Table 1 Gap analysis of the current care provision processes for the Iranian HD patients compared to elements of the devised comprehensive package of care for HD patients (CPC-HD)

1. Patients' participation in therapeutic decisions

Yes/No/Somewhat

1. Making the decision to start dialysis jointly by the family and healthcare provider (HCP) about renal replacement therapy (RRT) and several options [17, 18]

Yes

2. Ultrasound scan or ultrasound before vascular access operation 6 months before starting HD [17]

Yes

3. Vascular access ways checking in order of preference: arteriovenous fistula (AVF), arterio-venous graft (AVG) and central venous catheter (CVC) [19]

Yes

4. Training of infection control measures before start of work in HD wards and its annual repetition (topics may include hand washing / taking care of vascular access and detecting signs of infection / administering recommended vaccines) [20]

Yes

5. Awareness of the risk of dialysis flow interruption, pressure alarm limits and direct observation through an educational program to both physicians and caregivers [21]

Somewhat

6. Encouraging and empowering patients to actively participate in self-care [17]

Somewhat

7. Continuous counseling and support of patients and their family members regarding optimal diet and fluid intake [17]

Somewhat

8. Referring patients to other sources of information and support such as online resources, pre-dialysis classes and peer support groups [17]

Somewhat

9. Availability of required medicines such as erythropoietin and sevelamer [22]

Somewhat

10. Appropriate laboratory support for monitoring the effectiveness of HD and early detection of anemia, nutritional status, and infection [22]

Somewhat

11. Assessment of patient's functional capacity, planned exercise and fall risk reduction strategies [22]

No

12. Access to exercise facilities with trained staff during dialysis sessions to improve HD patients' quality of life without contraindications [21]

No

13. Facilitating HD patients' commuting to wards, their economic and activities of daily living (ADL) support [22]

Somewhat

14. Connecting HD patients to different support networks [22]

No

15. Identifying those risk factors that may interfere with a successful kidney transplantation such as: non-compliance with treatment, severe mental illness, etc. [17]

Somewhat

16. Assessment of home hemodialysis possibility [18]

No

17. Awareness the risks of repeated home HD such as: complications of vascular access and accelerated reduction of residual kidney function [18]

No

18. Limitations of the HD wards in admitting patients based on the defined personnel and equipment capacity [23]

No

19. Possibility of financial assistance to low-income patients [23]

Somewhat

20. Possibility of ensuring access to regular dialysis treatments [23]

Somewhat

21. Possibility of being responsible against HD patients’ requests to change dialysis schedules in case of problems [23]

Yes

22. Possibility of timely presence of a physician at the patient's bedside in emergency situations and access to ambulance services [23]

Somewhat

23. Availability of counseling services for HD treatment, dietary recommendations and medication adherence [23]

Yes

24. Confidentiality of personal and medical information of HD patients and their accessibility only for designated employees [23]

Yes

25. Obtaining the patient's informed consent before starting hemodialysis treatment regarding: treatment method, side effects, cost of care, etc. [23]

Yes

26. Availability of patients’ bill of rights and explanation of their responsibilities, the HD wards' working days/hours timetable (generally six (6) days a week, including official holidays), facilitation of HD patients' transfer to other HD centers based on their request, continuity of care for patients who transfer to other HD centers, establishing a patient complaint system for considering suspected errors and having an official patirnts' informed consent form [23]

Yes

2. Risk Management and infection control measures

Yes/No/Somewhat

1. Presence of a strict guideline and its enforcement to prevent the risk of cross-infection among HD patients [20, 24]

Somewhat

2. Examining patients for HBsAg and anti-HCV before starting the first HD treatment or accepting a patient from another HD center [20] along with checking initial liver function tests [24]

Yes

3. If HBsAg is negative, retest every three months [20]

Yes

4. Vaccination of patients if they are HBsAg and HBs Ab negative (four doses sould be administered: zero (0), one (1), two (2) and six (6) months) / if anti HBs Ab < 100 mIU/ml; a booster dose is required [20]

Yes

5. Examination of anti-HBs Ab serum one to two (1–2) months after completing the vaccination period [20]

Yes

6. Re-immunization after primary vaccination in patients without anti-HBs Ab response (> 10 mIU/ml) including one to three doses (1–3) [20]

Yes

7. Examining patients with anti-HBs titer less than 10 every 6 months [24]

Yes

8. Receiving a course of hepatitis B vaccination according to the national immunization guidelines for non-immune cases of HD patients [22, 24]

Yes

9. The nurses of HBsAg positive patients should not take care of other patients in the same shift [20]

Yes

10. Annual screening for blood viruses for HBsAg-negative employees (if anti-HBs antibody is zero, do a full course of vaccination / if anti-HBs antibody is less than 10 mIU/ml a booster dose is required) [20, 24] and re-checking the annual anti-HBs titer [24]

Yes

11. Receiving HBV vaccine by all dialysis ward staff if there is no proof of previous immunity or previous vaccination [24]

Yes

12. Refrain to employ a non-immune staff against hepatitis B or those who failed to respond to hepatitis B vaccine for caring HBsAg positive patients [24]

Yes

13. Training all employees at risk of occupational exposure to blood about hand hygiene, correct use of protective equipments, routes of blood-borne viruses' transmission [20]

Yes

14. Use of masks and gowns by all nurses and assistants, especially when starting or stopping treatment or blood sampling [22, 24]

Somewhat

15. Wearing gloves when contacting the dialysis machine and changing it between patients, presence of hand washing and disinfection facilities in several parts of HD wards [22]

Yes

16. Using gloves, gowns and protective glasses and using a mask/face shield while working to prevent the risk of exposure to blood or other body fluids [24]

Somewhat

17. Hand hygiene and aseptic technique and its regular observance in HD centers by dialysis staff [24]

Yes

18. Disinfection of reusable equipment (if disinfection is not possible, such as sphygmomanometer cuff, these devices must be cleaned and dried) [24]

Yes

19. Allocation of physiological monitoring equipment such as thermometer, barometer and scales for use by each patient [24]

No

20. Frequent disinfection of touchable places in the patient's environment in HD ward [24]

Yes

21. Disposing of needles in a metal container (or resistant plastic containers) as safety box using non-contact technique [24]

Yes

22. Using disposable items and throwing them away after use [24]

Yes

23. Central venous catheter (CVC), arteriovenous fistula (AVF) and breathing care of all HD patients [23]

Yes

24. Immunization of HD patients for influenza, pneumococcus and COVID-19 vaccines in addition to hepatitis B vaccine [23]

Except pneumococcal vaccines

Somewhat

25. Screening of patients before starting HD treatment for viral infections transmitted by blood (hepatitis B, C and HIV) and monitoring according to the national guideline [23]

Yes

3. Safe Environment, equipments and related products

Yes/No/Somewhat

1. Sufficient space for the dialysis machine and bed/couch/chair (4.5 m² to 10 m² with access to cardiopulmonary resuscitation (CPR) equipment) [20, 22]

Somewhat

2. A separate room with machines, equipment, tools, disposable items for HBsAg positive patients [20, 22, 24]

Yes

3. A separate room or an isolated area with a fixed partition and dedicated dialysis machines for patients with active hepatitis C [20, 24]

No

4. A separate room with machines, equipment, tools, disposable items for HIV-positive patients [20, 24]

No

5. A separate room for water purification of the necessary size and equipment [20, 22, 23] with the schematic diagram of water purification system [23]

Somewhat

6. A dialysis filter reprocessing room in case of reuse of filters and re-storage of processed and sterilized filters with proper and efficient ventilation to reduce the risk of inhalation [20, 22]

No

7. A separate room with a separate filter reprocessing machine to reprocess the filters of hepatitis B and hepatitis C patients separately [12, 14]

No

8. Releasing of dialysis and reprocessing effluent to the closed general drainage system / not using formaldehyde in case of discharging the effluent to a septic tank and having sufficient capacity of the tank to manage the volume of effluent [20]

Somewhat

9. Access to a stable electrical source as well as oxygen and suction outlets in each ward [22]

Yes

10. A list of items in the CPR trolley and its review at regular intervals [23]

Yes

11. Management and monitoring of cold chain storage for medicinal products [23]

Yes

Equipment

 1. Ability to perform conventional HD (diffusion) and preferably convection treatment in HD devices [20, 22]

Yes

 2. Providing a reliable power source (to ensure returning blood from the arterial-venous lines to the body in case of a power cut) [20, 22]

Yes

 3. At least one backup device for every ten (10) HD machines [20]

No

 4. Disinfection of external surfaces of HD devices after each session [20, 22]

Somewhat

 5. Disinfection of the internal hydraulic circuit of HD machines after the last daily session [20, 22]

Yes

 6. Having Planned Preventive Maintenance (PPM) and technical safety check for all machines and documentation [20]

Yes

 7. Possibility of continuous renal replacement therapy (CRRT) in all wards as part of a comprehensive program of RRT [21]

Somewhat

Dialysis consumables

 1. Request of a valid quality certificate for all commercial dialysis solution [20, 22]

Yes

 2. Validation of filters used for HD treatment [20, 22]

Yes

 3.Request of a valid quality certificate for the arterial-venous sets that are used for HD treatment and taking all precautionary measures for prevention of their reuse [20, 22]

Yes

 4. Request of a valid quality approval for arterial-venous needles that are used during HD treatment [20, 22]

Yes

 5. Disposal of clinical waste according to the current instructions of the Ministry of Health and Medical Education (MOHME) [20] (refrigerated storage in case of daily collection at 4–6 degree of celsius and daily recording of the room temperature) [23]

Yes

Water quality

 1. Daily chlorine/chloramine test and hardness test every morning before starting HD treatment [20]

No

 2. Perform monthly tests for bacterial and endotoxin pollutions [20, 22]

Yes

 3. Production of dialysis water by reverse osmosis (RO) process [20]

Yes

 4. Six months test in an accredited laboratory to analyze and check chemical compounds of the water are used [20]

Yes

4. Workforce and human resources management

Yes/No/Somewhat

1. Assigning the role of dialysis department head to a nephrologist or a general physician with at least 200 h of formal training in HD treatment [20,21,22]

Somewhat

2. Recruit nurses/medical assistants with at least six (6) months of training and experience in the field of HD [20,21,22] with valid annual practicing certificate (APC) [23]

Somewhat

3. Recruit head-nurses with a basic degree in renal nursing and valid APC with at least two years of work experience in the HD department [23]

Somewhat

4. The presence of at least one nurse/medical assistant with at least six months training of HD treatment for every six HD patients [20]

Somewhat

5. The presence of at least one nurse/medical assistant trained in CPR techniques in each shift [20]

Yes

6. Performing HD according to the order of a nephrologist or a general physician with the necessary training under the supervision of a nephrologist [20]

Yes

7. HD treatment and care by a nurse or medical assistant with training and experience in the field of HD treatment and care [20]

Yes

8. Availability of trained technicians to repair HD machines [21, 22]

No

9. The presence of social workers and nutritionists in the HD ward [22]

No

10. Monitor all proceedings of prevention and infection control processes at the facility by a designated and trained nurse and document catheter-related bloodstream infections (CRBSIs), fistula infections, blood-borne viral and bacterial infections, and COVID-19 infections [23]

Yes

5. Care Effectiveness and monitoring of HD patients' improvement

Yes/No/Somewhat

1. Start HD if uremic symptoms affect daily life, biochemical values, uncontrollable fluid overload or estimated glomerular filtration rate (eGFR) of about 5 to 7 ml/min/1.73 m2 [17, 18]

Yes

2. Recording each session and monitoring any complication during HD (nausea, vomiting and headache / hypotension or hypertension / pyrogenic reaction: shivering, convulsions, fever during dialysis / hemolysis / acute blood loss / air embolism / mental status change / signs and symptoms of first HD syndrome including: chest pain, anxiety, shortness of breath and back pain), vital signs during dialysis, vascular access [20] and informing the patient about all these risks before the start of treatment [18]

Yes

3. Staff training in dealing with emergencies during HD including: acute hypotension, blood loss, hemolysis, air embolism, dialysis membrane reactions, high fever, sepsis and cardiovascular emergencies and their management [21, 22]

Yes

4. Appropriate protocols to monitor complications such as: patency and infections in AVF and AVGs [22]

Somewhat

5. Blood tests should be done regularly at intervals of three months or more

Yes

6. Checking the adequacy of dialysis at least every three months (Kt/V more than 1.2 or urea reduction ratio (URR) more than 65%) [15, 19, 20]

Yes

7. Focus on preserving residual kidney function by emphasizing strategies to reduce the rate and frequency of hypotensive attacks during HD, applying slower ultrafiltration rates, encouraging a low-sodium diet, avoiding unnecessary use of nephrotoxic medicines (such as aminoglycosides and radiocontrast) and prevention of infection [22]

Yes

8. Evaluation of protein and energy status by nutritionists (prevalence of malnutrition problem is high in most HD patients due to insufficiency of HD, underlying inflammation and undiagnosed infections) [17, 22]

No

9. Having a quality improvement program for achieving objectives of the standard care, including management of high blood pressure, fluid overload, infections, and reporting physical findings [22]

No

10. Perform HD at least 12 h per week for most patients (3 times per week) with minimal residual function [18, 21]

Yes

11. Using filters with artificial or cellulose membranes to prevent blood pressure drop during HD with symptoms [25]

Yes

12. Using high-flux filters for patients with minimal residual function and removal of molecules such as microglobulin beta 2 [21, 25]

Yes

13. Considering the benefits of high-flux filters for the survival of diabetic patients, patients with HD history of more than 3.7 years and serum albumin less than 40 g/L [25]

Yes

14. Use of high-flux or low-flux filters (biocompatible) for intermittent HD [18]

Yes

15. Proposing hemodiafiltration as a treatment for resistant hypotensive patients in comparison to HD patients with good prognosis [21]

No

16. Washing HD lines and filters to lose minimal blood [21]

Yes

17. Fluid and volume control in HD patients through salt restriction, use of diuretics and antihypertensive medicines [22]

Yes

18. Starting erythropoietic stimulating agents to reach a hemoglobin level of 9 to 10 g/dL [22]

Yes

19. Treatment of mineral and bone disorders to reduce phosphorus serum level, diet counseling and prescription of medicines (such as Sevelamer with lower rate of mortality compared to calcium-based binders) to reduce phosphorus absorption from the gastrointestinal tract [22]

Yes

20. Parathyroid Hormone (PTH) lowering treatment with medicines: calcimimetics, calcitriol or vitamin D analogs [22]

Yes

21. Avoiding excessive ultrafiltration in case of fluid overload by using an additional schedule and adjusting the dialysis temperature [21]

Yes

22. Management of hyperkalemia through: reducing dialysis solution potassium, dietary recommendations, medication administration and increased dialysis frequency [21]

Yes

23. A combined approach to abnormal serum bicarbonate includes dialysate dose escalation, oral bicarbonate, nutritional support or individualization of dialysis solution buffer [21]

Yes

24. Use of unbroken or low molecular weight heparin during HD to reduce arterial-venous clotting [21]

Yes

25. Prescribing a type of non-heparin anticoagulant in patients with allergy reaction [21]

No

26. Regular assessment of individual risk in high-risk patients using special devices for further monitoring [21]

Yes

27. Additional sessions or longer HD time for patients with significant weight gain, high ultrafiltration rate, poor blood pressure control, difficulty achieving dry weight or poor metabolic control (eg, hyperphosphatemia, metabolic acidosis, and/or hyperkalemia) [18]

Yes

28. Reducing sodium intake in the diet and removing sodium/water by sufficient HD to control blood pressure, hypervolemia and left ventricular hypertrophy [18]

Yes

29. Changing the central venous catheter (CVC) dressing and using local ointments or solutions inside the catheter (antibiotic and non-antibiotic) to reduce the infection of the catheter exit site and related bacteremia [19]

Yes

30. Mandatory reporting of viral hepatitis, HIV seroconversion and death during HD in chronic dialysis patients to the Ministry of Health [23]

Yes

31. Root cause analysis, corrective and preventive protocols of incidents such as: patient fall, medication error, pyogenic reactions, catheter and venous needle displacement [23]

Yes

Outcome measures and quality imperatives in dyalisis

 1. Recording the parameters of dialysis treatment in the patients' daily sheet, including: dry weight, blood flow, dialysis solution flow, type and amount of anticoagulant, dialysis duration, dialysis frequency, dialysis filter type, calcium in the dialysis solution and prescribed medicines during dialysis (such as: erythropoietin, intravenous iron) [23]

Yes

 2. Monitoring of each patient at least once every three months by a nephrologist, including: clinical examination, blood test results and medicines [23]

Yes

 3. Monitoring HD results at least every three months regarding anemia, nutritional status, dialysis adequacy, and mineral metabolism [23]

Yes

 4. Adequacy of dialysis: > 95% of patients Kt/V > 1.3 prescribed / > 90% of patients Kt/V > 1.2 delivered

        Urea Reduction Ratio (URR): > 90% of patients > 65% [20]

Somewhat

 5. Anemia: Hemoglobin: in > 70% of patients > 10 g/dL; Serum ferritin: in > 90% of patients > 100 ng/ml; Transferrin saturation (TSAT): in > 80% of patients > 20% [20]

Somewhat

 6. Extracellular fluid management with the aim of removing fluids during HD in order to maintain the optimal weight, volume of the patient and normal blood pressure level [22]

Yes

 7. Accurate assessment of volume status and dry weight by monthly clinical assessment [21], chest radiography, echocardiographic assessment of inferior vena cava diameter, N-terminal pro-B-typenatriuretic peptide levels, bioelectrical impedance analysis [21], lung ultrasound, etc. [22]

Somewhat

 8. Optimal serum potassium before HD session in the range of 4.0–6.0 mmol/L and dialysis solution potassium between 1.0 and 3.0 mmol/L (for most patients) [21]

No

 9. Optimal serum bicarbonate before HD session in the range of 18.0–26.0 mmo/L and dialysis buffer less than or equal to 37.0 mEq/L (for most patients) [21]

No