QA Investigation Results

Pennsylvania Department of Health
ST. LUKE'S ALLENTOWN DIALYSIS
Health Inspection Results
ST. LUKE'S ALLENTOWN DIALYSIS
Health Inspection Results For:


There are  17 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 August 24, 2022, St. Luke's Allentown Dialysis was found to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.






Plan of Correction:




Initial Comments:


Based on the findings of an unannounced onsite Medicare recertification survey completed August 24, 2022, St. Luke's Allentown Dialysis was found to be in substantial compliance with the following requirements of 42 CFR, Part 494, 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/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 two (2) of two (2) 'Central Venous Catheter (CVC) Exit Site Care' and 'Initiation of Dialysis with Central Venous Catheter' observations (Observation #1, Observation #2).

Findings include:

A review was conducted of facility policy/procedure on August 24, 2022 at approximately 12:00 p.m. 'Procedure: 1-04-02B' 'Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure' (4) states "Remove old dressing and discard." .... (5) states "Remove gloves and discard. Perform hand hygiene per procedure and re-glove." ....(12) states "Place sterile 2x2 gauze over the catheter site ...." (14) states "Remove gloves and discard, perform hand hygiene per procedure and re-glove." (15) states "Holding catheter with non-dominant hand, use other hand to place sterile 4x4 dressing under catheter limbs ..." (16) states "Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. ....."
'Policy:1-05-01' 'Infection Control for Dialysis Facilities' 'Teammate Hygiene' (1) states "Hand hygiene is to be performed upon entering the patient treatment area, prior to gloving, after removal of gloves, ..."

Observations conducted in patient treatment area on August 22, 2022 between approximately 9:45 a.m. - 1:30 p.m. revealed the following:

Observation #1: During observation #1 of 'Central Venous Catheter Exit Site Care' on 08/22/22 at approximately 11:20 a.m. of patient #8, station #6, employee #10 did not remove gloves/perform hand hygiene/donn clean gloves after applying the sterile dressing and prior to starting 'Initiation of Dialysis with Central Venous Catheter'.

Observation #2: During observation #2 of 'Central Venous Catheter Exit Site Care' on 08/22/22 at approximately 11:45 a.m. of patient #7, station #9, employee #8 removed gloves and did not perform hand hygiene prior to donning clean gloves, after applying the sterile dressing and prior to starting 'Initiation of Dialysis with Central Venous Catheter'.


An interview with the facility Administrator on August 24, 2022 at approximately 12:15 p.m. confirmed the above findings.












Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/06/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-05 "Infection Control for Dialysis Facilities", Policy 1-04-02B "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure" with emphasis on but not limited to: 1. Hand hygiene: 1) Hand hygiene is to be performed upon entering the patient treatment area, prior to gloving, after removal of gloves... 2. CVC care: 1) Step #4 - Remove old dressing and discard. 2) Step #7 - Remove gloves and discard. Perform hand hygiene per procedure and re-glove. 3) Step #8 - Holding catheter with the non-dominant hand and using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds... 4) Step #10 - Remove gloves and discard, perform hand hygiene per procedure and re-glove. 5) Steps #12-13 - Place sterile 2x2 gauze over the catheter exit site leaving connections accessible. Apply label to dressing. 6) Step #14 - Remove gloves and discard, perform hand hygiene per procedure and re-glove. 7) Step #15 - Holding catheter with non-dominant hand, use other hand to place sterile 4x4 under catheter limbs. 8) Step #16 - Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Verification of attendance is evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct infection control audits to verify proper hand hygiene is utilized during CVC care and treatment initiation per policy: daily for two (2) weeks and weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audit. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with Medical Director during monthly Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.



494.30(a)(2) STANDARD
IC-STAFF EDUCATION-CATHETERS/CATHETER CARE

Name - Component - 00
Recommendations for Placement of Intravascular Catheters in Adults and Children

I. Health care worker education and training
A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections.
B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters.

II. Surveillance
A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site.

Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.

VI. Catheter and catheter-site care
B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections].





Observations:


Based on review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure that clinical staff maintain aseptic technique for the care of vascular accesses, including intravascular catheters for one (1) of two (2) observations (Observation #2).

Findings:

A review was conducted of facility policy/procedure on August 24, 2022 at approximately 12:00 p.m Procedure #1-04-02B 'Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure' /Notes' states "...Perform a 15 second hub scrub every time a CVC is connected or disconnected from the bloodlines, ...." 'Procedure' (4) states "Remove old dressing and discard." (8) ".... clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds, apply to the CVC exit site ...." (12) "Place sterile 2x2 gauze over the catheter exit site leaving connections accessible." (14) "Remove gloves and discard, perform hand hygiene per procedure and re-glove." (160 Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides, ..." (17) "Attach sterile 10 ml syringes to the arterial and venous limbs."


Observations conducted in patient treatment area on August 22, 2022 between approximately 9:45 a.m. - 1:30 p.m. revealed the following:

Observation #2: On August 22, 2022 at approximately 11:45 a.m. while observing 'Initiation of Dialysis with Central Venous Catheter' observation #2 for patient #7, station #9; employee #8 scrubbed the hubs for approximately 4-5 seconds prior to attaching sterile syringes. Employee #8 scrubbed the hubs for approximately 2-3 seconds after removing sterile syringes and prior to connecting the bloodlines.


An interview with the facility Administrator on August 24, 2022 at approximately 12:15 p.m. confirmed the above findings.













Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/06/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-04-02B "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure" with emphasis on but not limited to: 1) Step #16 - Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any residue, for example blood. Hold the limbs until the antiseptic has dried. 2) Step #17 - Attach sterile 10ml syringes to the arterial and venous limbs. Verification of attendance at in-service is evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee will conduct observational audits to verify CVC care is provided per policy: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits to verify compliance. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.


494.80(a)(2) STANDARD
PA-APPROPRIATENESS OF DIALYSIS RX

Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:

(2) Evaluation of the appropriateness of the dialysis prescription,




Observations:


Based on a review of facility policy/procedure, review of clinical records, and an interview with the facility Administrator; the facility failed to ensure that the patient prescription was being implemented as ordered by the physician for three (3) out of four (4) observations (Observation #2 - Observation #4).

Findings include:

A review was conducted of facility policy/procedure on August 24, 2022 at approximately 12:00 p.m. Policy:1-03-08 'Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment' section #3 states "Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment ....". "Prescription components include but are not necessarily limited to: ........ (b) Treatment time, ...... (f) Blood flow rate (BFR) (g) Dialysate flow rate (DFR)".

Patient prescription checks were conducted in patient treatment area with employee #1 on August 22, 2022 at approximately 1:10 p.m. revealed the following:

Observation #2: Prescription verification was conducted on patient #7, station #9. The patient began treatment at "12:03". Patient 'Kardex' hemodialysis treatment physician orders dated 05/05/22 show DFR orders for "500 ML/min." The dialysis machine DFR was set at "600 ML/min".

Observation #3: Prescription verification was conducted on patient #10, station #8. The patient began treatment at "12:38". Patient 'Kardex' hemodialysis treatment physician orders dated 02/19/22 show BFR orders for "500 ml/min". The dialysis machine BFR was set at "425".

Observation #4: Prescription verification was conducted on patient #11, station #7. The patient began treatment at "12:24". Patient 'Kardex' hemodialysis treatment physician orders dated 01/20/22 show "Dialysate: K 2.00, Ca: 2.50 ..." The dialysis machine was set at "3 K." (Note: Patient was receiving the phsician prescribed 2 K from wall outlet.) 'Treatment Time physician order was "240 minutes". The dialysis machine was set for '211' minutes.


An interview with the facility Administrator on August 24, 2022 at approximately 12:15 p.m. confirmed the above findings.












Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/06/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre- Intra- Post Treatment Data Collection Monitoring and Nursing Assessment" with emphasis on but not limited to: 1) Patient identity, prescription and machine settings are verified by teammates prior to initiation of treatment with the exception of blood flow rate (BFR) which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse by 1 hour of treatment initiation along with the nursing assessment. 2) Prescription components include but are not necessarily limited to: ...b. Treatment time... f. Blood flow rate. g. Dialysate flow rate... i. Correct dialysate composition... 3) If the dialysis prescription is not being met ... the reason will be documented and the licensed nurse informed. 4) Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 5) The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 6) All findings, interventions and patient response will be documented in the patient's medical record. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee will conduct audits to verify orders reflected on the flowsheets are accurate and follow physician orders for treatment: on twenty five percent (25%) of the flow sheets daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.


494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS

Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;


Observations:


Based on a review of facility policy/procedure, review of clinical records, and an interview with the facility Administrator; the facility failed to ensure the staff followed facility procedure for early termination of treatment for four (4) out of seven (7) in-center hemodialysis clinical records (CR) reviewed (CR#2, CR#3, CR#6, CR#7).

Findings include:

A review was conducted of facility policy/procedure on August 24, 2022 at approximately 12:00 p.m. 'Policy: 1-01-09' 'Prescribed Treatment Time Not Met' 'Policy' (A) 'Completion of the Early Termination of treatment Against Medical Advice Form' (1) The RN will verify that a patient signs the Early Termination of treatment Against Medical Advice form any time a patient requests to terminate their treatment earlier than the prescribed run time." (3) The RN will obtain the patients signature on the Early Termination of treatment Against Medical Advice form prior to the patient being rinsed back from their treatment. ..." (4) A RN must countersign all Early Termination of treatment Against Medical Advice forms A witness signature is required only if the patient refuses to sign the form." (5) If a patient refuses to sign the Early Termination of treatment Against Medical Advice form, the RN will document the patients refusal ...." (B) 'Prescribed Treatment Time Not Met' (1) If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patients attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patients specific needs."

A review of clinical records was completed on August 24, 2022 at approximately 11:45 a.m. Patients admission date is listed below:

CR#2 Date of admission 12/07/20: Physician orders for Hemodialysis dated 07/23/22: 'Tx Time' "180" minutes.
Patient treatment flow sheets were reviewed from 08/03/22-08/15/22.
On 08/05/22 patient treatment flow sheet stated Duration : "122".
On 08/15/22 patient treatment flow sheet stated Duration : "126".
No documentation of the early termination form being signed, and/or the physician being notified, and/or documentation by the registered nurse documenting patient refusal to sign.

CR#3 Date of admission 01/12/18: Physician orders for Hemodialysis dated 05/23/22: 'Tx Time' "255" minutes.
Patient treatment flow sheets were reviewed from 08/08/22-08/15/22.
On 08/08/22 patient treatment flow sheet stated Duration : "245".
On 08/15/22 patient treatment flow sheet stated Duration : "233".
No documentation of the early termination form being signed, and/or the physician being notified, and/or documentation by the registered nurse documenting patient refusal to sign.

CR#6 Date of admission 06/16/22: Physician orders for Hemodialysis dated 06/28/22: 'Tx Time' "240" minutes.
Patient treatment flow sheets were reviewed from 08/18/22-08/20/22.
On 08/18/22 patient treatment flow sheet stated Duration : "212".
On 08/20/22 patient treatment flow sheet stated Duration : "215".
No documentation of the early termination form being signed, and/or the physician being notified, and/or documentation by the registered nurse documenting patient refusal to sign.

CR#7 Date of admission 05/02/22: Physician orders for Hemodialysis dated 05/05/22: 'Tx Time' "210" minutes.
Patient treatment flow sheets were reviewed from 08/08/22-08/17/22.
On 08/88/22 patient treatment flow sheet stated Duration : "153".
On 08/10/22 patient treatment flow sheet stated Duration : "195".
On 08/17/22 patient treatment flow sheet stated Duration : "161".
No documentation of the early termination form being signed, and/or the physician being notified, and/or documentation by the registered nurse documenting patient refusal to sign.



An interview with the facility Administrator on August 24, 2022 at approximately 12:15 p.m. confirmed the above findings.













Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/06/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-01-09 "Prescribed Treatment Time Not Met" and Form 1-01-09A "Early Termination of Treatment against Medical Advice" form with emphasis on but not limited to: 1. Completion of the "Early Termination of Treatment against Medical Advice" Form: 1) The Registered Nurse (RN) will verify that a patient signs the "Early Termination of Treatment against Medical Advice" form any time the patient requests to terminate their treatment earlier than the prescribed run time. 2) The RN will obtain the patient's signature on the "Early Termination of Treatment against Medical Advice" form prior to the patient being rinsed back from their treatment. If unable to obtain the patient's signature prior to rinse-back, the RN will obtain the patient's signature on the form prior to the patient's departure from the facility. 3) A RN must countersign all "Early Termination of Treatment against Medical Advice" forms. A witness signature is required only if the patient refuses to sign the form. 4) If a patient refuses to sign the "Early Termination of Treatment against Medical Advice" form, the RN will document the patient's refusal with the words "patient refused" in the patient signature box along with the date. Under such circumstances, the RN will sign the form and will also obtain a witness' signature on the form. 2. Prescribed Treatment Not Met: 1) If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient's attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient's specific needs. 2) If a patient's treatment is shortened/early terminated, the RN will document the event in the patient's medical record. Documentation will include, as appropriate... A copy of the "Early Termination of Treatment against Medical Advice" form signed by the patient, if shortened voluntarily by patient... Verification of attendance is evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee will conduct flowsheet audits to verify patient treatments that are not are meeting prescribed treatment times are correctly documented, and that "Early Termination of Treatment against Medical Advice" form is completed by RN: on twenty five percent (25%) of the flow sheets daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records 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 Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.


494.90(a)(6) STANDARD
POC-P/S COUNSELING/REFERRALS/HRQOL TOOL

Name - Component - 00
The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis.


Observations:


Based on a review of facility policy/procedure, review of medical records, and an interview with facility Administrator, the facility failed to ensure that the standardized mental and physical assessment tool (KDQOL-36) or an age appropriate assessment tool was administered by the time of the first reassessment (i.e., within 4 months of initiating treatment) and administered and repeated at least annually for two (2) of two (2) in-center hemodialysis pediatric patient clinical records (CR) reviewed (CR#1, CR#2).

Findings:

A review was conducted of facility policy/procedure on August 24, 2022 at approximately 12:00 p.m. Policy 3-01-10 'Quality of Life Assessment Survey' 'Policy' (1) "The Quality of Life (QOL) assessment survey is to be administered by the Social Worker to patients within the first four (4) months of initiating treatment, on an as needed basis, and repeated at least annually thereafter". (2) "If a patient refuses to complete the KDQOL-36 at any time, the Social Worker needs to have the patient sign the Refusal of Permission to Survey to document the refusal". (3) ".... The completed survey and results should be maintained in the patients medical record." (4) A patient would not be eligible to complete the KDQL-36 for the following reasons: The patient is under 18 years of age. ........." (
Note: The policy provided does not specify what is utilized as an age appropriate assessment tool in place of the KDQOL-36.)


A review of clinical records was completed on August 24, 2022 at approximately 11:45 a.m. Patients admission date is listed below:

CR#1 Date of admission 12/30/20: This patient is under 18 years of age. No documentation provided of pediatric patient being assessed using an age appropriate assessment tool within the first four (4) months of initiating treatment and repeated at least annually thereafter. On 08/24/22 at approximately 10:30 a.m., the Administrator was asked what the facility utilizes as an age appropriate assessment tool. The Administrator, in correspondence with the facility Social Worker, provided a twenty-one page 'Your Kidneys' packet with activities such as coloring, connect the dots, crossword puzzles, etc.
No exemption to completing an age appropriate assessment tool was documented in the medical record.

CR#2 Date of admission 12/07/20: This patient is under 18 years of age. No documentation provided of pediatric patient being assessed using an age appropriate assessment tool within the first four (4) months of initiating treatment and repeated at least annually thereafter. On 08/24/22 at approximately 10:30 a.m., the Administrator was asked what the facility utilizes as an age appropriate assessment tool. The Administrator, in correspondence with the facility Social Worker, provided a twenty-one page 'Your Kidneys' packet with activities such as coloring, connect the dots, crossword puzzles, etc.
No exemption to completing an age appropriate assessment tool was documented in the medical record.



An interview with the facility Administrator on August 24, 2022 at approximately 12:15 p.m. confirmed the above findings.







Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates and the Interdisciplinary Team (IDT) starting on 09/6/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 3-01-10 "Quality of Life Assessment Survey" with emphasis on but not limited to: 1) The Quality of Life (QOL) assessment survey is to be administered by the Social Worker to patients within four (4) months of initiating treatment, on an as needed basis, and repeated at least annually thereafter. 2) If a patient refuses to complete the KDQOL – 36 at any time, the Social Worker needs to document the refusal in the KDQOL Psychosocial condition in the electronic medical record. 3) The KDQOL Patient Results Report is to be reviewed by the Social Worker with the patient within 30 days of completing the survey. The completed survey and results should be maintained in the patient's medical record. 4) A patient would not be eligible to complete the KDQOL – 36 for the following reasons: the patient is under 18 years of age; has cognitive impairment, dementia or active psychosis that is documented by the attending physician; patient who is non English speaker/reader (for whom there is no native-language translation or interpreter). Patients under 18 will be presented with an age appropriate assessment tool, 'Pediatric Petey Activity Book-Your Kidneys and Dialysis.' This tool has been approved through Governing Body on 8/31/22. The social worker will document that the tool was provided and whether it was completed or refused. The completed tool will be maintained in the patient's medical record. Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee, will immediately complete an audit of one hundred percent (100%) of the eligible patient medical records for a current KDQOL survey. Eligible patients without a current survey, or documented refusal, will have one completed by 10/23/22. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audit. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit findings with the Interdisciplinary Team and the Medical Director during Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation 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, clinical records, and an interview with facility Administrator, it was determined the facility failed to ensure medications were administered as ordered for one (1) of five (5) patient clinical records (CR) reviewed (CR#3); failed to ensure TB (tuberculosis) screening and/or color blindness testing was conducted according to facility policy for three (3) of three (3) employee files (EF) reviewed (EF#10, EF#11, EF#14); and failed to ensure a licensed nurse verified each chlorine test for one (1) of one (1) chlorine testing logs reviewed (Log #1).

Findings include:

A review was conducted of facility policy/procedure on August 11, 2022 at approximately 10:00 a.m. Policy: 1-06-01 'Medication Policy' 'Policy' (9) states "Medications are administered as prescribed."

A review of clinical records was completed on August 24, 2022 at approximately 11:45 a.m. Patients admission date is listed below.

CR#3 Date of admission 01/12/18: 'Hemo Treatment Orders' with a start date of 05/23/22 include 'Heparin' 'Load: 3000 units', 'Hourly dose: 1500 units/hour', 'Stop: 60 minutes before the end of dialysis'. Patient treatment flowsheet dated 08/19/22 reviewed. Entry by Employee #10, 'Medications and Ancillaries Administered' 'Heparin Pork' 'Bolus/Infusion 4875 units PM, (Concentration 1:1,000)' 'Status' "Given" 'Time Given' "11:43". 'Intradialytic's (Patient Statistics)' lists 'Heparin' "2.1" (administered).
(The hourly dose order was for 1500 units= 4875 units total. 2100 units were administered.)


Policy: 4-06-05 'Tuberculosis Monitoring and Follow-Up' 'Purpose' "The Tuberculosis (TB) Monitoring and Follow-Up Policy consists of the following: Baseline new hire requirements ..........." 'Baseline new hire requirements for all new teammates including ...... will complete the following: (c) "If exemption criteria for TST (tuberculin skin test) is not met, the following testing options are available: (i) Baseline TST using a two step Purified Protein Derivative (PPD) Mantoux test (a second TST repeated one to three weeks after the first, if the initial test is negative.)" (iv) "Baseline TST results must be documented and recorded in millimeters within 10 days of employment."
Policy: 8-02-03 'Color Vision Evaluation' 'Policy' (1) ...... Color blindness testing is performed at time of hire."

A review of employee files was completed on August 24, 2022 at approximately 11:00 a.m. Employee date of hire is listed below.

EF#10 Date of hire 01/15/21: No documentation of employee being screened for TB upon hire (within 10 days of employment) per policy. Documentation provided of first TST administered late on 03/08/21. No documentation of second step TST being administered.
Documentation of 'Color Vision Test Results' 'Date of Test' "4/1/22." No documentation provided of color test being conducted at the time of hire

EF#11 Date of hire 08/05/20: No documentation of employee being screened for TB upon hire (within 10 days of employment) per policy. Documentation provided of first TST administered late on 06/18/22. Documentation of second step TST being administered on 07/04/22.

EF#14 Date of hire 04/11/22: No documentation of employee being screened for TB upon hire (within 10 days of employment) per policy. Documentation provided of first TST administered late on 05/16/22. Documentation of second step TST being administered on 06/15/22.


Policy: 2-05-02 'Daily Water System Total chlorine Monitoring' 'Policy' (11) "......., record results on the test time, signature of the person performing the test, test results, and signature of licensed nurse verifying that each test on the daily log is complete and results appropriate. ....."

A review of the facility 'Routine Total Chlorine Testing Log' was completed on August 23, 2022 at approximately 11:30 a.m.

Log#1: Log entries were reviewed from 01/24/22 - 08/06/22. The first log chlorine testing entries of each day (approximately 5:00 a.m. on days the facility operates and provides patient dialysis) within the above stated time frame is entered by a personal care technician. The first entry of the day is not verified by a licensed nurse. "No RN (registered nurse)present" is written in the log section 'Signature of licensed nurse verifying each test is documented and results appropriate'. An RN does verify the second and subsequent chlorine testing each day (approximately 5:45 a.m. on days the facility operates and provides patient dialysis).



An interview with the facility Administrator on August 24, 2022 at approximately 12:15 p.m. confirmed the above findings.













Plan of Correction:

A Governing Body meeting was held on 8/31/2022, with the Medical Director, Facility Administrator, Director of Nursing and Regional Operations Director to review the results of the survey ending on 8/24/22. 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 the facility teammates are trained and follow policy and procedure relative to patient admissions, patient care, infection control, and safety. 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 09/06/22. Surveyor observations were reviewed. Education included but was not limited to a review of facility policies with areas of emphasis on but not limited to:
1. Policy 1-06-01 "Medication Policy": 1) Medications are administered as prescribed and then documented in the patient's medical record. The Facility Administrator or designee will conduct flowsheet audits to verify medications given match medication ordered per physician: twenty five percent (25%) daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately.
2. Policy 4-06-05 "Tuberculosis (TB) Monitoring and Follow-up": 1) Baseline new hire requirements for all new teammates ... will complete the following: c. If exemption criteria for TST is not met, the following testing options are available: i. Baseline TST using a two-step Purified Protein Derivative (PPD) Mantoux test (a *second TST repeated one to three weeks after the first, if the initial test is negative)... iv. Baseline TST results must be documented and recorded in millimeters within 10 days of employment.
Policy 8-02-03 "Color Vision Evaluation": 1) Teammates/patients/helpers who will be utilizing test kits or strips that rely on color differentiation for test results will be evaluated for ability to see color. Color blindness testing is performed at time of hire. 2) Documentation of the color vision evaluation will be documented in the teammate's file and/or patient's medical record. The Facility Administrator or designee will complete an audit of one hundred percent teammate medical files in next two (2) weeks to verify documentation of Tuberculosis screening within first ten days of employment and Color blindness screening as applicable per role, upon hire. Any missing documentation will be updated by 10/23/22. Ongoing compliance will be monitored with the quarterly teammate file audits. Instances of non-compliance will be addressed immediately.
3. Policy 2-05-02 "Daily Water System Total Chlorine Monitoring": 1) If the results of Total Chlorine testing from the primary carbon filter or set of tanks indicate a level of less than or equal to 0.1 ppm (< 0.1 ppm), record results on the "Routine Total Chlorine Testing" log which contains entries for day, date, test number, test time, signature of person performing the test, test results, and signature of licensed nurse verifying that each test on the daily log is complete and results appropriate. The Facility Administrator or designee will conduct an audit of the Routine Total Chlorine Testing log for the presence of licensed nurse signature, which verifies the daily log is complete and results are appropriate: daily on treatment days for two (2) weeks, then weekly for two (2) weeks, and monthly for two (2) months. Instances of non-compliance will be addressed immediately. Verification of attendance at all in-services will be evidenced by teammates' signatures on the in-services sheets. 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.



494.170(b)(1) STANDARD
MR-COMPLETE RECORDS PROMPTLY

Name - Component - 00
(1) Current medical records and those of discharged patients must be completed promptly.


Observations:


Based on a review of facility policy, review of clinical records, and an interview with the facility Administrator, the facility failed to conduct and document post-dialysis treatment assessments and data collection, for five (5) of seven (7) in-center hemodialysis patient clinical records (CRs) reviewed (CR#1-CR#4, CR#6).

Findings include:

A review was conducted of facility policy/procedure on August 24, 2022 at approximately 12:00 p.m. Policy:1-03-08 'Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment' 'Purpose' "To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment." 'Policy' (1) Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. (a) Data collection includes but is not necessarily limited to: (i) Measurement of patient temperature (ii) Measurement of blood pressure (BP) .....(iii) Heart or pulse rate ..... (iv) Patient weight (v) respirations rate (vi) Patients report of well being, level of pain or discomfort, complaints, hospitalization (vii) Vascular access status."
'Post Treatment Data Collection/Assessment' (15) The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre-dialysis findings."

A review of clinical records was completed on August 24, 2022 at approximately 11:45 a.m. Patients admission date is listed below.

CR#1 Date of admit 12/30/20: Patient treatment flow sheets were reviewed from 08/10/22-08/17/22.
Treatment flow sheet dated 08/10/22 'Post-dialysis treatment data collection or assessment' section left blank with no entries.
Treatment flow sheet dated 08/17/22 'Post-dialysis treatment data collection or assessment' section left blank with no entries.

CR#2 Date of admit 12/07/20: Patient treatment flow sheets were reviewed from 08/08/22-08/10/22.
Treatment flow sheet dated 08/08/22 'Post-dialysis treatment data collection or assessment' section left blank with no entries.
Treatment flow sheet dated 08/10/22 'Post-dialysis treatment data collection or assessment' section left blank with no entries.

CR#3 Date of admit 01/12/18: Patient treatment flow sheet dated 08/19/22 was reviewed.
Treatment flow sheet dated 08/19/22 'Post-dialysis treatment data collection or assessment' section left blank with no entries.

CR#4 Date of admit 01/28/20: Patient treatment flow sheet dated 08/09/22 was reviewed.
Treatment flow sheet dated 08/09/22 'Post-dialysis treatment data collection or assessment' section left blank with no entries.

CR#6 Date of admit 06/16/22: Patient treatment flow sheet dated 08/20/22 was reviewed.
Treatment flow sheet dated 08/20/22 'Post-dialysis treatment data collection or assessment' section left blank with no entries.


An interview with the facility Administrator on August 24, 2022 at approximately 12:15 p.m. confirmed the above findings.









Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/06/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: 1) Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes but is not necessarily limited to: i. Measurement of patient temperature; ii. Measurement of Blood Pressure (BP) ... iii. Heart or pulse rate, noting also if the beat is regular or irregular; iv. Patient weight; v. Respiration rate; vi. Patient's report of well-being, level of pain or discomfort, complaints, hospitalization; vii. Vascular access status. 2) The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre dialysis findings. 3) If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. Verification of attendance at in-service is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee will conduct audits on flowsheet to verify documentation of post treatment data collection / assessment: on twenty five percent (25%) flowsheets daily on treatment days for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly ten percent (10%) medical records 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 Medical Director during monthly Quality Assessment Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.