Quality standards for celiac disease comprehensive care units: A Spanish multidisciplinary consensus integrating professional expertise and patient perspectives

Table 3 Process quality standards for establishing a Comprehensive Care Unit for patients with Celiac Disease

Position	Definition	Mean	CV (%)	Agreement
1	The diagnostic process for CD should ideally begin after confirming that the patient is consuming gluten. If the patient has previously followed a GFD, the exact dates should be documented in the clinical record whenever possible, and alternative diagnostic approaches should be considered if gluten exposure is deemed insufficient or interrupted	9.77	4.39	Very high
2	Following CD diagnosis, each patient should be assigned either a pediatric or adult gastroenterologist, as appropriate, for disease follow-up. Once clinical and serological response to the GFD has been confirmed, long-term follow-up may be conducted by a pediatrician or primary care physician under a consensus-based protocol	8.59	27.28	Very high
3	The medical record should include detailed documentation of the diagnostic criteria used to establish the CD diagnosis in both children and adults, as well as appropriate ICD coding for statistical and epidemiological purposes	10.00	0.00	Very high
4	The laboratory providing serological results to the CCU-CD must adhere to current diagnostic guideline recommendations for measuring anti-tTG2 and anti-EMA of IgA and IgG classes (the latter for IgA-deficient patients). A validated method must also be available to confirm IgA deficiency. Assay kits used should be clearly stated in reports, along with their sensitivity and specificity. Reports should also specify the diagnostic cut-offs required for positive results and for no-biopsy approach in children and adolescents, according to ESPGHAN recommendations. A note should clarify that quantitative results are method-dependent and may not be directly interchangeable with those obtained by other analytical systems. Internal quality control must be performed daily, and participation in external quality programs is mandatory	9.86	3.56	Very high
5	The CCU-CD should provide patients with a means of communication for reporting relevant clinical changes. Depending on available resources, this may include telephone contact, institutional email, or specific digital platforms	9.50	8.44	Very high
6	The CCU-CD must base its procedures on national and international guidelines and apply protocols supported by the best available scientific evidence to ensure excellence in diagnosis, treatment, and follow-up. These protocols should incorporate the elements described in Table 5 and undergo regular review and updating	9.36	12.99	Very high
7	Laboratories performing HLA genetic testing must provide standardized reports meeting the minimum requirements recommended by the SEEC to ensure accurate interpretation. To ensure compliance, it is advisable that the reports be endorsed by the SEEC	9.82	4.02	Very high
8	The CCU-CD should establish, in collaboration with the endoscopy and pathology departments, a Standard Operating Procedure defining the number and type of samples, as well as the collection and transport procedures for duodenal biopsies, both for histological study and intraepithelial lymphogram analysis by flow cytometry	9.73	5.66	Very high
9	Laboratories performing immunophenotyping of duodenal lymphocyte populations (intraepithelial lymphograms) should use standardized flow cytometry methods with regular quality control and, preferably, staff experienced in intestinal mucosa. Reports should meet the minimum requirements suggested by the SEEC to ensure accurate interpretation	9.82	5.10	Very high
10	The pathology department should provide standardized reports that supply pediatric and adult gastroenterologists with all necessary information for clinical interpretation. Reports should include a validated classification of histological lesions and a detailed description of findings to guide diagnosis and follow-up	9.86	3.56	Very high
11	Duodenal biopsy interpretation should be carried out by pathologists experienced in recognizing characteristic lesions. Double reading by two pathologists is recommended for all cases and mandatory in those with diagnostic uncertainty	9.77	4.39	Very high
12	The CCU-CD should offer newly diagnosed and follow-up CD patients access to dietary and nutritional counseling by qualified professionals (preferably dietitians or dietitian-nutritionists). Follow-up should be intensified in non-responsive cases or when symptoms persist	9.50	7.08	Very high
13	The CCU-CD should conduct regular nutritional follow-up to identify and correct nutritional deficiencies and monitor nutritional status over time. These data should be systematically recorded in the medical history	9.32	14.58	Very high
14	The CCU-CD should provide updated information on vaccination recommendations for CD patients, both at diagnosis and during follow-up, in accordance with regional public health guidelines	9.32	9.59	High
15	The CCU-CD should implement a clinical monitoring program focused on safety for patients receiving immunosuppressive or, in the future, biological therapies	9.45	11.18	Very high
16	The CCU-CD should inform patients about the existence of patient associations, which represent valuable complementary resources for psychosocial support and education on CD-related aspects	9.69	6.68	Very high

CV: Coefficient of variation; CCU-CD: Comprehensive Care Unit for patients with Celiac Disease; CD: Celiac disease; tTG2: Tissue transglutaminase type 2; EMA: Endomysial antibodies; ICD: International Classification of Disease; GFD: Gluten-free diet; SEEC: Spanish Society for Celiac Disease.