Initial Comments:
Based on the findings of an on-site, unannounced Medicare recertification survey conducted on August 2, 2021 through August 4, 2021, State College Dialysis, was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an on-site, unannounced Medicare recertification survey conducted on August 2, 2021 through August 4, 2021, State College Dialysis, was identified to have the following standard level deficiencies that were determined to be in compliance with the following requirements of 42 CFR, Subparts A, B, C, and D: Conditions for Coverage for End-Stage Renal Disease Facilities.
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, patient treatment area observations and interview with the facility Administrator (EMP# 1), it was determined the facility failed to ensure the staff followed infection control protocols, including but not limited to, ensuring staff performed hand hygiene/don clean gloves according to facility procedure, for one (1) of two (2) observations of 'Discontinuation of Dialysis with Central Venous Catheter' (Observation #1); for one (1) of two (2) observations of 'Discontinuation of dialysis and Post Dialysis Access Care for AV Fistula or Graft' (Observation # 2); and for five (5) of five (5) observations of patient treatment area (Observations #3, #4, #5, #6 and #7).
Findings include:
A review of facility policy, '1-05-01 Infection Control For Dialysis Facilities' section, 'Teammate Hygiene' on August 3, 2021 at approximately 1:00 p.m. reads, "Hand Hygiene is to be performed upon entering the patient treatment area, prior to gloving, after removal of gloves, after contamination with blood or other infectious material, after patient and dialysis delivery system contact, between patients even if the contact is casual, before touching clean areas such as supplies and on exiting the patient treatment area...Teammate/Patient Safety...11. Teammates will wear disposable gloves when caring for the patient or touching the patient's equipment a the dialysis station, and will remove gloves and wash hands or perform hand hygiene between each patient and/or station...13. Gloves should be changes when soiled with blood, dialysate or other body fluids, when going from a "dirty" area or task to a "clean" area or task, after touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient's dialysis delivery system..."
Observations conducted in the patient treatment area on August 2, 2021 between approximately 1:08 p.m. and 2:42 p.m. and on August 4, 2021 between approximately 8:35 a.m. and 10:43 a.m. revealed the following:
Observation #1 'Discontinuation of Dialysis with Central Venous Catheter': On August 2, 2021 at approximately 1:20 p.m., patient #6 in the private treatment room, employee #4 failed to remove gloves/perform hand hygiene/don clean gloves after reinfusing the extracorporeal circuit.
Observation #2 Discontinuation of dialysis and Post Dialysis Access Care for AV Fistula or Graft' : On August 2, 2021 at approximately 1:31 p.m., patient 9 at station #9, employee #4 failed to remove gloves/perform hand hygiene/don clean gloves after reinfusing the extracorporeal circuit.
Observation #3: On August 2, 2021 at approximately 1:24 p.m., employee # 2 removed used gown, threw it away and then went into the water room to get a new gown. No hand hygiene performed after gown removal and prior to touching the door handle of the water treatment room.
Observation #4: On August 4, 2021 at approximately 10:04 a.m., employee # 2 removed gloves after leaving station # 3 with patient # 7 and then returned to station # 3 to type on the computer. No hand hygiene performed after glove removal.
Observation #5: On August 4, 2021 at approximately 10:34 a.m., employee # 3 removed gloves and went to station # 8 to type on the computer. No hand hygiene performed after glove removal.
Observation #6: On August 4, 2021 at approximately 10:04 a.m., employee # 2 removed gloves after leaving station # 3 with patient # 7 and then returned to station # 3 to type on the computer. No hand hygiene performed after glove removal.
Observation #7: On August 4, 2021 at approximately 10:04 a.m., employee # 2 removed gloves after leaving station # 3 with patient # 7 and then returned to station # 3 to type on the computer. No hand hygiene performed after glove removal.
An interview with the facility administrator on August 4, 2021 at approximately 3:30 p.m. confirmed the above findings.
Plan of Correction:The Facility Administrator (FA) held mandatory in-service(s) for all Clinical Teammates starting on 8/09/2021. Surveyor observations were reviewed. Education included but was not limited to a review of Policy # 1-05-01 Infection Control for Dialysis Facilities with the emphasis on but not limited to: 1) TMs will wear disposable gloves/gown when caring for the patient or touching the patient's equipment at the dialysis station. 2) TMs will remove gloves and perform hand hygiene between each patient and/or station and between clean and dirty tasks. 3) TMs will remove gloves and perform hand hygiene before entering clean supply area/cart. 4) TMs will perform hand hygiene every time personal protective equipment (PPE) is removed. Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet. The FA or designee will conduct infection control audits daily for two (2) weeks then weekly for two (2) weeks then monthly during internal infection control audits to verify compliance. Instances of non-compliance will be addressed immediately.
The FA will review the results of the audits with TMs during homeroom meetings and with Medical Director during monthly Facility Health Meetings (FHM-QAPI) with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this 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 review of facility policy, patient treatment area observations and interview with the facility Administrator (EMP# 1), it was determined the facility failed to ensure staff demonstrated proper management of non-disposable supplies for one (1) of two (2) 'Cleaning and Disinfection of the Dialysis Station' (Observation #1); and five (5) of five (5) observations conducted. (Observation #2, #3, #4, #5, and #6)
Findings include:
A review of facility policy, '1-05-01 Infection Control For Dialysis Facilities' section, 'Dialysis Station Management' on August 3, 2021 at approximately 1:15 p.m. reads, "...65. Items taken into the dialysis station will be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before taken to a common clean area or used on another patient. 66. Teammates will thoroughly wipe down all non-disposable items and equipment..."
Observations conducted in the patient treatment area on August 2, 2021 between approximately 1:08 p.m. and 2:42 p.m. and on August 4, 2021 between approximately 8:35 a.m. and 10:43 a.m. revealed the following:
Observation #1: Cleaning and Disinfection of the Dialysis Station' On August 2, 2021 at approximately 1:41 p.m., employee #1 removed the biohazard bin out of station #3 without disinfecting it. Employee #1 failed to disinfect the dialysis station trash can during cleaning of the dialysis station.
Observation #2: On August 2, 2021 at approximately 2:16 p.m., employee #4 moved the biohazard bin from station #11 to station #10. Employee #4 failed to disinfect the biohazard bin between stations.
Observation #3: On August 2, 2021 at approximately 2:21 p.m., employee #2 failed to disinfect dialysis station trash can from station #11 during cleaning of the dialysis station.
Observation #4: On August 2, 2021 at approximately 2:30 p.m., employee #1 returned the biohazard bin from station #1 to the middle of the treatment area. Employee #1 failed to disinfect the biohazard bin after removing it from station #1.
Observation #5: On August 2, 2021 at approximately 2:32 p.m., employee #4 returned the biohazard bin from station #10 to the middle of the treatment area. Employee #4 failed to disinfect the biohazard bin after removing it from station #10.
Observation #6: On August 4, 2021 at approximately 9:55 a.m., employee #3 removed the Myron-L out of station #3. Employee failed to disinfect the Myron-L prior to removing it from station #3.
An interview with the facility administrator on August 4, 2021 at approximately 3:30 p.m. confirmed the above findings.
Plan of Correction:The Facility Administrator held mandatory in-service(s) for all Clinical Teammates starting on 8/09/2021. Surveyor observations were reviewed. Education included but was not limited to a review of Policy # 1-05-01 Infection Control for Dialysis Facilities with the emphasis on but not limited to: 1) Items taken into the dialysis station will be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before taken to a common clean area or used on another patient. 2) Teammates will thoroughly wipe down all non-disposable items and equipment such as conductivity meters, biohazard bins and trash containers. Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet. The FA or designee will conduct infection control audits daily for two (2) weeks then weekly for two (2) weeks then monthly during internal infection control audits. Instances of non-compliance will be addressed immediately. The FA will review the results of the audits with TMs during homeroom meetings and with the Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA 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 review of facility policy, patient treatment area observations and interview with the facility Administrator (EMP# 1), it was determined the facility failed to ensure standard infection control precautions were followed for four (4) of four (4) 'Cleaning and disinfection of the Dialysis Station' (Observations #1, #2, #3 and #4); and (2) of two (2) observations conducted. (Observations #5 and #6)
Findings include:
A review of facility policy, '1-05-01 Infection Control For Dialysis Facilities' section, 'Facility Hygiene' on August 3, 2021 at approximately 1:27 p.m. reads, "...43. If a common supply cart is used to store clean supplies in the patient treatment area, this cart is to remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. The cart will not be moved between stations to distribute supplies. Items taken to the patient station during the treatment will not be returned to the supply cart, only teammates with clean hands may remove items from the supply cart...45...Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible...46. Equipment including the dialysis delivery system....will be wiped clean with a bleach solution of the appropriate strength after completion of procedures, before used on another patient, after spills of blood and throughout the work day and after each treatment..."
Observations conducted in the patient treatment area on August 2, 2021 between approximately 1:08 p.m. and 2:42 p.m. and on August 4, 2021 between approximately 8:35 a.m. and 10:43 a.m. revealed the following:
Observation #1: 'Cleaning and disinfection of the Dialysis Station' On August 2, 2021 at approximately 2:46 p.m. at station # 6, after patient # 3 left the dialysis station, employee #2 emptied the prime bucket after disinfecting the dialysis chair and the dialysis machine. Dialysis station trash can was not emptied and was not disinfected.
Observation #2: 'Cleaning and disinfection of the Dialysis Station' On August 2, 2021 at approximately 2:54 p.m. at station # 8, after patient # 6 left the dialysis station, employee #2 emptied the prime bucket after disinfecting the dialysis chair.
Observation #3: 'Cleaning and disinfection of the Dialysis Station' On August 2, 2021 at approximately 2:59 p.m. surveyor observed dried spots of blood on the floor near station #6 after confirming that the station was cleaned and disinfected with employee #1.
Observation #4: 'Cleaning and disinfection of the Dialysis Station' On August 2, 2021 at approximately 3:05 p.m. surveyor observed dried spots of blood on the floor between stations #10 and #11 after confirming that both stations have been cleaned and disinfected with employee #1.
Observation #5: On August 4, 2021 at approximately 9:47 a.m. employee #2 used a stethoscope at station #1 on patient # 10, then with her hands still gloves grabbed an alcohol pad from the clean supply cart. After the stethoscope was clean, it was hung on the clean supplies cart and returned to prepping patient # 10 access site.
Observation #6: On August 4, 2021 at approximately 10:16 a.m., Surveyor observed the Myron-L was sitting on the clean nurses station ledge. Employee #3 walked over and began using the Myron-L. Surveyor asked employee #3 if the Myron-L was dirty. Employee # 3 replied, "It is clean now but it will be dirty in a minute" and continued to use the Myron-L. Surveyor asked if the nurses station ledge was a clean area and employee #3 replied, "Yes" and lifted up the Myron-L. Employee #3 failed to disinfect the clean nurses ledge after Myron-L was removed.
An interview with the facility administrator on August 4, 2021 at approximately 3:30 p.m. confirmed the above findings.
Based on review of facility policy, home programs training rooms, clean supplies area observations and interview with the facility Administrator (EMP# 1), it was determined the facility failed to ensure expired items/supplies were discarded and replaced for three (3) of three (3) observations. (Observation #1, #2 and #3).
Findings include:
A review of facility policy, '12-07-09 Disposable Supplies' section, 'Policy' on August 2, 2021 at approximately 11:45 a.m. reads, "1. The expiration date must be check on all disposable supplies before the package is opened and the contents are used..."
Observations conducted in the home programs training rooms on August 2, 2021 between approximately 10:13 a.m. and 10:20 p.m. and in the clean supplies area on August 3, 2021 between approximately 10:15 a.m. and 12:35 p.m. revealed the following:
Observation #1: The following expired item was observed in the cabinet in Home Training Room # 1: One (1) Pure Bright Germicidal Ultra Bleach 1 gallon, expired Jan. 09, 21.
Observation #2: The following expired item was observed in the cabinet in Home Training Room #3: One (1) Pure Bright Germicidal Ultra Bleach 1 gallon, expired Apr. 01, 21.
Observation #3: The following expired items was observed on the shelf in the clean supplies area: Seven (7) Pure Bright Germicidal Ultra Bleach 1 gallon, expired Jan. 09, 21.
An interview with the facility administrator on August 4, 2021 at approximately 3:30 p.m. confirmed the above findings.
Plan of Correction:The Facility Administrator held mandatory in-service(s) for all Clinical Teammates starting on 8/09/2021. Surveyor observations were reviewed. Education included but was not limited to a review of Policy # 1-05-01 Infection Control for Dialysis Facilities with the emphasis on but not limited to: 1) Equipment including the dialysis delivery system and prime container ... will be wiped clean with a bleach solution of the appropriate strength after completion of procedures, before being used on another patient. 2) Items taken to the patient station during the treatment will not be returned to the supply cart, only teammates with clean hands may remove items from the supply cart. 3) Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials. 4) After each treatment the floor area around chair/bed and dialysis delivery system will be evaluated and cleaned if necessary. 5) Clean areas should be clearly separated from contaminated areas. The conductively meter will be used is designated areas only. The Facility Administrator also reviewed Policy # 12-07-09 Disposable Supplies with the Home Program Teammates emphasizing the verification of disposable supplies are within their approved shelf life. The expiration date must be check on all disposable supplies before the package is opened and the contents are used. Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet. The facility audited the Home Program area for expiration dates on all products and discarded identified items. The FA or designee will conduct infection control audits daily for two (2) weeks then weekly for two (2) weeks then monthly during internal infection control audits to verify compliance. FA or designee will also perform disposable supplies expiration audits daily for two (2) weeks then weekly for two (2) weeks then monthly for two months. Instances of non-compliance will be addressed immediately. The FA will review the results of the audits with TMs during homeroom meetings and with Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA 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 review of facility policy, review of equipment maintenance logs, and an interview with the facility Administrator (EMP #1), it was determined the facility failed to maintain equipment per facility policy for one (1) of one (1) equipment maintenance logs reviewed (Log #1).
Findings include:
A review of facility policy, '2-05-03A Calibration Check and Calibration of Myron-L DS Meter (RO-1)' section, 'Procedure' on August 3, 2021 at approximately 2:35 p.m. reads, "...9. Document reading on Calibration Log for Myron L DS Meter (RO-1)"
Review of equipment maintenance logs were conducted on August 3, 2021 between approximately 10:30 a.m. and 12:00 p.m. revealed the following:
Log #1: 'Calibration Log for Myron L Conductivity/TDS DS Meter' reviewed from March 2021- August 2021 revealed the following:
'Meter Value' section for Myron-L # 1 was blank for the date range of: 3/5/21 through 6/4/21.
'Meter Value' section for Myron-L # 2 was blank for the date range of: 3/5/21 through 6/4/21.
An interview with the facility administrator on August 4, 2021 at approximately 3:30 p.m. confirmed the above findings.
Plan of Correction:EMP #1 conducted in-service on 8/6/2021 at approximately 1430 to review policy 2-05-03A Calibration Check and Calibration of Myron-L DS Meter (RO-1) to ensure direct patient care teammates are competent in utilizing calibration documentation form. EMP #1 to conduct daily audits x two weeks and weekly audits x four weeks to ensure Calibration Log for Myron L Conductivity/TDS DS Meter is being utilized each treatment day prior to the use of Myron L machine. Plan of correction to be completed on 9/22/2021.
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 review of facility policy, review of medical records (MR), and an interview with the facility Administrator (EMP# 1), it was determined the facility failed to ensure newly admitted patients had a minimal evaluation completed by a registered nurse (RN), prior to initiating treatment for immediate needs which contained the minimal elements of nursing standards of care for three (3) of five (5) MRs reviewed. (MR #2, MR #3 and MR #5)
Findings include:
A review of facility policy, '1-03-07 New Patient Pre-Treatment Evaluation' section, 'Policy' on August 2, 2021 at approximately 11:45 a.m. reads, "1. A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all new patients prior to the initiation of their first treatment at the facility..."
Review of medical records was conducted on August 3, 2021 between approximately 1:00 p.m.-3:30 p.m. revealed the following:
MR #2, Date of admission: 5/14/21: Patient flow sheet dated 5/14/21 revealed the initial dialysis treatment started at 11:14 a.m. The initial RN assessment was dated for 5/14/21 and timed at 1400. Initial RN assessment conducted approximately 2 hours and 46 minutes after the start of the initial dialysis treatment.
MR #3, Date of admission: 4/16/21: Patient flow sheet dated 4/16/21 revealed the initial dialysis treatment started at 11:03 a.m. The initial RN assessment was dated for 4/16/21 and timed at 1200. Initial RN assessment conducted approximately 57 minutes after the start of the initial dialysis treatment.
MR #5, Date of admission: 12/14/18: Patient flow sheet dated 12/17/18 revealed the initial dialysis treatment started at 3:47 p.m. The initial RN assessment was dated for 5/14/21 but was not timed.
An interview with the facility administrator on August 4, 2021 at approximately 3:30 p.m. confirmed the above findings.
Plan of Correction:A Governing Body with the Medical Director, Facility Administrator, Director of Nursing and Regional Operations Director was held upon receiving the results of the survey ending on 8/04/2021. The Governing Bod reviewed the document Medical Director Qualifications and Responsibilities. The Medical Director acknowledges that he/she is responsible to ensure the facility Teammates are trained and follow policy and procedure, and deficiencies identified need to be corrected timely with the support of the facility team. The Facility Administrator then held a mandatory in-service for all Clinical Teammates starting on 8/11/2021. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-07 New Patient Pre Treatment Evaluation emphasizing that a registered nurse as required by federal regulation will perform an initial pre-treatment evaluation of all new patients prior to the initiation of their first treatment at the facility. Verification of attendance is evidenced by teammate signature on in-service sheet. The FA or designee will conduct 100% of medical record audits on all new admissions for three (3) months to monitor for adherence regarding Policy 1-03-07 New Patient Pre Treatment Evaluation, including ICHD, PD, and HHD modalities. Instances of non-compliance will be addressed immediately. Governing Body The Medical Director will review progress of TM education, results of audits, and adherence to this plan of correction during monthly FHM -QAPI. The FA will report progress, as well as any barriers to maintaining compliance, with supporting documentation included in the meeting minutes. Action plans will be evaluated for effectiveness, new plans developed as applicable to achieve compliance with TM adherence to policy and procedure. The FA on behalf of the Governing Body is responsible for compliance with this plan of correction.
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