QA Investigation Results

Pennsylvania Department of Health
LEHIGH VALLEY HOSPITAL ESRD
Health Inspection Results
LEHIGH VALLEY HOSPITAL ESRD
Health Inspection Results For:


There are  8 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 unannounced onsite Medicare recertification survey completed February 6, 2023, Lehigh Valley Hospital ESRD was identified to be in 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:




Initial Comments:


Based on the findings of an unannounced onsite Medicare recertification survey completed February 6, 2023, Lehigh Valley Hospital ESRD 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)(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 phoenix meter for one (1) out of one (1) observations (Observation #1).

Findings include:

A review was conducted of facility policy on February 3, 2023 at approximately 9:30 a.m. Policy 'Dialysis Center: Infection Control' (C) 'Patient Care Practices' (6) "Dispose of items taken into the dialysis station or clean and disinfect non-disposable equipment before taking to a common clean area."

Observations conducted in patient treatment area on February 1, 2023 between approximately 11:45 a.m. - 12:30 p.m. revealed the following:

Observation #1: During observation #1 of 'Access of AV Fistula or Graft for Initiation of Dialysis' on 02/01/23 at approximately 11:50 a.m. of patient #1, station #10, employee #11 utilized a phoenix meter to test conductivity of the dialysis machine. Employee #11 took the phoenix meter to the patient station and returned the meter to the nursing cart in the common area. Employee #11 did not disinfect the meter after use.


An interview with the facility Administrator on February 3, 2023 at approximately 11:30 a.m. and email correspondence on February 6, at approximately 12:15 p.m. confirmed the above findings.














Plan of Correction:



LVH: Medicare Recertification Survey of ESRD Facility) Plan of Correction Dialysis

V0116 494.30(a)(1)(i) IC-IF TO STATION = DISP/DEDICATE OR DISINFECT

CITED FOR: FAILURE TO ENSURE STAFF FOLLOWED IC PROTOCOLS: "RETURNED THE METER IN THE COMMON AREA AND DID NOT DISINFECT AFTER USE'
1. On 2/3/23, clinical dialysis staff were immediately reeducated about the proper disinfection of the phoenix meter in between patient use and prior to returning to common storage.
2. A mandatory learning module will be developed by the Dialysis director, in collaboration with Infection Control and Prevention, which addresses proper disinfection of the phoenix meter in between patient use and prior to returning to common storage. The education reflects protocols in the policy 'Dialysis Center: Infection Control'.
3. Dialysis clinical staff will compete the assigned education by March 15, 2023. Proper disinfection method will be reinforced during daily Patient Safety Huddle through the end of March.
4. The Director or trained designee will conduct cleaning, disinfection, and disposal observations of items taken into the dialysis treatment stations. Audits will occur beginning 3/20/23 and will be conducted 3 times per day for 2 weeks, then 3 times/week for 2 weeks, and then 20 observations/month for a minimum of 3 months.
5. Observation data will initially be reported weekly to the Vice President of Patient Care Services, and then monthly to the Vice President of Patient Care Services, CNO Council, and Vice President/Chief Nursing Quality & Patient Safety Officer. It will also be reported bimonthly during the Division of Nephrology meeting and reviewed monthly at the outpatient dialysis QAPI meeting.
6. The Vice President Patient Care Services is responsible for implementation of this plan of correction.




494.40(a) STANDARD
SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL

Name - Component - 00
5.2.4 Softeners: auto regen/timers/salt/salt level
Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as "regeneration," which involves exposure of the resin bed to a saturated sodium chloride solution.

5.2.4 Softeners
Refer to RD62:2001, 4.3.10
Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration.

The face of the timers used to control the regeneration cycle should be visible to the user.

6.2.4 Softeners
Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated.

The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head.



Observations:


Based on a review of facility policy/procedure, a review of water logs, and an interview with the facility Administrator, it was determined the facility failed to ensure that salt pellets fill at least half the brine tank for one (1) of one (1) water logs reviewed (Water System Checks Log #1).

Findings:

Policy for the brine tank level was requested on February 2, 2023 at approximately 10:30 a.m. Facility Form: 'Water System Checks - RDC' included the following location/check/limits/action for 'Brine Tank' 'Salt Level' 'Greater than 1/4 full 'Add Salt'.

Water System Checks Log #1: The facility water log documentation was requested on 02/2/23 at approximately 9:00 a.m. The 'Water System Log' included a section 'Brine Tank Level Greater Than 1/4 Full'.

12/02/22: Brine Tank Level Entry marked as "3/8."
12/03/22: Brine Tank Level Entry marked as "1/4."
12/04/22: Brine Tank Level Entry marked as "1/4."
12/14/22: Brine Tank Level Entry marked as "1/4."
12/26/22: Brine Tank Level Entry marked as "1/4 +."
01/07/22: Brine Tank Level Entry marked as "1/4."
01/08/23: Brine Tank Level Entry marked as "1/4."
01/09/23: Brine Tank Level Entry marked as "1/4."
01/21/23: Brine Tank Level Entry marked as "1/4."


An interview with the facility Administrator on February 3, 2023 at approximately 11:30 a.m. and email correspondence on February 6, at approximately 12:15 p.m. confirmed the above findings.














Plan of Correction:



LVH: Medicare Recertification Survey of ESRD Facility) Plan of Correction Dialysis

V0190 494.40(A) SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL

CITED FOR: FAILURE TO ENSURE SALT PELLETS FILL AT LEAST HALF THE BRINE TANK FOR WATER LOGS REVIEWED

1. The 'Reverse Osmosis- Water System- Renal Therapies' policy was revised to include a requirement for salt pellets to fill the brine tank a minimum level of greater than half full.
2. The Dialysis facility's form 'Water System Checks -RDC' was revised to include a brine tank minimum level of greater than ½ half full.
3. The Dialysis Director will develop a mandatory learning module by 3/1/23 to include rationale and requirements for minimum salt pellet quantity in the brine tank, as well as revisions to the policy and log.
4. Facilities Management staff assigned to dialysis tasks and all dialysis clinical staff will complete the education by 3/15/23 and information will be reinforced at daily Facility Management huddles led by the Supervisor, Plumbing through the end of March.
5. The Director of Dialysis or Supervisor of Facilities will conduct observations 2 times/week of the brine tank to verify the required amounts of pellets are present and documented on the log 'Water System Checks-RDC'. Observations will begin 3/20/23 for a minimum of 3 months
6. Data results will initially be reported weekly to the Vice President of Patient Care Services, and then monthly to the Vice President of Patient Care Services, CNO Council, and Vice President/Chief Nursing Quality & Patient Safety Officer. It will also be reported bimonthly during the Division of Nephrology meeting and reviewed monthly at the outpatient dialysis QAPI meeting.
7. The Administrator, Facilities Management, is responsible for implementation of this plan of correction.




494.40(a) STANDARD
DI-CONTIN MONITOR/LOGGED 2X/DAY

Name - Component - 00
5.2.8 Deionization: continuous monitor resistivity/logged 2 X day
Refer to RD62:2001, 4.3.6 Deionization: Deionization systems, when used to prepare water for hemodialysis applications, shall be monitored continuously to produce water of one megohm/cm or greater specific resistivity (or conductivity of one microsiemen/cm or less) at 25°C.

6.2.8 Deionization
Deionizers shall be monitored continuously using resistivity monitors that compensate for temperature and are equipped with audible and visual alarms. Resistivity monitors shall have a minimum sensitivity of 1.0 megohm-cm. Patients shall not be dialyzed on deionized water with resistivity less than 1.0 megohm-cm measured at the output of the deionizer

Resistivity monitor readings should be recorded on a log sheet twice each treatment day.



Observations:


Based on a review facility policy/procedure, a review of water logs, and an interview with the facility Administrator, the facility failed to ensure resistivity monitor readings were recorded on a log sheet twice each treatment day for one (1) of one (1) deionized (DI) water logs reviewed (DI Water System Log Review #1).

Findings include:

A review was conducted of facility policy on February 3, 2023 at approximately 9:30 a.m. Policy 'Reverse Osmosis- Water System- Renal Therapies (Dialysis)' (IV. ) 'SKILL LEVEL:' "The Medical Director is ultimately responsible for the water quality delivered to patients. Trained Engineering Personnel and Dialysis staff is responsible for ongoing monitoring activity."
'Start up Procedure for Deionization System' (1) "The DI systems located at ...... are designed in an OFF-Line (bypass) mode of operation." (5) .... Engineering must notify the Unit ....."
(Note: The policy/procedure does not specify recording resistivity readings on a log sheet twice each treatment day, as per regulatory requirements.)

DI Water System Log Review #1: The facility water log documentation was requested on 02/2/23 at approximately 9:00 a.m. DI system utilization logs were reviewed for October 2022 and November 2022 revealed the following:

10/03/22: Documentation of DI system utilized. Log sheet section 'DI TANK 1' 'EVERY 4 HOURS' time entered at 7:31 a.m. No second resistivity reading entered on the log.
Documentation provided of a 'Marcor Purification Field Service Report' 'Reason for Visit:' "RO shut down on this A.M." 'Arrival Time: 10:00 a.m., Depart Time: 2:30 p.m.


11/08/22: Documentation of DI system utilized. Log sheet section 'DI TANK 1' 'EVERY 4 HOURS' time entered at 7:30 a.m. No second resistivity reading entered on the log.
Documentation provided of a 'Marcor Purification Field Service Report' 'Reason for Visit:' "Membrane Pressure Alarm" 'Arrival Time: 11:00 a.m., Depart Time: 1:00 p.m.



An interview with the facility Administrator on February 3, 2023 at approximately 11:30 a.m. and email correspondence on February 6, at approximately 12:15 p.m. confirmed the above findings.










Plan of Correction:

LVH: Medicare Recertification Survey of ESRD Facility) Plan of Correction Dialysis

CITED FOR: FAILED TO ENSURE RESISTIVITY MONITOR READINGS WERE RECORDED TWICE EACH TREATMENT DAY, NOTE: THE POLICY DOES NOT SPECIFY RECORDING READINGS ON LOG SHEET TWICE EACH TREAMENT DAY AS PER REGULATORY REQUIREMENTS.
V0202 494.40(A) DI-CONTIN MONITOR/LOGGED 2X/DAY

1. The Dialysis Director revised the 'Reverse Osmosis- Water System- Renal Therapies' policy to include the specific requirement for completion of resistivity readings 'twice each treatment day' and green light presence when using DI water.
2. This facility runs on R/O water, with DI water being the backup water system and utilized infrequently. The DI Water System Log was revised to reflect the revised policy, and includes documentation requirements for readings twice each treatment day, with time initiated, time discontinued, notification of Medical Director, Dialysis Director or designee, recording of greenlight and sensitivity according to the policy only when DI water is used.
3. The Dialysis Director will develop a mandatory e-learning module by 3/1/23 which includes the requirements of second resistivity readings, documentation twice each treatment day when there has been a disruption of R/O water and DI water is used, and notification to Dialysis leadership.
4. Facilities Management staff assigned to dialysis tasks and all dialysis clinical staff will complete the education by 3/15/23 and information will be reinforced at daily Facility Management huddles led by the Supervisor, Plumbing through the end of March.
5. The Director of Dialysis or Supervisor of Facilities will conduct weekly audits of the DI Water System Log to verify resistivity readings are recorded as required if DI water has been used during that week. If the backup DI water system has not been used during 4 consecutive weeks, a mock change to the backup DI water system will occur. Audits will begin 3/20/2023 for a minimum of 3 months.
6. Results of data collection will be reported monthly to the Vice President of Patient Care Services, CNO Council, and Vice President/Chief Nursing Quality & Patient Safety Officer. It will also be reported monthly during the Division of Nephrology meeting and reviewed monthly at the outpatient dialysis QAPI meeting.
7. The Vice President of Patient Care Services is responsible for implementation of this plan of correction.





494.40(a) STANDARD
MICROB MONITOR-REPEAT CULTURES

Name - Component - 00
7.2 Microbial monitoring methods
7.2.1 General: repeat cultures
Cultures should be repeated when bacterial counts exceed the allowable levels. If culture growth exceeds permissible standards, the water system and dialysis machines should be cultured weekly until acceptable results are obtained. Additional samples should be collected when there is a clinical indication of a pyrogenic reaction or septicemia, and following a specific request by the clinician or the infection control practitioner.

If repeat cultures are performed after the system has been disinfected (e.g., with formaldehyde, hydrogen peroxide, chlorine, or peracetic acid), the system should be flushed completely before collecting samples. Drain and flush storage tanks and the distribution system until residual disinfectant is no longer detected before collecting samples.


Observations:


Based on a review facility policy/procedure, review of water logs, and an interview with the facility Administrator, the facility failed to ensure water cultures were repeated weekly when bacterial counts exceeded the allowable levels for one (1) of one (1) water logs reviewed (Water Log Review #1).

Findings include:

A review was conducted of facility policy on February 3, 2023 at approximately 9:30 a.m. Policy 'Reverse Osmosis- Water System- Renal Therapies (Dialysis)' 'Infection Control and Monitoring' .... (1) "Product water should not contain a total viable microbial count of greater than or equal to 100 CFU/mL in water used to prepare dialysate. The action level is greater then 50 CFU/ml." ... (4) The recommendation for bacteria counts shall be less than 100 CFU/mL in proportioned dialysate exiting the dialyzer. The action level is greater than 50 CFU/mL." 'Procedures for Testing' 'Water Cultures for Stations' (1) Water cultures will be monitored for the Main ROs monthly. ....."
'Water Cultures and LAL Specimen Results:' 'Water culture or LAL is above the action level: (1) "If only the LAL or the water culture are above the action level repeat the water culture or LAL within the month."
(Note: This policy/procedure is not compliant with regulation.)


Water Log Review #1: The facility water log documentation was requested on 02/2/23 at approximately 9:00 a.m. Water Culture laboratory results were reviewed from July 2022 - January 2023.

07/05/22: The 'RDC TP10 Tank TP' water culture results were "60." Documentation of repeat testing results on 07/27/22. ( > weekly repeat testing).
07/05/22: The 'RDC13 Work Room' water culture results were "80." Documentation of repeat testing results on 07/27/22. ( > weekly repeat testing).

08/02/22: The 'RDC TP9 Post TP' water culture results were ">100." Documentation of repeat testing results on 08/26/22. ( > weekly repeat testing).
08/22/22: The 'RDC11' water culture results were ">100." Documentation of repeat testing results on 08/26/22. ( > weekly repeat testing).

10/04/22: The 'RDC TP9 Post TP' water culture results were ">100." Documentation of repeat testing results on 10/25/22. ( > weekly repeat testing).

11/15/22: The 'RDC TP9 Post TP' water culture results were "82." Documentation of repeat testing results on 11/29/22. ( > weekly repeat testing).


An interview with the facility Administrator on February 3, 2023 at approximately 11:30 a.m. and email correspondence on February 6, at approximately 12:15 p.m. confirmed the above findings.














Plan of Correction:

LVH: Medicare Recertification Survey of ESRD Facility) Plan of Correction Dialysis

CITED FOR: FAILED TO ENSURE WATER CULTURES WERE REPEATED WEEKLY WHEN BACTERIAL COUNTES EXCEEDED THE ALLOWABLE LEVELS, NOTE: THIS POLICY /PROCEDURE IS NOT COMPLIANT WITH REGULATION
V0255 494.40(A) MICROB MONITOR-REPEAT CULTURES

1. A 'Water Testing: ROs and Stations – Renal Therapy' policy will be developed by 3/01/23 by the Dialysis Director and Infection Control Director to ensure repeat cultures are conducted according to 494.40(a), which includes repeating cultures weekly when bacterial counts exceed allowable levels.
2. A mandatory water system update learning module will be developed by the Dialysis Director which includes repeat weekly sampling of those specimens exceeding action level.
3. Facilities Management staff assigned to dialysis tasks and all dialysis clinical staff will complete the education by 3/15/23 and information will be reinforced with clinical staff during daily Patient Safety Huddles and with the Facilities Management staff during daily Facilities Management huddles by the Supervisor, Plumbing and will continue until the end of March.
4. The Dialysis Director will conduct monthly audits of all water and dialysate samples to assure weekly repeat testing occurred on water system and dialysis machines exceeding permissible standards. Audits will begin 3/20/2023 for a minimum of 3 months.
5. Data results will be reported monthly to the Vice President of Patient Care Services, LVH-
Cedar Crest Director of Facilities Management, CNO Council, and Vice President/Chief Nursing Quality & Patient Safety Officer. It will also be reported monthly during the Division of Nephrology meeting and reviewed monthly at the outpatient dialysis QAPI meeting.
6. The Vice President of Patient Care Services is responsible for implementation of this plan of correction.




494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU

Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.



Observations:


Based on a review of facility policy/procedure, observations, and an interview with the Administrator, facility failed to ensure testing equipment was calibrated daily for one (1) of one (1) equipment calibration logs reviewed (Phoenix Meter Log #1).

Findings:

Policy for calibrating the Phoenix Meter was requested on February 2, 2023 at approximately 11:00 a.m. No specific facility policy nor Manufacturers Directions for Use were provided.

Manufacturers Directions for Use 'pHoenix XL User Guide' section (G) 'When to Calibrate' states "Mesa recommends that users verify meter values against NIST-traceable solutions daily and calibrate (adjust) the meter when these verifications are out of tolerance."


A review conducted of the facility calibration logs on February 2, 2023 at approximately 10:00 a.m. revealed the following:

Phoenix Meter Log #1: No documentation provided of daily calibration of the Phoenix Meter on 12/08/22. (Documentation provided of patients being dialyzed on 12/08/22).

An interview with the facility Administrator on February 3, 2023 at approximately 11:30 a.m. and email correspondence on February 6, at approximately 12:15 p.m. confirmed the above findings.
















Plan of Correction:

LVH: Medicare Recertification Survey of ESRD Facility) Plan of Correction Dialysis

CITED FOR: FAILED TO ENSURE TESTING EQUIPMENT WAS CALIBRATED DAILY
V0403 494.60(B) PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU

1. The Dialysis Director reviewed the Manufacturer's Directions for Use (DFU). The Dialysis Safety Huddle Sheet was revised to include the name of the person responsible for calibration of the Phoenix meter on each day that it is used.
2. The Dialysis Director will develop a mandatory e-learning module by 3/1/23 which includes a requirement for daily meter calibration as per the Manufacturer's DFU and required documentation.
3. All dialysis clinical staff will complete the education by 3/15/23 and information will be reinforced at daily Patient Safety Huddle through the end of March.
4. The Dialysis Director or designee will conduct daily audits of the calibration logs for both Phoenix meters for 2 weeks, then weekly for 2 weeks, and then monthly audits to ensure daily calibration has been completed. Audits will begin 3/20/23 for a minimum of 3 months.
5. Data results will initially be reported weekly to the Vice President of Patient Care Services, and then monthly to the Vice President of Patient Care Services, CNO Council, and Vice President/Chief Nursing Quality & Patient Safety Officer. It will also be reported bimonthly during the Division of Nephrology meeting and reviewed monthly at the outpatient dialysis QAPI meeting.
6. The Vice President Patient Care Services is responsible for implementation of this plan of correction.



494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS

Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.


Observations:


Based on a review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure that the staff performed proper aseptic technique while initiating treatment for a patient with an AV fistula for one (1) of one (1) observations (Observation #1).

Findings include:

A review was conducted of facility policy on February 3, 2023 at approximately 9:30 a.m. Policy 'Initiating Hemodialysis - Renal Therapies (Dialysis)' 'Procedure' .... (3) Put on gloves, face shield and gown." (4) Cleanse site, using aseptic technique. Insert dialysis needles ..." (Note: This policy does not include the steps listed on the 'CMS ESRD Core Survey Version 1.6' 'Access of AV Fistula or Graft for Initiation of Dialysis' observation checklist. The checklist includes "Wash skin over access with soap and water or antibacterial scrub ...." and "Apply antiseptic to skin over cannulation sites .....").

Observations conducted in patient treatment area on February 1, 2023 between approximately 11:45 a.m. - 12:30 p.m. revealed the following:

Observation #1: During observation #1 of 'Access of AV Fistula or Graft for Initiation of Dialysis' on 02/01/23 at approximately 11:50 a.m. of patient #1, station #10, employee #11 began to initiate dialysis treatment. Patient #1 arrived for treratment with a bandage covering his access site. Employee #11 removed bandage and did not wash skin over access with soap and water or antibacterial scrub prior to applying antiseptic to skin over the cannulation sites.


An interview with the facility Administrator on February 3, 2023 at approximately 11:30 a.m. and email correspondence on February 6, at approximately 12:15 p.m. confirmed the above findings.
















Plan of Correction:

LVH: Medicare Recertification Survey of ESRD Facility Plan of Correction
Dialysis
V0550 494.90(A)(5) POC-VASCULAR ACCESS-MONITOR/REFERRALS

CITED FOR: FAILURE TO USE SOAP AND WATER OR ANTIBACTERIAL SCRUB ON ACCESS

1. On 2/3/23 the staff were immediately educated on the need to use soap and water or antibacterial scrub prior to disinfecting fistulas and grafts.
2. The "Initiating Hemodialysis" policy will be revised by 3/1/23, to include requirements for using soap and water or antibacterial scrub to disinfect the access site.
3. A mandatory learning module will be developed by the Director which addresses the requirement for using soap and water or antibacterial scrub prior to accessing fistulas and grafts. The education will reflect protocols in the policy "Initiating Hemodialysis".
4. All dialysis clinical staff will complete the education by 3/15/23, and information will be reinforced during the Patient Safety Huddle through the end of March.
5. The Director or designee will conduct an audit observing the use of an antibacterial wash prior to disinfecting the access site. All outpatient hemodialysis patient access site disinfection will be observed daily for 2 weeks, then weekly for 2 weeks, then monthly for a minimum of 3 months beginning 3/20/23.
6. Data results will initially be reported weekly to the Vice President of Patient Care Services, and then monthly to the Vice President of Patient Care Services, CNO Council, and Vice President/Chief Nursing Quality & Patient Safety Officer. It will also be reported bimonthly during the Division of Nephrology meeting and reviewed monthly at the outpatient dialysis QAPI meeting.
7. The Vice President Patient Care Services is responsible for implementation of this plan of correction.




494.110 STANDARD
QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL

Name - Component - 00
The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility's organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS.



Observations:


Based on a review of the QAPI (quality assessment and performance improvement) program and an interview with the facility Administrator, the facility failed to ensure the program was facility specific and includes facilioty wide data including but not limited to current professionally accepted clinical practice standards used to track health outcomes for one (1) of one (1) QAPI programs reviewed (QAPI Review #1).

Findings include:

Policy for the facility quality improvement and performance improvement program was requested on February 3, 2023 at approximately 1:30 p.m. No specific facility policy was provided.

QAPI Review #1: The facility QAPI program documentation was requested on 02/2/23 at approximately 2:00 p.m. Per the Administrator, the facility combines two (2) separate certified facilities, the certified acute hospital facility and the certified chronic outpatient facility. The facility could not present a facility specific QAPI program. The combined QAPI program that was provided did not encompass all of the required minimum components, which include but are not limited to, adequacy of dialysis, nutritional status, mineral metabolism/renal bone disease, anemia management, vascular access, medical injuries/medical errors identification, patient satisfaction/grievances, infection control, monitoring performance improvement.

No documentation provided of the professional members of the facility's "interdisciplinary team" (IDT), who participate in the QAPI activities, consist of a physician, registered nurse, masters-prepared social worker, a registered dietitian, and being led by the medical director.


An interview with the facility Administrator on February 3, 2023 at approximately 11:30 a.m. and email correspondence on February 6, at approximately 12:15 p.m. confirmed the above findings.

















Plan of Correction:

LVH: Medicare Recertification Survey of ESRD Facility) Plan of Correction
Dialysis
V0626 494.10 QAPI-COVERS SCOPE SERVICE/EFFECTIVE/IDT/INVOL

1. A facility dialysis QAPI program will be developed for the outpatient hemodialysis program. The policy outlining the QAPI program will be completed by the Dialysis Director, with input from the interdisciplinary team and Administrator, Quality Services.

2. A monthly outpatient dialysis QAPI meeting will be established to review the required minimum components of the program, as applicable to this patient population with a length of stay generally less than two weeks. The medical director will lead the interdisciplinary team QAPI meeting. The minimum components include adequacy of dialysis, nutritional status, mineral metabolism/renal bone disease, anemia management, vascular access, medical injuries/medical errors identification, patient satisfaction/grievances, infection control, and monitoring performance improvement.

3. All dialysis staff, including the interdisciplinary dialysis team, will be assigned the QAPI program and policy education by the Director of Dialysis via a mandatory learning module for completion by 3/15/2023.

4. The Director of Dialysis will audit completion of monthly outpatient dialysis QAPI meetings, which will include inclusion of component data, beginning in April 2023.

5. The corrective actions will be completed by 3/22/2023. Audit data will be shared monthly with the Vice President Patient Care Services, and Administrator, Quality Services.

6. The Vice President Patient Care Services is ultimately responsible for 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, medical record review, and an interview with the facility Administrator, it was determined the facility failed to ensure an initial registered nurse evaluation was conducted, prior to the initiation of first treatment, for four (4) of five (5) patient medical records (MR) reviewed (MR#1, MR#2, MR #3, MR#5) and failed to ensure accurate quarterly facility data input for utilization by the Centers for Medicare & Medicaid Services (CMS) for one (1) of one (1) dialysis facility reports (DFR) reviewed (DFR #1).


Findings include:

Policy for the initial registered nurse evaluation prior to the first dialysis treatment was requested on February 3, 2023 at approximately 10:30 a.m. No specific facility policy was provided.

A review of the patient medical records conducted on 02/03/23 at approximately 9:00 a.m. revealed the following:

MR#1 Date of Admission 01/30/23: Patient's first treatment flowsheet dated 01/30/23 was reviewed. Treatment initiated at 12:51 a.m. No documentation provided of a registered nurse patient evaluation containing all (9) required elements (*Neurologic: level of alertness/mental status, orientation, identification of sensory deficits. *Subjective complaints. *Rest and comfort: pain status. *Activity: ambulation status, support needs, fall risk. *Access: assessment. *Respiratory: respirations description, lung sounds. *Cardiovascular: heart rate and rhythm; presence and location of edema. *Fluid gains, blood pressure and temperature pre-treatment. *Integumentary: skin color, temperature and as needed, type/location of wounds.), prior to the initiation of the first dialysis treatment.
Documentation provided of the registered nurse completing the evaluation at 1:50 p.m.

MR#2 Date of Admission 09/29/22: Patient's first treatment flowsheet dated 09/29/22 was reviewed. Treatment initiated at 12:07 a.m. No documentation provided of a registered nurse patient evaluation containing all (9) required elements (*Neurologic: level of alertness/mental status, orientation, identification of sensory deficits. *Subjective complaints. *Rest and comfort: pain status. *Activity: ambulation status, support needs, fall risk. *Access: assessment. *Respiratory: respirations description, lung sounds. *Cardiovascular: heart rate and rhythm; presence and location of edema. *Fluid gains, blood pressure and temperature pre-treatment. *Integumentary: skin color, temperature and as needed, type/location of wounds.), prior to the initiation of the first dialysis treatment.
Documentation provided of the registered nurse completing the evaluation at 12:42 a.m.

MR#3 Date of Admission 01/03/23: Patient's first treatment flowsheet dated 01/03/23 was reviewed. Treatment initiated at 8:12 a.m. No documentation provided of a registered nurse patient evaluation containing all (9) required elements (*Neurologic: level of alertness/mental status, orientation, identification of sensory deficits. *Subjective complaints. *Rest and comfort: pain status. *Activity: ambulation status, support needs, fall risk. *Access: assessment. *Respiratory: respirations description, lung sounds. *Cardiovascular: heart rate and rhythm; presence and location of edema. *Fluid gains, blood pressure and temperature pre-treatment. *Integumentary: skin color, temperature and as needed, type/location of wounds.), prior to the initiation of the first dialysis treatment.
Documentation provided of the registered nurse completing the evaluation at 8:30 a.m.

MR#5 Date of Admission 09/12/22: Patient's first treatment flowsheet dated 09/12/22 was reviewed. Treatment initiated at 12:48 p.m. No documentation provided of a registered nurse patient evaluation containing all (9) required elements (*Neurologic: level of alertness/mental status, orientation, identification of sensory deficits. *Subjective complaints. *Rest and comfort: pain status. *Activity: ambulation status, support needs, fall risk. *Access: assessment. *Respiratory: respirations description, lung sounds. *Cardiovascular: heart rate and rhythm; presence and location of edema. *Fluid gains, blood pressure and temperature pre-treatment. *Integumentary: skin color, temperature and as needed, type/location of wounds.), prior to the initiation of the first dialysis treatment.
Documentation provided of the registered nurse completing the evaluation at 1:07 p.m.



(Dialysis Facility Report (DFR):
"Purpose of the Report: The Dialysis Facility Report (DFR) for FY ....... is provided as a resource for characterizing selected aspects of clinical experience at this facility relative to other caregivers in this state, ESRD Network, and across the United States. Since these data could be useful in quality improvement and assurance activities, each state ' s surveying agency may utilize this report as a resource during the FY ......survey and certification process. This report has been prepared for this facility by the University of Michigan Kidney Epidemiology and Cost Center (UM-KECC) with funding from the Centers for Medicare & Medicaid Services (CMS) and is based primarily on data reported in CROWNWeb, Medicare claims and data collected for CMS.")
(Overview: "The University of Michigan Kidney Epidemiology and Cost Center (UM-KECC) has produced the Dialysis Facility Reports for FY ........ with funding from the Centers for Medicare & Medicaid Services (CMS). Each facility ' s report is distributed to the facility on the secure Dialysis Reports Web site (www.Dialysisdata.org) each July. Those state agencies responsible for certifying dialysis facilities also receive the reports.")

Policy for facility DFR quarterly data entry was requested on February 3, 2023 at approximately 11:00 a.m. No specific facility policy provided.

DFR #1: The 'Quarterly Update of the Fiscal Year 2023 Dialysis Facility Report for State Surveyors, December 2022' was reviewed on 02/03/23at approximately 10:30 a.m. There were entries during '2020' 'Jan-Dec', '2021' 'Jan-Dec', and '2022' 'Qt1:' 'Jan-Mar'. Per the Administrator on 02/01/23 at approximately 11:00 a.m. and confirming again on 02/03/23 at approximately 11:00 a.m., "The entered data is not accurate and the person who is entering the data is unknown. This happened during the last survey also."


An interview with the facility Administrator on February 3, 2023 at approximately 11:30 a.m. and email correspondence on February 6, at approximately 12:15 p.m. confirmed the above findings.























Plan of Correction:

LVH: Medicare Recertification Survey of ESRD Facility) Plan of Correction
Dialysis
V0715 494.150(C)(2)(I) MD RESP-ENSURE ALL ADHERE TO P&P
1. A policy entitled 'Nursing Assessment/Evaluation of Outpatient Hemodialysis Patient' is being developed and will be approved by 2/27/23.
2. A mandatory e-learning module outlining requirements for timing of assessment and its components prior to initiating first dialysis treatment will be developed by the Dialysis Director.
3. The dialysis clinical staff will complete the e-Learning module by March 15, 2023. The information in the e-Learning module will be reinforced during daily Patient Safety Huddles and will continue until the end of March.
4. The Director of Dialysis, or designee, will conduct a monthly audit of all outpatient hemodialysis initial treatments for a minimum 3 months for compliance with timing of the assessment and components of assessment. Audits will begin March 15, 2023.
5. Audit results will be submitted monthly to the Vice President Patient Care Services, Vice President Patient Care Services Chief Nursing Quality & Patient Safety Officer, and every other month during the Division of Nephrology meeting. The audit results will also be reviewed at the monthly outpatient dialysis QAPI meeting.
6. The Dialysis Director queried ESRD Network #4 Quality Insights and Dialysisdata.org to inquire about the Dialysis Facility Report quarterly data entry and reporting. A response was received on 2/21/23 from Teamdynamix@umich.edu on behalf of dialysisdata.org. This Facility does not enter into the CrownWeb system as these outpatients are not primary ESRD patients of this facility. This Facility does not receive a Dialysis Facility Report (DFR).
With the assistance of ESRD Network #4/Quality Insights, Dialysisdata.org and CMS, Lehigh Valley Hospital will investigate the origins of the data reported on the Dialysis Facility Report. Based on the information provided by the forementioned agencies, a summary of the investigation and determination regarding the data will be submitted by April 15, 2023.
7. The VP Patient Care Services is responsible for implementation of this plan of correction.




494.170 STANDARD
MR-COMPLETE, ACCURATE, ACCESSIBLE

Name - Component - 00
The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility.


Observations:


Based on a review of facility policy/procedure and an interview with the facility Administrator, the facility failed to ensure patient consent for dialysis treatment was obtained for four (4) of five (5) (MR#1, MR#2, MR#4, MR#5).

Findings include:

A review was conducted of facility policy on February 3, 2023 at approximately 9:30 a.m. Policy 'Consent-Administrative' 'Policy' states "It is required that a general consent be obtained from patients who are competent to give consent, ...... "

A review of the patient medical records conducted on 02/03/23 at approximately 9:00 a.m. revealed the following:

MR#1 Date of Admission 01/30/23: Documentation provided of a patient 'Authorization and Consent for Treatment at (Hospital) Transitional Skilled Unit' (hospital rehabilitation unit) signed on 01/27/23.
No documentation provided of the patient signing a dialysis facility specific consent form to be dialyzed at the facility.

MR#2 Date of Admission 09/29/22: Documentation provided of a patient 'Authorization and Consent for Treatment at (Hospital) Transitional Skilled Unit' (hospital rehabilitation unit) signed on 09/27/22.
No documentation provided of the patient signing a dialysis facility specific consent form to be dialyzed at the facility.

MR#4 Date of Admission 07/27/22: Documentation provided of a patient 'Authorization and Consent for Treatment at (Hospital) Transitional Skilled Unit' (hospital rehabilitation unit) signed on 07/26/22.
No documentation provided of the patient signing a dialysis facility specific consent form to be dialyzed at the facility.

MR#5 Date of Admission 09/12/22: Documentation provided of a patient 'Authorization and Consent for Treatment at (Hospital) Transitional Skilled Unit' (hospital rehabilitation unit) signed on 09/11/22.
No documentation provided of the patient signing a dialysis facility specific consent form to be dialyzed at the facility.


An interview with the facility Administrator on February 3, 2023 at approximately 11:30 a.m. and email correspondence on February 6, at approximately 12:15 p.m. confirmed the above findings.











Plan of Correction:

LVH: Medicare Recertification Survey of ESRD Facility) Plan of Correction Dialysis

V0726 494.170 MR-COMPLETE, ACCURATE, ACCESSIBLE
CITED FOR: FAFILED TO ENSURE PATIENT CONSENT FOR DIALYSIS TREATMENT WAS OBTAINED. THE DEFICIENCY REFERENCED THE ADMIN POLICY – REQUIRNG GENERAL CONSENT.

1. As of 2/21/23, a general consent to treat is obtained by the dialysis facility prior to initial treatment.
2. A mandatory learning module will be developed by the Dialysis Director which addresses obtaining general consent to the dialysis facility prior to initiation of initial treatment. Dialysis clinical staff will complete the education by 3/15/23 and the information will be reinforced during the Patient Safety Huddle through the end of March.
3. The Director, or designee, will conduct a medical record audit for presence of consent documentation prior to initial dialysis treatment. The medical records of all initial outpatient dialysis treatment patient will be audited daily for 2 weeks, then weekly for 2 weeks, and then monthly for a minimum of 3 months. Audits will begin 3/15/23 for a minimum of 3 months.
4. Audit results will initially be submitted weekly to the Vice President of Patient Care Services, and then monthly to the CNO Council, Vice President of Patient Care Services Chief Nursing Quality & Patient Safety Officer, bimonthly during the Division of Nephrology meeting, and reviewed monthly at the outpatient dialysis QAPI meeting
5. The VP Patient Care Services is responsible for implementation of this plan of correction.