Initial Comments:
Based upon the findings of an unannounced onsite Medicare recertification survey conducted on August 21,2023 through August 23, 2023, Elizabethtown 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 for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.
Plan of Correction:
494.62(d)(3) STANDARD
ESRD Patient Orientation Training
Name - Component - 00
The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section.
Observations:
Based on medical records (MRs) review, agency policy review, and interview with facility administrator, agency failed to maintain documentation of completed emergency preparedness (EP) fire safety quarterly patient education in three (3) out of five (5) medical records reviewed (MR #2-4).
Findings include:
Review conducted on August 22, 2023, at approximately 1:00 PM to 3:15 PM, and August 23, 2023, at approximately 11:00 AM to 2:00 PM, of medical records revealed:
MR#2, soc 7/23/18, contained no documentation of EP Fire Safety Preparedness training for 2022 quarters 1-4.
MR#3, soc 4/24/17, contained no documentation of EP Fire Safety Preparedness training for 2002 quarters 1-3, and 2023 quarter 3.
MR#4, soc 7/7/17, contained no documentation of EP Fire Safety Preparedness training for 2021 quarter 3.
Review conducted on August 22, 2023, at approximately 2:00 PM, of agency policy "4-07-01 Facility Emergency Management Plan (ICD, HOME) pages 26-27 of 37, b. Patients: ... ii. Quarterly 1. Fire Safety Preparedness. ... v. Document training on applicable forms."
Interview conducted on August 22, 2023, at approximately 2:30 PM, with facility administrator confirmed above findings.
Plan of Correction:1. The Facility Administrator held mandatory in-service for all clinical teammates starting on 09/06/23. Surveyor observations were reviewed. Education included but not limited to a review of Policy 4-07-01 "Facility Emergency Management Plan (EMP) (ICHD, HOME)" 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.
2. The Facility Administrator or designee will immediately audit all patients' files to verify documentation for emergency preparedness training, and update as needed by 10/04/23. The Facility Administrator or designee will audit fire drill documentation for three (3) quarters, with final audit taking place in March 2024 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.
3. 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 August 21,2023 through August 23, 2023, Elizabethtown Dialysis was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the 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)(i) STANDARD
IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK
Name - Component - 00
Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.
Observations:
Based on observations, agency policy review, and interview with facility administrator, clinical staff failed to instruct ambulance crew members to wear appropriate personal protective equipment (PPE i.e. gown, mask, face shield, gloves) when present in the dialysis treatment area in one (1) out of one (1) observation. (OBS#1).
Findings include:
Observation conducted on August 21, 2023, at approximately 10:15 AM, of a two-person ambulance team in uniforms not wearing PPE (gown, mask, face shield, gloves) during the ambulance litter transfer of a dialysis patient in the treatment area; clinical staff did not request ambulance team to use hand hygiene or wear appropriate PPE; and in the entry/waiting room, no PPE supplies (gown, masks, face shield, gloves) are available for visitors and ambulance team use nor any posted signage requiring PPE use by ambulance team members and visitors when in treatment area.
Review conducted on August 21, 2023, at approximately 1:00 PM, of agency policy "1-05-01 INFECTION CONTROL FOR DIALYSIS FACILITIES ... HAND HYGIENE 1. All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area ... PPE (i.e., gown, gloves, eye protection, face shield) 5. Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemical, contaminated equipment and environmental surfaces, for example patient care areas. ... 6. Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, Physicians and Non-Physician (NNP), and visitors when in the treatment area."
Interview conducted on August 23, 2023, at approximately 2:30 PM, with facility administrator confirmed the above finding.
Plan of Correction:1. The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/06/23. 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: 1) 1. All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area ... PPE (i.e., gown, gloves, eye protection, and face shield). 2) Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemical, contaminated equipment and environmental surfaces, for example patient care areas... 3) Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, Physicians and Non-Physician (NNP), and visitors when in the treatment area. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.
2. The Facility Administrator or designee immediately placed PPE supplies of gowns, masks, gloves and hand hygiene in patient lobby area. Teammates were instructed to remind ambulance team of the need to wear PPE on the treatment area. The Facility Administrator or designee will conduct infection control audits to verify PPE is being worn appropriately by all teammates, physicians, non-physician practitioners and visitors while in the treatment area: daily for two (2) weeks ending 09/20/23, then weekly for two (2) weeks ending 10/04/23 then monthly during internal infection control audits. Instances of non-compliance will be addressed immediately.
3. The Facility Administrator or designee will review the audit results 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)(2) STANDARD
IC-STAFF EDUCATION-CATHETERS/CATHETER CARE
Name - Component - 00
Recommendations for Placement of Intravascular Catheters in Adults and Children
I. Health care worker education and training
A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections.
B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters.
II. Surveillance
A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site.
Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.
VI. Catheter and catheter-site care
B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections].
Observations:
Based on observation, agency policy review, and interview with facility administrator, clinical staff failed to provide a face mask to a patient prior to initiation of right femoral catheter insertion site cleansing procedure in one (1) of (1) observations (MR#1).
Findings include:
Observation conducted on August 21, 2023, at approximately 10:45 AM, of clinical staff performing catheter insertion site skin cleansing procedure for MR#1's right femoral catheter insertion site revealed: Clinical staff did not offer MR#1 a face mask prior to initiating the insertion site cleansing; staff member realized this error immediately and promptly offered MR#1 a mask with appropriate hand hygiene performed; cleansing of insertion site continued, but MR#1 wore the mask's top portion below her nose; and clinical staff did not request MR#1 to place/wear the mask over their nose.
Review conducted on August 22, 2023, at approximately 10:00 AM, of agency policy "1-04-02B CENTRAL VENOUS CATHETER (CVC) WITH CLEARGARD HD ANTIMICROBIAL END CAPS PROCEDURE ... Procedure (page 2) 1. Perform hand hygiene per procedure. Put on PPE and provide mask to the patient. Teammate and patient will wear masks covering the nose and mouth during this procedure."
Interview conducted on August 22, 2023, at approximately 2:00 PM, with facility administrator revealing confirmation of the above finding.
Plan of Correction:1. The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/06/23. Surveyor observations were reviewed. Education included but was not limited to a review of Procedure 1-04-02B "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure" with emphasis on but not limited to: 1) Step #1: Perform hand hygiene per procedure. Put on PPE and provide a mask to the patient. Teammate and patient will wear masks covering the nose and mouth during this procedure. Rationale: These measures are vital to preventing the exposure of the catheter and exit site to nasal droplets and infectious bacteria such as methicillin-resistant Staphylococcus aureus (MRSA). Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
2. The Facility Administrator or designee will conduct observational audits for CVC care to verify teammates and patients are wearing masks covering the nose and mouth during CVC procedure: daily for two (2) weeks ending 09/20/23, then weekly for two (2) weeks ending 10/04/23, then ongoing compliance will be monitored monthly during internal infection control audits. Instances of non-compliance will be addressed immediately.
3. The Facility Administrator or designee will review the 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, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.40(a) STANDARD
DIALYS PROPORT-MONITOR PH/CONDUCTIVITY
Name - Component - 00
5.6 Dialysate proportioning: monitor pH/conductivity
It is necessary for the operator to follow the manufacturer's instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient.
Observations:
Based on observations, agency policy, and interview with facility administrator, clinical staff failed to perform independent conductivity tests of dialysate prior to initiation of dialysis treatments in two (2) of two (2) observations. (OBS #1-2)
Findings include:
Observations conducted on August 21, 2023, at approximately 9:58 AM, and August 23, 2023, at approximately 9:25 AM, for preparation of dialysis machines revealed:
August 21, 2023, Station #1, no observation of staff performing an independent conductivity test for dialysate.
August 23, 2023, Station #12, no observation of staff performing an independent conductivity test for dialysate.
Review conducted on August 23, 2023, at approximately 2 PM, of agency policy 1-03-06U "PRIMING A SINGLE USE DIALYZER UTILIZING FRESENIUS 208 SERIES DIALYSIS DELIVERY SYSTEMS ... Procedure 33. If using Fresenius 2008K or K2 model machines, check independent conductivity with approved independent meter for testing final dialysate (page 6 of 9) ... 37. Document these numeric values in the patient's electronic treatment record or flowsheet (page 7 of 9)."
Interview conducted on August 23, 2023, at approximately 2:30 PM, with facility administrator confirmed the above findings.
Plan of Correction:1. The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/06/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-02 "Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate" with emphasis on but not limited to: 1) Trained teammates will test pH and conductivity of final dialysate utilizing appropriate test strips and/or meters prior to each patient treatment. 2) Document results in the electronic treatment record or dialysis delivery system log, as applicable. Verification of attendance will be evidenced by teammate's signature on in-service sheet.
2. The Facility Administrator or designee or designee will perform audits to verify manual pH and conductivity readings of final dialysate are taken and documented prior to each patient treatment: daily for two (2) weeks ending 9/20/23 then weekly for two (2) weeks ending 10/04/23, then ongoing monthly with the facility's internal biomedical audits to verify compliance. Instances of non-compliance will be addressed immediately.
3. The Facility Administrator or designee will review the 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, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.
Observations:
Based on observation, agency policies review, and interview with facility administrator, clinical staff failed to verify the expiration date for expired blood specimen vacuum tubes and discard expired lab tubes as per agency policy in one (1) out of one (1) observation. (OBS #1)
Findings include:
Observation (OBS #1) conducted on August 21, 2023, at approximately 10:25 AM, of treatment room storage cabinet for lab blood specimen vacuum tubes revealed an opened package of 100 count "green top" blood specimen vacuum tubes (98 tubes present) with expiration date of 3/31/23; and two blood specimen tubes are missing.
Review conducted on August 21, 2023, at approximately 1:00 PM, of agency policies revealed: "1-08-02 OBTAINING PATIENT LAB SPECIMENS ... (item) 5. Teammates are to verify the expiration date on all laboratory specimen tubes prior to collection. Expired laboratory specimen tubes are not to be used and are to be discarded in the sharps container; and "1-05-01 INFECTION CONTROL FOR DIALYSIS FACILITIES ... (page 2) SUPPLIES 8. Supplies will be stored in a manner that maintains their intergrity. b. Expiration date and package integrity will be verified prior to use."
Interview conducted on August 21, 2023, at approximately 12:00 PM, with facility administrator confirming the expired lab blood specimen tubes finding.
Plan of Correction:1. The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/06/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-08-02 "Obtaining Patient Lab Specimens" with emphasis on but not limited to: 1) Teammates are to verify the expiration date on all laboratory specimen tubes prior to collection. Expired laboratory specimen tubes are not to be used and are to be discarded in the sharps container. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
2. The Facility Administrator or designee conducted an immediate audit of all laboratory supplies to verify expiration dates. Any items past expiration date were removed and appropriately discarded, including the items identified in surveyor's observations. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately.
3. The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with the Medical Director during 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.
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 medical records (MRs) review, agency policy review, and interview with facility administrator, clinical staff failed to timely document required nursing pre-treatment patient assessments as per agency policy in four (4) out of five (5) patient medical record reviews (MRs #1-3, and #5).
Findings include:
Review conducted on August 22, 2023, at approximately 1:00-3:00 PM and August 23, 2023, at approximately 10:30 AM to 1:30 PM, of five MRs revealed:
MR#1 start of care (soc) 1/16/23, dialysis treatment report 8/21/23 treatment initiated at 10:50 AM with termination at 1:00 PM, and Registered Nurse (RN) completed "Pre-treatment Assessment" documentation at 1:09 PM.
MR#2 soc 7/23/18, dialysis treatment report 8/18/23 treatment initiated at 11:38 AM with treatment termination at 3:11 PM, and RN completed "Pre-treatment Assessment" documentation at 4:12 PM.
MR#3 soc 4/24/17, dialysis treatment report 8/7/23 treatment initiated at 11:16 AM with treatment termination at 3:02 PM, and RN completed "Pre-treatment Assessment " documentation at 3:48 PM; and dialysis treatment report 8/18/23 treatment initiated 10:55 AM with termination at 2:53 PM, and RN completed "Pre-treatment Assessment" documentation at 3:01 PM.
MR#5 soc 12/19/22, dialysis treatment report 8/11/23 treatment initiated at 10:59 AM with treatment termination at 14:31/2:41 PM, Registered Nurse (RN) completed "Pre-treatment Assessment" documentation at 3:39 PM; and dialysis treatment report 8/14/23 treatment initiated at 10:56 AM with treatment termination at 2:27 PM, RN completed "Pre-treatment Assessment" documentation at 12:56 PM.
Review conducted on August 23, 2023, at approximately 2:00 PM, of agency "Policy 1-03-08 CWOW-PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT" revealed: ... 2. The Nursing assessment will be performed and documented by a licensed nurse; specifically a Registered Nurse (RN) or ... a Licensed Practical Nurse (LPN) / Licensed Vocational Nurse (LVN). ... INTRADIALYTIC DATA COLLECTION/ASSESSMENT 8. The licensed nurse will round on these patients without reported abnormal findings and complete the nursing assessment within one hour of dialysis treatment initiation. "
Interview conducted on August 23, 2023, at approximately 2:30 PM, with facility administrator confirmed the above findings.
Plan of Correction:1. A Governing Body meeting with the Medical Director, Facility Administrator, Director of Nursing and Regional Operations Director was held on 09/06/23 to review the results of the survey ending on 08/23/23. 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 the facility teammates are trained and follow policy and procedure relative to patient admissions, patient care, infection control, and safety. Plans of correction have been developed and initiated to correct identified deficiencies and to sustain compliance.
2. The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/06/23. Surveyor observations were reviewed. Education included but was not limited to Policy 1-03-08 "CWOW - Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: 1) The Nursing assessment will be performed and documented by a licensed nurse; specifically a Registered Nurse (RN) or if performance of a nursing assessment is permitted by state law, a Licensed Practical Nurse (LPN) / Licensed Vocational Nurse (LVN). 2) The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. 3) The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation. Verification of attendance is evidenced by teammate's signature on the in-service sheet.
3. The Facility Administrator or designee will conduct audits to verify the nurse assessment is completed on each patient within one (1) hour of treatment initiation: on twenty five percent (25%) of 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 audit. Instances of non-compliance will be addressed immediately.
4. 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 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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