QA Investigation Results

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


There are  2 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 11, 2022, St. Luke's Macungie 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 11, 2022, St. Luke's Macungie 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)(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/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure the staff followed infection control protocols for use of the thermometer for one (1) out of one (1) treatment area observations (Observation #1).

Findings include:

A review was conducted of facility policy/procedure on August 11, 2022 at approximately 1:00 p.m. Policy #1-05-01 'Infection Control for Dialysis Facilities' section 'Dialysis Station Management' section #65 states "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".

Observations conducted in patient treatment area on August 10, 2022 between approximately 8:00 a.m. - 11:45 a.m. revealed the following:

Observation #1: During treatment area observations on 08/10/2022 at approximately 9:50 a.m., of patient #6, station #8, employee #3 obtained the patients temperature and did not disinfect the thermometer before returning to the common supply area (the stand near the treatment area exit entry/exit door where the 'COVID-19 Daily Screening Log' is kept.)


An interview with the facility Administrator on August 11, 2022 at approximately 1:30 p.m. confirmed the above findings.













Plan of Correction:

V 0116
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/12/22. 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) If electronic thermometers and/or blood glucose meters are used, measures will be taken to prevent cross contamination between patients. For example, the thermometer should not be placed on potentially contaminated equipment such as the dialysis delivery system. If the potential for contamination exists, the device outer casing is wiped with an appropriate disinfectant before being returned to clean area or using on another patient. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee will perform observational infection control audits to verify teammates are compliant with disinfection practices for non-disposable items per policy: daily for two (2) weeks, and then weekly for two (2) weeks. Ongoing compliance will be monitored with the facility's monthly infection control audit. Instances of non-compliance will be addressed immediately. The Facility Administrator will review audit results with the monthly Quality Assessment Performance Improvement Meeting known as Facility Health Meeting, with supporting documentation in the meeting minutes. The Facility Administrator is responsible for ongoing 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 five (5) of five (5) observations. (Observation #1 - Observation #5).

Findings:

A review was conducted of facility policy/procedure on August 11, 2022 at approximately 1:00 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 10, 2022 between approximately 8:00 a.m. - 11:45 a.m. revealed the following:

Observation #1: On August 10, 2022 at approximately 10:00 a.m. while observing 'Discontinuation of Dialysis with Central Venous Catheter (CVC)' observation #1 of (3) for patient #8, station #9; Employee #3; employee #3 scrubbed the hubs for approximately 4-5 seconds after disconnecting the bloodlines and prior to attaching sterile syringes.

Observation #2: On August 10, 2022 at approximately 10:15 a.m. while observing 'Discontinuation of Dialysis with Central Venous Catheter (CVC)' observation #2 of (3) for patient #4, station #11; Employee #2; employee #2 did not disinfect the hub after disconnecting the bloodline and prior to attaching a sterile syringe.

Observation #3: On August 10, 2022 at approximately 10:25 a.m. while observing 'Discontinuation of Dialysis with Central Venous Catheter (CVC)' observation #3 of (3) for patient #6, station #8; Employee #3; employee #3 scrubbed the hubs for approximately 4-6 seconds after disconnecting the bloodline and prior to attaching sterile syringe.

Observation #4: On August 10, 2022 at approximately 11:00 a.m. while observing 'Central Venous Catheter Exit Site Care' observation #1 of (2) for patient #3, station #9; Employee #3; employee #3 left central venous catheter (CVC) site exposed without a dressing as CVC dialysis was initiated. Employee #3 applied sterile dressing to CVC site after cleaning CVC ports and connecting sterile syringes. Prior to attaching sterile syringes, employee #3 scrubbed the hubs for approximately 3-5 seconds. Patients shirt made contact with the CVC exit site during the procedure. This was due to the shirt not being secured back away from the exit site during the exit site care and during dialysis initiation. The CVC exit site was not cleansed again after the shirt made contact.

Observation #5: On August 10, 2022 at approximately 11:00 a.m. while observing 'Central Venous Catheter Exit Site Care' observation #2 of (2) for patient #7, station #2; Employee #2; Employee #2 left central venous catheter (CVC) site exposed without a dressing as CVC dialysis was initiated. Employee #2 did not cleanse area around CVC exit site prior to applying sterile dressing. Employee #2 applied sterile dressing to CVC site after cleaning CVC ports and connecting sterile syringes.


An interview with the facility Administrator on August 11, 2022 at approximately 1:30 p.m. confirmed the above findings.






















Plan of Correction:

V 0147
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/12/22. Surveyor observations were reviewed. Education included but was not limited to a review of Procedure 1-04-02B "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure" with emphasis on but not limited to: 1. Exit Site: 1) Step #3: Place patient in comfortable supine position, as tolerated. Verify patient's clothing is secured away from the exit site/work area... Rationale: Securing the patient's clothing away from the work area minimizes the risk of cross contamination. 2) Step #4: Remove old dressing and discard. 2) Step #8: Holding catheter with the non-dominant hand using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds, and apply to CVC exit site in a "back and forth" pattern, using gentle friction progressing from insertion site to periphery using both sides of the swab... Then wait 60 seconds for air dry time. 3) Step #12 - Place sterile 2x2 gauze over the catheter exit site leaving connections accessible. 2. Hub Scrub: 1) Step #14: Remove gloves and discard, perform hand hygiene per procedure and re-glove. 2) 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. 3) Step #17 Connection and Treatment Initiation: Attach sterile 10 ml syringes to the arterial and venous limbs. 3. Upon Completion of Dialysis: 1) Step #30: Clamp arterial catheter limb and blood line. Aseptically disconnect arterial blood line from arterial CVC limb. Attach a 10 ml syringe filled with normal saline to arterial catheter limb. Unclamp arterial catheter limb and push normal saline into arterial port and quickly clamp arterial catheter limb. Attach arterial blood line to saline infusion line and conclude dialysis and rinse back... 2) Step #31: Clamp venous catheter limb and blood line. Aseptically disconnect venous blood line and connect 10 ml syringe with normal saline to the venous catheter limb. Unclamp venous catheter limb and push normal saline into venous port and quickly clamp venous catheter limb. 3) Step #33: Remove syringes and disinfect the CVC hubs with a new alcohol prep pad for each CVC hub. Scrub the sides, threads and end of hub thoroughly with friction for 15 seconds, making sure to remove any residue, for example blood. Hold the catheter until the antiseptic has dried. 4) While holding the shield and catheter hub in one hand, remove the single ClearGuard HD cap (red or blue), by rotating the lock ring counterclockwise, taking care to only handle the lock ring, do not touch the rod. Carefully insert the ClearGuard HD rod into the catheter hub and using a simultaneous push and twist motion, tighten by rotating clockwise. Repeat with the other ClearGuard HD cap and dispose of the shield and foil pouch. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee will conduct observational audits to verify compliance with procedure for CVC care: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control 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.



494.40(a) STANDARD
CARBON ADSORP-MONITOR, TEST FREQUENCY

Name - Component - 00
6.2.5 Carbon adsorption: monitoring, testing freq
Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours.

Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet.

Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L].
Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly.


Observations:


Based on review of facility policy/procedure, water log reviews, and an interview with the facility Administrator, the facility failed to ensure free chlorine, chloramine, or total chlorine testing was performed at least every 4 hours, per facility policy, for one (1) of one (1) 'Daily Water Log' reviews (Water Log Review #1).

Findings include:

A review was conducted of facility policy/procedure on August 11, 2022 at approximately 10:00 a.m. Policy: 2-05-02 'Daily Water System Total Chlorine Monitoring'' 'Policy' (3) states "Total chlorine testing is done on a daily basis prior to the first patient treatment and every four (4) hours until all activities that require us of dialysis quality water are completed. ... Document results on Routine Total Chlorine Testing Log and in Snappy."

Daily Water Logs were reviewed on August 11, 2022 at approximately 10:00 a.m. revealed the following:

Water Log Review #1: On August 11, 2022 at approximately 10:00 a.m. a review of the 'Routine Total Chlorine Testing Log' revealed late chlorine testing. On 12/17/21, Total Chlorine Testing documentation revealed time of testing "0830". The next chlorine reading revealed time of testing "1300". This is a total of (4) hours and (30) minutes between chlorine testing.

On 12/22/21, Total Chlorine Testing documentation revealed time of testing "0830". The next chlorine reading revealed time of testing "1245". This is a total of (4) hours and (15) minutes between chlorine testing.

On 01/03/22, Total Chlorine Testing documentation revealed time of testing "0845". The next chlorine reading revealed time of testing "1330". This is a total of (4) hours and (45) minutes between chlorine testing.

On 01/05/22, Total Chlorine Testing documentation revealed time of testing "0830". The next chlorine reading revealed time of testing "130". This is a total of (4) hours and (30) minutes between chlorine testing.

On 01/12/22, Total Chlorine Testing documentation revealed time of testing "0756". The next chlorine reading revealed time of testing "1245". This is a total of (4) hours and (49) minutes between chlorine testing.

On 01/14/22, Total Chlorine Testing documentation revealed time of testing "0800". The next chlorine reading revealed time of testing "1300". This is a total of (5) hours between chlorine testing.

On 01/21/22, Total Chlorine Testing documentation revealed time of testing "0815". The next chlorine reading revealed time of testing "1300". This is a total of (4) hours and (45) minutes between chlorine testing.

On 01/26/22, Total Chlorine Testing documentation revealed time of testing "0845". The next chlorine reading revealed time of testing "1315". This is a total of (4) hours and (30) minutes between chlorine testing.

On 01/28/22, Total Chlorine Testing documentation revealed time of testing "0500". The next chlorine reading revealed time of testing "0930". This is a total of (4) hours and (30) minutes between chlorine testing.


An interview with the facility Administrator on August 11, 2022 at approximately 1:30 p.m. confirmed the above findings.











Plan of Correction:

V 0196
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/12/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 02-05-02 "Daily Water System Total Chlorine Monitoring" and with emphasis on but not limited to: 1) Total Chlorine testing is done on a daily basis prior to the first patient treatment and every four (4) hours until all activities that require use of dialysis quality water are completed. All samples are to be drawn only after the water system has been operating for at least 15 minutes... 2) 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. If the licensed nurse performs the total chlorine test, they may sign results as verified. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The Facility Administrator or designee will perform observational audits to verify total chlorine testing log is complete and compliant with policy: daily for two (2) weeks, then weekly for two (2) weeks, and monthly for two (2) months. 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.



494.40(a) STANDARD
DIALYS PROPORT-MONITOR PH/CONDUCTIVITY

Name - Component - 00
5.6 Dialysate proportioning: monitor pH/conductivity
It is necessary for the operator to follow the manufacturer's instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient.




Observations:


Based on review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure the approximate pH was measured with an independent method before starting the treatment of the next patient, for one (1) of one (1) 'Preparation of the Hemodialysis Machine/Extracorporeal Circuit' observations (Observation #1) and one (1) of one (1) interviews conducted (Interview #1).

Findings include:

A review was conducted of facility policy/procedure on August 11, 2022 at approximately 10:00 a.m. Procedure: 1-03-06M 'Priming A Non-ETO Sterilized Single Use Dialyzer Utilizing B Braun Dialog+ Dialysis Delivery Systems and Streamline Blood Lines' 'Procedure' (45) states "Once the rinsing with UFP is initiated the pump speed will default to 400 ml/min. During rinsing with UFP, check manual pH." 'Rationale' states "pH testing must be performed prior to each patient treatment."

Observations conducted in patient treatment area on August 10, 2022 between approximately 8:00 a.m. - 11:45 a.m. revealed the following:

Observation #1: On August 10, 2022 at approximately 10:40 a.m. while observing 'Preparation of the Hemodialysis Machine/Extracorporeal circuit' observation #2 of (2) for patient #3, station #9; Employee #3; employee #3 did not manually measure the approximate pH with an independent method before starting the dialysis treatment. Patient treatment was initiated at approximately 11:16 a.m.

Interview #1: On August 10, 2022 at approximately 11:30 a.m. an interview was conducted with employee #3. The surveyor inquired about pH testing prior to the patient #3 treatment initiation. Employee #3 confirmed that she did not manually measure the pH prior to the initiation of dialysis.


An interview with the facility Administrator on August 11, 2022 at approximately 1:30 p.m. confirmed the above findings.











Plan of Correction:

V 0250
The Facility Administrator held mandatory in-services for all clinical teammates starting on 08/12/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-06M "Priming a Non-eto Sterilized Single Use Dialyzer Utilizing B Braun Dialog+Dilaysis Delivery Systems and Streamline Blood lines" with emphasis on but not limited to: 1) Once the rinsing with UFP is initiated the pump speed will default to 400 ml/min. During rinsing with UFP, check manual pH. Verify appropriate sodium and bicarbonate level prescribed. Rationale: pH testing must be performed prior to each patient treatment. Verification of attendance will be evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee will conduct observational audits to verify pH testing is completed prior to each patient treatment: daily for two (2) weeks, then weekly for two (2) weeks, and monthly for two (2) months. 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.



494.150(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/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#5).

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."

CR#5 Date of admission 11/24/21: 'Hemo Treatment Orders' with a start date of 03/14/22 include 'Heparin' 'Load: 2600 units', 'Hourly dose: 600 units/hour', 'Stop: 60 minutes before the end of dialysis' (1800 units). Patient treatment flowsheets dated 08/01/22 - 08/08/22 reviewed.
Flowsheet dated 08/01/22, entry by Employee #5, 'Medications and Ancillaries Administered' 'Heparin Pork' 'Bolus/Infusion 1 units PM, (Concentration 1:1,000)' (Note: This entry is not the correct physician order) 'Status' "Given". 'Intradialytic's (Patient Statistics)' 'Heparin' "1.2" (administered). The hourly dose order was for 600 units/1800 units total.
Flowsheet dated 08/05/22, entry by Employee #5, 'Medications and Ancillaries Administered' 'Heparin Pork' 'Bolus/Infusion 1 units PM, (Concentration 1:1,000)' (Note: This entry is not the correct physician order) 'Status' "Given". 'Intradialytic's (Patient Statistics)' 'Heparin' "1.3" (administered). The hourly dose order was for 600 units/1800 units total.
Flowsheet dated 08/08/22, entry by Employee #5, 'Medications and Ancillaries Administered' 'Heparin Pork' 'Bolus/Infusion 1 units PM, (Concentration 1:1,000)' (Note: This entry is not the correct physician order) 'Status' "Given". 'Intradialytic's (Patient Statistics)' 'Heparin' "0" (administered). The hourly dose order was for 600 units/1800 units total.


An interview with the facility Administrator on August 11, 2022 at approximately 1:30 p.m. confirmed the above findings.










Plan of Correction:

V 0715
A Governing Body meeting was held on 08/12/22, with the Medical Director, Facility Administrator, Director of Nursing and Regional Operations Director to review the results of the survey ending on 08/11/22. 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 08/12/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-06-01 "Medication Policy" with emphasis on but not limited to: 1) Medications are administered as prescribed and then documented in the patient's medical record. 2) All medication errors are reported to the Facility Administrator /designee. She/he will then notify the patient's physician of the event and of any adverse changes in the patient's condition. Physician will be notified of any medication errors prior to patient leaving the facility. Examples of medication errors include: Administration of an incorrect dosage of an ordered medication. Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee will conduct audits of treatment flowsheets to verify compliance with medication administration per physician order per policy: daily each treatment day for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the ten percent (10%) monthly medical records audit. Instances of non-compliance will be addressed 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.