Pure Life Renal of Lansdowne Inc.

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. This Standard is not met as evidenced by: 42929 Based on observations, interviews, and document review, it was determined the facility staff failed to maintain required documentation in the evacuation box to be used during an emergency, as per the facility’s policy. Findings: During the flash tour on 01/08/2024 at 11:27 a.m., the surveyor reviewed the facility’s evacuation box. The evacuation box contained a folder of patient orders that was taped to the top of the box, there was no other documentation included in the folder aside from the patient orders. As per the facility’s policy titled “Emergency Evacuation Box/Cart” last reviewed on 07/07/2015, the evacuation box/cart should contain “... Current list of back up facilities and hospitals (names, addresses, and phone numbers) ...” In addition, the facility’s emergency policy states in part “... The Emergency Box for Record Management ... A sturdy, waterproof and portable container will be purchased to hold the following records. The contents of the container will be up-dated regularly but not less than quarterly. In an emergency, it will be the responsibility of the highest-ranking person on duty to evacuate this box. The following records will be maintained in the box: For each patient: a copy of the CMS 2728, hemodialysis orders, admitting face sheet. These documents should be filed alphabetically in a 3-ring binder for ease of access. Advance Healthcare Directives for each patient who has completed one. A schematic drawing of the flow pattern and operation of the water treatment system. A census of patients and staff by shift (for accurate head count in evacuation area). Telephone contact numbers for patients, staff, physicians, and emergency contacts. Copies of agreements with other dialysis providers for emergency aid. Staff will be educated about the Emergency Record Management Box and its location.” During an interview on 01/09/2024, Staff Member (SM)1 reviewed the above policies with the surveyor and confirmed that the facility did not have a box separate from the evacuation box on the treatment floor to contain the documentation addressed in the policy. SM1 stated that there was documentation in the folder on top of the evacuation box on the treatment floor, but the surveyor made SM1 aware that the folder only included patient orders and patient emergency contact information, that the surveyor noticed was added on 01/09/2024. SM1 stated that SM1 would update the documentation as per the policy. The above concerns were discussed with SM1 at the exit conference on 01/09/2024 at 3:30 p.m.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 42929 Based on interviews and medical record review, it was determined the facility failed to maintain documentation of emergency preparedness orientation and training for two (2) patients (P), P9 and P10, of the six (6) patients sampled. Findings: On 01/09/2024, the surveyor reviewed the medical records for two (2) peritoneal dialysis (PD) patients and found no documented evidence that P9 and P10 received education and orientation on emergency preparedness. During an interview on 01/09/2024 at 2:20 p.m., Staff Member (SM) 2 (Peritoneal Dialysis Nurse) stated that SM2 completes emergency education and orientation with the PD patients but has not documented the education. SM2 stated that SM2 needs to find a form to document that education. A review of the facility’s policy titled “Disaster and Emergency Readiness” last reviewed 07/07/2015 states in part: ... Each patient will receive training quarterly as outlined on the Patient Education Training Form (attached).... Documentation of the initial training will also be completed on the Emergency Evacuation Procedure - Training Form (attached).... Patient Education on Emergency Evacuation Procedure - Training Form ... Copy goes to patient and copy goes to medical record. A review of the facility’s policy titled “2.0 Medical Record General Policies” last revised 04/01/2018 states in part: ... F. ... Medical records should include evidence of education in emergency evacuation and emergency preparedness, to include some measure of patient understanding, such as return teaching or demonstration.... The above concerns were discussed with SM1 at the exit conference on 01/09/2024 at 3:30 p.m.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) 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. This Standard is not met as evidenced by: 49355 Based on observation, interview and review of documentation, it was determined that facility staff failed to follow the facility’s policy on handwashing to prevent the spread of infection among patients and staff. The findings include: On 01/08/2024 at 4:10 p.m., the surveyor observed Staff Member (SM)8 perform Central Venous Catheter (CVC) exit site care and initiation of dialysis with a CVC on Patient (P)6 at station #1. SM8 changed gloves frequently and appropriately, per policy, but never performed hand hygiene by using soap and water or an alcohol-based hand rub before donning a new pair of gloves. An interview with SM1 confirmed the need to perform hand hygiene before donning a new pair of gloves. A review of the facility’s policy titled, “5.0 Handwashing” last reviewed 04/01/2018 reads, in part: “Hands will be washed prior to gloving, after removal of gloves, after contamination with blood... CDC recommends the use of alcohol-based hand rub...” A review of the facility’s procedure titled, “5.0g Handwashing Technique,” reads, in part: When using an alcohol-based hand rub, apply product to palm of one hand and rub hands together, covering all surfaces of hands until hands are dry. The above concern was discussed with SM #1 at the exit conference on 01/09/2024 at 3:30 p.m.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [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. This Standard is not met as evidenced by: 49355 Based on observations and document review, it was determined the facility staff failed to ensure that dialysis stations and chairs were appropriately disinfected between patients in two (2) out of three (3) observations. The findings include: On 1/8/2024 at 11:30 a.m., the surveyor observed Staff Member (SM) #4 cleaning and disinfecting a vacated chair at station #5. SM #4 did not wipe down either side of the chair under the chair side tables nor did SM #5 clean the wall box behind the chair, where the patient’s belongings had been stored. The SM also laid a dirty blood pressure cuff on the clean chair before picking the cuff back up, wiping it down and laying it on the chair side table. On 1/8/2024 at 3:45 p.m., the surveyor observed SM #8 cleaning and disinfecting a vacated chair at station #2. SM #8 did not wipe down either side of the chair under the chair side tables nor did SM #8 clean the wall box behind the chair. A review of the facility’s policy titled, “5.0p Environmental Surfaces,” (last reviewed 04/01/18) states, in part: Equipment and chairs will be cleaned with a 1:100 household bleach solution (300-600 mg/L free chlorine) between each treatment. The above concerns were discussed with SM #1 at the exit conference on 1/9/2024.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 42929 Based on observations, interviews, and document review, it was determined the facility staff failed to: include all of the necessary components of medication labeling, remove expired medications and supplies from the treatment floor, secure medications, and wipe the medication vial prior to accessing. Findings: During the flash tour on 01/08/2024 at 11:27 a.m., the surveyor observed a pre-drawn heparin syringe for Patient (P) 12 that was not labeled with a time when the medication was drawn. There were three (3) upside down heparin vials at the medication preparation counter not labeled with initials or date opened. There were eight (8) vials of vancomycin that expired on 01/01/2024 in the medication cabinet. There were multiple vials of heparin unsecured in the evacuation kit. On 01/08/2024 at 1:39 p.m., the surveyor observed Staff Member (SM) 12 draw up three syringes of heparin and did not clean the septum of the multi-dose vial with alcohol before inserting each needle into the vial. A review of the facility’s policy titled “7.0 Medication Policy” last reviewed 04/01/2018 states in part: ... An emergency cart is stocked with medications routinely used in [sic] during patient emergencies. The emergency cart drawer is checked monthly to monitor expiration dates and available stock. It is then relocked with a plastic break -away lock and the lock is dated and initialed. ... Pre-drawn or pre-mixed meds must be labeled with the name of the drug, dosage, date and time prepared, and signature of the person who prepared it as well as the patient’s name. ... Multi-dose vials are to be dated, initialed when opened and kept after opening for the period of time as recommended by the manufacturer. A multi-dose vial may only be entered each time with a new sterile syringe and needle. All medications are monitored monthly for expiration dates.... The expired meds are removed from med area and disposed of per policy.... A review of the facility’s policy titled “7.0a Medication Administration” states in part: ... Policy: 1. Multi-dose vials will be labeled with the date first opened and person’s initials who opened vial. ... 3. ... Staff preparing medications should clean the septum of multi-use vial and the injection port with alcohol swab before administration of medication. ... 5. Medications drawn up will always be labeled clearly with the following information: Medication name and dose. Date and time med was drawn up. Initials of staff drawing up the med. ... 9. Expired medications will be discarded. ... 14. All medications are to be kept in appropriate storage areas. A review of the facility’s policy titled “7.7 Multi-Dose IV Medication Vial” last revised 04/01/2018 states in part: ... 4. ... Note: Vials must be labeled to document the time of first entry ... 5. ... F. All drawn up medications in syringes must be administered within [four] 4 hours. These syringes must be labeled and note the time that it was drawn up. ... 8. Remove vial top, wipe the top with an alcohol wipe and inject the amount of air for the same amount of medication to be drawn up. The above concerns were discussed with SM1 at the exit conference on 01/09/2024 at 3:30 p.m.”

“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: 42929 Based on observations, interviews, and document review, it was determined the facility staff failed to ensure aseptic technique when accessing a central venous catheter (CVC) for two (2) of two (2) observations. Findings: On 01/08/2024 at 11:39 a.m., the surveyor observed Staff Member (SM) 4 initiating dialysis for a patient with a CVC at station #3. SM4 did not clean each CVC limb with a new alcohol prep pad starting close to the exit site and down to the connector for sixty (60) seconds to provide antimicrobial effectiveness, as per the facility’s policy. SM4 scrubbed the red hub threads for about five (5) seconds and scrubbed the blue hub threads for about three (3) seconds prior to attaching the syringe to the hub, not fifteen (15) seconds to reduce bacteria and biofilm from entering the lumen, as per the facility’s policy . On 1/8/2024 at 4:10 p.m., the surveyor observed SM8 initiating dialysis for Patient (P) 6 with a with CVC at station #1. SM8 did not clean each CVC limb with a new alcohol prep pad starting close to the exit site and down to the connector for sixty (60) seconds to provide antimicrobial effectiveness, as per the facility’s policy . SM8 scrubbed each lumen hub threads for about seven (7) seconds prior to attaching the syringe to the hub, not fifteen (15) seconds to reduce bacteria and biofilm from entering the lumen, as per the facility’s policy . A review of the facility’s policy titled “4.18 Pre and Post Treatment Catheter Care” last revised 02/06/2017 states in part: ... 9. Clean each CVC limb with a new alcohol prep pad starting close to the exit site and down to the connector. Each site must be scrubbed for at least [sixty] 60 seconds to provide antimicrobial effectiveness. 10. Remove each catheter cap and clean the hub thread. Place a sterile 10 cc syringe on the end of each extension. Scrub the hub thread for [fifteen] 15 seconds with alcohol swab. This reduces bacteria and biofilm from entering the lumen.... A review of the facility’s policy titled “4.1l Initiation of Treatment Via Central Venous Catheter/Heparin Administration and Catheter Care” last revised 02/06/2017 states in part: ... CVC Limb and Port Care: 9. Clean each CVC limb using appropriate Antiseptic/Disinfectant per facility choice starting close to the exit site and down to the connector. 10. Remove gloves and discard, perform hand hygiene and re-glove. 11. ... Remove arterial cap from port. Using fresh Antiseptic/Disinfectant, scrub the hub thread and attach empty 10 ml syringe.... Scrub the hub threads for [fifteen] 15 seconds reduces bacteria and biofilm from entering the lumen. ... 13. Repeat step [eleven] for the venous port ... The above concerns were discussed with SM1 at the exit conference on 01/09/2024 at 3:30 p.m.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) 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; This Standard is not met as evidenced by: 42929 Based on interviews and document review, it was determined the facility staff failed to obtain a standing blood pressure for four (4) of four (4) in-center patient’s (P) sampled. Findings: On 01/09/2024, the surveyor reviewed dialysis treatment flow sheets for four (4) in-center hemodialysis patients. There was no pretreatment standing blood pressure for P5 on 12/20/2023, 12/22/2023, 12/24/2023, 12/29/2023, 01/01/2024, and 01/03/2024. There was no pretreatment standing blood pressure for P6 on 12/24/2023, 12/27/2023, 12/29/2023, 01/01/2024, 01/03/2024, and 01/05/2024. There was no pretreatment standing blood pressure for P11 on 12/24/2023, 12/27/2023, 12/29/2023, 01/01/2024, 01/03/2024, and 01/05/2024. There was no pretreatment standing blood pressure for P12 on 12/24/2023, 12/27/2023, 12/29/2023, 01/01/2024, 01/03/2024, and 01/05/2024. During an interview on 01/09/2024 at 9:53 a.m., Staff Member (SM) 1 stated that the facility staff are no longer obtaining pre-treatment standing blood pressures on in-center hemodialysis patients. SM1 stated that it was discussed and the team came to the consensus not to obtain standing blood pressures because there is such a difference between the standing and sitting blood pressure readings. SM1 stated that the decision to stop obtaining standing blood pressures on dialysis patients has not been discussed at governing body or documented. The surveyor reviewed the facility’s policy “4.11 Pre-Dialysis Preparation and Patient Assessment” with SM1 that states in part “... 4. Obtain patient’s blood pressure (BP) sitting and standing ... 8. Document on the treatment sheet all results, or findings prior to initiating dialysis ...” The above concerns were discussed with SM1 at the exit conference on 01/09/2024 at 3:30 p.m.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 42929 Based on observations, interviews, and document review, it was determined the facility staff failed to auscultate the patient’s vascular access for a bruit (vascular murmur/sound) prior to accessing the site with a needle, for three (3) of three (3) patients (P) observed. Findings: On 01/08/2024 at 11:40 a.m., Staff Member (SM) 4 did not auscultate the vascular access of P3 (at station #12) prior to accessing the site with a needle. On 01/08/2024 at 11:45 a.m., the patient care technician at station #2 did not auscultate the vascular access on the patient’s right upper arm prior to accessing the site with a needle. On 01/08/2024 at 12:02 p.m., SM4 did not auscultate or palpate the vascular access on P4 (at station #5) prior to accessing the site with a needle. A review of the facility’s policy titled “4.21 Vascular Access Monitoring” last revised 03/09/2016 states in part: ... In an effort to identify problems in the early stages, the vascular access will be thoroughly assessed prior to each treatment. The assessment will include palpation, auscultation and dynamic or static venous pressure measurement. All findings will be carefully documented and trended. The above concerns were discussed with SM1 at the exit conference on 01/09/2024 at 3:30 p.m.”