Fmc Holy Name

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) 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]. This Standard is not met as evidenced by: 50912 Based on two of two observations of the discontinuation of hemodialysis using a central venous catheter (CVC), review of policy and procedures and staff interview, it was determined that the facility failed to ensure the hub and threads of the CVS are cleaned adequately during termination of the hemodialysis treatment. Findings include: On 08/28/24 at 12:40 PM, Staff (S) 6, a Registered Nurse (RN), was observed discontinuing hemodialysis treatment for Patient (P) 1 through a right chest CVC at Station 5. After disconnecting the blood lines from the blue and red ports of the CVC, S6 scrubbed the threads and the open CVC hubs with alcohol prep pads for seven seconds. S6 then applied the end caps onto both open hubs. S6 did not clean the arterial and venous ends of the hubs for 10 to 15 seconds as required by facility policy. On 08/28/24 at 1:41 PM in Station 29, S6 was observed discontinuing hemodialysis treatment through P2’s right chest CVC. S6, after disconnecting blood lines from the blue and red ports of the CVC, scrubbed the threads and top of open CVC hubs with alcohol prep pads for seven seconds. S6 then applied end caps onto both open hubs. S6 did not clean the arterial and venous ends of the hubs for 10 to 15 seconds as required by facility policy. During interview at 1:46 PM, S6 when questioned about the procedure for cleaning the CVC after hemodialysis, he/she stated, “It takes about three to five seconds to clean the tip of the CVC site.” Facility policy titled, “Termination of Treatment using a Central Venous Catheter and Optiflux Single use Ebeam Dialyzer,” revised 02/07/22, stated, “ ... Step 6. Using a sterile alcohol pad, (or other appropriate antiseptic product such as chlorhexidine or povidone iodine ...) scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue ... This step should take 10-15 seconds ... Repeat steps 5 through 8 for the venous end of the catheter limb. ...” N.J.A.C. 8:43A-24.8(b)”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 48966 Based on staff interview and review of facility documents, it was determined that the facility failed to ensure that one of four dry acid mixing log records that is prepared at the facility are completed accurately. Findings include: A review of four weeks of the “Granuflo Mixing Logs” provided by Staff (S) 2, the Area Technical Operations Manager, revealed the following: The “Granuflo Mixing Log” record dated 08/26/24 initially indicated the catalog number “OFD3251” of 3K (potassium) 2.5CA (calcium) acid concentration. Further review of the document indicated a different acid concentration, 3K 2.0CA, and catalog number, “OFD3201,” of 3K 2.0CA acid. During an interview on 08/29/24 at 12:35 PM, S2 stated that this facility does not mix 3K 2.0CA acid. S2 confirmed the wrong catalog number was chosen under the “temperature range” section on the log. The “Granuflo Mixing Log” form instructs to select the correct catalog number from the drop down box. Facility policy titled, “Acid Concentrate Mixing And Handling: Dry Acid Dissolution Unit,” published on 09/05/23, stated, “... Batch Records ... All data derived by mixing a batch of Granuflo or Citrasate Dry acid concentrate will be recorded on the Granuflo or Citrasate Batch Mixing Log in the approved electronic record system (e.g. TMS). The batch record will contain the following information: Case catalog #[number] (label on the box), each box lot #, Potassium Value (2K, #k, etc) ...” N.J.A.C 8:43A-24.10(a)(5)”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 48966 Based on medical record review, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that post hemodialysis treatment assessments are completed for nine of nine hemodialysis treatments reviewed for Patient (P) 7. Findings include: A review of P7’s medical record indicated that he/she received hemodialysis treatments three times per week. Further review of the hemodialysis treatment flowsheets revealed the following: On 08/08/24 at 09:59 AM, the pre-treatment “Nursing Evaluation” indicated lungs rales (crackles) and bilateral lower leg and ankle edema. The post-treatment “Nursing Evaluation” at 01:55 PM lacked documented evidence of a re-assessment of lungs sounds and the bilateral lower leg and ankle edema. On 08/09/24 at 09:36 AM, the pre-treatment “Nursing Evaluation” indicated lungs rales (crackles) and bilateral lower extremity edema. The post-treatment “Nursing Evaluation” at 01:10 PM lacked documented evidence of a re-assessment of lungs sounds and the bilateral lower extremity edema. On 08/12/24 at 09:28 AM, the pre-treatment “Nursing Evaluation” indicated lungs rales (crackles) and bilateral lower extremity edema. The post-treatment “Nursing Evaluation” at 01:11 PM lacked documented evidence of a re-assessment of lungs sounds and the bilateral lower extremity edema. On 08/13/24 at 09:19 AM, the pre-treatment “Nursing Evaluation” indicated lungs rales (crackles) and bilateral lower extremity edema. The post-treatment “Nursing Evaluation” at 01:06 PM lacked documented evidence of a re-assessment of lungs sounds and the bilateral lower extremity edema. On 08/15/24 at 09:28 AM, the pre-treatment “Nursing Evaluation” indicated lungs rales (crackles) and bilateral lower extremity edema. The post-treatment “Nursing Evaluation” at 01:07 PM lacked documented evidence of a re-assessment of lungs sounds and the bilateral lower extremity edema. On 08/16/24 at 09:38 AM, the pre-treatment “Nursing Evaluation” indicated lungs rales (crackles) and bilateral lower extremity edema. The post-treatment “Nursing Evaluation” at 02:03 PM lacked documented evidence of a re-assessment of lungs sounds and the bilateral lower extremity edema. On 08/19/24 at 09:44 AM, the pre-treatment “Nursing Evaluation” indicated decreased breath sounds and bilateral lower leg and ankle edema. The post-treatment “Nursing Evaluation” at 01:28 PM lacked documented evidence of a re-assessment of lungs sounds and the bilateral lower leg and ankle edema. On 08/20/24 at 09:33 AM, the pre-treatment “Nursing Evaluation” decreased breath sounds and bilateral lower extremity edema. The post-treatment “Nursing Evaluation” at 01:11 PM lacked documented evidence of a re-assessment of lungs sounds and the bilateral lower extremity edema. On 08/22/24 at 09:34 AM, the pre treatment “Nursing Evaluation” indicated decreased breath sounds and bilateral lower extremity edema. The post-treatment “Nursing Evaluation” at 01:17, PM lacked documented evidence of a re-assessment of lungs sounds and the bilateral lower extremity edema. During an interview on 08/29/24 at 02:11 PM, Staff (S) 14, a Registered Nurse, confirmed the post re-assessment was not documented on the above mentioned hemodialysis flowsheets. S14 stated that he/she should reassess post-treatment if abnormal findings were found pre-treatment. S14 indicated that P7 has chronic conditions, and he/she should document accordingly. During an interview on 08/30/24 at 09: 33 AM, S1, the Clinical Manager, confirmed that a post re-assessment should be done if pre-treatment abnormal findings were identified. S1 stated, “I will continue to emphasize to document abnormal findings with the staff.” A review of facility policy and procedure titled, “Patient Assessment and Monitoring,” published 05/01/23, stated, “... Post-Treatment Follow the steps below for obtaining post-treatment assessment data: ... 1 ... Lungs sounds Edema Heart sounds ... The registered nurse will assess/reassess post treatment as indicated. ... 2 Document findings in the patient’s record. ...” N.J.A.C 8:43A-8.4(b)”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 39223 Based on one of three observations of initiation of hemodialysis treatment through an arteriovenous fistula/graft (AVF/G), medical record review, staff interview, and personnel file review, it was determined that the facility failed to ensure a physician’s plan of care for the hemodialysis dialysate is implemented as prescribed (Patient (P) 1). Findings include: During an observation on 08/28/24 at 10:54 AM, Staff (S) 10, a Patient Care Technician, initiated hemodialysis treatment via an AVF/G on P1. The treatment was initiated using an acid concentrate jug of 2.0 K (potassium), 3.0 Ca (calcium). During an interview at 11:06 AM, S10 stated that the acid concentrate ordered for P1 was 2.0 K, 2.0 Ca. Upon bringing to S10’s attention that the current acid concentrate jug was different, S10 changed the acid concentration jug out for the prescribed strength. A review of Medical Record (MR) 1 revealed a physician order, dated 07/24/24, which stated, “... Dialysate 2.0 K, 2.0 Ca ...” There was no documented evidence that an acid concentration of 2.0 K, 3.0 Ca was ordered. A review of S10’s personnel file indicated that on 03/13/23, S10 was validated for his/her skills documented on the “Fresenius Medical Care Direct Patient Care - Skills Validation Checklist.” This indicated S10 was trained and competent for: “... Infection Control Skill Component ... Preparation of the Dialysis Machine ... Assessment, Treatment, Documentation Skill Components ... Prescription verification: UFR [ultrafiltration rate], EDW [estimated dry weight], DFR [dialysis facilty report], BFR [blood flow rate], dialysate, dialyzer, treatment time (HD only) ... Initiation of treatment ...” N.J.A.C. 8:43A-24.4(a)”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 39228 Based on two of three observations of the initiation of hemodialysis through an arteriovenous fistula/graft (AVF/G), staff interview, and a review of facility policy and procedure, it was determined that the facility failed to ensure that the patient’s vascular access is maintained through proper skin disinfection of the access site prior to initiating the dialysis treatment. Findings include: On 08/28/24 at 10:03 AM, Staff (S) 14, a Patient Care Technician (PCT), initiated dialysis through the patient’s AVF at Station 30. S14 cleansed the first site of the AVF with an alcohol pad in a circular motion for 16 seconds. S14 cleansed the second site of the AVF with an alcohol pad in a circular motion for 13 seconds. Upon interview at 10:28 AM, S14 stated he/she should clean the sites with an alcohol pad for 60 seconds and then allow them to dry. When questioned regarding the observation noted above, S14 stated, “I thought I cleaned the sites for 60 seconds each.” On 08/28/24 at 11:44 AM, Staff (S) 10, a PCT, initiated dialysis through a patient’s AVF at Station 19. S10 cleansed the first site of the AVF with an alcohol pad in a circular motion for 14 seconds. S10 cleansed the second site of the AVF with an alcohol pad in a circular motion for 15 seconds. Upon interview at 11:55 AM, S10 stated that he/she should clean the sites with an alcohol pad for 20 seconds each. A review of facility policy titled, “Access Assessment and Cannulation”, published 05/06/24, stated, “... Skin Disinfection ... Disinfect cannulation site as follows ... 70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating. ... Perform skin antisepsis on one site at a time, allow to dry and them [sic] cannulate. ...” N.J.A.C. 8:43A-24.8(b)”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) 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; This Standard is not met as evidenced by: 39228 Based on observation, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure that: 1) one of one container used for the soaking of soiled plastic hemostat clamps is labeled in accordance with facility policy and procedure and; 2) pre-drawn medications, available for use, in one of two medication carts, are administered within one hour of preparation. Findings include: 1. On 08/28/24 at 10:34 AM, during an observation on the Treatment Floor, a container that had more than 10 blue and white, plastic hemostat clamps soaking in a clear solution, was next to a dirty sink across from Station 4. The container had a label on it that was blank and did not specify the type of solution, the strength of the solution, the date and time the solution was prepared and the preparer’s initials, as required by facility policy. Upon discovery, an interview was conducted with Staff (S) 7, the Charge Nurse, who stated that the clamps were used on patients from the prior shift that morning and that they were soaking in a 1:100 bleach solution that was prepared earlier that day by a staff member. S7 then stated that the container had a label with the date written on it earlier that morning but someone must have covered it up with a blank label. S7 then peeled away the label and another label was visualized underneath it that appeared to have writing on it, but it was smudged and illegible. Review of facility policy and procedure titled, “Mixing Bleach,” published 06/05/24, stated, “... Procedure Follow the steps below for mixing bleach: ... Step 4 Action Label opaque container with “Bleach solution”, strength of solution, date and time prepared, and preparer’s initials ...” Review of facility policy and procedure titled, “Cleaning and Disinfecting Plastic Hemostat,” published 07/01/24, stated, “... Visibly Soiled Plastic Hemostat Clamps ... 2) Place soiled plastic hemostat clamps in the labeled opaque plastic container filled with 1:100 bleach solution according the Mixing Bleach policy. ...” N.J.A.C. 8:43A-24.4(a) 2. On 08/28/24 at 10:48 AM, during an observation of the Treatment Floor, the top drawer of a medication preparation/storage cart, located across from Station 7, contained the following pre-drawn medication syringes, available for use, that were individually labeled with the patient’s name, the medication, and the date, time, and initials of the person who prepared the medications: One syringe of Heparin prepared on 08/28/24 at 08:00 AM Two syringes of Hectorol prepared on 08/28/24 at 08:00 AM Two syringes of Venofer prepared on 08/28/24 at 08:00 AM One syringe of Hectorol prepared on 08/28/24 at 08:45 AM Three syringes of Venofer prepared on 08/28/24 at 08:50 AM Upon discovery of the medications, an interview was conducted with S7, the Charge Nurse, who stated that all pre-drawn medications must be administered within one hour of preparation. At 11:01 AM, an interview was conducted with S9, a Registered Nurse, who confirmed that he/she had prepared the above medications earlier that day, for his/her patient’s on the second treatment shift. S9 then proceeded to discard all nine pre-drawn medication syringes and stated that he/she would re-draw them and administer them within one hour of preparation. Review of facility policy titled, “Medication Preparation and Administration”, published 02/06/23, stated, “... Pre-drawing Medications Medications may be pre-drawn up to 4 hours prior to administration (unless state specific requirements, such as New Jersey, ... where there is a 1 hour maximum to pre drawing medications). ...” N.J.A.C. 8:43A-9.3(a)”