Facility Staff Medical Record Abstraction

Attachment 6a

Medical History Form

OMB NO: 0920-0740

EXPIRATION DATE: 06/30/2010

Medical Monitoring Project (MMP)

Medical Record Abstraction Form

2008 Medical History Form (MHF)

VERSION 3.0.0

Public reporting burden of this collection of information is estimated to average 3 minutes per patient record pulled, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: CDC, Project Clearance Officer, 1600 Clifton Road, MS D-24, Atlanta, GA 30333, ATTN: PRA (0920-0740). Do not send the completed form to this address.

O PTIONAL- FOR LOCAL USE ONLY

M MP MHF v3.0.0

Abstraction

MMP Participant ID: Facility ID:

(ID of the facility where abstraction is being conducted)

Medical record number:

Patient name:

Patient residence:

Street:

City/County: State:

ZIP code:

Physician name:

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control & Prevention

M edical Monitoring Project (MMP)

Medical Record Abstraction Form

2008 Medical History Form (MHF) v3.0.0

I. ABSTRACTION AND IDENTIFICATION
MMP Participant ID:
Surveillance Period (SP) SP start date: (12 months prior to date of interview OR 1st contact attempt if no interview obtained)	SP end date: (date of interview OR 1st contact attempt if no interview obtained)
Medical History Period (MHP) MHP start date: (date of first HIV care (at any facility) documented in this medical record) First visit to this facility: (date of first available visit to this facility for HIV care) MHP end date: (day before the SP start date) OR No documented care in medical records prior to SP start date Complete sections I, II, and IX (documentation of the first positive HIV test result)
Abstraction Facility ID: (ID of the facility where abstraction is being conducted)		For the medical history period Abstract information on all HIV care documented in the medical records at the “Abstraction Facility” using a single MHF regardless of where the care was actually provided to the patient.
Date of abstraction: Abstractor ID: Mo. Day Year
II. PATIENT DEMOGRAPHICS
Date of birth: Date not documented Mo. Day Year If date of birth is not documented, enter documented age: Enter date of this documented age: Date not documented Mo. Year Age not documented
Most recent height (ft/in) prior to the SP start date: Enter date of this documented height: Date not documented ft. inches Height not documented
Sex at birth: Male Not documented (select one) Female
Gender: Male Male to female Not documented (select one) Female Female to male

II. PATIENT DEMOGRAPHICS cont’d
Hispanic or Latino ethnicity: Yes, Hispanic or Latino Not documented (select one) No, not Hispanic or Latino
Race: 1 Asian (select all that are documented) 2 American Indian or Alaska Native 3 Black or African American 4 Native Hawaiian or Pacific Islander 5 White 6 Other, Specify:­­­­ 7 Other, Specify:­­­­ 8 Other, Specify:­­­­ 9 Not documented
Country of birth: 1 United States (select one) 2 US Dependencies/Possessions (including Puerto Rico) 3 Other, Specify:­­­­ 4 Not documented
III. MEDICAL HISTORY FORM SECTIONS - OPTIONAL
Is there documentation of any of the following prior to the SP start date? Yes Select all that are documented below. No This form is now complete except for optional section XIII (Remarks).
Diagnosis of AIDS defining opportunistic illnesses (AIDS OI) Complete section IV.	First positive HIV test result, or laboratory test results for CD4 cell count, HIV viral load, or abnormal ALT (SGPT) or AST (SGOT) Complete section IX.
Prescription for prophylaxis of Pneumocystis jiroveci pneumonia (PCP) or Mycobacterium avium complex (MAC) Complete section V.	Testing for HIV ART resistance Complete section X.
Screening for hepatitis (A, B, or C), Toxoplasma, or tuberculosis (TB) Complete section VI.	Reported or suspected substance abuse, including substance abuse counseling or treatment Complete section XI.
Whether or not hepatitis A, B, A and B, or pneumococcal immunizations were given Complete section VII.	Diagnosis of anxiety, bipolar disorder, psychosis, or depression Complete section XII.
Prescription of antiretroviral therapy (ART) Complete section VIII.
IV. AIDS DEFINING OPPORTUNISTIC ILLNESSES (AIDS OI)
Is there documentation that any AIDS defining opportunistic illnesses (AIDS OI) were diagnosed prior to the SP start date? Yes Enter all that are documented below. No
AIDS defining opportunistic illnesses (AIDS OI) prior to the SP start date (select all that are documented and record dates)		Date of first diagnosis	Date not documented
1 Candidiasis, bronchi, trachea, or lungs			1
2 Candidiasis, esophageal			2
3 Carcinoma, invasive cervical			3
4 Coccidioidomycosis, disseminated or extrapulmonary			4
5 Cryptococcosis, extrapulmonary			5

IV. AIDS DEFINING OPPORTUNISTIC ILLNESSES (AIDS OI) cont’d
AIDS defining opportunistic illnesses (AIDS OI) prior to the SP start date (select all that are documented and record dates)		Date of first diagnosis	Date not documented
6 Cryptosporidiosis, chronic intestinal (>1 month duration)			6
7 Cytomegalovirus disease (other than in liver, spleen, or nodes)			7
8 Cytomegalovirus retinitis (with loss of vision)			8
9 HIV encephalopathy			9
10 Herpes simplex: chronic ulcer (>1 month duration) or bronchitis, pneumonitis, or esophagitis			10
11 Histoplasmosis, disseminated or extrapulmonary			11
12 Isosporiasis, chronic intestinal (>1 month duration)			12
13 Kaposi’s sarcoma			13
14 Lymphoma, Burkitt’s (or equivalent term)			14
15 Lymphoma, immunoblastic (IBL, or equivalent term)			15
16 Lymphoma, primary in brain			16
17 Mycobacterium avium complex or M. kansasii, disseminated or Extrapulmonary			17
18 M. tuberculosis, pulmonary			18
19 M. tuberculosis, disseminated or extrapulmonary			19
20 Mycobacterium, of other species or unidentified species, disseminated or extrapulmonary			20
21 Pneumocystis jiroveci pneumonia (PCP)			21
22 Pneumonia, recurrent in 12 month period			22
23 Progressive multifocal leukoencephalopathy (PML)			23
24 Salmonella septicemia, recurrent			24
25 Toxoplasmosis of brain			25
26 Wasting syndrome due to HIV			26
V. PROPHYLAXIS
Is there documentation of prescription for prophylaxis of Pneumocystis jiroveci pneumonia (PCP) prior to the SP start date? Yes No Prescription must be for PCP prophylaxis. Medications include: Bactrim® (Septra, Cotrim, Co-trimoxazole, trimethorprim, sulfamethoxazole) Dapsone® Pentamidine® (pentamidine isothianate) Mepron® or Mepron® Suspension (atovaquone) Clindamycin® (clindamycin hydrochloride) + Primaquine® (primaquine phosphate) Dapsone® + Daraprim® (pyrimethamine) + Folinic Acid	Is there documentation of prescription for prophylaxis of Mycobacterium avium complex (MAC) prior to the SP start date? Yes No Prescription must be for MAC prophylaxis. Medications include: Biaxin Filmtab® (clarithromycin) Biaxin Granules® Biaxin XL® Zithromax® Zithromax Single Pack® (azithromycin, azithromycin dihydrate) Mycobutin® (rifabutin)

VI. HEPATITIS, TOXOPLASMA, AND TUBERCULOSIS (TB) SCREENING
Is there documentation of screening for hepatitis A, B, C, Toxoplasma, or tuberculosis (TB) prior to the SP start date? Yes Enter all that are documented for each screening below. No
Was hepatitis A screening performed prior to the SP start date? (select one) 1 Yes – screening done Enter all that are documented for “Yes” below 2 No – documented that screening not done 3 Hepatitis A screening not documented
If “Yes,” what were the results? Select all that apply OR result not documented
Positive	Date of 1st positive test: Date not documented		Which Hepatitis A test(s) was/were positive on this date? (select all that apply) Anti HAV IgG or HAV Ab IgG Anti HAV total or HAV Ab total Anti-HAV IgM or HAV Ab IgM Test type not documented
Negative	Date of last negative test: Date not documented
Result not documented
Was hepatitis B screening performed prior to the SP start date? (select one) 1 Yes – screening done Enter all that are documented for “Yes” below 2 No – documented that screening not done 3 Hepatitis B screening not documented
If “Yes,” what were the results? Select all that apply OR result not documented
Positive	Date of 1st positive test: Date not documented		Which Hepatitis B test(s) was/were positive on this date? (select all that apply) Anti HBc IgG Anti HBs IgG or HBsAb IgG Anti HBc IgM Anti HBs or HBsAb total Anti HBc total HBsAg Test type not documented
Negative	Date of last negative test: Date not documented
Result not documented
Was hepatitis C screening performed prior to the SP start date? (select one) 1 Yes – screening done Enter all that are documented for “Yes” below 2 No – documented that screening not done 3 Hepatitis C screening not documented
If “Yes,” what were the results? Select all that apply OR result not documented
Positive		Date of 1st positive test: Date not documented		Which Hepatitis C test(s) was/were positive on this date? (select all that apply) Anti HCV (EIA or RIBA) HCV RNA quantitative (PCR) HCV RNA qualitative Test type not documented
Negative		Date of last negative test: Date not documented
Result not documented

VI. HEPATITIS, TOXOPLASMA, AND TUBERCULOSIS (TB) SCREENING cont’d
Was Toxoplasma screening performed prior to the SP start date? (select one) 1 Yes – screening done Enter all that are documented below. 2 No – documented that screening not done 3 Toxoplasma screening not documented Was there a positive result for the most recent Toxoplasma antibody titer prior to the SP start date? (select one) 1 Yes Enter date of positive result: Date not documented 2 No (negative result for most recent test) 3 Result not documented
Was screening for tuberculosis (TB) performed prior to the SP start date? (select one) 1 Yes – screening done Enter all that are documented below. 2 No – documented that screening not done 3 TB screening not documented Date of the most recent tuberculin skin test (TST/PPD/Mantoux) or QuantiFERON test (QFT) prior to the SP start date: Date not documented Result of the most recent TST/PPD/Mantoux or QFT prior to the SP start date: (enter one for TST/PPD/Mantoux OR one for QFT)
TST/PPD/Mantoux: (enter OR select one) Result in millimeters: 1 Positive, no value reported 2 Negative, no value reported 3 Not read 4 Anergic 5 Not documented					OR	QFT: (select one) 1 QFT positive 2 QFT negative 3 QFT indeterminate 4 Not documented
VII. HEPATITIS AND PNEUMOCOCCAL IMMUNIZATIONS
Is there documentation of whether or not hepatitis A, B, A and B, or pneumococcal immunizations were given prior to the SP start date? Yes Enter all that are documented for each vaccine below. No
Was hepatitis A vaccine (Havrix, Vaqta) given prior to the SP start date? (select one: Yes, No, or Not documented)
1 Yes		Enter a maximum of 3 documented doses and dates: Dose No. (If documented) Date						Date not documented
2 Yes – but number of doses not documented							_____
3 No – documented that vaccine not given
	Reason vaccine not given: (select one)						_____
		Prior vaccination		Patient declined
		Previously infected		Not documented
		Other, specify					_____
4 Hepatitis A vaccination not documented

VII. HEPATITIS AND PNEUMOCOCCAL IMMUNIZATIONS cont’d
Was hepatitis B vaccine (Energix B, Recombivax) given prior to the SP start date? (select one: Yes, No, or Not documented)
1 Yes		Enter a maximum of 4 documented doses and dates: Dose No. (If documented) Date				Date not documented
2 Yes – but number of doses not documented					_____
3 No – documented that vaccine not given
	Reason vaccine not given: (select one)				_____
		Prior vaccination		Patient declined
		Previously infected		Not documented
		Other, specify			_____
					_____
4 Hepatitis B vaccination not documented
Was combination hepatitis A and B vaccine (Twinrix) given prior to the SP start date? (select one: Yes, No, or Not documented)
1 Yes		Enter a maximum of 4 documented doses and dates: Dose No. (If documented) Date				Date not documented
2 Yes – but number of doses not documented					_____
3 No – documented that vaccine not given
	Reason vaccine not given: (select one)				_____
		Prior vaccination		Patient declined
		Previously infected		Not documented
		Other, specify			_____
					_____
4 Hepatitis A and B vaccination not documented
Was pneumococcal vaccine (Pneumovax 23, Pneu-Immune 23) given prior to the SP start date? (select one Yes, No, or Not documented)
1 Yes		Enter date of last dose given before the SP start date:			Mo. Year Date	Date not documented
2 No – documented that vaccine not given
	Reason vaccine not given: (select one)
		Prior vaccination		Patient declined
				Not documented
		Other, specify
3 Pneumococcal vaccination not documented

VIII. ANTIRETROVIRAL THERAPY (ART)
Is there documentation of prescription of antiretroviral therapy (ART) prior to the SP start date? Yes Enter all that that are documented below. No
Date of first prescribed antiretroviral medication: Date not documented Prescribed antiretroviral medications prior to the SP start date: (select all that are documented)
1 Abacavir (ABC, Ziagen)		9 Efavirenz (EFV, Sustiva)	17 Lopinavir/Ritonavir (LPV/RTV, Kaletra, Meltrex)	25 Tenofovir (TDF, Viread)
2 Amprenavir (APV, Agenerase)		10 Emtricitabine (FTC, Emtriva)	18 Maraviroc (MRC, Selzentry)	26 Tipranavir (TPV, Aptivus)
3 Atazanavir (ATV, Reyataz)		11 Enfuvirtide (ENF, T-20, Fuzeon)	19 Nelfinavir (NFV, Viracept)	27 Trizivir (ABC/3TC/AZT)
4 Atripla (EFV/FTC/TDF)		12 Epzicom (ABC/3TC)	20 Nevirapine (NVP, Viramune)	28 Truvada (FTC/TDF)
5 Combivir (AZT/3TC)		13 Etravirine (Intelence, ETR, formerly TMC125)	21 Raltegravir (RAL, Isentress, MK-0518)	29 Zalcitabine (ddC, Hivid)
6 Darunavir (DRV, TMC 114, Prezista)		14 Fosamprenavir (FPV, Lexiva)	22 Ritonavir (RTV, Norvir)	30 Zidovudine (AZT, Retrovir)
7 Delavirdine (DLV, Rescriptor)		15 Indinavir (IDV, Crixivan)	23 Saquinavir (SQV-HGC, Invirase, Fortovase)
8 Didanosine (ddl) Videx		16 Lamivudine (3TC, Epivir)	24 Stavudine (d4T, Zerit)
31 Other, Specify:
3 2 Other, Specify:
3 3 Other, Specify:
3 4 Other, Specify:
IX. LABORATORY TEST RESULTS
Is there documentation of the first positive HIV test result, or laboratory test results for CD4 cell count, or HIV viral load, prior to the SP start date? Yes Enter all that are documented for each diagnosis or test below. No
Is there documentation of the first positive HIV test result? Yes Enter date of first positive HIV test: Date not documented
No
Is there documentation of CD4 cell count test results prior to the SP start date? Yes Lowest CD4 cell count: / µl or mm3
No	Date of lowest CD4 cell count: Date not documented
Is there documentation of HIV viral load (VL) test results prior to the SP start date? Yes Is there documentation of an undetectable VL?
No	Yes Enter date of most recent undetectable result: Date not No documented

X. HIV ART RESISTANCE TESTING
Is there documentation of HIV ART resistance testing prior to the SP start date? Yes Select all that are documented for each resistance test below. No
Was genotypic ART resistance testing performed prior to the SP start date? (Select one: Yes, No, or Testing not documented)
	Select all ART classes documented with resistance and/or possible resistance:
1 Yes – resistance reported	FI PI NRTI NNRTI ART classes not specified
2 Yes – possible resistance reported	FI PI NRTI NNRTI ART classes not specified
3 Yes – but no resistance reported
4 Yes – but result was indeterminate
5 Yes – but test result not documented
6 No – documented that genotypic resistance testing was not done
7 Genotypic resistance testing not documented
Was phenotypic ART resistance testing performed prior to the SP start date? (Select one: Yes, No, or Testing not documented)
	Select all ART classes documented with resistance and/or intermediate resistance:
1 Yes – resistance reported	FI PI NRTI NNRTI ART classes not specified
2 Yes – intermediate resistance reported	FI PI NRTI NNRTI ART classes not specified
3 Yes – but no resistance reported
4 Yes – but result was indeterminate
5 Yes – but test result not documented
6 No – documented that phenotypic resistance testing was not done
7 Phenotypic resistance testing not documented
Was virtual phenotypic ART resistance testing performed prior to the SP start date? (Select one: Yes, No, or Testing not documented)
		Select all ART classes documented with resistance and/or possible / intermediate resistance reported:
1 Yes – resistance reported		FI PI NRTI NNRTI ART classes not specified
2 Yes – possible/intermediate resistance reported		FI PI NRTI NNRTI ART classes not specified
3 Yes – but no resistance reported
4 Yes – but result was indeterminate
5 Yes – but test result not documented
6 No – documented that virtual phenotypic resistance testing was not done
7 Virtual phenotypic resistance testing not documented
XI. SUBSTANCE ABUSE
Is there documentation of reported or suspected alcohol abuse or other non-prescribed use of substances, including counseling or treatment for alcohol and/or substance use/abuse prior to the SP? Yes Enter all that are documented below. No
Alcohol Abuse
Is there documentation of alcohol abuse prior to the SP? Yes No
Other Non-prescribed Use of Substances
Is there evidence of any injection substance use (e.g., track marks) documented prior to the SP? Yes No

XI. SUBSTANCE ABUSE cont’d
Non-prescribed use of substances documented prior to the SP: (select all that are documented and type of use)
Substance				Type of Use (select all that apply OR select Not documented)
				Injection		Non-Injection		Not documented
1 Amphetamines (other than methamphetamines)
2 Cocaine (other than crack)
3 Crack cocaine
4 Ecstasy (MDMA, X)
5 GHB
6 Hallucinogens such as LSD or mushrooms
7 Heroin
8 Ketamine (Special K)
9 Marijuana
10 Methadone
11 Methamphetamines
12 Painkillers such as Oxycontin, Vicodin or Percocet
13 Poppers (amyl nitrate)
14 Rohypnol
15 Steroids/Hormones
16 Tranquilizers such as Valium, Ativan, or Xanax
17 Viagra, Levitra or Cialis
1 8 Other, Specify:
1 9 Other, Specify:
2 0 Other, Specify:
21 Substance not specified
XII. MENTAL HEALTH
Is there documentation of any of the following mental illnesses prior to the SP start date? Yes Select all that are documented below. No
1	Anxiety disorder (General anxiety disorder, GAD)	3	Depression (Major depression, depressive disorder)
2	Bipolar disorder	4	Psychosis

O PTIONAL- FOR LOCAL USE ONLY

MMP MHF v3.0.0

Abstraction

MMP Participant ID: Facility ID:

(ID of the facility where abstraction is being conducted)

XIII. REMARKS

Page 20 of 20

OMB 0920-0740 – Medical History Form - 6/2010