Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed December 15, 2022, Pocono Dialysis Center was identified to have the following standard level deficiency that was determined to be in substantial compliance with the following 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 a review of facility policy, review of patient clinical records, and an interview with facility Administrator, the facility failed to ensure patients were provided with quarterly emergency training for six (6) of seven (7) in-center patient medical records reviewed (MR#1 - MR#5, and MR#7).
Findings:
A review was conducted of facility policy on December 15, 2022 at approximately 3:00 p.m.
Policy: 4-07-07 'Emergency preparedness Drills' section #3 states "Fire Safety drills: (b) Required on a quarterly basis. (e) Include patient emergency takeoff procedure ...". (f) Document training for both teammates and patients. (i) Patients use Reggie form Emergency Evacuation Acknowledgement Form".
A review of clinical records was conducted on December 14, 2022 between approximately 11:00 a.m.-2:00 p.m. Patients admission date is listed below:
MR#1 Date of admission 10/29/19: No quarterly emergency training documentation provided for the 1st, 2nd, nor 3rd quarter of 2022.
MR#2 Date of admission 11/01/13: No quarterly emergency training documentation provided for the 1st nor 3rd quarter of 2022.
MR#3 Date of admission 04/13/13: No quarterly emergency training documentation provided for the 1st, 2nd, nor 3rd quarter of 2022.
MR#4 Date of admission 06/04/20: No quarterly emergency training documentation provided for the 1st nor 3rd quarter of 2022.
MR#5 Date of admission 02/26/20: No quarterly emergency training documentation provided for the 1st, 2nd, nor 3rd quarter of 2022.
MR#7 Date of admission 10/09/12: No quarterly emergency training documentation provided for the 1st, 2nd, nor 3rd quarter of 2022.
An interview with the facility Administrator on December 14, 2022 at approximately 2:15 p.m. confirmed the above findings.
Plan of Correction:Lona Schelero, Facility Administrator
00862 Pocono Dialysis Center PA CMS Core 12/15/22
POC Completion Date: 2/13/23
CMS 39-2606
E 040
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting 12/21/22. 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 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 unannounced onsite Medicare recertification survey completed December 15, 2022, Pocono Dialysis Center 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 a review of facility policy, observations, and an interview with the facility Administrator, the facility failed to ensure the staff followed infection control protocols, included but not limited to, performing hand hygiene/donning clean gloves, for three (3) of three (3) 'Access of AV Fistula or Graft for Initiation of Dialysis' observations (Observations #1- #3) and failed to ensure the staff followed infection control protocols, included but not limited to, performing hand hygiene/donning clean gloves, for two (2) of four (4) 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' observations (Observations #3, #4).
Findings include:
A review was conducted of facility policy on December 14, 2022 at approximately 2:00 p.m. Policy #1-04-01E 'AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose' 'Procedure' (1) states "Have patient wash access site with appropriate antibacterial soap, if able. If patient is unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent." (2) Perform hand hygiene. Put on PPE." ...... (11) "While maintaining aseptic technique, cleanse the site by applying skin antiseptic ...."
Observation conducted in the patient treatment area on December 9, 2022 between approximately 9:00 a.m. and 1:00 p.m. revealed the following:
Observation #1: During observation #1 of 'Access of AV Fistula or Graft for Initiation of Dialysis' on 12/09/22 at approximately 10:12 a.m., of patient #9 at station #2, Employee #7 washed skin over access site and did not remove gloves/perform hand hygiene before applying antiseptic over cannulation site.
Observation #2: During observation #2 of 'Access of AV Fistula or Graft for Initiation of Dialysis' on 12/09/22 at approximately 10:30 a.m., of patient #10 at station #1, Employee #7 washed skin over access site and did not remove gloves/perform hand hygiene before applying antiseptic over cannulation site.
Observation #3: During observation #3 of 'Access of AV Fistula or Graft for Initiation of Dialysis' on 12/09/22 at approximately 10:45 a.m., of patient #11 at station #4, Employee #3 washed skin over access site and did not remove gloves/perform hand hygiene before applying antiseptic over cannulation site.
Policy #1-03-12A 'Termination of Dialysis Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Combiset or Nipro Blood Lines' 'Procedure' section (7) states ".....Aseptically disconnect arterial bloodline from arterial access connection. ...." Section (14) states "Disconnect Venous bloodline from venous access." Section (16) states "Perform post dialysis access care per procedure."
Policy #1-04-01B 'Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles' 'Procedure' section (1) states "Perform hand hygiene. Put on PPE." Section (7) states "Remove needle at same or similar angle of insertion ..."
Observation #3: During observation #3 of 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' on 12/09/22 at approximately 10:00 a.m., of patient #12 at station #7, Employee #2 reinfused the extracorporeal circuit and disconnected the bloodlines. Employee #2 did not remove gloves and perform hand hygiene/don clean gloves prior to removing the needle.
Observation #4: During observation #4 of 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' on 12/09/22 at approximately 10:10 a.m. of patient #13 at station #12, Employee #6 reinfused the extracorporeal circuit and disconnected the bloodlines. Employee #6 did not remove gloves and perform hand hygiene/don clean gloves prior to removing the needle.
An interview with the facility Administrator on December 14, 2022 at approximately 2:15 p.m. confirmed the above findings.
Plan of Correction:V 0113
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/21/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-04-01E "AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose" and Policy 1-03-12A "Termination of Dialysis Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Combiset or Nipro Blood Lines" with emphasis on but not limited to:
1. Cannulation: 1) Have patient wash access site with appropriate antibacterial soap, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry. 2) Perform hand hygiene. Put on PPE. Rational: Hand hygiene protects patient and teammate from cross contamination.
2. Treatment termination: 1) Disconnect venous blood line from the venous access. 2) Discard gloves, perform hand hygiene and put on new gloves. Rationale: Hand hygiene and new gloves are used for performing post dialysis access care per procedure. 3) Perform post dialysis access care per procedure. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee will conduct observational infection control audits to verify proper hand hygiene is utilized during cannulation and treatment termination per policy: daily for two (2) weeks and weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audit. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with 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.
494.30(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 a review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure the staff followed infection control protocols for use of the thermometer for three (3) out of three (3) treatment area observations (Observation #1 - Observation #3).
Findings include:
A review was conducted of facility policy on December 14, 2022 at approximately 2:00 p.m. Policy #1-05-01 'Infection Control for Dialysis Facilities' section 'Dialysis Station Management' section #65 states "Items taken into the dialysis station will be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before taken to a common clean area or used on another patient".
Observation conducted in the patient treatment area on December 9, 2022 between approximately 9:00 a.m. and 1:00 p.m. and on December 13, 2022 between approximately 10:30 a.m. and 11:40 a.m. revealed the following:
Observation #1: During treatment area observations on 12/09/2022 at approximately 9:20 a.m., of patient #4, station #3, employee #7 obtained the patient's temperature and did not disinfect the thermometer before returning to the common supply area (the mobile nursing computer stand.)
Observation #2: During treatment area observations on 12/09/2022 at approximately 10:50 a.m., of patient #8, station #5, employee #6 obtained the patient's temperature and did not disinfect the thermometer before returning to the common supply area (the counter at the nursing station.)
Observation #3: During treatment area observations on 12/13/2022 at approximately 10:37 a.m., of patient #15, station #10, employee #3 obtained the patient's temperature and did not disinfect the thermometer before returning to the common supply area (the counter at the nursing station.)
An interview with the facility Administrator on December 14, 2022 at approximately 2:15 p.m. confirmed the above findings.
Plan of Correction:V 0116
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/21/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" and Policy with emphasis on but not limited to: 1) If electronic thermometers and/or blood glucose meters are used, measures will be taken to prevent cross contamination between patients. For example, the thermometer should not be placed on potentially contaminated equipment such as the dialysis delivery system. If the potential for contamination exists, the device outer casing is wiped with an appropriate disinfectant before being returned to clean area or using on another patient. 2) Items taken into the dialysis station will be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before taken to a common clean area or used on another patient. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The Facility Administrator or designee will conduct infection control audits to verify teammate compliance with disinfection of non-disposable thermometers per policy: 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 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.
V 0147
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/21/22. 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. Exit Site: 1) Step #8 - Holding catheter with the non-dominant hand using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds, and apply to CVC exit site in a "back and forth" pattern, using gentle friction progressing from insertion site to periphery using both sides of the swab... Then wait 60 seconds for air dry time. 2) Step #12 - Place sterile 2x2 gauze over the catheter exit site leaving connections accessible. 3) 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 including the sides, threads and end of hub thoroughly. 4) Step #17 - Attach sterile 10 ml syringes to the arterial and venous limbs. Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee will conduct audits to verify CVC care complies with policy: 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 will review audit results with the Medical Director during monthly Quality Assessment Performance Improvement Meeting known as Facility Health Meeting, with supporting documentation in the meeting minutes. The Facility Administrator is responsible for ongoing 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 a review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure that clinical staff maintain aseptic technique for the care of vascular accesses, including intravascular catheters for one (1) of two (2) 'Central Venous Catheter Exit Site' and 'Initiation of Dialysis with Central Venous Catheter' observations (Observation #2).
Findings:
A review was conducted of facility policy on December 14, 2022 at approximately 2:00 p.m. Procedure #1-04-02B 'Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure' section (12) states "Place sterile 2x2 gauze over the catheter exit site ...." Section (14) states "Remove gloves and discard, perform hand hygiene per procedure and reglove." Section (16) states "Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol pad. ...." Section (17) states "Attach sterile 10 ml syringes to the arterial and venous limbs."
Observation conducted in the patient treatment are on December 13, 2022 between approximately 10:30 a.m. and 11:40 a.m. revealed the following:
Observation #2: On Decembe 13, 2022 at approximately 11:35 a.m. while observing 'Central Venous Catheter Exit Site Care' observation #2 of (2) for patient #14, station #3, Employee #5 removed old dressing and discarded, removed gloves, performed hand hygiene, and donned clean gloves and cleansed area around the CVC site with antiseptic. Employee #5 left central venous catheter (CVC) site exposed without a dressing as CVC dialysis was initiated. Employee #5 applied sterile dressing to CVC site after cleaning CVC ports and connecting sterile syringes.
An interview with the facility Administrator on December 14, 2022 at approximately 2:15 p.m. confirmed the above findings.
Plan of Correction:V 0147
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/21/22. 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. Exit Site: 1) Step #8 - Holding catheter with the non-dominant hand using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds, and apply to CVC exit site in a "back and forth" pattern, using gentle friction progressing from insertion site to periphery using both sides of the swab... Then wait 60 seconds for air dry time. 2) Step #12 - Place sterile 2x2 gauze over the catheter exit site leaving connections accessible. 3) 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 including the sides, threads and end of hub thoroughly. 4) Step #17 - Attach sterile 10 ml syringes to the arterial and venous limbs. Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee will conduct audits to verify CVC care complies with policy: 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 will review audit results with the Medical Director during monthly Quality Assessment Performance Improvement Meeting known as Facility Health Meeting, with supporting documentation in the meeting minutes. The Facility Administrator is responsible for ongoing compliance with this plan of correction
494.80(a)(2) STANDARD
PA-ASSESS B/P, FLUID MANAGEMENT NEEDS
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
Blood pressure, and fluid management needs.
Observations:
Based on a review of facility policy/procedure, clinical record review, and an interview with the facility Administrator, it was determined the facility failed to follow policy for addressing patient hypertension for one (1) of seven (7) incenter patient medical records (MR) reviewed (CR#4).
Findings include:
A review was conducted of facility policy on December 14, 2022 at approximately 2:00 p.m.
Policy: 1-03-08 'CWOW-Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment' 'Policy' section (11) states "Abnormal findings or findings outside of any specific physician ordered parameters will be reported to the licensed nurse immediately (Refer to "Abnormal Findings" section in this policy.) "Post Treatment Data Collection' section (16) states "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." 'Abnormal Findings' 'Blood Pressure Post Treatment:' states "If the patient can stand: Standing systolic BP greater than 140 mm/Hg (millimeters of Mercury) or less than 90 mm/Hg. Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg." "Sitting patient that cannot stand: Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg. Siting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg."
A review of clinical records was conducted on December 14, 2022 between approximately 11:00 a.m.-2:00 p.m. Patients admission date is listed below:
MR#4 Date of admission 06/04/2029: Treatment flowsheet dated 12/06/2022 with a treatment time span of 6:57 a.m.-11:10 a.m.
At 11:04 a.m., patient's blood pressure was recorded as 198/126 by Employee #5 (patient care technician). The 'Comments' section included "On cell phone."
No documentation of Employee #5 reporting hypertension to a licensed nurse.
At 11:10 a.m., blood pressure was recorded as 220/125 by Employee #5 (patient care technician). The 'Comments' section included "Treatment terminated."
No documentation of Employee #5 reporting hypertension to a licensed nurse.
An interview with the facility Administrator on December 14, 2022 at approximately 2:15 p.m. confirmed the above findings.
Plan of Correction:V 0504
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/21/22. 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: 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 and pre and post patient weight. 2) Abnormal findings or findings outside of any patient specific physician ordered parameters will be documented and 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. 3) The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status.
4) 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. 5) All findings, interventions and patient response will be documented in the patient's medical record. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The Facility Administrator or designee will conduct audits to verify complete and accurate documentation, with notification of and response by the licensed nurse, per policy: on twenty five percent (25%) of the flow sheets daily on treatment days 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 Facility Administrator 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.
494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS
Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;
Observations:
Based on a review of facility policy/procedure, review of clinical records, and an interview with the facility Administrator; the facility failed to ensure the staff followed facility procedure for early termination of treatment for three (3) out of seven (7) in-center hemodialysis medical records (MR) reviewed (MR#5, MR#6, and MR#7).
Findings include:
A review was conducted of facility policy on December 14, 2022 at approximately 2:00 p.m. 'Policy: 1-01-09' 'CWOW-Prescribed Treatment Time Not Met' 'Policy' (A) 'Completion of the Early Termination of treatment Against Medical Advice Form' section (1) states "The RN will verify that a patient signs the Early Termination of treatment Against Medical Advice form any time a patient requests to terminate their treatment earlier than the prescribed run time." Section (3) states "The RN will obtain the patients signature on the Early Termination of treatment Against Medical Advice form prior to the patient being rinsed back from their treatment. ..." Section (4) states "A RN must countersign all Early Termination of treatment Against Medical Advice forms A witness signature is required only if the patient refuses to sign the form." Section (5) states "If a patient refuses to sign the Early Termination of treatment Against Medical Advice form, the RN will document the patients refusal ...."
(B) 'Prescribed Treatment Time Not Met' Section (1) states "If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patients attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patients specific needs."
A review of clinical records was conducted on December 14, 2022 between approximately 11:00 a.m.-2:00 p.m. Patients admission date is listed below:
MR#5 Date of admission 02/26/20: Physician 'Treatment Orders' for Hemodialysis: 'Tx Time' "255" minutes total.
Patient treatment flow sheets were reviewed.
On 11/04/22 patient treatment flow sheet stated Duration : "221 minutes".
No documentation of the early termination form being signed, and/or the physician being notified, and/or documentation by the registered nurse documenting patient refusal to sign.
MR#6 Date of admission 11/10/22: Physician 'Treatment Orders' for Hemodialysis: 'Tx Time' "240" minutes total.
Patient treatment flow sheets were reviewed.
On 11/29/22 patient treatment flow sheet stated Duration : "225 minutes".
On 12/01/22 patient treatment flow sheet stated Duration : "197 minutes".
On 12/03/22 patient treatment flow sheet stated Duration : "206 minutes".
On 12/06/22 patient treatment flow sheet stated Duration : "213 minutes".
No documentation of the early termination form being signed, and/or the physician being notified, and/or documentation by the registered nurse documenting patient refusal to sign.
MR#7 Date of admission 10/09/12: Physician 'Treatment Orders' for Hemodialysis: 'Tx Time' "225" minutes total.
Patient treatment flow sheets were reviewed.
On 11/25/22 patient treatment flow sheet stated Duration : "184 minutes".
No documentation of the early termination form being signed, and/or the physician being notified, and/or documentation by the registered nurse documenting patient refusal to sign.
An interview with the facility Administrator on December 14, 2022 at approximately 2:15 p.m. confirmed the above findings.
Plan of Correction:V 0543 – Need in-service date.
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/21/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-01-09 "Prescribed Treatment Time Not Met" with emphasis on but not limited to: 1) The Registered Nurse (RN) 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 prescribed run time. 2) The RN will obtain the patient's signature on the "Early Termination of Treatment against Medical Advice" form prior to the patient being rinsed back from their treatment. If unable to obtain the patient's signature prior to rinse-back, the RN will obtain the patient's signature on the form prior to the patient's departure from the facility. 3) A RN must countersign all "Early Termination of Treatment against Medical Advice" forms. A witness signature is required only if the patient refuses to sign the form. 4) If a patient refuses to sign the "Early Termination of Treatment against Medical Advice" form, the RN will document the patient's refusal... 5) If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient's attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient's specific needs. NOTE: Shortened/Early Termination of the dialysis treatment includes all reason he prescribed dialysis time is not met by 30 or more minutes. 6) Reasons why a patient's treatment may be terminated early include, but are not limited to: Facility emergency (power outages, weather-related emergencies, and other facility wide equipment failure... 7) If a patient's treatment is shortened/early terminated, the RN will document the event in the patient's medical record. Documentation will include, as appropriate: ...Whether the patient's nephrologist was notified... A copy of the Early Termination of Treatment against Medical Advice form signed by the patient, if shortened voluntarily by patient. Verification of attendance is evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct flowsheet audits to verify: a. patient treatments which are not are meeting prescribed treatment times are documented correctly and have Early Termination of Treatment forms in the medical record; b. additionally, for treatment times terminated greater than thirty (30) minutes, the Registered Nurse has documented notification of patient's nephrologist in the patient's medical record: on twenty five percent (25%) of the flow sheets 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 Facility Administrator or designee will review 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 a review of facility policy/procedure, observations, and an interview with the facility Administrator, it was determined the facility failed to ensure specific facility personnel were notified of water DI (deionization) utilization for one (1) of one (1) water 'DI Monitoring Log' reviews (Water Log Review #1) and failed to ensure that clinical staff adhered to facility documentation policy for one (1) of one (1) 'Bicarb (bicarbonate) Mix Log' water log reviews (Water Log Review #1).
Findings include:
A review was conducted of facility policy on December 14, 2022 at approximately 2:00 p.m.
Policy: 2-03-01 'Water Treatment Systems Minimum Component Requirement' section (29) states "Deionization (DI) may be utilized as a polish post RO (reverse osmosis) or as a primary water treatment on an interim basis in the event the RO is inoperative." "DI tank(s) will not be used without the prior approval of the Area Biomed Supervisor, Facility Administrator, and Medical Director."Section (30) states "When DI is used in a facility, in the event the RO is inoperable or as a polish: The DI Monitoring Log will be implemented."
Water Log Review #1: The facility water logs were reviewed on December 13, 2022 at approximately 10:00 a.m.
Documentation of the water DI method being utilized as a polisher 04/01/22 - 05/10/22.
No documentation provided of obtaining prior approval to utilize the DI system from the Area Biomed Supervisor, Facility Administrator, and Medical Director.
Facility Specific Policy 'Better Water-Central Bicarb Mixing and Delivery' 'Mixing in #1 Tank' 'Procedure' section (15) states "Document date, time, expiration, date on Bicarb bags if applicable, lot number, manufacturer, # of bags added, test results and signature of teammate preparing and testing solution and verifier signature on the appropriate Bicarb Mixing Log." 'Mixing in #2 Tank' 'Procedure' section (7) states "Document date, time, expiration, date on Bicarb bags if applicable, lot number, manufacturer, # of bags added, test results and signature of teammate preparing and testing solution and verifier signature on the appropriate Bicarb Mixing Log."
A review of the 'Bicarb Mixing Log' on December 13, 2022 at approximately 10:00 a.m. revealed the following:
Water Log Review #1: The June 2022 'Bicarb Mixing Log' included entries on Friday "06/03/22" and on Monday "06/06/22." No documentation of the 'Bicarb Mixing Log' being completed per policy on Saturday 06/04/22. The facility treats patients Monday - Saturday and is closed on Sundays.
Documentation was provided of the 'Bicarb System Daily Rinse Log' including entries on "06/04/22" at "2:14 p.m."
The September 2022 'Bicarb Mixing Log' included entries on Friday "09/02/22" and on Monday "09/05/22." No documentation of the 'Bicarb Mixing Log' being completed per policy on Saturday 09/03/22. The facility treats patients Monday - Saturday and is closed on Sundays.
Documentation was provided of the 'Bicarb System Daily Rinse Log' including entries on "09/03/22" at "2:00 p.m."
An interview with the facility Administrator on December 14, 2022 at approximately 2:15 p.m. confirmed the above findings.
Plan of Correction:V 715
A Governing Body meeting was held on 12/19/22 with the Facility Administrator, Regional Operations Director, and Registered Nurse to review the results of the survey ending on 12/15/22. 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.
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/21/22. 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. Water Treatment: Policy 2-03-01 "Water Treatment Systems Minimum Component Requirement", Facility Specific "Water Contingency Plan" (DaVita St. Luke's Quakertown #06928) and Policy 4-07-01 "Facility Emergency Management Plan (ICHD, Home)" Water Contingency Plan with emphasis on but not limited to: A. Water Policy: 1) In the event of equipment failure of the dialysis quality water treatment system, follow the approved facility specific Water Contingency Plan. 2) DI tank(s) will not be used without the prior approval of the Area Biomed Supervisor, Facility Administrator and Medical Director. B. Water Contingency Plan: 1) In the event the Reverse Osmosis (RO) water treatment system fails to provide dialysis quality water or you experience chlorine break through, immediately notify your Biomed Technician (BMT). 2) The BMT will then make the determination to make the repair themselves, or contact an outside vendor for assistance and or provide alternative water purification such as Deionized Water (D.I.). C. Emergency Management Plan (ICHD, Home)" Water Contingency Plan: 1) Facility specific water contingency plan will be developed by the Facility Administrator/designee, Medical Director, local Biomed department, and Regional Operations Director (ROD). This contingency plan is to be reviewed and approved by the facility Governing Body. The contingency plan is to be reviewed annually. 2) At a minimum, this facility specific water contingency plan will be printed and placed with facility's emergency and disaster plan and may also be posted in the water treatment room and included in the other general emergency preparedness plans. 3) In the event the RO system is found to be inoperable due to system failure or water product quality, the Medical Director, Facility Administrator/designee, local Biomed department and ROD will be notified. Local Biomed department will promptly make arrangements for RO repair. The Medical Director will decide if appropriate to switch to deionization (DI) as an alternate water treatment method until the RO system is repaired. If deemed appropriate by the Medical Director, local Biomed department will promptly make arrangements for DI to be used.
Implementation of water contingency plan will be documented in Governing Body and included with the Emergency Management Plan. The water contingency plan is reviewed as needed during the year and annually during the Annual Governing Body meeting. Instances of non-compliance will be addressed immediately.
2. Facility Specific Procedure 11862 "Better Water – Central Bicarb Mixing and Delivery" with emphasis on but not limited to: 1) Mixing in #1 Tank: Document date, time, expiration date on bicarb bags if applicable, lot number, manufacturer, # bags added, test results and signature of teammate preparing and testing solution and verifier signature on the appropriate Bicarb Mixing Log. 2) Mixing in #2 Tank: Document date, time, expiration date on bicarb bags if applicable, lot number, manufacturer, # bags added, test results and signature of teammate preparing and testing solution and verifier signature on the appropriate Bicarb Mixing Log.
The Facility Administrator or designee will audit bicarb mixing log to verify accurate and complete information is documented every treatment day: daily for two (2) weeks, weekly for two (2) weeks and monthly for two (2) months. Instances of non-compliance will be addressed immediately.
Verification of attendance at all in-services will be evidenced by teammates' signatures on the in-services sheets. The Medical Director will review progress of teammate education, results of audits, and adherence to this plan of correction, as provided by the Facility Administrator during monthly Quality Assessment Performance Improvement meetings known as Facility Health Meetings, and in Governing Body meetings, 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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