Usrc Solid Rock Dialysis

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 53173 Based interviews and record review, the facility failed to protect the privacy and confidentiality of patient’s protected health information (PHI) via encrypted email affecting 3 (P[patient] 13, 14 and 15) out of 15 (P1 through P15) patients reviewed. This deficient practice can lead to patient harm through identity theft, stigma, embarrassment, and a reluctance to seek necessary medical care due to a loss of trust in healthcare providers. It can also result in improper diagnosis or treatment if records are inaccurate or lost. The findings are: A. During an interview on 09/29/25 at 1:29 pm with S(staff)4, clinical, it was confirmed that staff received and opened PHI from an outside vendor via unencrypted email. B. During an interview on 09/29/25 at 1:29 pm with S4, clinical, they provided evidence of receipt and opening an unencrypted email containing PHI pertaining to multiple patients from a pharmaceutical company. C. During an interview on 09/30/25 at 10:09 am with S9, clinical, it was confirmed that staff received and opened unencrypted email containing patient protected health information (PHI) from an outside vendor. D. During an interview on 09/30/25 at 10:09 am with S9, clinical, they provided evidence of receipt and opening an unencrypted email containing PHI pertaining to multiple patients from a pharmaceutical company. E. During an interview on 09/30/25 at 10:09 am with S9, clinical, they provided evidence of sending via unencrypted email PHI pertaining to multiple patients to two pharmaceutical companies. F. During an interview on 09/30/25 at 10:09 am with S9, clinical, it was reported that they asked for extra training pertaining to office duties, to include sending and receiving emails securely, and were told by management that they did not require more training. G. Record review of facility’s policy dated 02/31/2018, “IT.35 Encrypting [facility name] Emails” states: “II.B. All email sent from any [facility name] email address to a non-[facility name] email address must use one of the approved encryption/protection processes detailed in the “Procedures” section, below. I. Password Protecting a Document A. Most popular document management software, such as Excel, Word and Acrobat, feature the option to password protect your document. B. Should you choose this option, remember to send the password to the recipient in a separate email. II. Using Secure Messaging A. Sending a Secure Email Using “Secure: “ 1. Putting “Secure: “ in the subject line will trigger additional protection rules on all outbound emails. 2. There must be a space after the word “Secure: “for the encryption rules to trigger. For example, Secure:test message will not encrypt. Use Secure: test. H. Record review of an email received by S4, clinical, demonstrates P13’s first and last name, pharmacy names, and P13’s medication prescription information. I. Record review of an unencrypted email sent outside the facility by S9, clinical, demonstrates P14’s first and last name, home phone number, date of birth, and nine digit social security number. J. Record review of an unencrypted email sent outside the facility by S9, clinical, demonstrates P15’s patient first and last name, date of birth, and prescription medication information.”

“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: 35949 Based on observation, interview, and facility policy review, the facility failed to ensure staff performed hand hygiene before touching patient care equipment (dialysis machine) and after removing gloves, during 2 of 2 observation days. Failure to perform hand hygiene provided a mode of cross contamination with the potential spread of pathogens, which could negatively impact the health and well-being of the 68 patients receiving dialysis treatments at the facility. Findings included: The facility’s policy titled, “Hand Hygiene,” revised 08/2020, indicated, “HAND HYGIENE will be performed: 1. Before and after touching a patient. 2. Prior to entering and on exiting station to provide care to patient.” Per the policy, “9. After gloves are removed.” During an observation of the dialysis treatment area on 08/13/2024 at 11:40 AM, with the Facility Administrator, Certified Clinical Hemodialysis Technician (CCHT) #7 was observed exiting Station #1 while wearing a pair of gloves. CCHT #7 obtained patient care supplies from a common storage area, re-entered Station #1, and touched the dialysis machine. During an interview on 08/13/2024 at 12:12 PM, CCHT #7 acknowledged she did not change gloves and perform hand hygiene before she touched the dialysis machine located in Station 1. During an observation of the dialysis treatment area on 08/13/2024 at 11:45 AM, CCHT #5 was observed exiting Station 17 while wearing a pair of gloves. CCHT #5 obtained a previously used face shield from a common storage area, entered Station 18, and touched the dialysis machine. During an interview on 08/13/2024 at 11:50 AM, CCHT #5 acknowledged her pair of gloves were not removed and hand hygiene was not performed before she touched the dialysis machine located in Station 18. CCHT #5 confirmed she was trained and expected to perform hand hygiene before touching patient care equipment. During an observation of the dialysis treatment area on 08/13/2024 at 11:55 AM, Registered Nurse (RN) #3 was observed typing on a computer keyboard near Station 16 while holding a pair of gloves in her left hand. RN #3 applied one of the held gloves to her right hand and obtained and applied a previously used face shield from a common storage area with her gloved right hand. RN #3 applied the additional held glove to her left hand, entered Station 1, and touched Patient #3. During an interview on 08/13/2024 at 12:05 PM, RN #3 acknowledged no hand hygiene was performed before she touched Patient #3. RN #3 confirmed she was trained to perform hand hygiene before touching a patient. During an interview on 08/13/2024 at 12:15 PM, the Facility Administrator confirmed staff were trained and expected to perform hand hygiene before they touched patient care equipment and before they touched patients. During an observation of the dialysis treatment area on 08/14/2024 at 12:00 PM, with the Facility Administrator, Patient Care Technician (PCT) #9 was observed obtaining a glove and covering her right index finger with the glove. PCT #9 entered Station 12 and touched the dialysis machine. PCT #9 exited the station and removed the glove. During an interview on 08/14/2024 at 12:05 PM, PCT #9 acknowledged she did not perform hand hygiene after she removed her glove. PCT #9 confirmed she was trained and expected to perform hand hygiene after removing glove(s). During an interview on 08/15/2024 at 11:00 AM, the Medical Director confirmed staff were expected to perform hand hygiene before they touched patient care equipment, before they touched patients, and after they removed their gloves.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 35949 Based on observation, interview, record review of manufacturer’s directions for use (DFU), and facility policy review, the facility failed to follow the bloodline manufacturer’s DFU during dialysis treatments by not maintaining the venous drip chamber fluid levels at 3/4 full during 3 of 3 observation days. Failure to follow the bloodline manufacturer’s DFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 68 patients who received dialysis treatments in this facility. Findings included: The facility’s policy titled, “Priming the Extracorporeal Circuit (CombiSet, NiproSet and Streamline Bloodlines),” revised 11/2023, indicated, “17. Once priming is complete, clamp arterial and venous bloodlines. Aseptically connect patient ends together to prepare for recirculation of the extracorporeal circuit. Unclamp arterial and venous patient end bloodlines. Fill venous drip chamber 65-75% (CombiSet) or s [sic] (NiproSet) full by loosening the side arm tubing cap, tighten cap and clamp the venous monitoring line.” Additional review indicated, “Note: Ensure arterial and venous chamber levels are maintained throughout the dialysis treatment as described in the priming procedure above.” Review of a manufacturer’s DFU titled, “Nipro Instructions for Use ...Nipro Set Blood Tubing Set,” indicated, “Dialysis Treatment Precautions: 1. Before initiating dialysis treatment, check the following: a. Drip chambers are in the upright position and have the fluid level at ¾ full.” Additional review indicated, “b. Periodically check fluid level in drip chamber and adjust if required.” Observation of the hemodialysis treatment area on 08/12/2024 at 10:15 AM, revealed the venous drip chamber fluid levels were greater than (>) 3/4 full in Stations 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 15, 16, 18, 20, 21, 22, 23, 24, and 25. Observation of the hemodialysis treatment area on 08/13/2024 at 11:20 AM, revealed the venous drip chamber fluid levels were > 3/4 full in Stations 2, 3, 4, 5, 13, and 14. Observation of the hemodialysis treatment area on 08/14/2024 at 11:30 AM, revealed the venous drip chamber fluid levels were > 3/4 full in Stations 3, 4, 7, 9, 11, 13, 14, 19, 20, 23, and 25. Observation of the hemodialysis treatment area on 08/14/2024 at 11:40 AM, with the Facility Administrator, revealed the venous drip chamber fluid levels were > 3/4 full in Stations 3, 4, 7, 9, 11, 13, 14, 19, 20, 23, and 25 During an interview on 08/14/2024 at 11:40 AM, the Facility Administrator confirmed the venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. The Facility Administrator confirmed the staff were trained and expected to follow the bloodline manufacturer’s DFU. During an interview on 08/15/2024 at 11:00 AM, the Medical Director confirmed the staff were expected to follow the bloodline manufacturer’s DFU.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 35949 Based on interview, record review, and facility policy review, the facility failed to complete an initial comprehensive assessment conducted by all members of the interdisciplinary team (IDT - a registered nurse, a physician treating the patient for end stage renal disease, a social worker, and a dietitian) within 30 calendar days or 13 dialysis treatments after admission, for 1 (Patient #1) of 1 sampled patients new to dialysis and admitted to the facility within the last 90 days. Failure to complete an initial comprehensive assessment performed by all members of the IDT within 30 calendar days or 13 dialysis treatments after admission for patients new to dialysis, provided opportunities for areas of concern to be unidentified and left unaddressed related to the patients’ plan of care, and had the potential to negatively impact the care and well-being of the 68 patients receiving dialysis treatments at this facility. Findings included: The facility’s policy titled, “Comprehensive Interdisciplinary Patient Assessment/Plan of Care (CIPA/POC),” revised 04/2024, indicated, “5. Frequency of CIPA/POC completion: a. Within the latter of 30 calendar days or 13 treatments beginning with admission for all new patients and modality changes OR [sic] as specified per stricter state regulations.” An untitled and undated list of current patients indicated Patient #1’s admission date was 06/13/2024. An untitled and undated list of dialysis treatments for Patient #1, indicated Patient #1’s first dialysis treatment at the facility occurred on 06/13/2024, and the 13th dialysis treatment occurred on 07/11/2024. During an interview on 08/13/2024 at 10:48 AM, the Facility Administrator confirmed an initial comprehensive assessment was not completed within 30 days or 13 dialysis treatments by the physician treating Patient #1. During an interview on 08/15/2024 at 11:00 AM, the Medical Director and physician treating Patient #1, stated they did not complete an initial comprehensive assessment within 30 days or 13 dialysis treatment, and was not aware an initial comprehensive assessment was required for Patient #1.”