QA Investigation Results

Pennsylvania Department of Health
LEHIGHTON DIALYSIS
Health Inspection Results
LEHIGHTON DIALYSIS
Health Inspection Results For:


There are  12 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 September 24, 2025, Lehighton Dialysis 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 September 24, 2025, Lehighton 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:




494.30(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 review of facility policy/procedures, observations, and an interview with the facility Administrator, the facility failed to ensure the staff followed infection control protocols, included but not limited to, performing hand hygiene/donning clean gloves, for one (1) of two (2) 'Access of AV Fistula or Graft for Initiation of Dialysis' observations (Observation #1) and two (2) of three (3) 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' observations (Observation #2, Observation #3).

Findings include:

A review was completed of facility policy/procedure on September 24, 2025 at approximately 9:15 a.m.

Procedure #1-04-01E 'AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose' 'Procedure' (1) states "Have patient wash access site with appropriate antibacterial soap, if able. If patient is unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent." (2) Perform hand hygiene. Put on PPE." ...... (11) "While maintaining aseptic technique, cleanse the site by applying skin antiseptic ...."

Observations conducted in patient treatment area on September 19, 2025 between approximately 9:20 a.m. - 1:45 p.m. revealed the following:

Observation #1: During observation #1 of 2 'Access of AV Fistula or Graft for Initiation of Dialysis' on 09/19/25 at approximately 10:35 a.m., of patient #5 at station #2; Employee #6 washed skin over access site and did not remove gloves/perform hand hygiene before applying antiseptic over cannulation site.

Procedure: 1-03-121 'Termination of Dialysis Utilizing B Braun Dialog+ Dialysis Delivery Systems with all Single Use Dialyzer Types and Streamline Bloodlines' 'Procedure' (7) "... Aseptically disconnect arterial blood line from arterial access connection. ...(14) "Disconnect venous blood line from the venous access. (15): Discard gloves, perform hand hygiene and put on new gloves." (16) "Perform post dialysis access care per procedure."

Observation #2: During observation #2 of 3 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' on 09/19/25 at approximately 9:25 a.m., of patient #7 at station #6; Employee #7 did not perform hand hygiene after disconnecting the bloodlines and prior to before removing the first needle.

Observation #3: During observation #3 of 3 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' on 09/19/25 at approximately 10:25 a.m., of patient #8 at station #7; Employee #7 did not perform hand hygiene after disconnecting the bloodlines and prior to before removing the first needle.


An interview with the facility Administrator on September 23, 2025 at approximately 2:45 p.m. and email correspondence with the facility Administrator on September 24, 2025 at approximately 9:00 a.m. confirmed the above findings.









Plan of Correction:

V 113 The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/30/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities", Procedure 1-04-01E "AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose" and Procedure 1-03-12I "Termination of Dialysis Utilizing B Braun Dialog+Dialysis Delivery Systems with all Single Use Dialyzer Types and Streamline Bloodlines" with the emphasis on but not limited to: A. Infection Control Policy: 1) All teammates, Physicians and Non-physician (NPP) will perform hand hygiene ... b. prior to gloving and immediately after removal of gloves... B. AVF AVG Cannulation Procedure: 1) Step 1: Have patient wash access site with appropriate antibacterial soap, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry. 2) Step 2: Perform hand hygiene. Put on PPE. C. Termination of Dialysis... B Braun Procedure: 1) Step 7: ... Aseptically disconnect arterial blood line from arterial access connection... 2) Step 14: Disconnect venous blood line from the venous access. 3) Step 15: Discard gloves, perform hand hygiene and put on new gloves. 4) Step 16: Perform post dialysis access care per procedure.

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 teammates are performing hand hygiene with glove donning per policy and treatment procedures: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control 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.


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, water log review, and an interview with the facility Administrator, it was determined the facility failed to ensure staff followed facility policy/procedure and/or manufacturers directions for use for dialysis machine cleaning/disinfection procedures for one (1) of one (1) 'B. Braun Dialysis Delivery System Clean and Disinfect Log' reviewed (Machine Log #1); failed to ensure the water purification machine annual preventive maintenance was conducted for one (1) of one (1) 'CWP Preventive Maintenance Checklist' reviewed (Maintenance Checklist #1); and failed to ensure the CWP water purification machine was disinfected weekly for one (1) of one (1) 'Daily Water Treatment Log' reviewed (Water Treatment Log #1).


Findings include:

A review was completed of facility policy/procedure on September 24, 2025 at approximately 9:15 a.m.

Policy 'B Braun Dialog Dialysis Delivery System Cleaning and Disinfection Policy' 'Purpose' "To promote patient safety by cleaning and disinfection of B Braun dialysis delivery Systems." (4) 'Examples of Cleaning. Disinfection Procedures and Intervals' 'Procedure' 'Thermal Disinfection' "Each Treatment Day" (if delivery system has not come in contact with bicarb concentrate, thermal disinfection is acceptable). '50 % Citric Acid/Thermal Disinfection' "Each Treatment Day" (after patient use, end of day).'Paracetic Acid End to End Disinfection' "Monthly" (Integrated Heat Program). (6) "Facilities will develop a specific Dialysis Delivery System Cleaning and Disinfection Log ..... Cleaning and disinfection of dialysis delivery systems will be documented on this log."

Facility water/machine maintenance logs were reviewed on September 22, 2025 at approximately 10:00 a.m.

Machine Log #1: A review of the 'B Braun Dialysis Delivery System Clean and Disinfect Log' (Date range from 02/12/24 - 11/09/24) revealed the following:

The 'Descale', 'Disinfect Type' 'Initials PM' columns were either blank with no entries and/or partial entries on the following dates: 02/13/24, 02/16/24, 02/24/24, 05/07/24, 10/23/24, 10/29/24, and 11/06/24.


Facility policy/procedure for the water purification machine was requested on September 22, 2025 at approximately 11:00 a.m. Per the facility Administrator on 09/23/25 at approximately 1:20 p.m., there is no Davita policy related to the water purification machine maintenance, the manufacturers directions for use are utilized.

'PM Schedule Matrix' was provided. It included but was not limited to 'Evoqua Water Technologies' 'Model Number' "CWP 100' series 'Equipment Sub Type Code' "Primary Water Treatment' 'Annual' "Yes."
'Marcor Purification CWP 100, Model H/S Service Manual' excerpts were provided. (3) Maintenance' 'Components' 'Number' included Numbers "1, 33, 34, 36, 41, 62, 102, 103, 105, 106, 125, and 154" 'Inspection Intervals' "Every Year."

Maintenance Checklist #1: Documentation provided of a 'CWP Preventive Maintenance Checklist' 'Service Date' 10/26/23 'Work Order' "1 year annual maintenance" and 'CWP Preventive Maintenance Checklist' conducted late with a 'Service Date' 02/03/25.

Policy 'Title: CWP RO Chemical Disinfect' 'Purpose' "To disinfect the CWP Internal components. .... This procedure will be performed on a weekly basis."
Manufacturers directions for use 'CWP 100, Model WRO H/S' (3.6.1) 'Frequency' "..... As a guideline, MCP recommends a minimum weekly chemical disinfection to ensure consistent product water microbiological quality."

Water Treatment Log #1: A review of the 'Daily Water Treatment Log' (Date range from 06/17/24 - 01/25/25) revealed the following:

'CWP RO Unit Chemical Disinfection' Line #37 'Chemical Disinfection Initiated' 'Time of Day/Initials' or Line #38 'Test for Chemical Residual after Disinfection' 'Yes or No/Initials' or Line #39 'Chemical Consumed and Jug marked with Date and Initials?' 'Yes or No/Initials'
was blank with no entries on the following dates: 06/19/24 (line #38, #39), 07/30/24 (line #37), 11/12/24 (line #37), 11/19/24 (line #37), 01/02/25 (line #38, #39, facility closed 01/01/25, test for chemical residual should have been conducted prior to treatment the next operating day), 01/22/25 (line #38, #39).


An interview with the facility Administrator on September 23, 2025 at approximately 2:45 p.m. and email correspondence with the facility Administrator on September 24, 2025 at approximately 9:00 a.m. confirmed the above findings.
















Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/30/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment", Policy 1-15-07 "B Braun Dialog Dialysis Delivery System Cleaning and Disinfection Policy" "PM Schedule Matrix" and "CWP RO Chemical Disinfect / Daily Water Treatment Manurfacturer's Directions for Use (DFU)" with emphasis on but not limited to: A. Physical Environment: 1) The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer's recommendations.

B. B Braun DDS Cleaning and Disinfection and Log: 1) Purpose: To promote patient safety by cleaning and disinfection of B Braun dialysis delivery systems. 2) All facilities are to follow manufacturer's procedures for cleaning and chemical disinfection. 3) Examples of Cleaning / Disinftection Procedures and Intervals: a) Thermal Disinfection – Each treatment day [If delivery system has not come in contact with bicarb concentrate, thermal disinfection is acceptable] b) 50% Citric Acid/Thermal Disinfection [After patient use, end of day] c) Peracetic Acid End to End Disinfection – Monthly [Integrated Heat Program] 4) Facilities will develop a specific Dialysis Delivery System Cleaning and Disinfection Log... Cleaning and disinfection of dialysis delivery systems will be documented on this log. 5) At a minimum the facility specific log must include the following elements: ...Type of procedure provided Cleaning / De-scaling; Disinfection (chemical or heat)... Teammate initials; Signature / initials legend. 6) Completed logs will be filed in the designated facility log book and maintained for the entire time the equipment is owned by DaVita.

C. PM Schedule Matrix – 1) CWP 100 series Primary Water Treatment – Annual – Yes; 2) Marcor Purification CWP 100 Model H/S Service Manual – Inspection Intervals – Every Year.

D. CWP RO Chemical Disinfect / Daily Water Treatment Manufacturer's Directions for Use (DFU): 1) Purpose: "To disinfect the CWP Internal components. .... This procedure will be performed on a weekly basis." Manufacturers directions for use 'CWP 100, Model WRO H/S' (3.6.1) 'Frequency' "..... As a guideline, Marcor Purification (MCPP recommends a minimum weekly chemical disinfection to ensure consistent product water microbiological quality." 2) Daily water log should include but not be limited to: a) Line 37: Chemical disinfection inititiated; Time of day / Initials or b) Line 38: Test for Chemical Residual after Disinfection; 'Yes or No/Initials' or c) Line 39: Chemical Consumed and Jug marked with Date and Initials? 'Yes or No/Initials'. 3) Completed logs will be filed in the designated facility log book and maintained by DaVita.

Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. The Facility Administrator will review the preventive maintenance schedule with the Biomed teammate quarterly, including but not limited to CWP annual inspection, per DFU, and verify the updated schedule is filed in the Equipment Maintenance Manual per policy. Results are reviewed in Facility Health Meeting and maintained in facility records. The Facility Administrator or designee will conduct audits of machine logs to verify machine maintenance logs reflect that policies, procedures and Manufacturer's DFU are followed appropriately, including but not limited to: a) B Braun DDS clean and disinfect logs are fully completed: daily for two (2) weeks, then weekly for two (2) weeks and monthly for two (2) months; b) RO Disinfection logs are completed per Manufacturer's DFU: weekly for four(4) weeks, and monthly for two (2) months. 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.


494.100(b)(2),(3) STANDARD
H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS

Name - Component - 00
The dialysis facility must -
(2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and
(3) Maintain this information in the patient ' s medical record.


Observations:


Based on a review of facility policy/procedure, a review of patient medical records, and an interview with the facility Administrator, it was determined the facility failed to ensure the home hemodialysis patient completed blood pressure results in the patient treatment flowsheet for one (1) of one (1) home hemodialysis patient medical records (MR) reviewed (MR#4).

Findings include:

A review was completed of facility policy/procedure on September 24, 2025 at approximately 9:15 a.m.

Policy '3-02-24 'Home Hemodialysis/Peritoneal Dialysis Daily/Monthly Reconciliation, Audit and Close Process' 'Definitions' (1) "Home treatment Records (flowsheets)- The record submitted by the patient or care partner of applicable treatment data including, but not limited to, date, vital signs, ...." (2) Reconcile - Review Home Treatment Records (flowsheets) for accuracy and completeness of documentation in the Clinical System."

A review was conducted of patient medical records on September 23, 2025 at approximately 12:00 p.m.

MR#4 Date of admission 08/14/23: A review of patient treatment flowsheets dated May 1, 2025 - July 28, 2025 revealed the following: 'Pre-Sys/Dia (mmHg) column several dates were marked "Skipped", with no blood pressure entry. The dates with no entries were 05/03/25 - 05/18/25, 05/27/25 - 05/31/25, 06/02/25 - 06/10/25, 06/13/25 - 06/15/25, 06/23/25 - 6/24/25, 06/26/25 - 06/28/25, 07/03/25 - 07/05/25.
Documentation provided of the patient treatment flowsheets being reviewed by the registered nurse. No documentation of the registered nurse providing education to the patient related to the importance of treatment flowsheet entry completeness.


An interview with the facility Administrator on September 23, 2025 at approximately 2:45 p.m. and email correspondence with the facility Administrator on September 24, 2025 at approximately 9:00 a.m. confirmed the above findings.






Plan of Correction:


V 587 The Facility Administrator or designee held mandatory in-services for Peritoneal Dialysis / Home Hemodialysis Licensed Nurses starting on starting on 09/30/25. Surveyor observations were reviewed. Education included a review of Policy 5-01-21 "Home Dialysis Monitoring and Ongoing Patient Education" Policy 5-01-29 "Daily Home Treatment Record (Flowsheet)" and Policy 3-02-24 "Home Hemodialysis/ Peritoneal Dialysis Daily/Monthly Reconciliation, Audit and Close Process"
with emphasis on but not limited to: A. Home Dialysis Monitoring: 1) Retrieve and review treatment information submitted electronically, every 7 days from receipt of treatment level data. Based on what the patient submits, follow-up may be necessary, and the patient's electronic health record will be updated to reflect any new information obtained.
B. Daily home treatment record: 1) Each peritoneal dialysis patient has agreed and been trained to complete documentation of each treatment procedure on the Daily Home Treatment Record, also referred to as a flowsheet. 2) As clinically applicable, all treatment data outlined on the Daily Home Treatment Record (flowsheet) must be collected. 3) Completed Daily Home Treatment Records (flowsheets) will 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 PD Registered Nurse (RN) documenting the review in the electronic health record. 4) The RN will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary.
C. Home Hemodialysis/Peritoneal Dialysis Daily/Monthly Reconciliation... 1) Home treatment
Records (flowsheets)- The record submitted by the patient or care partner of applicable
treatment data including, but not limited to, date, vital signs, ...." (2) Reconcile - Review
Home Treatment Records (flowsheets) for accuracy and completeness of documentation in
the Clinical System. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will utilize the PD / HHD treatment tracker as an audit tool to capture adherence to treatment prescription and completeness of home treatment documentation: all patients weekly for four (4) weeks, then monthly for two (2) months during the monthly patient's clinic visit. Instances of non-adherence will be corrected immediately by providing patient education and follow- up.
The Facility Administrator or designee will review audit results with teammates during check-in 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 a review of facility policy/procedure, a review of patient medical records, a review of air testing logs,and an interview with the facility Administrator, it was determined the facility failed to ensure medications were administered as ordered for one (1) of three (3) in-center hemodialysis patient medical records (MR) reviewed (MR#2) and failed to ensure air testing for one (1) of one (1) air testing logs reviewed (Air Testing Log #1).

Findings include:

A review was completed of facility policy/procedure on September 24, 2025 at approximately 9:15 a.m.

Policy '3-02-03' 'Physician Orders for Patient Care' 'Purpose' To verify that orders are properly documented, transcribed, verified, and implemented ......"

A review was conducted of patient medical records on September 23, 2025 at approximately 12:00 p.m.

MR#2 Date of admission 07/01/24: 'Treatment time:' 3 hours, 15 minutes. Initial Heparin order with a 'Start Date' of 10/05/24, 'Total Heparin Units' 1,900 units.
Patient treatment flowsheet dated 09/12/25 was reviewed. 'Treatment Duration' 197 minutes. 'Heparin Pork' '600 units/hour, intravenous; Infusion, 'Stop Time for hourly dose before end of treatment: 0 minutes.' 'Given' 1,300 units.
Medication dosage not administered as ordered by the physician.


Policy 1-22-04 'Air Testing Policy' 'Purpose' "To provide guidance for air testing." 'Policy' (3) "Quarterly, after successful baseline testing ....."

Facility general testing logs were reviewed on September 22, 2025 at approximately 10:00 a.m.

Air Testing Log #1): Documentation provided of 'Baseline Acetic Acid in Air Testing Logs' for 2022 and 2024. No documentation provided of quarterly air testing in 2023.


An interview with the facility Administrator on September 23, 2025 at approximately 2:45 p.m. and email correspondence with the facility Administrator on September 24, 2025 at approximately 9:00 a.m. confirmed the above findings.










Plan of Correction:

A Governing Body meeting was held on 09/30/25 with the Medical Director, Facility Administrator, Director of Nursing and Regional Operations Director to review the results of the survey ending on 09/24/25. 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 clinicaland biomedical teammates starting on 09/30/25. Surveyor observations were reviewed. Education included but was not limited to a review of the following policies:

A. Policy 3-02-03 "Physician Orders for Patient Care" with emphasis on but not limited to: 1) Purpose: To verify that orders are properly documented, transcribed, verified and implemented in a timely manner for patient care in DaVita facilities and hospital programs which meet all DaVita, federal and applicable state regulations.

The Facility Administrator or designee will conduct flowsheet audits to verify teammates are following physician orders for patient care, including but not limited to orders for total heparin units, per policy: on twenty five percent (25%) 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-adherence will be corrected immediately.

B. Policy 1-22-04 "Air Testing Policy" with emphasis on but not limited to: 1) Air levels of hazardous substances used to disinfect water systems and dialysis delivery systems are maintained at levels acceptable to the guidelines established by the current OSHA Environmental exposure limits. 2) Basic vapor concentration testing is performed in facilities... Quarterly, after successful baseline testing establishes Personal Exposure Limit (PEL) requirements are routinely met... Following patient or teammate complaints regarding chemical vapors; Following major changes in water treatment equipment, disinfection methods, chemicals used or the ventilation system. 3) Vapor concentration testing is performed quarterly during times of peak activities in areas listed below, as applicable: Water treatment area (during water treatment system disinfection); Patient treatment area (priming of dialyzers filled with PAA and/or during the monthly end to end water treatment system disinfection with PAA). 4) The vapor concentration testing results are recorded on the Acetic Acid and Hydrogen Peroxide in Air Test Results Log.

The Facility Administrator or designee will audit facilityAcetic Acid and Hydrogen Peroxing in Air Test Results Log to verify air testing is completed and documented per policy, including but not limited to quarterly air testing: quarterly for three (3) quarters, starting 09/2025. Instances of non-adherence will be corrected immediately.

Verification of attendance is evidenced by teammate's signature on the in-service sheet.

The Medical Director will review progress of teammate education, results of audits, and adherence to this plan of correction during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meeting. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. 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.


494.170(a) STANDARD
MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL

Name - Component - 00
The dialysis facility must-
(1)Safeguard patient records against loss, destruction, or unauthorized use; and
(2) Keep confidential all information contained in the patient's record, except when release is authorized pursuant to one of the following:
(i) The transfer of the patient to another facility.
(ii) Certain exceptions provided for in the law.
(iii) Provisions allowed under third party payment contracts.
(iv) Approval by the patient.
(v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program.



Observations:


Based on a review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure patient medical records were secure against unauthorized individuals for one (1) of one (1) observations (Observation #1).

Findings:

A review was completed of facility policy/procedure on September 24, 2025 at approximately 9:15 a.m.

Policy 'Medical Records Custodian and Maintenance' 'Policy' "Safeguards the confidentiality of the medical record in accordance with established policy and legal requirements. ..... Verifies that all medical records are stored in a safe manner to protect against loss, destruction, or unauthorized use."

Observations conducted in patient treatment area on September 19, 2025 between approximately 9:20 a.m. - 1:45 p.m. revealed the following:

Observation #1: On 09/19/25 at approximately 10:15 a.m., the door exiting the treatment area to the staff hallway with access to the front office (adjacent to the patient waiting room) was observed to not have a locking mechanism.
The door leading into the front office did not have a locking mechanism to prevent unauthorized entry. The front office contained patient medical records (inactive/active) in three (3) unlocked metal storage racks.
Direct access from unauthorized individuals from the patient treatment area was possible.


An interview with the facility Administrator on September 23, 2025 at approximately 2:45 p.m. and email correspondence with the facility Administrator on September 24, 2025 at approximately 9:00 a.m. confirmed the above findings.
















Plan of Correction:

The Facility Administrator had medical records secured behind locked cabinets and keypad lock was installed on the office door. The Facility Administrator or designee held a mandatory in-service for all clinical teammates starting on 09/25/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 3-02-01 "Medical Records Custodian and Maintenance" with emphasis on but not limited to: 1) The responsibilities of the Custodian of medical records include... Safeguards the confidentiality of the medical record in accordance with established policy and legal requirements... Verifies that all medical records are stored in a safe manner to protect against loss, destruction or unauthorized use. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.

The Facility Administrator took action to have medical records secured behind locked cabinets and keypad lock was installed on the office door immediately.

Facility Administrator or designee will monitor the medical records office to verify medical records are maintained secure against unauthorized use, loss or destruction, being located in locked cabinets, in an office secured with a closed, locked door: daily for two (2) weeks, then weekly for two (2) weeks, and monthly for two (2) months. Instances of non-adherence will be corrected 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