Hawthorn Kidney Center

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 37349 Based on observation, interview and audit review, the facility failed to conduct effective audits to monitor its plan of correction related to labeling of medications drawn up before the time it is to be administered. Findings include: Review of the facility policy titled, Medications: Handling, Administration Storage and Disposal, last revised 6/2023, included the following: * Any medication drawn up before the time it is to be administered shall be labeled with: patient name, medication name, dose of medication, date/time medication was drawn up, initials of nurse who drew up the medication. On Tuesday, 7/9/24, at 8:20 A.M., the surveyor and Charge Nurse observed 3 syringes of medications that had been drawn up, placed in an initiation kit and locked in a cabinet for future administration. Three of three had a label which included the patient name, medication name, and dose of medication, but failed to include the date/time the medication was drawn up or the initial of the person who drew up the medication. During an interview on 7/9/24 at 8:20 A.M., the Charge Nurse said that medications that are drawn up before use should be labeled with a date/time and initials of person who drew up the medication. Review of the facility plan of correction audit tool to be brought to the monthly Quality Assesserment Performance Improvement (QAPI) meeting included audits to spot check the medication drawer/cabinet to ensure all pre-drawn medications are labeled with patient name, medication, name, dose of medication, date/time mediation was drawn up, initial of nurse who drew up the medication. The form indicated that audits were conducted weekly on Mondays including 6/11/24, 6/17/24, 6/24/24 and 7/1/24. All audits indicated that there were no discrepancies. During an interview on 7/9/24 at 9:20 A.M., the Clinic Manager said that she does her audits on Mondays. She said she makes observations on other days but does not document them.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 37349 Based on observation, interview, and Manufacturer’s Directions for Use (MDFU), the facility failed to meet the Condition of Water and Dialysate Quality when 2 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #2 and CCHT #6) failed to follow the procedure of testing for the presence of Total Chlorine in the reverse osmosis (RO) water. Findings include: Review of MMWR 47(23);483-484, titled Multistate Outbreak of Hemolysis in Hemodialysis Patients - Nebraska and Maryland, 1998, dated June 19, 1998, indicated an increase in chlorine in dialysis water as one of the leading causes of hemolysis in dialysis patients. Patients with hemolysis (breakdown of red blood cells) can present with headache, lethargy, malaise, chills, diaphoresis, hypotension, dyspnea, chest pain, palpation, and leg cramps. Death has also been associated with hemolysis. *The facility failed to ensure that 2 of 2 dialysis staff members (Certified Clinical Hemodialysis Technician [CCHT] #2 and CCHT #6) followed the procedure of testing for the presence of Total Chlorine in the reverse osmosis (RO) water. Please refer to V196”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 37349 Based on observation, interview, and policy review, the facility failed to ensure that medical waste was stored in an area with restricted access. Findings include: Review of the facility policy titled, Medical Waste Management Plan, last revised 12/22/23, included the following: * On-site Storage of Medical Waste: Indoor storage areas will have restricted access and be designated as such. During the flash tour of the facility on 5/28/24 at 8:15 A.M., the surveyor observed 9 containers of medical waste stored in an unlocked storage room. There was no staff in the area. On 5/28/24 at 8:45 A.M., the surveyor and Biomedical Technician (Biomed) #1 observed 9 containers of medical waste stored in an unlocked storage room. Further review revealed that a piece of cardboard had been taped in place in the door latch to prevent the locking mechanism from working. During an interview on 5/28/24 at 8:45 A.M., Biomed #1 said that medical waste should be stored in a locked room, and the cardboard should not have been taped in place to prevent the lock from working.”

“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: 44223 Based on observation, interview, and policy review, the facility failed to ensure 14 of 30 blood pressure (BP) cuffs were free from lint and debris to allow for proper disinfection, and to reduce the risk of the spread of infection. Findings Include: Review of the facility policy titled, Cleaning and Disinfection of Equipment Supplies and Treatment area, revised 1/11/24, indicated the following: *Purpose: To prevent transmission of infectious agents in the the dialysis center. *All routinely touched reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. On 5/28/24 at 9:30 A.M., during observation of the treatment floor, the surveyor observed the BP cuffs at 14 of the 30 stations (stations 1, 2, 3, 4, 5, 7, 9, 11, 12, 14, 18, 23, 29 and 30) were laden with lint embedded in the Velcro portion of the BP cuffs, making it difficult to adequately disinfect them between patients. During an interview on 5/30/24 at 9:25 A.M., Certified Clinical Hemodialysis Technician (CCHT) # 6 said that she thought the BP cuffs were cleaned well enough because bleach is used, but she is not really sure if the bleach penetrates through the lint. She said when BP cuffs get linty they try to replace them, if they can.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 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. This Standard is not met as evidenced by: 37349 Based on observations, staff interview, and review of Manufacturers’ Directions For Use (MDFU), 2 of 2 dialysis staff (Certified Clinical Hemodialysis Technician [CCHT] #2 and CCHT #6) failed to follow the procedure of testing for the presence of Total Chlorine in the reverse osmosis (RO) water. Findings include: Review of the Ultra Low Total Chlorine Test Strips instructions for use included the following: * Collect a fresh 100 ml sample of water in a clean plastic sample cup. * Remove one test strip from its foil package and swish it in the sample for the amount of time indicated according to the temperature range: water sample temperature form 75 degrees to 88 degrees swish time 20 seconds. Move the strip back and forth at a constant gentle rate of approximately two 1-2 inch wide strokes (one forward and one backward) per second. * Remove the strip and shake once, briskly, to remove excess water. * Wait 20 seconds for the test strip color to develop. While waiting, fold the white plastic handle of the test strip under the reagent area aperture so that it proves a consistent viewing background. * After the 20 second wait period, immediately compare the strip color to the color chart to determine the Total Chlorine level in the sample. 1. On 5/28/24 at 11:40 A.M., the surveyor observed CCHT #2 perform the testing of RO water for the presence of Total Chlorine. She obtained a clean 100 ml sample of RO water, placed a thermometer into the sample of RO water, and obtained a temperature of 77 degrees Fahrenheit. She then obtained a second clean sample of RO water, but only 20 ml, not 100 ml per manufacturers’ instructions. She removed a test strip from its package and swished it back and forth in the 20 ml sample of RO water for 20 seconds. She removed the strip from the sample of RO water, and without shaking it to remove the excess water, she folded the white plastic handle under the reagent area, waited 20 seconds and compared the strip to the color chart to determine the Total Chlorine. During an interview on 5/29/24 at 9:15 A.M., Biomed #1 and Biomed #2 said the sample of RO water should have been 100 ml, not 20 ml and said that excess water should be shaken off before waiting 20 seconds to read the test results. 2. On 5/29/24 at 11:40 A.M., the surveyor observed CCHT #6 perform the testing of RO water for the presence of Total Chlorine. She obtained a clean 100 ml sample of RO water, she removed a test strip from its foil pack and swirled it in the sample of RO water for the appropriate amount of time. She removed the strip from the sample of RO water, shook the excess water off, folded the plastic handle under the reagent area and without waiting 20 seconds she immediately compared the strip to the color chart to determine the Total Chlorine. During an interview on 5/29/24 at 11:40 A.M., CCHT #6 said she did not know she needed to wait 20 seconds before comparing the strip to the chart. During an interview on 5/29/24 at 11:40 A.M., Biomed #2 said that staff should wait 20 seconds before comparing the test strip to the color chart.”

“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: 37349 Based on staff interview, Manufacturer’s Directions For Use (MDFU) and preventative maintenance record review, the facility failed to ensure that 1 of 4 dialysis machines (#31) was maintained per the MDFU. Findings include: Review of the MDFU for the dialysis machines included the following: * Perform the Annual Preventative Maintenance procedures every 12 months or 4000 hours of machine operation, whichever comes first. Review of the Preventative Maintenance records for dialysis machine #31 included the following: * June 17, 2022-Annual preventative maintenance checklist was completed with machine hours 23,237. * December 18, 2022-6 month preventative maintenance checklist with machine hours 24,244. * There was no documentation of an annual preventative maintenance checklist being completed for 2023 (would be due in June 2023 based on June 2022 being the last time an annual maintenance was completed). * December 27, 2023-6 month preventive maintenance checklist with machine hours approximately 26,800. Greater than 12 months since the last checklist was completed, indicating an annual checklist was recommended not a 6 month checklist. During an interview on 5/29/24 at 9:15 A.M., Biomed #1 and Biomed #2 said that the Annual preventive maintenance should be completed annually, or every 4000 machine hours, whichever comes first. Biomed #1 and Biomed #2 both said the annual prevention maintenance is a more comprehensive maintenance service than the 6 month checklist. They said that the Biomed who performed the December 2023 maintenance should have seen that the annual was missed in June 2023 and converted the December 2023 service from a 6 month maintenance to an annual maintenance. Biomed #2 said that machine #31 was on his schedule to complete an annual preventative maintenance in June 2024, 24 months since the last annual service.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 37349 Based on record review and interview, the facility failed to 1.) ensure that the care plans for 7 of 7 patient (#1, #2, #3, #4, #5, #6 and #7) records reviewed, out of a total sample of 7 patients, were signed by the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided; and 2.) ensure that care plans for 5 of 7 patients (#1, #2, #3, #5, and #6) records reviewed, out of a total sample of 7 patients, were signed by the interdisciplinary team. Findings include: Review of the facility policy, titled Treatment Plans, last revised 5/2022, included the following: * The patients will be an integral part of the planning process and will be part of the interdisciplinary meeting whenever possible. If the patient is not able or chooses not to attend the meeting, the treatment plan will be discussed with him/her by a member of the healthcare team and the patient’s signature obtained on the treatment plan. *The interdisciplinary team must make efforts to involve the patient and /or patient representative (if desired by the patient) in the treatment plan process. The team must document all efforts to include the patient in the process and patient’s response to those efforts in the patient’s electronic medical record. * If the patient chooses not to sign the treatment plan, this choice must be documented on the treatment plan along with the reason the signature was not provided. * The interdisciplinary team must meet as a team to review the comprehensive patient assessment and develop the treatment plan. If any team member cannot meet with the group in person it is acceptable to meet with the group via phone or video conference as long as the absent member is able to participate in discussion of the assessment data and development of the treatment plan. 1. For 7 of 7 patients (#1, #2, #3, #4, #5, #6, and #7), the facility failed to ensure the patient involvement in his/her plan of care occurred by signing the Comprehensive Assessment and Plan of Care Review Acknowledgement form; or if the patient chose to not sign, there was no documentation as to why he/she did not provide a signature. A.) For Patient #1, the facility failed to ensure the patient involvement in his/her plan of care occurred by signing the Annual Comprehensive Assessment and Plan of Care Review Acknowledgement form; or if the patient chose to not sign, there was no documentation as to why he/she did not provide a signature. Patient #1 was admitted to the facility in 11/2022 with a diagnosis of End Stage Renal Disease requiring hemodialysis. During record review, the Plan of Care, dated 2/7/24, included a Signature section which did not include the patient’s signature. During an interview on 5/29/24 at 9:20 A.M., the Regulatory Nurse said that there is an acknowledgement form that staff should have the patient sign when they review the plan of care with him/her, or if the patient refuses to sign the acknowledgement staff should document that on the form. She said that the facility had just started following the policy this month. B.) For Patient #2, the facility failed to ensure the patient involvement in his/her plan of care occurred by signing the Unstable Monthly Assessment and Plan of Care Review Acknowledgement form; or if the patient chose to not sign, there was no documentation as to why he/she did not provide a signature. Patient #2 was admitted to the facility in 11/2023 with a diagnosis of End Stage Renal Disease requiring hemodialysis. During record review, the Plan of Care, dated 4/23/24, included a Signature section which did not include the patient’s signature. During an interview on 5/29/24 at 9:20 A.M., the Regulatory Nurse said that there is an acknowledgement form that staff should have the patient sign when they review the plan of care with him/her, or if the patient refuses to sign the acknowledgement staff should document that on the form. She said that the facility had just started following the policy this month. C.) For Patient #3, the facility failed to ensure the patient involvement in his/her plan of care occurred by signing the Initial and 90 days Assessment and Plan of Care Review Acknowledgement form; or if the patient chose to not sign, there was no documentation as to why he/she did not provide a signature. Patient #3 was admitted to the facility in 11/2023 with a diagnosis of End Stage Renal Disease requiring hemodialysis. During record review, the Plan of Care, dated 2/7/24, included a Signature section which did not include the patient’s signature. During an interview on 5/29/24 at 9:20 A.M., the Regulatory Nurse said that there is an acknowledgement form that staff should have the patient sign when they review the plan of care with him/her, or if the patient refuses to sign the acknowledgement staff should document that on the form. D.) For Patient #4, the facility failed to ensure the patient involvement in his/her plan of care occurred by signing the Initial Comprehensive Assessment and Plan of Care Review Acknowledgement form, or if the patient chose not to sign, there was no documentation as to why he/she did not provide a signature. Patient #4 was admitted to the facility in 3/2024 with a diagnosis of End Stage Renal Disease requiring hemodialysis. During record review, the Plan of Care, dated 4/4/24, included a Signature section which did not include the patient’s signature. During an interview on 5/29/24 at 9:20 A.M., the Regulatory Nurse said that there is an acknowledgement form that staff should have the patient sign when they review the plan of care with him/her, or if the Patient refuses to sign the acknowledgement staff should document that on the form. E.) For Patient #5, the facility failed to ensure the patient involvement in his/her plan of care occurred by signing the Comprehensive Assessment and Plan of Care Review Acknowledgement form, or if the patient chose not to sign, there was no documentation as to why he/she did not provide a signature. Patient #5 was admitted to the facility in 3/2021 with a diagnosis of End Stage Renal Disease requiring hemodialysis. During record review, the Plan of Care, dated 7/21/23, included a Signature section which did not include patient’s signature. During an interview on 5/29/24 at 9:20 A.M., the Regulatory Nurse said that there is an acknowledgement form that staff should have the patient sign when they review the plan of care with him/her, or if the Patient refuses to sign the acknowledgement staff should document that on the form. F.) For Patient #6, the facility failed to ensure the patient involvement in his/her plan of care occurred by signing the Annual Assessment and Plan of Care Review Acknowledgement form; or if the patient chose to not sign, there was no documentation as to why he/she did not provide a signature. Patient #6 was admitted to the facility in 9/2017 with a diagnosis of End Stage Renal Disease requiring hemodialysis. During record review, the Plan of Care, dated 1/19/24, included a Signature section which did not include the patient’s signature. During an interview on 5/29/24 at 9:20 A.M., the Regulatory Nurse said that there is an acknowledgement form that staff should have the Patient sign when they review the plan of care with him/her, or if the Patient refuses to sign the acknowledgement staff should document that on the form. G.) For Patient #7, the facility failed to ensure the patient involvement in his/her plan of care occurred by signing the Comprehensive Assessment and Plan of Care Review Acknowledgement form, or if the patient chose not to sign, there was no documentation as to why he/she did not provide a signature. Patient #7 was admitted to the facility in with a diagnosis of End Stage Renal Disease requiring hemodialysis. During record review, the Plan of Care, dated 11/2/23, included a Signature section which did not include patient’s signature. During an interview on 5/29/24 at 9:20 A.M., the Regulatory Nurse said that there is an acknowledgement form that staff should have the Patient sign when they review the plan of care with him/her, or if the Patient refuses to sign the acknowledgement staff should document that on the form. 2. For 5 of 7 patients (#1, #2, #3, #5, and #6) the facility failed to ensure the plan of care was signed by the interdisciplinary team members. A.) For Patient #1, the facility failed to ensure the plan of care was signed by the interdisciplinary team members. Patient #1 was admitted to the facility in 11/2022 with a diagnosis of End Stage Renal Disease requiring hemodialysis. Review of the record indicated the Annual Plan of Care, dated, 2/7/24, included a Signature section for the interdisciplinary team to sign. Nurse, Dietitian, Social Worker and Nephrologist were all signed by the Clinic Manager, not the applicable discipline, on 3/18/24, greater than 30 days after the meeting was said to have occurred. During an interview on 5/29/24 at 11:05 A.M., the Regulatory Nurse said that care plans should be signed by the team. She said each discipline does an assessment and care plan and during the meeting it is closed out by the Clinic Manager and that may be why her signature is in all spaces. During an interview on 5/30/24 at 9:00 A.M., the Medical Director said there has been a steep learning curve with the new computer software program. He said each person should sign and it is not right to have only one person signing for everyone. B.) For Patient #2, the facility failed to ensure the Plan of Care was signed by the interdisciplinary team members. Patient #2 was admitted to the facility in 11/2023 with a diagnosis of End Stage Renal Disease requiring hemodialysis. Review of the medical record indicated the Unstable Plan of Care, dated 4/23/24, included a Signature section for the interdisciplinary team to sign. The Nurse, Dietitian, Social Worker, and Nephrologist sections were all signed by the Clinic Manager, not the applicable discipline, on 5/21/24, greater than 30 days after the meeting was said to have occurred. During an interview on 5/29/24 at 11:05 A.M., the Regulatory Nurse said that care plans should be signed by the team. She said each discipline does an assessment and care plan and during the meeting it is closed out by the Clinic Manager and that may be why her signature is in all spaces. C.) For Patient #3, the facility failed to ensure the Plan of Care was signed by the interdisciplinary team members. Patient #3 was admitted to the facility in 11/2023 with a diagnosis of End Stage Renal Disease requiring hemodialysis. Review of the medical record indicated the 90 day Plan of Care, dated 2/1/24, included a Signature section for the interdisciplinary team to sign. The Nurse, Dietitian, Social Worker, and Nephrologist sections were all signed by the Clinic Manager, not the applicable discipline, on 3/18/24, greater than 30 days after the meeting was said to have occurred. During an interview on 5/29/24 at 11:05 A.M., the Regulatory Nurse said that care plans should be signed by the team. She said each discipline does an assessment and care plan and during the meeting it is closed out by the Clinic Manager and that may be why her signature is in all spaces. D.) For Patient #5, the facility failed to ensure the Plan of Care was signed by the interdisciplinary team members. Patient #5 was admitted to the facility in 3/2024 with a diagnosis of End Stage Renal Disease requiring hemodialysis. Review of the medical record indicated the Plan of Care, dated 4/4/24, included a Signature section for the interdisciplinary team to sign. The Nurse, Dietitian, Social Worker, and Nephrologist sections were all signed by the Clinic Manager on 5/21/24, not the applicable discipline, greater than 30 days after the meeting was said to have occurred. During an interview on 5/29/24 at 9:20 A.M., the Regulatory Nurse said that the Clinic Manager was not available to ask why the care plan review was not signed by the interdisciplinary team. E.) For Patient #6, the facility failed to ensure the Plan of Care was signed by the interdisciplinary team members. Patient #6 was admitted to the facility in 9/2017 with a diagnosis of End Stage Renal Disease requiring hemodialysis Review of the medical record indicated the Annual Plan of Care, dated 1/10/24, included a Signature section for the interdisciplinary team to sign. The Nurse, Dietitian, Social Worker, and Nephrologist sections were all signed by the Clinic Manager, not the applicable discipline, on 2/2/24. During an interview on 5/29/24 at 9:20 A.M., the Regulatory Nurse said that the Clinic Manager was not available to ask why the care plan review was not signed by the interdisciplinary team. 38141 44223”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 37349 Based on observation, interview, policy review, and Total Quality Management Report review, the facility failed to ensure the QAPI committee identified and put a plan in place related to dialysis machine preventative maintenance. Findings include: Review of the facility policy titled, Quality Assessment and Performance Improvement (QAPI), effective 1/2021, included the following: * When discussing data/issues related to their specific roles/job functions the following staff should be included in the QAPI meeting: Biomedical Technician. * At minimum, the QAPI program must include: equipment maintenance. Review of the Preventative Maintenance records for dialysis machine #31 included the following: * June 17, 2022-Annual preventative maintenance checklist was completed with machine hours 23,237. * December 18, 2022-6 month preventative maintenance checklist with machine hours 24,244. * There was no documentation of an annual preventative maintenance checklist being completed for June 2023. * December 27, 2023-6 month preventive maintenance checklist with machine hours approximately 26,800. Greater than 12 months since the last checklist was completed, indicating an annual checklist was recommended not a 6 month checklist. Review of the Total Quality Attendance Sheet, dated 1/19/24, failed to indicate that the Technical Manager (Biomedical Technician Manager) attended the meeting, with a blank signature line. Review of the Technical Total Quality Management Reports, dated 1/26/24, indicated that December data was reviewed. Further review indicated that 100% of scheduled Annual and Semi Annual Preventative Maintenance had had been completed. in December. The report failed to identify that Machine #31 had missed an Annual maintenance in June of 2023 when the December 2023 6 month maintenance was performed. The QAPI committee failed to identify that machine #31 had not received an annual preventative maintenance service in greater than 12 months. During an interview on 5/29/24 at 9:15 A.M., Biomed #1 and Biomed #2 said that the Annual preventive maintenance should be completed annually or every 4000 machine hours, whichever came first and is a more comprehensive maintenance than the 6 month checklist. They said that the Biomed who performed the December 2023 maintenance should have seen that the annual was missed and converted the scheduled 6 month maintenance to an annual maintenance. Biomed #2 said that machine #31 was on his schedule to complete an annual preventative maintenance in June 2024, 24 months since the last annual service. During an interview on 5/30/24 at 10:45 A.M., the Regulatory Nurse said that in December technical should have identified that machine #31 had missed the annual preventative maintenance in June 2023, they should have converted the 6 month maintenance to an annual maintenance and reported the miss at the January meeting where December data was discussed.”

“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: 37349 Based on observation, interview, and policy review, the Medical Director failed to ensure 1.) that 2 of 2 dialysis staff (Certified Clinical Hemodialysis Technician [CCHT] #2 and CCHT #6) followed the procedure of testing for the presence of Total Chlorine in the reverse osmosis (RO) water and 2.) that 1 staff member (Certified Clinical Hemodialysis Technician [CCHT] #3 followed the facility policy related to the labeling of medications drawn up before the time it is to be administered. Findings include: 1. The Medical Director failed to ensure 2 of 2 dialysis staff (Certified Clinical Hemodialysis Technician [CCHT] #2 and CCHT #6) followed the procedure of testing for the presence of Total Chlorine in the reverse osmosis (RO) water. Review of the Ultra Low Total Chlorine Test Strips instructions for use included the following: * Collect a fresh 100 ml sample of water in a clean plastic sample cup. * Remove one test strip from its foil package and swish it in the sample for the amount of time indicated according to the temperature range: water sample temperature form 75 degrees to 88 degrees swish time 20 seconds. Move the strip back and forth at a constant gentle rate of approximately two 1-2 inch wide strokes (one forward and one backward) per second. * Remove the strip and shake once, briskly, to remove excess water. * Wait 20 seconds for the test strip color to develop. While waiting, fold the white plastic handle of the test strip under the reagent area aperture so that it proves a consistent viewing background. * After the 20 second wait period, immediately compare the strip color to the color chart to determine the Total Chlorine level in the sample. 1. On 5/28/24 at 11:40 A.M., the surveyor observed CCHT #2 perform the testing of RO water for the presence of Total Chlorine. She obtained a clean 100 ml sample of RO water, placed a thermometer into the sample of RO water, and obtained a temperature of 77 degrees Fahrenheit. She then obtained a second clean sample of RO water, but only 20 ml, not 100 ml per manufacturers’ instructions. She removed a test strip from its package and swished it back and forth in the 20 ml sample of RO water for 20 seconds. She removed the strip from the sample of RO water, and without shaking it to remove the excess water, she folded the white plastic handle under the reagent area, waited 20 seconds and compared the strip to the color chart to determine the Total Chlorine. During an interview on 5/29/24 at 9:15 A.M., Biomed #1 and Biomed #2 said the sample of RO water should have been 100 ml, not 20 ml and said that excess water should be shaken off before waiting 20 seconds to read the test results. 2. On 5/29/24 at 11:40 A.M., the surveyor observed CCHT #6 perform the testing of RO water for the presence of Total Chlorine. She obtained a clean 100 ml sample of RO water, she removed a test strip from its foil pack and swirled it in the sample of RO water for the appropriate amount of time. She removed the strip from the sample of RO water, shook the excess water off, folded the plastic handle under the reagent area and without waiting 20 seconds she immediately compared the strip to the color chart to determine the Total Chlorine. During an interview on 5/29/24 at 11:40 A.M., CCHT #6 said she did not know she needed to wait 20 seconds before comparing the strip to the chart. During an interview on 5/29/24 at 11:40 A.M., Biomed #2 said that staff should wait 20 seconds before comparing the test strip to the color chart. During an interview on 5/30/24 at 9:00 A.M., the Medical Director said based on the observations they needed to review the proper procedure for chlorine testing with the staff. 2. The Medical Director failed to ensure that CCHT #3 followed the facility policy related to the labeling of medications drawn up before the time it is to be administered. Review of the facility policy titled, Medications: Handling, Administration Storage and Disposal, last revised 6/2023, included the following: * Any medication drawn up before the time it is to be administered shall be labeled with: patient name, medication name, dose of medication, date/time medication was drawn up, initials of nurse who drew up the medication. On 5/28/24 at 10:45 A.M., the surveyor observed Certified Clinical Hemodialysis Technician [CCHT] #3 initiate dialysis treatment for a patient with a central venous catheter. During the initiation CCHT #3 administered 3,000 units of heparin (a blood thinning medication). The label included the patient name, medication name, and dose of medication, but failed to include the date/time the medication was drawn up or the initial of the person who drew up the medication. During an interview on 5/28/24 at 10:55 A.M., CCHT #3 said that she had drawn up the medication at approximately 10:00 A.M.. During an interview on 5/29/24 at 10:45 A.M., Charge Nurse #1 said that medications that are drawn up before use should be labeled with a date/time and initials of person who drew up the medication.”