QA Investigation Results

Pennsylvania Department of Health
COTTMAN KIDNEY CENTER
Health Inspection Results
COTTMAN KIDNEY CENTER
Health Inspection Results For:


There are  13 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey conducted August 5, 2024 through August 8, 2024, Cottman Kidney Center 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 medical records (MR), facility policies, and an interview with the facility administrator, the facility did not follow its policy regarding the performance of quarterly fire safety/emergency/disaster preparedness drills for eight (8) of eleven (11) records reviewed: MR#3, MR#4, MR#5, MR#6, MR#7, MR#8, MR#10, and MR#11.

Findings include:

A review of the following policies was conducted on August 6, 2024 starting at 8:00 AM:

Policy 4-07-01 The Facility Emergency Management Plan (ICHD, Home) states in part: "Emergency Management Plan Section b. Patients, ii. Quarterly, 1. Fire Safety Preparedness, 2. Emergency Take-off procedures."

Policy 5-01-21 Home Dialysis Monitoring and Ongoing Patient Education reads in part, The following need to be reviewed at least quarterly: Emergency/Disaster Preparedness."

A review of MRs was conducted on August 6, 2024 starting at 11:45 AM and again on August 7, 2024 starting at 8:15 AM. The admission date (AD) is indicated below.

MR#3 AD 07/28/2016 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 4th quarter of 2023.

MR#4 AD 03/25/2024 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 2nd quarter of 2024.

MR#5 AD 05/01/2014 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 4th quarter of 2023, and the 1st quarter of 2024.

MR#6 AD 10/18/2022 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 4th quarter of 2023.

MR#7 AD 12/16/2019 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 4th quarter of 2023, and the 1st and 2nd quarters of 2024.

MR#8 AD 08/05/2009 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 4th quarter of 2023.

MR#10 AD 01/15/2019 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 1st and 2nd quarters of 2024.

MR#11 AD 09/20/2023 did not contain evidence that quarterly fire safety preparedness drills were conducted at the time of admission, nor in the 1st and 2nd quarters of 2024.

An interview conducted with the facility administrator, regional operations director, manager of clinical services, home program manager, biomedical operations manager, and director clinical services on August 8, 2024 starting at 12:00 PM confirmed the above findings.






Plan of Correction:

The Facility Administrator or designee will in-service all clinical teammates starting on 08/15/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 4-07-01 "Facility Emergency Management Plan (EMP)" and Policy 5-01-21 "Home Dialysis Monitoring and Ongoing Education with emphasis on but not limited to: A. EMP: 1) the Facility Administrator or designee, is responsible to provide training for patients upon admission and quarterly: a. One drill to be conducted for each shift of patients. b. Include patient emergency takeoff procedure, policy: "Termination of Dialysis in an Emergency". Documentation of training will be kept in the patients charts, "Emergency Evacuation Acknowledgement Form" B. Home: 1) The following need to be reviewed at least Quarterly: Emergency/disaster preparedness. 2) Maintain information in the patient's medical record. Verification of attendance is evidenced by teammate's signature on the in-service sheet.
The Facility Administrator or designee immediately completed a one hundred percent (100%) audit of patient emergency preparedness / fire drill documentation. Missing training documentation for any patients, including for those identified by the surveyor was verified on 08/08/24. [Administrative Assistant developed tracker on 08/08/2024 to identify any patients missing on quarterly Emergency Preparedness dates going forward to ensure they are captured immediately upon return to the unit.] The Facility Administrator or designee will audit fire drill / emergency preparedness training 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-adherence will be correctly immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.



Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey conducted August 5, 2024 through August 8, 2024, Cottman Kidney 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 observations, a review of facility policies, and an interview with the administrator, the facility failed to follow its policies related to discontinuation of dialysis for an arteriovenous (AV) fistula for two (2) of two (2) observations at Station (STN)#4 (MR#18) and STN#5 (MR#19).

Findings include:

A review of the following policies occurred on August 6, 2024 starting at 8:00 AM.

Policy 1-05-01 Infection Control for Dialysis Facilities reads in part, "All teammates, physicians, and non-physicians (NPP) will perform hand hygiene....prior to gloving and immediately after removal of gloves."

Policy 1-04-01 B Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles states in part, "Perform hand hygiene. Put on gloves."

Observations were conducted on August 5, 2024 starting at approximately 9:15 AM.

OBS#1 at STN#4 occurred on 8/5/2024 at approximatley 9:50 AM. Prior to removing the 1st needle, PF#3 was observed to remove gloves and don clean gloves without performing hand hygiene in between doffing and donning gloves. PF#3 put the patient's footrest down and without changing gloves, proceeded to remove the 1st needle. Aseptic technique was not maintained prior to removal of the 1st needle.

OBS#2 at STN#5 occurred on 8/5/2024 at approximately 10:05 AM. Prior to removing the 1st needle, PF#2 was observed to remove gloves and don clean gloves without performing hand hygiene in between doffing and donning gloves. PF#2 pushed up the patient's blanket and put the footrest down and without changing gloves, proceeded to remove the 1st needle. Aseptic technique was not maintained prior to removal of the 1st needle.

An interview conducted with the facility administrator, regional operations director, manager of clinical services, home program manager, biomedical operations manager, and director clinical services on August 8, 2024 starting at 12:00 PM confirmed the above findings.





Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 8/14/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" and Procedure 1-04-01B "Post Dialysis Vascular Access Care: Fistula / Graft Using Safety Fistula Needles" with emphasis on but not limited to: A. Infection control: 1) All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves... 2) Disposable gloves will be worn when caring for the patient or touching the patient's equipment at the dialysis station ... 3) Gloves should be changed when: When going from a "dirty" area or task to a "clean" area or task. B. Post dialysis vascular access care: 1) Perform hand hygiene. Put on PPE. Rationale: Hand hygiene protects patient and teammate from cross contamination. PPE is worn to protect teammate. 2) Conclude dialysis and rinse back per termination procedure specific to dialysis delivery system and blood line used in facility. 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 hand hygiene is performed appropriately prior to gloving and immediately after removal of gloves, per policy: daily for two (2) weeks, then weekly for two (2) weeks, then ongoing compliance will be monitored during monthly infection control audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.



494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT

Name - Component - 00
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.


Observations:

Based on observations (OBS) of the Incenter Dialysis Treatment Area, a review of facility policies, a review of infection control documents, and an interview with the facility administrator, the facility failed to remove expired supplies and medications for two (2) of four (4) observations: OBS#1 and OBS#2.

Findings include:

A review of the following facility policies took place on August 6, 2024 starting at approximately 8:00 AM.

Policy 1-05-01 Infection Control For Dialysis Facilities reads in part, "Supplies will be stored in a manner that maintains their integrity."

Policy 1-06-01 Medication Policy reads in part, "All medications in the facility are checked monthly; and Medications containing a preservative must be discarded 28 days after opening or accessed.....each vial is labeled with the initials of the person opening the vial and the expiration date."

A review of infection Control Audits was conducted on August 6, 2024 at approximately 8:15 AM. The facility provided a folder labeled 2024 Infection Control Audits (electronic audits). Three audits were contained in the file. One audit was dated April 2024, the other two audits did not contain audit dates. All three audits noted that all medications, medical treatment supplies and lab supplies were not expired.

Observation #1 took place on the Incenter Treatment Area from 9:15 AM to 12:30 PM on 08/05/2024. The observation revealed the following:

A white three drawer cart near the lab area contained four (4) adult oxygen masks, expired 07/22/2024, lot#1503690.

The medication preparation area across from stations 23-24 contained two (2) opened multi-dose vials of Heparin Na (sodium) injection with Benzyl Alcohol (a preservative), 30000 units per 30 ml, located in a drawer. Both vials were opened. Vial #1 contained approximately 10 to 15 milliliters (ml) of remaining solution. Vial #2 contained approximately 20 ml of remaining solution. Neither of the vials contained the initials of the person who opened the vials, nor the expiration dates.

The lab area contained:

On the counter, fifteen (15) green top lab tubes containing gel and lithium heparin, expired 07/31/2024, lot#3194891.

In the cabinet, two-hundred (200) green top lab tubes containing gel and lithium heparin, expired 07/31/2024, lot#3194799.

In the cabinet, 4 packages Hemosure IFOB (immunological fecal occult blood test):
Lot#E1110767, quantity of five, expired 05/31/2024
Lot#E1200871, quantity of five, expired 05/31/2024
Lot#E1110767, quantity of five, expired 05/31/2024
Lot#G1211275, quantity of five, expired 07/31/2024

Observation #2 on the Incenter Treatment Area on 08/05/2024 from 2:05 PM to 2:30 PM found the following:

The crash cart contained five (5) adult oxygen masks with a use by date of 05/06/2024, lot#0004094523, a yankauer suction set, expired 07/31/2024, lot#1504323, and two (2) Med Source Suction Catheters, expired 07/19/2024, lot#1504326.

An interview conducted with the facility administrator, regional operations director, manager of clinical services, home program manager, biomedical operations manager, and director clinical services on August 8, 2024 starting at 12:00 PM confirmed the above findings.









Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 8/14/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities", Policy 1-02-08 "Emergency Equipment Checks", Policy 1-06-01 "Medication Policy" and Policy 1-08-02 "Obtaining Lab Specimens" with emphasis on but not limited to:
A. Infection control: 1) Supplies will be stored in a manner that maintains their integrity ... Expiration date and package integrity will be verified prior to use. B. Emergency cart: 1) Emergency equipment, including, but not limited to, oxygen, airways, suction, automated external defibrillator (AED), and artificial resuscitator (ambu bag), and emergency drugs will be on the premises at all times. 2) The following equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional: Weekly: Emergency cart (crash cart) is clean, operational and supplies/medications have not expired. C. Medication: 1) Medications containing a preservative must be discarded 28 days after opening or accessed ... Each vial is labeled with the initials of the person opening the vial and the expiration date. 2) All medications are checked monthly for expiration dates. 3) Medications are ordered and replaced prior to expiration. 4) Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of per state/local regulations. D. Obtaining lab specimens: 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 sharp's container. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
On 08/05/24, the Facility Administrator directed teammates to remove expired items identified by surveyor's observation and appropriately discard them. The Facility Administrator or designee immediatley completed a one hundred percent (100%) audit of all medications and treatment supplies, crash cart supplies and laboratory supplies with expiration dates to verify all expired items were removed from all areas of the the facility on 08/05/24. Ongoing compliance will be monitored with the monthly infection control audit and the emergency equipment checks per policy. 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 Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.



494.80(d)(2) STANDARD
PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO

Name - Component - 00
In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted-

At least monthly for unstable patients including, but not limited to, patients with the following:
(i) Extended or frequent hospitalizations;
(ii) Marked deterioration in health status;
(iii) Significant change in psychosocial needs; or
(iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.





Observations:

Based on a review of medical records (MR), facility policy, and an interview with the administrator and clinical coordinator, the facility failed to assure that an interdisciplinary plan of care (POC) was conducted in accordance with timeframes for patients who are declared unstable. One (1) of one (1) medical record noting instability did not meet the requirement: MR#5.

Findings include:

A review of the following facility policy took place on August 6, 2024 starting at approximately 8:00 AM.

Policy 1-14-01 Interdisciplinary Team (IDT) Patient Assessment and Plan of Care states in part that care plans will be conducted, "Monthly (unstable patients) - Monthly until patient is determined by interdisciplinary team to be stable."

A review of MRs was conducted on August 6, 2024 starting at 11:45 AM and again on August 7, 2024 starting at 8:15 AM. The admission date (AD) is indicated below.

MR#5 AD 05/01/2024 found that the patient was declared unstable on 01/05/2023. Subsequent care plans were completed on 02/29/2023 (unstable), and 03/20/2023 (unstable). There were no care plans completed after 03/20/2023 until 07/31/2023 at which time the patient was declared to be stable. The facility failed to provide evidence of a monthly care plan after 03/20/2023 when the patient was still found to be unstable.

An interview conducted with the facility administrator, regional operations director, manager of clinical services, home program manager, biomedical operations manager, and director clinical services on August 8, 2024 starting at 12:00 PM confirmed the above findings.




Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates and the Interdisciplinary Team starting on 08/19/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-14-01 "Interdisciplinary Team (IDT) Patient Assessment and Plan of Care" with emphasis on but not limited to: 1) A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted... At least monthly for unstable patients, including but not limited to, patients with the following: Extended or frequent hospitalizations; Marked deterioration in health status; Significant changes in psychosocial needs; Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. 2) Assessments continue monthly until patient is determined by interdisciplinary team to be stable. Complete patient plan of care meeting within 15 days of the completion of the re-assessment and plan of care. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.
The Facility Administrator designated a Care Plan Champion who will be responsible for identifying which care plans are due with the IDT, then verify plans are completed timely. The Facility Administrator or designee will conduct an audit on all care plans scheduled to be completed during the month, to verify stability status is designated appropriately, [including but not limited to those patients meeting unstable criteria per policy], and assessments and care plans are completed timely: monthly for three (3) months. 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 IDT during Core Team meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed, until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.



494.90(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 review of facility policies, medical records (MR), hemodialysis (HD) treatment records, peritoneal dialysis (PD) treatment records, and an interview with the facility administrator and clinical coordinator, the facility did not address abnormal findings per the facility's policy and/or did not conduct post treatment nursing assessments for hemodialysis (HD) patients for two (2) of nine (9) HD MR reviewed: MR#1 and MR#4, and did not provide evidence that pertinent clinical data was captured for peritoneal dialysis (PD) patients for one (1) of two (2) PD MR reviewed: MR#10.

Findings include:

The following facility policies were reviewed on August 6, 2024 starting at 8:00 AM.

Policy 1-03-08 Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment reads in part, All medications including time administered, dose, route, and initials of person administering the medication and indication and response to PRN medication. Pre-Dialysis: Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initialed. Abnormal Findings: Blood pressure: systolic greater than 180 mmHg or less than 90 mm HG; diastolic greater than or equal to 100 mm HG or less than 50 mm HG. Intradialytic: Abnormal findings will be reported to the licensed nurse immediately (refer to Abnormal Findings section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notified the physician or NPP as needed of changes in patient status. All findings, interventions and patient response will be documented in the patient's medical record. Abnormal findings: Blood pressure (BP): systolic greater than 180 mm/Hg or less than 90 mm/Hg; diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg; Post Treatment: If an abnormal finding 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. Licensed nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician or NPP is necessary prior to discharge of the patient from the facility: Abnormal findings: systolic BP greater than 140 mm/Hg or less than 90 mm/HG; diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg."

Facility Policy 5-01-29 Daily Home Treatment Record (Flowsheet) states in part, "As clinically applicable, all treatment data outlined on the Daily Home Treatment Record must be collected. Completed Daily Home Treatment Records must be reviewed to assist in evaluating the patient's progress and self-care decision-making process. This post-treatment data review will be verified by the Peritoneal Dialysis registered nurse documenting review in the medical record per guidance below: a) the licensed nurse will review the patient's data via submitted Daily Home Treatment Records....d) the licensed nurse is responsible for end of month review for all Daily Home Treatment Records." The policy also contains a section on Abnormal Findings which reads in part, "...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient's medical record....Fluid Status: if patient is above or below 2 kg from the target weight; if patient is using 4.25% (red) dialysate....All Daily Home Treatment Records will be reviewed, attested to, and maintained as part of the patient's medical record."

Policy 1-06-01 Medication Policy reads in part, "Medications are administered as prescribed and then documented in the patient's medical record; Document the name of the medication, dose, route, time patient response and signature of the teammate administering the medication."

A review of MRs was conducted on August 6, 2024 starting at 11:45 AM and again on August 7, 2024 starting at 8:15 AM. The admission date (AD) is indicated below.

MR#1 AD 05/08/2024. HD Treatment Records reviewed from 07/22/2024 to 08/02/2024 found the following:

07/26/2024: HD Treatment was initiated by the licensed practical nurse at 6:27 AM. Blood pressure (BP) was 203/115 at the start of treatment. RN was notified of the elevated blood pressure. The RN, at 6:34 AM, noted that the patient was hypertensive, and that PRN (as needed) Clonidine would be administered. BP at 7:04 AM was 224/183, and 200/104 at 7:05 AM as noted by the RN. BP improved to 156/90 at 7:34 AM per the RN. However, there was no documentation on the treatment details report or in the electronic medical record that PRN Clonidine was administered.

MR#4 AD 02/07/2024. HD Treatment Records reviewed from 7/11/2024 to 08/01/2024 found the following:

07/11/2024: BP readings were as follows: 7:30 AM (start of treatment) 175/110, 7:32 AM 184/109, 8:02 AM 171/105, 8:32 AM 159/107, 9:02 AM 172/100, 9:32 AM 159/98, 10:02 AM 151/105, 10:11 AM 164/110 (end of treatment). There was no indication that the licensed nurse was notified of the elevated diastolic blood pressures throughout the treatment. There was no evidence of completion of a post nursing assessment addressing the abnormal findings.

07/13/2024: BP readings were as follows: 7:59 AM (start of treatment) 201/131, 8:02 AM 201/130. There was no note that RN was notified of the elevated blood pressures at the start of treatment. An RN note at 8:12 acknowledged the elevated BP and stated that the patient would take his/her BP medications at chairside. Continued BP readings by the patient care technician (PCT) throughout the treatment were: 8:32 AM 187/123, 9:02 AM 181/113 (note that patient took BP medications), 9:32 AM 187/115, 10:02 AM 191/110, 10:32 AM BP 179/114, 11:02 AM 192/122, 11:21 AM 178/123 (end of treatment). There was no indication that the RN was notified of the continued elevated diastolic BP's, nor was there a subsequent RN note or post nursing assessment addressing the abnormal findings.

MR#10 AD 01/15/2019. PD Treatment Records reviewed from 05/06/2024 to 07/29/2024 found that the patient failed to document the dextrose concentration (either 1.5%, 2.5% or 4.25%) over the time frame noted above. Therefore, it was unable to be determined if the patient had used a 4.25% dextrose solution which is considered an abnormal finding per facility policy.

An interview conducted with the facility administrator, regional operations director, manager of clinical services, home program manager, biomedical operations manager, and director clinical services on August 8, 2024 starting at 12:00 PM confirmed the above findings.






Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/16/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment" [In-center], Policy 1-06-01 "Medication Policy" and Policy 5-01-29 "Daily Home Treatment Record (Flowsheet)" with emphasis on but not limited to:
A. Policy ICHD- Data collection, monitoring and nursing assessment: [Pre-treatment data collection]: 1) Patient data will be obtained and documented by the patient care technician or licensed nurse. Data collection includes: Measurement of blood pressure, sitting and standing and intradialytic BP in the sitting/reclined or supine position and pre and post patient weight. 2) Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse ... If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. [Intradialytic monitoring]: 1) 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 or sooner as required by state law. 2) Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately... The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 3) The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 4) All findings, interventions and patient response will be documented in the patient's medical record. 5) Additional documentation if applicable includes the following: a. All medications including time administered, dose, route and initials of person administering the medication; b. Indication and patient response to PRN medication... [Post Treatment]: 1) 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]: a. Blood pressure - Pre dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg. b. Blood Pressure-Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. c. Blood Pressure Post Treatment if the patient can stand: Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg; Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg. Sitting BP for patient's that cannot stand: Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg; Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg.
B. Policy – Medication: 1) Medications are administered as prescribed and then documented in the patient's medical record. No medications are given without an order from the physician or non-physician practitioner (NPP). Medication orders must include the patient name, drug name, dose, route, frequency, date and time the order was received.
C. Policy - Daily home treatment record: 1) As clinically applicable, all treatment data outlined on the Daily Home Treatment Record must be collected. Completed Daily Home Treatment Records must be reviewed to assist in evaluating the patient's progress and self-care decision-making process. This post-treatment data review will be verified by the Peritoneal Dialysis registered nurse documenting review in the medical record per guidance below. a) The licensed nurse (RN/LPN/LVN) will review the patient's data via the submitted Daily Home Treatment Records...d) The licensed nurse is responsible for end of month review for all Daily Home Treatment Records. 2) All Daily Home Treatment Records will be reviewed, attested to, and maintained as part of the patent's medical record.
In-Center: The Facility Administrator or designee will complete flow sheet audits to verify any documentation of abnormal findings is also reported to the licensed nurse, and response is documented including but not limited to post treatment assessment, and physician notification as needed, per policy: 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.
PD: PD nurses will re-train all patients on the new treatment form, re-educating them on the importance of placing Dextrose choice on either the flowsheet or in the Electronic Treatment Record. The Facility Administrator or designee will conduct audits on one hundred percent (100%) of the home treatment forms to verify all treatment data which is outlined on the daily treatment record is collected; PD nurse has reviewed; if abnormalities are noted, they will be documented in the clinical record and physician notified if applicable: monthly for three (3) months. 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 Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.



494.90(a)(1) STANDARD
POC-ACHIEVE ADEQUATE CLEARANCE

Name - Component - 00
Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.


Observations:

Based on a review of medical records (MR), hemodialysis (HD) treatment records, facility policies, and an interview with the administrator, the agency failed to follow hemodialysis (HD) treatment physician orders for five (5) of nine (9) HD MR's reviewed: MR#1, MR#3, MR#4, MR#5, and MR#6.

Findings include:

The following policies were reviewed on August 6, 2024 starting at approximately 8:00 AM.

Facility Policy 1-03-08 Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment reads in part, "Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment...The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation. Prescription components include but are not necessarily limited to:.....Blood flow rate (BFR), Dialysate flow rate... The nursing assessment includes the following components: verification or prescription including machine parameters; If the dialysis prescription is not being met the reason will be documented and the licensed nurse informed..."

A review of MRs was conducted on August 6, 2024 starting at 11:45 AM and again on August 7, 2024 starting at 8:15 AM. The admission date (AD) is indicated below.

MR#1 AD 05/08/2024. A review of hemodialysis treatment records from 07/22/2024 to 08/02/2024 revealed the following: 07/26/2024: Dialysate Flow Rate (DFR) was ordered to run at 600 ml (milliliters) per min. The HD treatment started at 6:27 AM and ended at 9:18 AM. Throughout the treatment, the DFR ran at 500 ml/min. instead of the ordered 600 ml/min. There was no reason for or note addressing the altered DFR.

MR#3 AD 07/28/2016. A review of hemodialysis treatment records from 07/23/2024 to 08/03/2024 found the following: 08/03/2024: DFR was ordered at run at 700 ml/min. The HD treatment began at 6:13 AM and ended at 9:29 AM. Throughout the treatment, the DFR ran at 500 ml/min, instead of the ordered 700 ml/min. 07/30/2024: DFR was ordered at 700 ml/min. The HD treatment began at 6:13 AM and ended at 9:43 AM. Throughout the treatment, the DFR ran at 500 ml/min, instead of the ordered 700 ml/min. 07/25/2024: DFR was ordered at 700 ml/min. The HD treatment began at 6:06 AM. The DFR ran at 500 ml/min until 7:03 AM at which time it was increased to 700 ml/min. There was no reason for or note addressing the altered DFR during the first hour of treatment.

MR#4 AD 03/25/2024. A review of hemodialysis treatment records from 7/11/2024 to 08/01/2024 found the following: 08/01/2024: Blood Flow Rate (BFR) was ordered to run at 400 ml/min. The HD treatment began at 7:27 AM and ended at 10:52 AM. The BFR ran at 350 ml/min from 7:27 AM to 10:32 AM instead of 400 ml/min. There was no indication or note addressing the reason for the altered BFR.

MR#5 AD 05/01/2014. A review of hemodialysis treatment records from 07/12/2024 to 07/31/2024 found the following: 07/31/2024: BFR was ordered to run at 400 ml/min. The HD treatment began at 7:54 AM and ended at 9:31 AM. BFR varied throughout the treatment from 200 ml/min to 350 ml/min. 07/26/2024 BFR was ordered to run at 400 ml/min. The HD treatment began at 7:02 AM and ended at 10:19 AM. The BFR ran at 350 ml/min throughout the treatment. There was no reason for or note addressing the altered BFR. 07/22/2024: DFR was ordered to run at 700 ml/min. The HD treatment began at 7:24 AM and ended at 9:29 AM. The DFR ran at 500 ml/min throughout the treatment.

MR#6 AD 10/18/2022. A review of the hemodialysis treatment records from 07/23/2024 to 08/03/2024 revealed the following; 08/01/2024: DFR was ordered to run at 800 ml/min. The HD treatment began at 9:52 AM and ended at 2:09 PM. The DFR ran at 500 ml/min throughout the treatment. There was no reason for or note addressing the altered DFR.

An interview conducted with the facility administrator, regional operations director, manager of clinical services, home program manager, biomedical operations manager, and director clinical services on August 8, 2024 starting at 12:00 PM confirmed the above findings.







Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/16/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: 1) Patient identity, prescription and machine settings are verified by teammates prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. 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. Prescription components include but are not necessarily limited to: Blood Flow rate, Dialysate flow rate ... 2) If the dialysis prescription is not being met [including dialysis flow rate or change to/inability to obtain prescribed blood flow rate] the reason will be documented, and the licensed nurse informed. 3) 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 when teammates document the prescription is not being met, the licensed nurse is notified, and the nurse responds appropriately to the findings per policy: 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 and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed, until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.



494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P

Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;



Observations:

Based on medical record (MR) reviews, observations on the incenter treatment area, facility policies, and an interview with the administrator, the facility failed to provide evidence of following its policies related to hemodialysis (HD) access visibility for three (3) of ten (10) observations at the following stations (STN): STN#4, STN#5, and STN#6, cleansing of the HD access site for one (1) of two (2) observations: STN#5, and temperature monitoring related to peritoneal dialysis (PD) patients for two (2) of two (2) MR's reviewed: MR#10 and MR#11.

Findings include:

The following policies were reviewed on August 6, 2024 starting at approximately 8:00 AM

Policy 1-03-08 Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment reads in part, "The vascular access site, blood line connections and the patient's face should be visible throughout the dialysis treatment; the nursing assessment includes the following components...verification that the patient access is visible..."

Policy 1-04-01 Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Access Care states in part, "Patient are encouraged to wash access extremity with soap and water upon arrival for dialysis, if able. If patient unable to wash site, patient care teammate will clean access extremity with skin cleansing agency and pat dry."

Policy 1-04-01E AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose reads in part, "Procedure: 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. Rationale: Verifies that access extremity has been cleaned."

Policy 5-01-29 Daily Home Treatment Record (Flowsheets) states in part, "Abnormal Findings: Temperature Pre/Post/PRN (as needed): Greater than 100 degrees Fahrenheit or a 2 degree rise over baseline."

Observations on the dialysis treatment area took place on Monday, August 5, 2024 starting at 9:15 AM. The facility provided a seating chart/schedule for Monday-Wednesday-Friday (3 shifts), and Tuesday-Thursday-Saturday (2 shifts). The following situations were observed:

STN#4 (MR#18) was observed on 08/05/2024 at 9:20 AM to have a blanket covering the access site such that the access site was not able to be visualized.

STN#5 (MR#19) was observed on 08/05/24 at 9:25 AM to have a blanket covering the access site such that the access site was not able to be visualized.

STN#6 (MR#22) was observed on 08/05/2024 at 9:30 AM to have a blanket covering the access site such that the access site was not able to be visualized.

STN#5 (MR#16) was observed on 08/05/2024 at 11:20 AM as PF#2 prepared to access the arteriovenous (AV) fistula. PF#2 did not wash the patient's arm with soap or an antibacterial scrub prior to palpating and cannulating the access site, and PF#2 did not ask the patient if s/he cleansed the arm upon entering the incenter dialysis unit. After initiating treatment, PF#2 was interviewed and asked by the surveyor if s/he cleansed the patient's arm, to which PF#2 responded yes. PF#2 was asked to show the surveyor what process what used to cleanse the arm. PF#2 produced an alcohol swab. PF#2 was asked if s/he cleansed the arm with the alcohol swab to which PF#2 stated that s/he only cleansed the access sites with the alcohol swab, and did not cleanse the arm. The surveyor then proceeded to ask the patient is s/he cleansed his/her arm upon entering the unit. The patient responded that s/he did not cleanse the arm because s/he did not put cream on his/her arm. It should be noted that the sink intended to be used by patients for cleansing the arm upon entry to the unit is not visible from the treatment floor. It is located at the patient entrance and sits behind a wall which prohibits viewing the sink/activity unless one is standing in the immediate area. The incenter treatment area does contain other sinks throughout the unit which are labeled as clean sinks.

A review of MRs was conducted on August 6, 2024 starting at 11:45 AM and again on August 7, 2024 starting at 8:15 AM. The admission date (AD) is indicated below.

MR#10 AD 01/15/2019. PD treatment records for the time frame 05/06/2024 and 07/29/2024 did not contain any evidence that the patient was monitoring his/her temperature pre or post PD treatments during the time frame noted above.

MR#11 AD 09/20/2024. PD treatment records for the time frame 05/09/2024 to 07/31/2024 did not contain any evidence that the patient was monitoring his/her temperature pre or post PD treatments during the time frame noted above.

An interview conducted with the facility administrator, regional operations director, manager of clinical services, home program manager, biomedical operations manager, and director clinical services on August 8, 2024 starting at 12:00 PM confirmed the above findings.





Plan of Correction:

On 8/14/24, a Governing Body meeting with the Medical Director, Facility Administrator, Nursing Manager and Regional Operations Director was held to review the results of the survey ending on 08/08/24. 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 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 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 08/15/24. Surveyor observations were reviewed. Education included but was not limited to a review of facility policies outlined below. Verification of attendance is evidenced by teammate's signature on the in-service sheet.

1. [Visible access]: Policy 1-03-08 "Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: 1) Intradialytic treatment monitoring and data collection includes, Vital signs completed at least every thirty (30) minutes. At a minimum, obtain and document: Vascular access visible and line connections intact... 2) The vascular access site, blood line connections and the patient's face should be visible throughout the dialysis treatment.
The Facility Administrator or designee will conduct daily observational audits to verify teammates are confirming patient's access site, face and bloodline connections are visible throughout the dialysis treatment, including but not limited to uncovering the blanket from the access site]: daily for two (2) weeks, then weekly for two (2) weeks, then ongoing monthly during infection control audits. Instances of non-adherence will be addressed immediately. Patients refusing to keep access, bloodline connection or faces visible will be re-educated by the physician. Care conferences will be scheduled with the Interdisciplinary team and the patient to develop individual plans of correction.

2. [Cleanse access extremity]: Policy 1-05-01 "Infection Control for Dialysis Facilities and Policy 1-04-01E "AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula
Needles (SFN) and Administration of Heparin Loading Dose" with emphasis on but not limited to:
A. Infection control: 1) Patients and caregivers will be encouraged to a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis.
B. AV Fistula or Graft 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. Rationale: Verifies that access extremity has been cleaned.
The Facility Administrator or designee will conduct observational audits to verify teammates are encouraging patients to wash hands and access extremity upon entering the treatment area and confirm with the patients they are doing so: daily for two (2) weeks, then weekly for two (2) weeks, then monthly for two (2) months. Instances of non-adherence will be corrected immediately.

3.[Home treatment flow sheets]: Policy 5-01-29 "Daily Home Treatment Record" [Home] with emphasis on but not limited to: 1) As clinically applicable, all treatment data outlined on the Daily Home Treatment Record must be collected. Completed Daily Home Treatment Records must be reviewed to assist in evaluating the patient's progress and self-care decision-making process. 2) All Daily Home Treatment Records will be reviewed, attested to, and maintained as part of the patent's medical record.
The Facility Administrator or designee will conduct audits on one hundred percent (100%) of the home treatment forms to verify all treatment data which is outlined on the daily treatment record is collected, [including but not limited to pre and post temperature readings]; PD nurse has reviewed; if abnormalities are noted, they will be documented in the clinical record and physician notified if applicable: monthly for three (3) months. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately.

The Medical Director will review progress of teammate education, results of audits, and adherence to this plan of correction during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meeting. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed if applicable to achieve sustained compliance. Supporting documentation will be included in the meeting minutes. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this plan of correction.