QA Investigation Results

Pennsylvania Department of Health
CARLISLE REGIONAL DIALYSIS CENTER
Health Inspection Results
CARLISLE REGIONAL DIALYSIS CENTER
Health Inspection Results For:


There are  11 surveys for this facility. Please select a date to view the survey results.

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



Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted April 14, 2025 through April 15, 2025, Carlisle Regional Dialysis Center, 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 April 14, 2025 through April 15, 2025, Carlisle Regional Dialysis Center, was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.








Plan of Correction:




494.30 STANDARD
IC-SANITARY ENVIRONMENT

Name - Component - 00
The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.


Observations:


Based on treatment area observations, and an interview with the facility Administrator, it was determined failed to ensure all liquids in the patient treatment areas were labeled and contained lids for one (1) of one (1) container observations. (Container Observation #1) and failed to ensure staff members maintained a clean treatment area for one (1) of three (3) Treatment Area Observations. (Treatment Area Observation # 1)

Findings:

Policy regarding labeling liquids was request. No policy was provided.

Observations conducted in the patient treatment area on April 14, 2025 between approximately 9:47 a.m. and 4:07 p.m. revealed the following:

Container Observation #1: On April 14, 2025 at approximately 8:37 a.m. surveyor observed a clear pitcher with a clear liquid. The container did not have any label identifying what the liquid inside the pitcher was and no label that included the date, time and initials of the individual that filled the pitcher.

Treatment Area Observation # 1: On April 14, 2025 at approximately 3:58 p.m. Surveyor observed gloves, used facemasks, scrapes of paper, and caps from supplies on the treatment area floor, including around dialysis stations, under dialysis machines and under dialysis chairs. Surveyor asked employees to clean up the trash on the treatment floor. Employee # 4 cleaned up a few pieces and then stopped. Surveyor was told by employee # 4 stated, "We are told to just leave it. We are also sent home during turnover at times because we are constantly told about the budget." Employee #3 verbalized agreement with employee # 4's statement.

An interview with the facility Administrator on April 15, 2025 at approximately 2:00 p.m. confirmed the above findings.








Plan of Correction:

V 0111 The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 04/16/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities", Infection Control Quick Reference Guide, Policy 1-06-01 "Medication Policy" with emphasis on but not limited to: A. Infection Control: 1) Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. 2) Cleaning and/or disinfection of equipment and work services will be performed as soon as possible following exposure to blood or other potentially infectious materials... B. IC Quick Reference Guide: 1) After each treatment the floor area around chair/bed and dialysis delivery system will be evaluated and cleaned if necessary. Verification of attendance is evidenced by teammate's signature on the in-service sheet.

Water pitchers are no longer in use on the treatment floor. Paper cups for oral medication administration will be filled as needed. Verification of attendance is evidenced by teammate's signature on the in-service sheet.

The water pitcher is no longer in use on the treatment floor, and has been removed. Paper cups will be filled for oral medication administration as needed.

The Facility Administrator or designee will conduct observational audits to verify the facility is maintained in a clean and sanitary manner, including the floor area in the dialysis station as needed, per infection control guidance: daily for two (2) weeks, then weekly for two (2) weeks, then ongoing compliance will be monitored with the monthly during infection control audits. 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


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 treatment area observations, and an interview with the facility Administrator (EMP# 1), it was determined the facility failed to ensure the staff followed infection control protocols, included but not limited to, hand hygiene/don clean gloves for one (1) of four (4) 'Cleaning and Disinfection of the Dialysis Station' observations. (Cleaning and Disinfection of the Dialysis Station Observation #3) and for one (1) of three (3) treatment area observations (Treatment Area Observation # 2)

Findings:

A review was conducted of facility policy titled, 'Infection Control for Dialysis Facilities 1-05-01' on April 14, 2025 at approximately 12:00 p.m. 'Hand Hygiene' section, reads, "...1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene...b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact..."

Observations conducted in the patient treatment area on April 14, 2025 between approximately 9:47 a.m. and 4:07 p.m. revealed the following:

Cleaning and Disinfection of the Dialysis Station Observation #3: On April 14, 2025 at approximately 10:22 a.m. employee #4 failed to remove gloves, perform hand hygiene and don clean gloves after emptying prime waste receptacle and before disinfecting and wiping the dialysis machine.

Treatment Area Observation # 2: On April 14, 2025 at approximately 11:50 employee # 5 removed gloves, went into isolation room, used a glove to push a button on dialysis machine in the isolation room. Employee failed to perform hand hygiene after removing gloves and prior to donning on clean gloves.

An interview with the facility Administrator on April 15, 2025 at approximately 2:00 p.m. confirmed the above findings.











Plan of Correction:

V 0113 The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 04/16/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with emphasis on but not limited to: 1) All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene ... b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact ... 2) Disposable gloves will be worn when caring for the patient or touching the patient's equipment at the dialysis station ... 3) Gloves should be changed when: When going from a "dirty" area or task to a "clean" area or task. Verification of attendance is evidenced by teammate's signature on the in-service sheet.

The Facility Administrator or designee will conduct infection control audits to verify teammates perform hand hygiene appropriately, including with glove wearing and glove changing per policy: daily for two (2) weeks, then weekly for two (2) weeks, then ongoing compliance will be monitored during monthly infection control audits. Instances of non-compliance will be addressed immediately.

The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.


494.30(a)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL

Name - Component - 00
[The facility must demonstrate that it follows standard infection control precautions by implementing-
(4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.



Observations:


Based on treatment area observations, and an interview with the facility Administrator (EMP# 1), it was determined the facility failed to ensure the staff followed infection control protocols, included but not limited to, using clean bleach soaked wipes to disinfect dialysis equipment for one (1) of four (4) 'Cleaning and Disinfection of the Dialysis Station' observations. (Cleaning and Disinfection of the Dialysis Station Observation #4)

Findings:

A review was conducted of facility policy titled, 'Infection Control for Dialysis Facilities 1-05-01' on April 14, 2025 at approximately 12:00 p.m. 'Disinfection' section, reads, "...b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaced..."

Observations conducted in the patient treatment area on April 14, 2025 between approximately 9:47 a.m. and 4:07 p.m. revealed the following:

Cleaning and Disinfection of the Dialysis Station Observation #4: On April 14, 2025 at approximately 3:18 p.m. surveyor observed employee # 4 drop bleach wipes on the floor at station # 1, pick up the wipes and then proceed to wipe dialysis machine. Surveyor requested that employee # 4 get new bleach wipes. Employees #4 stated to surveyor "I don't understand why, it has bleach on it. It doesn't make any sense why I need to get new bleach wipes."


An interview with the facility Administrator on April 15, 2025 at approximately 2:00 p.m. confirmed the above findings.








Plan of Correction:

Relabel each bleach container making sure staff are using the appropriate bleach solution to clean the equipment. Teammates are being audited each turnover that equipment needs wiped down to make sure that they are using the appropriate bleach solution. Teammates will be audited for the next 2-3 weeks to make sure that they following the appropriate policy.


494.30(b)(2) STANDARD
IC-ASEPTIC TECHNIQUES FOR IV MEDS

Name - Component - 00
[The facility must-]
(2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and




Observations:


Based on a review of facility policy/procedure, treatment area observations, and an interview with the facility Administrator, the facility failed to ensure medications were labeled appropriately for one (1) of one (1) medication observations. (Observation #1).

Findings:

A review was conducted of facility policy titled, 'Medication Policy 1-06-01' on April 14, 2025 at approximately 1:00 p.m. 'Policy' section, reads, "...20. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication..."

Observations conducted in the patient treatment area on April 14, 2025 between approximately 9:47 a.m. and 4:07 p.m. revealed the following:

Medication Observation #1: Observation #1: On April 14, 2025 at approximately 8:34 a.m. the following was observed on top of the medication station countertop:
- One (1) prefilled syringe with Heparin Pork 1,500 units for patient # 1- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,600 units for patient # 1- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,600 units CVC Venous for patient # 2- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,600 units CVC Arterial for patient # 2- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 2,000 units for patient # 2- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 2,100 units for patient # 2- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,800 units CVC Venous for patient # 3- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,800 units CVC Arterial for patient # 3- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,800 units CVC Venous for patient # 6- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,800 units CVC Arterial for patient # 6- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 2,500 units for patient # 6- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,800 units CVC Venous for patient # 7- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,800 units CVC Arterial for patient # 7- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 2,600 units for patient # 11- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 2,100 units for patient # 11- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,800 units CVC Venous for patient # 12- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,800 units CVC Arterial for patient # 12- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,600 units CVC Venous for patient # 13- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,600 units CVC Arterial for patient # 13- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1,000 units for patient # 13- the section on the label that read, 'initials' and 'time" was left blank.
- One (1) prefilled syringe with Heparin Pork 1, 200 units for patient # 13- the section on the label that read, 'initials' and 'time" was left blank.


An interview with the facility Administrator on April 15, 2025 at approximately 2:00 p.m. confirmed the above findings.






Plan of Correction:

Audit RN every shift to make sure that they are initialing, dating and timing the medications. Making sure that the RN is following the protocol for medications. RN will be audited each shift that medications are given. Medication labels are pre printed for patients as well but theses must also must be checked when the RN is initialing, dating and timing.


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 treatment area observations, and an interview with the facility Administrator (EMP# 1), it was determined the facility failed to ensure the staff followed infection control protocols, included but not limited to, no food or drink in the patient treatment area for one (1) of three (3) treatment area observations (Treatment Area Observation # 3)

Findings:

A review was conducted of facility policy titled, 'Infection Control for Dialysis Facilities 1-05-01' on April 14, 2025 at approximately 12:00 p.m. 'Facility Hygiene' section, reads, "...17. Food and drinks in the treatment area will be limited to patients...."

Observations conducted in the patient treatment area on April 14, 2025 between approximately 9:47 a.m. and 4:07 p.m. revealed the following:

Treatment Area Observation # 3: On April 14, 2025 at approximately 8:44 a.m. surveyor observed a water bottle sitting on the nurse's station desk. Surveyor asked whose water bottle it was and employee # 4 replied, "It's mine." and removed the water bottle from the treatment floor.

An interview with the facility Administrator on April 15, 2025 at approximately 2:00 p.m. confirmed the above findings.






Plan of Correction:

V 0715 Governing Body meeting was held on 04/16/2025with the Medical Director, Facility Administrator, Director of Nursing and Regional Operations Director to review the results of the survey ending on 04/15/25. 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 clinical teammates starting on 04/16/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with emphasis on but not limited to: 1) Food and drinks in the treatment area will be limited to patients. Sharing and storage in the treatment area is not allowed. Verification of attendance is evidences by teammate's signature on the in-service sheet.

The Facility Administrator or designee will conduct infection control audits to verify food and drink are limited to patients' use per policy: daily for two (2) weeks, then weekly for two (2) weeks, then ongoing compliance will be monitored during monthly infection control audits. Instances of non-adherence will be corrected immediately.

The Medical Director will review progress of teammate education, results of audits, and adherence to this plan of correction, as provided by the Facility Administrator during monthly Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. Action plans will be evaluated for effectiveness, new plans developed as applicable to achieve compliance with teammate adherence to policy and procedure. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this plan of correction.