CDER Manual Diagnostic Element - California Department Of .
CDER Field ManualDiagnostic ElementDIAGNOSTIC ELEMENTREASON FOR THE 2015 REVISIONThe 2015 version of the Diagnostic Element of the CDER manual was updated toreflect the changes needed at the developmental centers. The changes whichwere implemented in 2014 and 2011 (at the regional centers) will now beimplemented at the developmental centers. The diagnostic codes to be enteredshould be selected from the 10th Revision of the International Classification ofDiseases-10th Revision-Clinical Modification (ICD-10-CM) (hereinafter ICD-10) setof codes and the fifth edition of the American Psychiatric Association’s Diagnosticand Statistical Manual of Mental Disorders (DSM5) set of codes. The use of DSM5codes will replace the use of the DSM-IV codes.Source of Diagnostic Data: The diagnostic information for this form should beprovided primarily by the client’s physician and psychologist. The medicaldiagnoses should be made by the physician. Diagnoses of mental disordersshould be made by those persons qualified to utilize the DSM5 set of codes.Other information required for this form should be provided by persons mostqualified to provide accurate data.Multiple Diagnoses: Information on the various developmental disabilitiesintellectual disability, cerebral palsy, etc. – is arranged in separated sections onthe form. For each section, information on “etiology” or contributing factors” isrequested, using ICD-10/DSM5 codes. Two seven digit spaces are allotted forthe ICD-10/DSM5 coding of each disability. This permits entering both the majoror primary cause and secondary or contributing cause for each disability. When aclient has more than one developmental disability, it is possible the same causalfactor(s) have been found to be associated with each of the conditions. Forexample, a premature infant with anoxic brain damage might have an intellectualdisability, cerebral palsy and epilepsy. The ICD-10 codes for the prematurity andanoxic brain damage would then be entered for each of the three disabilities.Coding of “Risk Factors”: To provide more precise information for preventionplanning, a series of “risk factors” or factors that could contribute to or beassociated with the occurrence of developmental disabilities has been identified.The factors, which include teenage pregnancy, accidents of near drowning, familyhistory of intellectual disability, and so forth, have been developed to permitclassification of special conditions associated with the occurrence ofdevelopmental disabilities. The section on Risk Factors, Items 35-49, follows thesections on the specific developmental disabilities.Organization of Manual: In the following pages the various developmentaldisabilities and other diagnostic information are presented sequentially, in a seriesof sections that correspond to the items on the form. For each item within asection, a description of the item or concept is given first, followed by codinginstructions and usually, an example. Item numbers given in the left margin in themanual refer to item numbers on the revised CDER form.Department of Developmental ServicesRevised September 2015- 17 -
CDER Field ManualDiagnostic ElementEligibility Determination and CDER: The CDER is not an eligibilitydetermination document. Decisions about the client’s eligibility for services aremade separately, by the persons designated by the regional center to make suchdecisions, and usually prior to completion of the CDER form. The CDER is adocument on which data are recorded for clients found to be eligible for regionalcenter services through other mechanisms. The various categories of informationincluded on the CDER form are not intended to define eligibility, either for thesystem or for individual clients. The CDER simply provides a descriptive database about clients; neither the individual items nor the particular examples ofcoding included in the CDER Manual should be interpreted as guidelines foreligibility decisions.Etiology: The term “Etiology” on the CDER form refers to those factors that mayhave contributed to or been associated with the client’s developmental disability ormedical condition. Recording a factor or condition in an “Etiology” item on CDERis not a statement of definitive causation in any medical-legal sense. Thesefactors or associated conditions are to be used for review and statistical purposesonly and do not constitute a diagnostic opinion as to the exact cause of adevelopmental disability or medical condition.Department of Developmental ServicesRevised September 2015- 18 -
CDER Field ManualDiagnostic ElementINTELLECTUAL DISABILITYIntellectual disability (intellectual developmental disorder) is a disorder with onsetduring the developmental period (childhood or adolescence) that includes bothintellectual and adaptive functioning deficits in conceptual, social, and practicaldomains. The diagnosis of intellectual disability is based on both clinicalassessment and standardized testing of intellectual and adaptive functions.Additional sources of information should also be assessed, including education,development, medical, and mental health evaluations.Deficits in intellectual functions, such as reasoning, problem solving, planning,abstract thinking, judgment, academic learning, and learning from experience,should be confirmed by both clinical assessment with one or more individuallyadministered psychometrically valid, comprehensive, culturally appropriate,psychometrically sound tests of intelligence, combined with clinical judgment.Deficits in adaptive functioning result in failure to develop developmental and sociocultural standards for personal independence and social responsibility. Withoutongoing support, the adaptive deficits limit functioning in one or more activities ofdaily life, such as communication, social participation, and independent living,across multiple environments, such as home, school, work, and community.11. LEVEL OF INTELLECTUAL DISABILITY (ICD-10 Code)This item refers to the severity or level of the client’s intellectual disability.The appropriate ICD-10 code is to be used to record this information.Determination of the level of intellectual disability must be consistent with theDSM5, which uses conceptual, social, and practical domains to determineseverity. The level of severity of intellectual disability is determined by adaptivefunctioning and not IQ scores, because it is adaptive functioning thatdetermines the levels of supports required. The level of intellectual disabilityshould be obtainable from a psychological evaluation report or other sourcesin the client’s records.The ICD-10 codes below represent the various levels of intellectual disability.Enter the appropriate code in Item 11.Intellectual Disability - Level Codes0F70F71F72F73F78F79No intellectual disabilityMild intellectual disabilitiesModerate intellectual disabilitiesSevere intellectual disabilitiesProfound intellectual disabilitiesOther intellectual disabilitiesUnspecified intellectual disabilitiesUse category F79, ID unspecified (level) in the following situations:Department of Developmental ServicesRevised September 2015- 19 -
CDER Field ManualDiagnostic Element The individual is over the age of 5 years when assessment of thedegree of intellectual disability, by means of locally availableprocedures, is rendered difficult or impossible because of associatedsensory or physical impairments, as in blindness or prelingualdeafness; locomotor disability; or presence of severe problembehaviors or psychiatric disorders. This category should only be usedin exceptional circumstances and reassessed after a period of time. As a temporary coding until a determination can be made.Example of Coding Level of Intellectual DisabilityExample 1: Consumer has a severe intellectual disabilityLevel of Intellectual Disability (ICD-10 Code)11. F72 0No intellectual disabilityF70 Mild intellectual disabilityF71 Moderate intellectual disabilityF72 Severe intellectual disabilityF73 Profound intellectual disabilityF78 Other intellectual disabilityF79 Unspecified intellectual disability12a. and 12b. ETIOLOGY OF INTELLECTUAL DISABILITYItems 12a and 12b are to be used to record the major cause(s) of the client’sintellectual disability. ICD-10 codes are to be used.-If the client does not have an intellectual disability, enter 0 in Item12a and leave Item 12b blank.-If the client has an intellectual disability and the cause orcontributing factor is known, enter the appropriate ICD-10 code inItem 12a; if more than one causal factor is known, record theadditional factor in item 12b using the appropriate ICD-10 code.-If the client has a diagnosis of intellectual disability, butetiological factors are not known, enter “F79” in Item 12a andleave Item 12b blank.NOTE: Risk factors and associated conditions related to theintellectual disability, as well as to all other developmentaldisabilities, are to be coded in Items 35-49. Manual instructions forthese are provided in sequence below.Department of Developmental ServicesRevised September 2015- 20 -
CDER Field ManualDiagnostic ElementExample of Coding Etiology of Intellectual DisabilityExample 1: Consumer is an infant with Down Syndrome who had subsequentbrain damage due to lack of oxygen at birthDown Syndrome, unspecified (primary cause) code Q90.9Severe Birth Asphyxia (secondary cause) code P21.0Etiology of Intellectual Disability ICD-10 Code12a.(Down Syndrome, unspecified) Q90.9 12b.(Severe Birth Asphyxia) P21.0 13. DATE OF LAST EVALUATIONThis is the most recent date (month and year) on which the last determinationor review of the client’s intellectual disability level was made. It usually will befound in the psychologist’s report.If Item 11 is coded “0” or if there is no psychological evaluation report in theclient’s records, enter “0” in the boxes for this item.The remaining items in this section are applicable to developmental centerclients only. They may be, but do not have to be, completed for regionalcenter clients.Date of Last Evaluation M M Y YDepartment of Developmental ServicesRevised September 2015- 21 -
CDER Field Manual14.Diagnostic ElementINTELLIGENCE QUOTIENT SCOREEnter here the three-digit numerical Intelligence Quotient (I.Q.) whichbest represents the client’s level of intellectual functioning, for example,047. If the client has previously been evaluated, there should be apsychological evaluation report in which the psychologist will report onenumber as best representing the client’s I.Q. If more than one numberis reported, ask the client’s psychologist to give and document the onebest representative number. This item cannot be scored unknownor left blank for developmental center clients.15.INTELLIGENCE TEST NAMESelect the two-digit code listed in Appendix D to indicate the individualized,standardized intelligence test which is used to give the I.Q. (actual orestimated) in Item 14. If more than one test is used, select the one that isgiven primary weight. If the test is not listed, or if the client’s I.Q. has beendetermined by other means, use code 22 or 27, respectively.Examples of Coding Client’s Intelligence Quotient and Intelligence TestExample 1: Consumer’s most representative score was 67 on the Wechsler AdultIntelligence Scale-IV.Developmental Center Clients OnlyIntelligence Quotient14. 0 6 7 Intelligence Test15. 3 2 Example 2: Consumer’s intelligence quotient of 55 was determined by meansother than one of the tests on the lists:Intelligence Quotient14. 0 5 5 16.Intelligence Test15. 2 7 ADAPTIVE FUNCTIONINGThis item refers to the level of the client’s ability to meet the developmentaland sociocultural standards of personal independence and socialresponsibility, in comparison to others of similar age and socioculturalbackground. Adaptive functioning involves adaptive reasoning in threedomains: conceptual, social, and practical. The various levels of severityare defined on the basis of adaptive functioning, and not IQ scores.Further, the deficits in adaptive functioning must be directly related tointellectual impairments.Department of Developmental ServicesRevised September 2015- 22 -
CDER Field ManualDiagnostic ElementThe codes below represent the various levels of adaptive functioning. Enterthe appropriate code, as listed below, in the space provided.Adaptive Functioning fied/UnknownIf the client has been previously evaluated, there should be a rating in therecords. Enter the appropriate code “0” – “4”. If there is nothing to indicatethe client’s adaptive functioning, enter “5” for Unspecified/Unknown.Example of Coding Adaptive FunctioningExample 1: The client below has moderate adaptive functioning.Adaptive Functioning16. 2 UnknownDepartment of Developmental ServicesRevised September 2015- 23 -
CDER Field ManualDiagnostic ElementCEREBRAL PALSYThe term Cerebral Palsy (CP) refers to a group of non-progressive lesions ordisorders in the brain characterized by paralysis, spasticity, or abnormal control ofmovement or posture, such as poor coordination or lack of balance. Thesedisorders may be due to developmental anomalies of the central nervous systemor injury of the brain during intrauterine life, the perinatal period, or within the firstfew months of life, and are usually manifested during early childhood.Common prenatal causes of CP are maternal infections such as toxoplasmosis,rubella, and cytomegalic inclusion disease. Examples of perinatal causes arecerebral trauma, anoxia, or intra-cerebral bleeding during birth. In the first fewmonths of life, important etiological factors are kernicterus, meningitis, encephalitis,or child abuse.Although diagnoses of later-onset neurological disorders (e.g., cerebrovasculardisease and tumors) and well-defined neurodegenerative diseases (e.g., EarlyOnset Primary Dystonia or Friedreich Ataxia) are excluded from this CPd efinition, the motor dysfunction associated with such conditions are similar to CPand, therefore, should be coded in this section.In this section, attention is given both to Cerebral Palsy and to other conditions withmotor dysfunction that are similar to Cerebral Palsy. Items are provided below forrecording either Cerebral Palsy or other significant motor dysfunction. Forexample, if an older child with homocystinuria suffered a stroke, causing severe leftcerebral damage in the motor area giving rise to a right hemiplegia, the code formotor dysfunction similar to CP could be used. In this example, the items foretiology would be reflected by codes A52.05 (Other Cerebrovascular Syphilis) andE7211 (homocystinuria).17.PRESENCE OF CEREBRAL PALSYThis item is for recording whether the consumer has Cerebral Palsy orsome other condition that produces a significant motor dysfunction.Presence of Cerebral Palsy0 No CP or other significant motor dysfunction2 Has CP3 Has other significant motor dysfunctionWhen coding Presence of Cerebral Palsy If the consumer does not have Cerebral Palsy or another condition thatproduces a significant motor dysfunction, enter a "0" in Item 17 andleave Items 18a-22 blank. If the consumer has Cerebral Palsy, enter code "2"; then complete Items18a-22.Department of Developmental ServicesRevised September 2015- 24 -
CDER Field Manual Diagnostic ElementIf the consumer has a condition that produces a significant motordysfunction, enter code “3”; then complete Items 18a-22.Example of Coding Presence of Cerebral PalsyExample 1: Consumer has been diagnosed with Cerebral Palsy.17. 2 Presence of Cerebral Palsy0No CP or other significant motor dysfunction2Has CP3Has other significant motor dysfunction18a & 18b. ETIOLOGY OF CEREBRAL PALSYThe Etiology items are used to record the major cause(s) of or contributingfactor(s) to Cerebral Palsy or other significant motor dysfunction. Record theetiologic factor(s) using ICD-10 codes. Etiology does not mean the severity, type,or location of motor dysfunction. These descriptors are addressed as separateitems and are discussed in detail later in this section. If the consumer does not have Cerebral Palsy or othersignificant motor dysfunction, as indicated in Item 17, leavethis item blank. If the consumer has Cerebral Palsy or other significant motordysfunction, enter the appropriate ICD-10 code that indicatesthe major cause or factor contributing to the disability in theseven spaces provided in Item 18a. Add any additional factorin Item 18b. If the etiology of the consumer's motor dysfunction is notknown, enter “0” in Item 18a and leave Item 18b blank.NOTE: Any risk factors associated with, but not directlycausing, the disability should be recorded in Items 35-49.Example of Coding Etiology of Cerebral PalsyExample 1: Consumer was born prematurely with hemolytic disease due to RHisoimmunization.EtiologyICD-10 Code18a. (RH isoimmunization)18b. (Prematurity)Department of Developmental ServicesRevised September 2015 P550 P558 - 25 -
CDER Field Manual19.Diagnostic ElementSEVERITY OF MOTOR DYSFUNCTIONThis item refers to the severity of disability caused by Cerebral Palsy orother significant motor dysfunction.The categories used to indicate the severity or degree of impairment of CerebralPalsy or other type of significant motor dysfunction are mild, moderate, andsevere; however, there are no commonly accepted standards. Refer below fordefinitions of the severity of impairment as they pertain to this manual.Prior to rating the consumer's severity of motor dysfunction, make certain thatthe correct entry has been made in Presence of Cerebral Palsy (Item 17),indicating whether or not Cerebral Palsy or another significant motordysfunction is present.The categories for Severity of Motor Dysfunction are as follows:Severity of Motor DysfunctionMild: Condition exists but does not have limiting effects ondaily activities and functions.Moderate: Level of impairment is between mild and severewith respect to performance of daily activities and functions.Severe: The disability significantly limits or precludes dailyactivities and functions.Severity of Motor Dysfunction Codes1 Mild: Does not limit activities.2 Moderate: In between mild and severe.3 Severe: Significantly limits or precludes daily activity.When Coding Severity of Motor Dysfunction If the consumer does not have Cerebral Palsy or other type ofsignificant motor dysfunction (a "0" in Item 17), leave this item andsubsequent items in this section blank. If the consumer is diagnosed as having Cerebral Palsy or other significantmotor dysfunction, enter the appropriate code as listed above.Example of Coding Severity of Motor DysfunctionExample 1: Severity of motor dysfunction significantly limits consumer’sdaily activities and functions.Department of Developmental ServicesRevised September 2015- 26 -
CDER Field ManualDiagnostic Element19. 3 Severity of Motor Dysfunction123Mild: Does not limit activities.Moderate: In between mild and severe.Severe: Significantly limits or precludes daily activity.20.TYPE OF MOTOR DYSFUNCTIONThe type of motor dysfunction should be included in the consumer's records.The categories used for this item are defined below:Type of Motor Dysfunction DefinitionsHypertonic (includes Spasticity and Rigidity): Hypertonia is defined as a "stateof increased muscle tension.” The major manifestation of spasticity is increased orexaggerated stretch reflex that exhibits itself by an exaggerated contraction of amuscle when it is suddenly stretched. Rigidity is a form of hypertonia that isindependent of the speed or range of movement.Ataxic: This type of motor dysfunction is characterized by "disturbance in posturalbalance and coordination of muscle activity; usually generalized but may beconfined to one side of body or one extremity."Dyskinetic (includes Athetosis, Dystonia, Chorea, and Ballismus):Dyskinetia, or involuntary movements, may be of four types—athetosis, dystonia,chorea, and ballism
DIAGNOSTIC ELEMENT REASON FOR THE 2015 REVISION The 2015 version of the Diagnostic Element of the CDER manual was updated to reflect the changes needed at the developmental centers. The changes which were implemented in 2014 and 2011 (at the regional centers) will now be implemented at the developmental centers. The diagnostic codes to be entered
Generalized coordiDate finite element lDodels ·11 17 'c. IT,I .f: 20 IS a) compatible element mesh; 2 constant stress a 1000 N/cm in each element. YY b) incompatible element mesh; node 17 belongs to element 4, nodes 19 and 20 belong to element 5, and node 18 belongs to element 6. F
bliss element glass tile anatolia tile stone anatoliatile.com bliss - element glass tile 01 3" x 9" element ice beveled glass tile 38-018 3" x 12" element ice glass tile 38-000 3" x 12" element ice artisan glass tile 38-010 1.5" x 6" element ice stacked glass mosaics 35-114 element ice chevron glass mosaics 35-122
Development Workshop Presenter and Facilitator Biographies . Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA) Karen Bengtson is a Senior Regulatory Health Project Manager in the Office of Research and Standards (ORS), Office of . industry for 14 years
For questions regarding this draft document contact Robert Temple at 301-796-2270 or Robert O’Neill at 301-796-1700 (CDER), or the Office of Communication, Outreach, and Development (CBER) at 301-800-835-4709 or 301-827-1800. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
Featured FDA Speakers, Panelists & Moderators RICHARD A. MOSCICKI, M.D. Deputy Center Director for Science Operations, Center for Drug Evaluation and Research (CDER), FDA ROBERT TEMPLE, M.D. Deputy Center Director for Clinical Science, Center for Drug Evaluation and Research (CDER), FDA PETER MARKS, M.D., Ph.D.
John Scott (FDA/CBER) Short Course Subcommittee Chris Holland (Amgen) Telba Irony (FDA/CDRH) Bret Musser (Merck) Mark Levenson (FDA/CDER) Camille Orman (Janssen) Yue Shentu (Merck) Yuqing Tang (FDA/CDRH) Roundtable Luncheon Subcommittee Freda Cooner (FDA/CDER) Rakhi Kilaru (PPD) Inna Perevozs
Dec 19, 2012 · CDER Inspection Site Selection Tool . Objectives: – – – – – Develop a tool to support prioritization of clinical trial sites for inspection. Define a multi-decision approach to score clinical site/investigator based on risk-based multi-attribute algorithm. Goals: Develop a more consistent, science- based approach to selection of .
Waves API 550 User Manual - 3 - 1.2 Product Overview . The Waves API 550 consists of the API 550A, a 3-Band parametric equalizer with 5 fixed cutoff points per band and the API 550B, a 4-Band parametric equalizer with 7 fixed cutoff points per band. Modeled on the late 1960’s legend, the API 550A EQ delivers a sound that has been a hallmark of high end studios for decades. It provides .
