QA Investigation Results

Pennsylvania Department of Health
HERITAGE LAKE DIALYSIS
Health Inspection Results
HERITAGE LAKE DIALYSIS
Health Inspection Results For:


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Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted on March 18, 2024 through March 20, 2024, Heritage Lake Dialysis was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.




Plan of Correction:




Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted on March 18, 2024 through March 20, 2024, Heritage Lake Dialysis, was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.






Plan of Correction:




494.60 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 reviews of observations, facility policy, and an interview with the facility administrator, the facility failed to ensure proper inventory control for four (4) of four (4) observations (Observation #1-#4).

Findings include:

Review of Davita inc. Incenter Hemodialysis Policies and Procedures: Title: Medication Policy: " Purpose: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications; Policy: 1. The Facility Administrator/designee is responsible for supervising the handling, storing, disposing, administering, and controlling of medications and performs monthly audit and inventory; 13. All open or unopened medication packages (i.e. vials, ampules, etc) are stored according to the manufacturer ' s directions. Do not use any medication that has been stored improperly or has expired; 30. All medications in the facility are checked monthly for expiration dates; 32. 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. "
Review of Davita inc. Incenter Hemodialysis Policies and Procedures: Title: " Infection Control for dialysis facilities: " Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment.; Policy: The Center for Disease Control (CDC) recommendations for preventing transmission of infections among chronic hemodialysis patients (dialysis precautions) will be followed when caring for all patients. Supplies: 8. Supplies will be stored in a manner that maintains their integrity. b. expiration date and package integrity will be verified prior to use.

Observations conducted in the center's medication area drawers on 3/18/24 between approximately 3:30 PM-3:50 PM revealed the following:

Observation (OBS) #1 revealed: Eighty-six (86) BD Precision glide needle twenty-one (21) gauge by one (1) inch with expiration date of 9/30/2023.

OBS # 2 revealed: Eighty-one (81) BD Precision glide needle twenty-one (21) gauge by one (1) inch with expiration date of 12/31/2022.

OBS # 3 revealed: Thirty-one (31) BD Eclipse needle twenty-two (22) gauge by one and a half (1.5) inch with expiration date of 5/31/2022.

OBS # 4 revealed: One (1) BD Eclipse needle twenty-two (22) gauge by one and a half (1.5) inch with expiration date of 8/31/2020.


An interview conducted with the Facility Administrator on 3/18/24 at approximately 3:50 PM confirmed the above findings.








Plan of Correction:

V401
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 03/29/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-01 "Medication Policy" and Policy 1-05-01" Infection Control for Dialysis Facilities" with emphasis on but not limited to: A. Medication: 1) The Facility Administrator / designee is responsible for supervising the handling, storing, disposing, administering, and controlling of medications and performs monthly audit and inventory. 2) All open or unopened medication packages (i.e. vials, ampules, etc.) are stored according to the manufacturer's directions. Do not use any medication that has been stored improperly or has expired. 3) All medications in the facility are checked monthly for expiration dates. 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. B. Infection control: 1) Supplies will be stored in a manner that maintains their integrity. 2) Expiration date and package integrity will be verified prior to use. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee immediately conducted a one hundred percent (100%) audit of all medications and supplies with expiration dates. Any items identified as expired in the audit were immediately and appropriately discarded, including items identified by the surveyor's observations.
Ongoing compliance will be monitored by Facility Administrator or designee per policy with the monthly infection control audit. 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.



494.90(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 review of medical records (MR), policies and procedures and interviews with facility clinical manager and facility administrator, it was determined that the facility failed to adequately monitor prescribed blood flow and dialysate flow rates during treatment in three (3) of four (4) MR reviewed (MR # 1, # 3 and # 4) and the facility failed to ensure prescibed treatment times were achieved in two (2) of four (4) MR reviewed. (MR # 2 and # 4)

Findings:
Review of Davita inc. Incenter Hemodialysis Policies and Procedures: Title: Pre-Intra-post treatment data collection, monitoring and nursing assessment: " Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient ' s dialysis treatment, monitoring during treatment and for reviewing the patient ' s response to the treatment and status prior to discharge.; Policy: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse; 2. The nursing assessment will be performed and documented by a licensed nurse ....a. the assessment includes the following components: iii. Verification of prescription including machine parameters; 3. 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: f. blood flow rate (BFR); g. dialysate flow rate (DFR); Intradialytic data collection/assessment: 9. Intradialytic treatment monitoring and data collection ....includes: b. At a minimum, obtain and document the following: iii. Blood and dialysate flows, arterial and venous pressures; 10. 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. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately ... "

Review of Davita inc. Incenter Hemodialysis Policies and Procedures: Title: Prescribed treatment time not met: Purpose: To provide requirements for teammates to follow when a patient ' s treatment is terminated early.; Policy: " a. completion of the early termination of treatment against medical advice form: 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. 3. The RN will obtain the patient ' s signature ...4. 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. B. Prescribed treatment time not met: 1. If shortened/early termination of treatment exceeds thirty (30) or more minutes, the RN will notify the patient ' s attending nephrologist to discuss the appropriate intervention ...; Note: Shortened/early termination of the dialysis treatment includes all reasons the prescribed dialysis time is not met by thirty (30) or more minutes. This includes but is not limited to: the late initiation of treatment with termination at scheduled time, early termination at the end of treatment and interruptions of dialysis during the treatment (i.e. machine or access problems or use of the bathroom by the patient) ... "

Review of Davita inc. Incenter Hemodialysis Policies and Procedures: Title: Early termination of treatment against medical advice form revealed: " I, Patient ' s name, request to terminate my dialysis treatment prior to the prescribed time. I am fully aware that this is against the medical advice of my physician. The risk and consequences of terminating my treatment early have been explained to me ...I hereby willfully assume the risk of my early termination of dialysis treatment and agree not to hold my physician, the dialysis facility, it ' s employees or agents responsible for any harm or injury which may result from my action. "

Review of medical records (MR) on 3/20/24 between 10:15 AM-10:55 AM and 11:10 AM and 12: 30 PM revealed:
MR # 1: Start of care (SOC): 2/7/23; Review of treatment flow sheets from 3/7/24-3/19/24 revealed:
a. Dialysis prescription dated 3/5/24: Treatment time: three (3) hours thirty (30) minutes (two hundred ten (210) minutes; Blood flow rate (BFR): four hundred (400) milliliters per minute; Dialysate flow rate (DFR): six hundred (600) milliliters per minute; Dialysate: one (1) potassium (K), two (2) and a half (0.5) calcium (Ca) acid-dry, Granuflo; ordered target weight: ninety-eight (98.0) kilograms (kg) or two hundred sixteen and one tenth (216.1) pounds (lbs)
b.Treatment flow sheet from 3/7/24: Prescribed Blood flow rate (BFR): four hundred (400);Dialysate flow rate (DFR): six hundred (600): BFR from 8:01 AM through 11:27 AM: three hundred fifty (350) to three hundred sixty (360).
c.Treatment flow sheet from 3/9/24: Prescribed Blood flow rate (BFR): four hundred (400); Dialysate flow rate (DFR): six hundred (600): BFR from 7:46 AM through 11:23 AM: three hundred fifty (350).
d.Treatment flow sheet from 3/12/24: Prescribed Blood flow rate (BFR): four hundred (400);Dialysate flow rate (DFR): six hundred (600): BFR from 7:54 AM through 11:24 AM: ranged between three hundred fifty (350) to three hundred (300).
e.Treatment flow sheet from 3/14/24: Prescribed Dialysate flow rate (DFR): six hundred (600): DFR from 8:31 AM through 11:32 AM: ranged between five hundred ninety (590) through six hundred twenty (620)
f.Treatment flow sheet from 3/16/24: Prescribed Blood flow rate (BFR): four hundred (400); Dialysate flow rate (DFR): six hundred (600): BFR from 7:52 AM through 11:25 AM: three hundred (300); DFR from 8:52 AM through 10:22 AM: ranged between five hundred ninety (590) through six hundred twenty (620).
g.Treatment flow sheet from 3/19/24: Prescribed Blood flow rate (BFR): four hundred (400); Dialysate flow rate (DFR): six hundred (600): BFR from 7:52 AM through 11:22 AM: three hundred fifty (350); DFR from 8:22 AM through 11:22 AM: ranged between five hundred ninety (590) through six hundred twenty (620)

MR # 2: Start of care (SOC): 5/25/22; Review of treatment flow sheets from 3/6/24-3/18/24 revealed:
a. Dialysis prescription dated 3/5/24: Treatment time: four (4) hours (two hundred forty (240) minutes; Blood flow rate (BFR): three hundred (300) milliliters per minute; Dialysate flow rate (DFR): five hundred (500) milliliters per minute; Dialysate: two (2) potassium (K), two (2) and a half (0.5) calcium (Ca) acid-dry, Granuflo; ordered target weight: forty-six and a half (46.5) kilograms (kg) or one hundred two and a half (102.5) pounds (lbs)
b.Treatment flow sheet from 3/8/24: Prescribed Treatment time: Four (4) hours or two hundred forty (240) minutes; post-treatment vitals revealed: Treatment duration: three (3) hours and thirty-two (32) minutes or two hundred twelve (212) minutes; treatment shortened by twenty-eight (28) minutes with no documentation of why treatment was shortened.
c.Treatment flow sheet from 3/11/24: Prescribed Treatment time: Four (4) hours or two hundred forty (240) minutes; post-treatment vitals revealed: Treatment duration: three (3) hours and thirty-two (32) minutes or two hundred twelve (212) minutes; treatment shortened by twenty-eight (28) minutes with no documentation of why treatment was shortened.
d.Treatment flow sheet from 3/13/24: Prescribed Treatment time: Four (4) hours or two hundred forty (240) minutes; post-treatment vitals revealed: Treatment duration: three (3) hours and thirty-one (31) minutes or two hundred eleven (211) minutes; treatment shortened by twenty-nine (29) minutes with no documentation of why treatment was shortened.

MR # 3: Start of care (SOC): 12/24/20; Review of treatment flow sheets from 3/7/24-3/19/24 revealed:
a. Dialysis prescription dated 12/2/23: Treatment time: three (3) hours (one hundred eighty (180) minutes; Blood flow rate (BFR): three hundred (300) milliliters per minute; Dialysate flow rate (DFR): five hundred (500) milliliters per minute; Dialysate: two (2) potassium (K), two (2) and a half (0.5) calcium (Ca) acid-dry, Granuflo; ordered target weight: ninety-eight (98.0) kilograms (kg) or two hundred sixteen and one tenth (216.1) pounds (lbs)
b.Treatment flow sheet from 3/12/24: Prescribed Dialysate flow rate (DFR): five hundred (500): DFR from 8:43 AM through 11:43 AM: ranged between six hundred ninety (600) through six hundred ten (610).
c.Treatment flow sheet from 3/14/24: Prescribed Blood flow rate (BFR): three hundred (300): BFR from 10:20 AM through 10:50 AM: two hundred fifty (250).

MR # 4: Start of care (SOC): 2/15/21; Review of treatment flow sheets from 3/7/24-3/19/24 revealed:
a. Dialysis prescription dated 11/12/22: Treatment time: three (3) hours and thirty (30) minutes (two hundred ten (210) minutes; Blood flow rate (BFR): three hundred and fifty (350) milliliters per minute; Dialysate flow rate (DFR): seven hundred (700) milliliters per minute; Dialysate: three (3) potassium (K), two (2) and a half (0.5) calcium (Ca) acid-dry, Granuflo; ordered target weight: ninety-seven (97.0) kilograms (kg) or two hundred thirteen and nine tenths (213.9) pounds (lbs)
b.Treatment flow sheet from 3/7/24: Prescribed Dialysate flow rate (DFR): seven hundred (700): DFR from 10:50 AM through 11:20 AM: seven hundred ten (710).
c.Treatment flow sheet from 3/9/24: Prescribed Blood flow rate (BFR): three hundred fifty (350): BFR from 9:46 AM through 11:46 AM: three hundred (300).
d.Treatment flow sheet from 3/12/24: Prescribed Blood flow rate (BFR): thirty hundred fifty (350): BFR from 9:44 AM through 12:48 PM: ranged between two hundred (200) through three hundred (300). Prescribed Dialysate flow rate (DFR): seven hundred (700); DFR from 9:44 AM through 10:44 AM ranged between five hundred seventy (570) through seven hundred twenty (720).
e.Treatment flow sheet from 3/14/24: Prescribed Dialysate flow rate (DFR): seven hundred (700): DFR from 8:32 AM through 11:32 AM: ranged between seven hundred ten (710) through seven hundred twenty (720).
f.Treatment flow sheet from 3/16/24: Prescribed Dialysate flow rate (DFR): seven hundred (700): DFR from 8:36 AM through 10:36 AM: ranged between five hundred ninety (590) through seven hundred ten (710).
g. Treatment flow sheet from 3/7/24: Prescribed Treatment time: Three (3) hours and thirty (30) minutes or two hundred ten (210) minutes; post-treatment vitals revealed: Treatment duration: three (3) hours and one (1) minute or one hundred eighty-one (181) minutes; treatment shortened by thirty (30) minutes with no documentation of why treatment was shortened.
h.Treatment flow sheet from 3/12/24: Prescribed Treatment time: Three (3) hours and thirty (30) minutes or two hundred ten (210) minutes; post-treatment vitals revealed: Treatment duration: three (3) hours and five (5) minutes or one hundred eighty-five (185) minutes; treatment shortened by twenty-five (25) minutes with no documentation of why treatment was shortened.

An interview conducted with the Facility Administrator on 3/20/24 at approximately 2:00 PM confirmed the above findings.









Plan of Correction:

V544

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 03/29/24. 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", Policy 1-01-09 "Prescribed Treatment Time Not Met" and Policy 1-01-09A "Early Termination of Treatment Against Medical Advice" form, with emphasis on but not limited to:
A. Policy "Pre- Intra- Post Treatment...": 1) Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. 2) The nursing assessment will be performed and documented by a licensed nurse. The assessment includes, but is not limited to ... verification of prescription including machine parameters... 3) 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. 4) 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 and Dialysate flow rate. 5) Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes, but is not limited to... Blood and dialysate flows... 6) 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. 7) 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. 8) All findings, interventions and patient response will be documented in the patient's medical record.
B. Policy "Prescribed Treatment Time Not Met": 1) [Completion of the Early Termination of Treatment Against Medical Advice form]: a) 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. b) 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. c) An 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.
2) [Prescribed Treatment Time Not Met]: a) 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. b) Shortened/Early Termination of the dialysis treatment includes all reasons the prescribed dialysis time is not met by 30 or more minutes. This includes but is not limited to: the late initiation of treatment with termination at scheduled time, early termination at the end of treatment and interruptions of dialysis during the treatment i.e. machine or access problems or use of the bathroom by the patient. c) If a patient's treatment is shortened/early terminated, the RN will document the event in the patient's electronic health record. Documentation will include, as appropriate: the amount of time by which the treatment was shortened; a description of why the treatment was shortened; whether the patient's nephrologist was notified; a description of the follow-up medical orders provided by the patient's attending nephrologist (if any); a description of all other interventions planned to address the shortened treatment, including recommendations to the patient. d) A completed copy of the Early Termination of Treatment Against Medical Advice form will be kept in the patient's health record
C. Form "Early Termination of Treatment Against Medical Advice": 1) " I, ____ request to terminate my dialysis treatment prior to the prescribed time. I am fully aware that this is against the medical advice of my physician. The risk and consequences of terminating my treatment
early have been previously explained to me by my physician. I understand that if, before my next treatment, I have any unusual symptoms such as shortness of breath or chest pain I should immediately contact my physician. I hereby willfully assume the risk of my early termination of dialysis treatment and agree not to hold my physician, the dialysis facility, its employees or agents responsible for any harm or injury which may result from my action."
Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct audits:
1) to verify teammates complete appropriate documentation on the treatment record and notify the RN concerning prescribed blood flow rate, and dialysis flow rate if parameters are not meeting treatment prescription, with appropriate RN intervention documented.
2) to verify the "Early Termination of Treatment against Medical Advice" form is signed by the patient and Registered Nurse when treatment times are not met on the treatment record as prescribed.
Each audit series will be conducted 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 on the monthly ten percent (10%) medical records audits to verify compliance. 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.