Quality of care assessment and adherence tothe international guidelines consideringdialysis, water treatment, and protection

against transmission of infections inuniversity hospital-based dialysis units

in Cairo, Egypt

Salwa IBRAHIM

Department of Internal Medicine, Cairo University, Cairo, Egypt

AbstractEnd-stage renal disease has emerged as a major public health problem around the world. In recent

decades, several important advances have been made in the therapy of hemodialysis (HD) with the

introduction of international guidelines to ensure the delivery of optimum care to HD patients. An

increased mortality risk in HD patients unable to meet six targets in different areas of HD practice has

been reported by the Dialysis Outcomes and Practice Patterns Study investigators. In this retrospec-

tive study, we assessed the current practice patterns of care for HD patients in the Kaser El-Aini

Nephrology and Dialysis Center in comparison with Dialysis Outcomes Quality Initiative Guidelines,

European Best Practice Guidelines, Centers for Disease Control and Prevention guidelines for pre-

vention of transmission of infections among HD patients, and American Association for Medical In-

strumentation (AAMI) standards for dialysis water quality. The mean percent of urea reduction was

63 � 8.8% in prevalent HD patients. An arteriovenous fistula was the vascular access in 91% of prev-

alent HD patients, whereas a temporary catheter was used in 9% of cases mostly as a bridge till

arteriovenous fistula creation/maturation. Bicarbonate was the base used in 80% of the cases. Ninty-

seven percent patients had thrice-weekly sessions and 3% had two dialysis sessions/wk. The mean

serum albumin was 4.19 � 0.39 g/dL; 66.66% of prevalent patients had serum albumin level 44 g/

dL. The mean serum calcium was 8.66 � 1.4 mg/dL, phosphorus was 6.26 � 2.54 mg/dL, and ap-

proximately 60% of patients had a serum phosphorus level 45.5 mg/dL. The CaxPi product was

higher than 55 in around 40% of the cases, and the parathyroid hormone level was in the range of

150 to 300 pg/mL in around 10% of prevalent patients. The mean hemoglobin was 9.23 � 7.18 g/dL

in prevalent cases; around 70% of cases had a hemoglobin level o11 g/dL. Iron deficiency was

prevalent as 18% of patients, with serum ferritin o200 ng/L, and 34% had total serum test o20%.

Seventy percent of the patients were hepatitis C virus positive and 4% were hepatitis B surface an-

tigen positive, and all were negative for the human immunodeficiency virus serological test. Dialysis

water was monitored regularly for chemical and bacterial contamination as recommended by the

American Association for Medical Instrumentation, but an endotoxin assay is currently not included

in the monitoring checklist. The annual mortality rate was 8% in 2007. The current audit revealed

a reasonable quality of care for HD patients in the fields of vascular access care, dialysis adequacy,

and nutrition areas. It also reveals the need for improving anemia management and control of

Correspondence to: S. Ibrahim, MD MRCP, 3 Refaah Street, Flat 14, Dokki, Giza 12311, Egypt. E-mail: salwa Ibrahim@hotmail.com

Hemodialysis International 2010; 14:61–67

r 2009 The Author. Journal compilation r 2009 International Society for Hemodialysis

DOI:10.1111/j.1542-4758.2009.00398.x 61

hyperphosphatemia with dietary counseling and more frequent dialysis. To fully meet the guideline

targets, each patient should be treated in an individualized way with more counseling, nutritional

education, and individualized dialysis prescription. Besides, the unit needs to adopt primary and

secondary intervention strategies to prevent and promptly correct any deviation from the desired

targets.

Key words: Quality of care, adherence, guidelines, hemodialysis, Egypt

INTRODUCTION

Chronic kidney disease (CKD) and end-stage renal dis-

ease (ESRD) are emerging health problems that need

long–term, often costly care.1 While renal replacement

therapy has improved many patients’ care, questions

remain regarding the quality of care provided to patientsby dialysis facilities. In a report issued by the US General

Accounting office, 16% of dialysis patients did not have

an adequate amount of toxins removed from their blood,

24% had anemia that was not brought under control, and

19% of the patients were dialyzing for extended periods

using catheters.2

Clinical practice guidelines were established to provide

recommended ranges for parameters associated withmanagement of ESRD patients.3–6 These guidelines ad-

dressed the quality of care of ESRD with regard to the

vascular access, anemia management, bone metabolism,

and nutritional assessments. Besides, the quality of dial-

ysis water has received special attention recently due to

the large volumes of water each dialysis patient is exposed

to during treatment.7 The American Association of Med-

ical Instrumentations (AAMI) had issued guidelines ofdialysis water treatment and quality of product water to

ensure patients’ safety.7 To prevent transmission of infec-

tions in dialysis units, Centers for Disease Control and

Prevention (CDC) set out guidelines to protect against

spread of infections especially hepatitis B and C.8

Infrequent, poorly targeted, and inadequate inspec-

tions by survey agencies allow facilities’ quality of care

problems to go undetected or remain uncorrected. Evenwhen deficiencies are identified and facilities take correc-

tive actions, little incentive exists for these facilities to

remain in compliance. This problem is often seen in the

developing countries’ dialysis units where financial restric-

tions lie behind the inability of dialysis units to reach the

proposed targets.

Studies showed clearly that compliance with guidelines

results in a better outcome.9,10 Port et al.9 confirmed thatdialysis dose levels below the Kidney Disease Outcomes

Quality Initiative (K/DOQI) guidelines are associated with

higher mortality risks. Studies of compliance with K/DOQIguidelines of anemia management showed that higher he-

moglobin concentrations were associated with a decreased

relative risk for mortality and hospitalization.10 A trend to-

ward increased hemoglobin concentrations was observed

following publication of the European Best Practice

Guidelines on anemia management for CKD patients.10

We plan to accurately assess the current compliance

status of the Dialysis Unit at the Kasr el Aini Nephrologyand Dialysis Centre, Cairo University Hospital, with the

K/DOQI guidelines, CDC guidelines, and AMMI stan-

dards and measure the major patient outcomes. By doing

this, we can explore the potentials for improvement in the

current practice. Areas of weakness can be highlighted for

the scientific design of programs to improve the practice

in the dialysis units within the university hospitals. Find-

ings from international studies support this claim. All thecountries involved in the Dialysis Outcomes and Practice

Patterns Study (DOPPS) showed better compliance with

guidelines and better patient outcomes after publishing,

compared with findings before the publication of the

DOPPS.9

PATIENTS AND METHODS

The study revised clinical and laboratory data of allchronic hemodialysis (HD) patients attending the dialy-

sis units (N=100) at the Kasr Al Aini Nephrology and

Dialysis Centre and King Fahd Unit from January 2007 to

December 2007. The study looked at the extent of ad-

herence to the K/DOQI, CDC, and AAMI standards3–8

including:

� The dialysis dose delivered to the patients and the

frequency and method of measurement.

� The vascular access used to be assessed cross-section-

ally to detect the percentage of patients with arterio-

venous fistulae (AVF), and the percentage of patients

with temporary/permanent catheters.� Hemoglobin and serum iron studies and the rate of

prescription of intravenous iron and erythropoietin

Ibrahim

Hemodialysis International 2010; 14:61–6762

therapy. This includes the frequency of measure-

ment of the above-mentioned tests, and the targets

achieved.� Serum calcium, phosphorus, and parathyroid hor-

mone levels (PTH) including the frequency of mea-

surements and targets achieved.

� Compliance with infection control guidelines and the

prevalence of hepatitis B and C infection among

patients. The study will also assess the adherence to

the CDC recommendations regarding hepatitis B vac-

cination of dialysis patients.� Compliance with the AAMI standards for quality of

dialysis water used.

Patients’ outcomes at the end of the studyperiod were assessed by the investigator

� Nutritional status scoring using subjective global as-

sessment scale (SGA).11

� Quality of life (QoL) questionnaire (SF 36).12

� Patient survival rate for the study period using hos-

pital records; we could not include the hospitalization

rates in the current analysis as the information avail-

able from hospital records was not sufficient.

Statistical analysis

Data are shown as mean � SD. The ranges and frequen-

cies of different laboratory parameters are also given. In

addition, we examined the correlation between QoL and

SGA scores on the one hand and the targets achieved in

anemia control, serum albumin, calcium, phosphorous,

and PTH using Spearman’s correlation test on the other.Statistical analysis was conducted using MedCal software

version 9.3.9.0 (Broekstraat, Mariakerke, Belgium).

RESULTS

Demographic data

The study included 100 chronic HD patients. There were

48 females and 52 males. The mean age was 42.67 �12.56 years (range 17–71 y). They received 2 to 3 weekly

HD sessions at the Kasr El Aini Nephrology and DialysisCenter and King Fahd Dialysis units. The mean duration

of HD therapy was 6.413.2 (range 1–17 y). All patients

received 3 to 5 hours of HD using volumetric machines

and low-flux hemophan membrane 1.2 m2 (Haidylena

Medical, SAE, Cairo, Egypt). The dialysate flow was

500 mL/min and the blood flow rate ranged from 270

to 350 mL/min. Table 1 shows the main data of the study

group.

Vascular access

Arteriovenous fistulae were the vascular access in 91% of

prevalent HD. Temporary or permanent central venous

catheters (CVC) were used in 9% of prevalent HD casesmostly as a bridge till AVF creation/maturation.

Anemia management

The mean hemoglobin level was 9.23 � 7.18 g/dL in

prevalent cases (range 5.4–16.4 g/dL). Seventy-three per-

cent of the cases had a hemoglobin level o11 g/dL over

the last 12 months. Nine percent of cases had a mean

hemoglobin level 412 g/dL over the study period. Eigh-

teen percent of patients achieved the target hemoglobin of

11 to 12 g/dL during the study period. The mean serumferritin was 640.34 � 323.45 ng/dL (range was 7.30–

2000 ng/dL). Iron deficiency was prevalent as 26% of pa-

tients had serum ferritin o100 ng/dL and 44% had total

iron-binding capacity (total serum test) o20%. Serum

ferritin was 4800 ng/dL in 31% of prevalent cases. Forty-

three percent of dialysis patients had serum ferritin be-

tween 100 and 800 ng/dL during the study period. The

hemoglobin level was measured every 2 months and an

Table 1 Clinical and biochemical data of the study group

Parameter Mean � SD (range)

Age (y) 42.67112.56 (17–71)Gender (M/F) 52/48BMI (kg/m2) 27.59 � 5.24 (22.35–32.83)Predialysis systolic bloodpressure (mmHg)

135.23 � 16.56

Predialysis diastolicblood pressure (mmHg)

82.87 � 13.73

Interdialytic weight gain(IDWG) (Kg)

2.81 � 1.23 (1.58–4.05)

Vascular access (AVF/CVC) 91/9Hemoglobin (g/dL) 9.23 � 7.18 (5.4–16.4)Serum albumin (g/L) 4.19 � 0.39 g/L (3.3–5.1)Serum calcium (mg/dL) 8.66 � 1.47 (5–12)Serum phosphorus (mg/dL) 6.26 � 2.54 (2.20–14)PTH (pg/mL) 689.93 � 754.56 (6.9–3976)Calcium � phosphorusproduct

55.00 � 15.16 (13–126.10)

URR% 63.5 � 8.7 (52–80)SGA scores 6.13 � 0.32 (2–7)QoL scores 66.25 � 11.90 (48–90)

PTH=parathyroid hormone; QoL=quality of life; SGA=subjectiveglobal assessment scale; URR%=urea reduction%.

Audit of quality of care in hemodialysis units in Cairo, Egypt

Hemodialysis International 2010; 14:61–67 63

iron study was conducted every 3 to 6 months. Erythro-

poietin was administered at doses of 4000 to 12,000 IU/

wk subcutaneously in patients with hemoglobin levelswere o11 g/dL, with some interruptions that last for 1 to

2 months if the funds are limited. The budget for erythro-

poietin administration largely comes from charity as each

dose costs around 100 Egyptian Pound (EGP). Iron de-

ficiency was corrected with intravenous iron dextran in-

jections (100–200 mg) weekly or every other week with

target transferrin saturation (TSAT) between 25% and

35% (Figure 1).

Compliance with the CDC guidelines forinfection control in a HD unit

Adherence to infection control guidelines is partially met

in daily practice. Wearing gloves and hand washing are

among the practices that are not well adhered to by all

nurses on all occasions. The practice of hand washing

before and after patient contact remained low especially

in busy shifts and reduced patient-nurse ratio. Nurses dosometimes care for patients and touch patients’ equip-

ment at the dialysis station without gloves. Otherwise,

multiple-dose medication vials are prohibited as well as

common medication carts. Dialysis stations (chairs, beds,

tables, and machines) are disinfected and cleaned be-

tween patients.

All new cases are tested for hepatitis B, C infection us-

ing the hepatitis B surface antigen (HBsAg) test and anti-HCV antibodies. Follow-up testing is performed every

6 months for anti-HCV antibodies and HBsAg status.

Hepatitis B vaccination is not yet a routine practice for

either dialysis patients or the healthcare personnel. Sev-

enty-five percent of prevalent dialysis patients are anti-

HCV positive and 4% are HBsAg positive. Hepatitis B

surface antigen-positive patients are dialyzed on separate

machines in isolation rooms and have dedicated nurses.

We do not isolate HCV-infected patients from HCV-neg-ative patients. We do not dedicate separate machines or

nurses to HCV-infected patients.

Adequacy of HD and frequency ofmonitoring

The delivered dose of HD was measured by the percent

of urea reduction (URR), which was assessed every 1 to

2 months during the study duration. The mean URR%

was 63.5% � 8.7% in prevalent cases. Sixty-six of the

patients had a mean URR%465 over the study period.

Bicarbonate dialysate was the base used in 80% of the

patients. Ninty-seven percent of the patients had thrice-

weekly dialysis sessions and 3% had twice-weekly dialy-sis sessions. Synthetic hemodialyzers were used for a sin-

gle session; dialyzer reprocessing is not practiced in the

unit.

Calcium, phosphorus, and PTH

The mean serum calcium level was 8.66 � 1.47 mg/dL.

Forty-one percent of dialysis patients had a mean serum

calcium level o8.4 mg/dL. Serum calcium levels were

between 8.4 and 9.5 mg/dL in 30% of prevalent HD pa-

tients. Twenty-nine percent of dialysis patients had a

mean serum calcium level 49.5 mg/dL. The dialysate

calcium concentration was 2.5 mEq/L.The mean serum phosphorus was 6.26 � 2.54 mg/dL

in prevalent dialysis patients during the study period.

Forty percent of dialysis patients had a serum phosphorus

level o5.5 mg/dL. Sixty percent of dialysis patients, on

the other hand, had serum phosphorus 45.5 mg/dL.

Fifty-eight percent of patients had a mean calcium phos-

phorus product o55% and 42% had a calcium phos-

phorus product 455. The mean serum PTH was689.93 � 754.56 (range 6.9–3976 pg/mL). Thirty-nine

percent of patients had a serum PTH level o300 pg/

mL, 11% had serum PTH between 300 and 600 pg/mL,

20% had serum PTH between 600 and 1200 pg/mL, and

30% of patients had a serum PTH level 41200 pg/mL.

Adherence to quality of dialysis waterstandards (AAMI standards)

Product water chemical testing, both biochemically and

bacteriologically, is compliant with AAMI guidelines that

advise to perform an annual biochemical analysis of prod-

uct water and to perform microbial cultures monthly.

Corrective measures are routinely undertaken if the col-

ony count exceeds the allowable limit (50 CFU).7 Testing

73%

18%9%

HgB < 11 g/dL

HgB 11–12 g/dL

HgB >12 g/dL

Figure 1 Hemoglobin levels among prevalent hemodialysispatients.

Ibrahim

Hemodialysis International 2010; 14:61–6764

for endotoxin has not yet been included in the monthlymicrobial testing.

Dialysis outcomes

� Survival

The annual mortality rate in the year 2007 was 8%.

Causes of death included cardiovascular events (4 cases),

sepsis and multiple organ failure (2 cases), and suddendeath (2 cases). The ESRD patients who died were sig-

nificantly older compared with surviving patients

(Po0.05) and had a previous history of cardiovascular

disease. There were no significant differences in URR,

vascular access, hemoglobin, calcium, phosphorus, PTH,

and albumin levels between decreased and surviving pa-

tients.

� Nutritional status

The serum albumin mean level was 4.19 � 0.39 g/L

(range 3.3–5.1 g/L); 67% of prevalent dialysis patients

had a serum albumin level 44 g/L. The mean SGA score

was 6.13 � 0.32 (range 2–7). Seventy-seven of patientshad SGA scores in the range of 6 to 7 (mild malnutrition

to well nourished). Ninteen percent had SGA scores in

the 3 to 5 range (mild to moderate malnourished). Four

percent were severely malnourished.

� QoL

Eleven patients had QoL scores o50, 13 patients had

QoL scores in the range 50 to 60, 40 patients had QoL

scores of 60 to 70, 20 patients had QoL scores of 70 to

80, and 16 patients had scores 480. There were no sig-

nificant correlations between age, gender, hemoglobin,

URR, calcium, phosphorus, calcium, PTH, and albumin

levels on the one hand and QoL scores on the other.

DISCUSSION

The study revealed partial compliance with the K/DOQI

guidelines in the study center. The vascular access cre-

ation rate showed excellent adhesion to the K/DOQI

guidelines in our unit. The lower prevalence rate of

CVC among dialysis patients in the present study canbe attributed to two main reasons: (1) the high rate of

AVF creation and (2) the relatively long duration of RRT

among prevalent cases of the study unit. Dialysis Out-

comes and Practice Patterns Study has shown that dialysis

facilities with higher catheter use display substantially

higher risks of mortality, and all-cause hospitalization.13

Dialysis Outcomes and Practice Patterns Study analyses

suggest that reducing catheter use could provide one of

the largest possible gains in patient longevity in manyparticipating countries.14 Several studies have shown

variable rates of AVF use in different countries.15–17

Arteriovenous fistulae accounts for 80% of all vascular

access in Spain, 53% of prevalent Canadian patients, and

91% of prevalent dialysis patients in Tehran.15–17

Another area of excellent compliance with K/DOQI

guidelines is nutrition. Sixty-seven percent of prevalent

dialysis patients had a serum albumin level 44 g/L. Sev-enty-seven percent of patients had SGA scores in the

range of 6 to 7 (mild malnutrition to well nourished).

However, our units lack a dedicated dietician and we do

not monitor regularly other nutritional indicators like en-

ergy and protein intake, muscle mass, serum bicarbonate,

and visceral protein pools as recommended by the K/

DOQI.18

Sixty-six percent of patients had a mean URR%465over the study period. We have reported a persistent ad-

equate dialysis dose among dialysis patients in the Kasr El

Aini Dialysis units.19–22 The main limitations behind the

lack of achievement of URR465 in the other patients are

a poor blood flow, fixed dialyzer size (1.2 m2), and diffi-

culties in extending the dialysis time beyond 5 hour be-

cause of high turnover rate of the patients. Achieving

excellent clearance in all dialysis patients needs individ-ual rather than mass prescription of dialysis dose, paying

special attention to dialyzer size in relation to body

weight and blood flow. The United States Renal Data Sys-

tem 2008 Annual report revealed that 91.6% of prevalent

dialysis patients in 2006 achieved URR� 65%.23

For the management of anemia, intravenous iron and

erythropoietin therapy were provided by the administra-

tion on an intermittent basis due to financial constraints.Correction of anemia to the K/DOQI target of 11 to 12 g/dL

was achievable only in 18% of prevalent dialysis cases. The

mean value of hemoglobin (Hgb) in our study (9.23 �7.18 g/dL) is lower than that reported by the DOPPS

study.24 The mean Hgb levels were 12 g/dL in Sweden;

11.6 to 11.7 g/dL in the United States, Spain, Belgium,

and Canada; 11.1 to 11.5 g/dL in Australia/New Zealand,

Germany, Italy, the United Kingdom, and France; and10.1 g/dL in Japan.24 Iron deficiency was prevalent as

26% of patients had serum ferritin o100 ng/dL. Correc-

tion of anemia was associated with improved well-being,

QoL, cardiac function, and patient outcomes.25,26 Achiev-

ing the KDOQI target for anemia is challenging in any de-

veloping country because of the limited governmental

budget and poor personal incomes.

Another area of weakness is the maintenance of cal-cium and phosphorus metabolism within KDOQI targets

in our dialysis patients. The mean serum phosphorus was

Audit of quality of care in hemodialysis units in Cairo, Egypt

Hemodialysis International 2010; 14:61–67 65

6.26 � 2.54 mg/dL in prevalent dialysis patients duringthe study period. These data are comparable to the data

reported by the DOPPS study.9 The overall seven coun-

tries serum phosphorus by guideline categories above

45.5 mg/d was reported in 50.4% of patients (DOPPS I,

1999) and in 46.6% of patients (DOPPS II, 2002).9 The

main reasons for the poor phosphate control in our study

group are dietary noncompliance, lack of dietician ser-

vice, limited chances of recieving frequent or daily dial-ysis, and unaffordable noncalcium phosphate binders.

Our study show poor control of secondary hype-

rparathyroidism as the PTH level was in the range of

150 to 300 pg/mL in around 10% of prevalent patients.

Achievement of the PTH target within that recommended

by the K/DOQI guidelines is the most difficult task for

physicians due to difficulties in maintaining calcium and

phosphorus levels within targets. The DOPPS study hadreported overall serum iPTH levels exceeding the K/DOQI

target (i.e., 4300 pg/mL) in 28.6% of patients (DOPPS I,

1999) and in 26.1% of patients (DOPPS II, 2002).9

Infection control measures were considerably adhered

to in the units especially in the care of hepatitis B patients.

Wearing gloves and hand washing are two areas of weak-

ness that need more training. Hepatitis C antibodies were

positive in 75% of HD patients. The seroprevalence ofHCV antibodies was reported to be high (49.1%) among

ESRD patients in Egypt and was correlated significantly

with blood transfusion.27 Hepatitis B vaccination of the

dialysis patients, nurses, and staff is not carried out as a

routine in the unit. The government pays around

18,000 EGP/y/patient to cover the combined cost of dial-

ysis therapy, monthly investigations, and treatment. This

restricted fund makes universal vaccination difficult as itbarely covers the cost of dialysis sessions and the neces-

sary medications, besides the costs of vaccination. The

same applies to checking dialysis water for endotoxin as

recommended by the AAMI.7

The study showed impaired QoL among prevalent di-

alysis patients. Poor QoL had been reported in a previous

cross-sectional analysis of prevalent dialysis patients in

our dialysis units.20,21 Development of ESRD in middle-aged subjects usually leads to disruption of patients’ social

and physical activities, with subsequent psychological

distress and poor QoL.20,21 The lack of association be-

tween laboratory parameters and QoL scores may suggest

that socioeconomic factors, symptom burden, and co-

morbidities are the main determinants of general health

perception and physical and mental capabilities in this

cohort of patients.20,21

The annual mortality rate was as low as 8%. Old age,

cardiovascular disease, and sepsis were associated with

mortality in the present audit. Cardiovascular disease, di-abetes, and old age were associated with higher mortality

rates in the DOPPS study.28 The relatively low mortality

rate in our dialysis population can be explained by their

relatively young age, lower comorbidity rates, higher se-

rum albumin achieved, and the low rate of use of a CVC.

To conclude, the study revealed a reasonable quality of

care for HD patients in the fields of vascular access care,

dialysis adequacy, and nutrition areas. It also reveals theneed for improving anemia management and control of

hyperphosphatemia with dietary counseling and more

frequent dialysis.

ACKNOWLEDGMENTS

The author thanks Eng. Sahar Ibrahim for the technical

assistance and Walid Saeed for data collection.

Manuscript received April 2009; revised May 2009.

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