations:
Based on a facility tour and an interview with the administrator and director of operations, the facility did not dedicate supplies and equipment used in the isolation room for one (1) of one (1) observation. Observation 1.
Findings include:
During the observational tour of the isolation room on October 10, 2023 at approximately 9:45 AM it was noted that none of the supplies, equipment, dialysis machine centrifuge, chair, television, etc. were labelled "isolation".
An interview with the administrator and operations director on October 10, 2023 at 9:45 AM confirmed the above findings and stated that the room is not currently being used for isolation and that the facility does not have any patients who are positive for hepatitis B. The room is currently used for the facility's general dialysis population.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 10/17/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-02 "Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance" with emphasis on but not limited to: 1) A designated dialysis machine, temporary or permanent, will be used for treatment in the isolation room/isolation area or station and will be labeled as an isolation machine. i. Label should read "Isolation Machine only" or "Temporary Isolation Machine" ii. Label should be attached with adhesive and visible on the front of the machine. 2) Dedicated ancillary supplies such as blood pressure cuffs, clamps, tourniquets, stethoscope, blood glucose meter, bicarb/dialysate jugs, bleach buckets, sharps' container, thermometer, pens, centrifuge, and non-disposable items will be used. b. Such supplies will be labeled "isolation" and will remain in the isolation room/area or station and be disinfected after every patient use with a 1:100 (one to one hundred) bleach solution. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee labeled all items as required per policy 1-05-02 as "Isolation" by 10/20/2023.
The Facility Administrator or designee will conduct infection control audits to verify Isolation room machine and supplies are labeled "Isolation": daily for two (2) weeks, weekly for two (2) weeks. Ongoing compliance will be monitored with infection control audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the results of the audits with teammates during homeroom meetings and with the Medical Director during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meetings with supporting documentation 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 observation, facility policy and an interview with the facility administrator and director of operations, the facility did not adhere to its policy on cannulation. The facility did not adhere to its policy on patient early discontinuation of treatment for two (2) of seven (7) medical records (MR). MR# 4 and 5.
Findings include:
A review of facility policy 1-04-01E "AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose" on October 12, 2023 at 1:30 PM states: 10. While maintaining aseptic technique, prep each planned needle site...13. Do not palpate insertion site once area has been prepped.... "23. Tape across butterfly wings but do not cover the insertion site. Aseptically place sterile gauze or adhesive type dressing over the needle insertion site. Tape the wings using a chevron method. Check that needle is secure."
A review of facility policy 1-04-02B "Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure" states: "24...remove syringe from each access port one at a time then attach each bloodline carefully..."
A review of facility policy 1-01-09 "Prescribed Treatment Time Not Met" states: "1. The Registered Nurse (RNO will verify that a patient signs the Early Termination of Treatment Against Medical Advice form .."any time the patient requests to terminate their treatment earlier than the prescribe run time....4. A copy of the Early Termination of Treatment Against Medical Advice form signed by the patient, if shortened voluntarily by patient, will be kept in the patient's health record..."
Observation of the treatment area was conducted on October 10, 2023 from 10:00 AM-1:00 PM and 2:10 PM-2:45 PM and on October 11, 2023 from 10:23 AM-11:00 AM.
During observation of cannulation of the vascular access, PCT4 at machine 5 after cleaning the insertion site palpated and then inserted the needle without re-cleansing.
During observation of cannulation of the vascular access, PCT4 at machine 5 taped across the butterfly wings of the needle covering the insertion site and then placed a gauze dressing above the tape. The wings were not taped using a chevron method to secure the needle.
During observation of initiation of dialysis using a CVC, PCT8 at station 2 after removing syringes from the catheter ports, left the patient station without attaching the bloodlines. The ports were left uncovered/uncapped.
A review of MRs was conducted on October 11, 2023 at approximately 10:00 AM and on October 12, 2023 at approximately 9:30 AM.
MR#4 admission date 1/21/2020. Orders state 4 hour treatment. Patient discontinued treatment early due to transportation on 9/7/2:3 (1 hour early), 9/29/23 (1/2 hour early), 10/2/23 (1 hour early) and 10/6/23 (1/2 hour early). There was no documentation of the Early Termination of Treatment Against Medical Advice form in the MR.
MR#5 admission date 6/6/18 Orders state 4 hour treatment. Patient discontinued treatment early on: 9/26/23 (off 35 minutes early), 9/30/23 (off 2 hours early), 10/3/23 (off 1 hour early), 10/5/23 (off 3 hours early), 10/7/23 (off 1 hour early). There was no documentation of the Early Termination of Treatment Against Medical Advice form in the MR.
An interview with the administrator and operations director on October 12, 2023 at 12:30 PM confirmed the above findings.
Plan of Correction:A Governing Body meeting was held on 10/19/2023 with the Medical Director, Facility Administrator and Regional Operations Director to review the results of the survey ending on 10/12/23. The Governing Body reviewed Policy COMP-DD-017 "Medical Director Qualifications and Responsibilities" with the Medical Director, who acknowledges that he/she is responsible to ensure that the 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 non-physician providers. 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 10/17/23. Surveyor observations were reviewed. Education included but was not limited to a review of facility policies with areas of emphasis on but not limited to:
1. Policy 1-04-01E "AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose": 1) Step 8: Locate and palpate the needle cannulation sites prior to skin preparation. 2) Step 11: While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out and allow to dry. 3) Step 13: Do not palpate insertion site once area has been prepped. 3) Step 22: If using NIPRO safety fistula needles: Insert NIPRO safety fistula needle until only a small portion of the needle is still visible. 4) Step 24: Tape across butterfly wings but do not cover needle insertion site. Aseptically place sterile gauze or an adhesive type dressing over the needle insertion site. Tape the wings using a chevron method. Check that needle is secure.
2. Policy 1-04-02B "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure": 1) Step 24 ... remove syringe from each access port one at a time, then attach each blood line carefully, as not to contaminate blood line tips or catheter limbs.
3. Policy 1-01-09 "Prescribed Treatment Time Not Met": 1) The Registered Nurse (RNO will verify that a patient signs the "Early Termination of Treatment Against Medical Advice" form any time the patient requests to terminate their treatment earlier than the prescribe run time. 2). A copy of the "Early Termination of Treatment Against Medical Advice" form signed by the patient, if shortened voluntarily by patient, will be kept in the patient's health record. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.
The Facility Administrator or designee will conduct access audits to verify: a. AVF/AVG care follows policy steps for antisepsis during cannulation and for proper taping of the cannulation site: daily for two (2) weeks then weekly for two (2) weeks; b. Treatment initiation via CVC follows policy steps including connection of bloodlines immediately after syringes are removed: daily for two weeks, then weekly for two weeks. Ongoing compliance will be monitored for each access audit series [AVF/AVG and CVC] with the monthly infection control audit.
The Facility Administrator or designee will perform a one hundred percent (100%) daily review of run time report and compare with submitted AMA's by RNs, prior to filing in patient charts: daily for two (2) weeks, weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance found in all audits will be addressed immediately.
The Medical Director will review progress of teammate education, results of audits, and adherence to this plan of correction 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, 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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