3c - MMP Surveillance Visit Form

Attachment 3c

Medical Monitoring Project (MMP) Formative Research

Medical Record Abstraction Form

2013 Surveillance Period Visit Form (SPVF)

VERSION 7.1.0

O PTIONAL- FOR LOCAL USE ONLY

M MP SPVF v7.1.0

Abstraction

MMP Participant ID: Facility ID:

(ID of the facility where abstraction is being conducted)

Date of Visit: Date not documented

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

2013 Surveillance Period Visit Form (SPVF) v7.1.0

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)
Date of abstraction: Abstractor ID:
Date of visit:				This visit for laboratory tests only Complete Sections I, X, and XI
Abstraction Facility ID: (ID of the facility where abstraction is being conducted)
Was the documented care abstracted with this form given at another facility (i.e., outside the Abstraction Facility)?
		Yes Complete information about the “Care” Facility				Enter Care Facility ID or indicate that Care Facility was not documented or was outside jurisdiction: Care Facility ID (ID of the facility where the documented care was provided)
		No Continue to Section II below				Care Facility not documented or outside jurisdiction
II. PATIENT WEIGHT
Weight during this visit (lbs): lbs. Weight not documented
III. SURVEILLANCE PERIOD VISIT FORM SECTIONS - OPTIONAL
Is there documentation of any of the following during this visit? Yes Select all that are documented below. No This form is now complete except for optional section XII (Remarks).
New or existing diagnoses of AIDS defining opportunistic illnesses (AIDS OI) Complete section IV.					Prescription or continuation of antiretroviral therapy (ART) Complete section VIII.
New or existing diagnoses of conditions other than AIDS OI Complete section V.					Prescription or continuation of medications other than ART Complete section IX.
Prescription for prophylaxis of Pneumocystis jiroveci pneumonia (PCP) or Mycobacterium avium complex (MAC) Complete section VI.					Frequently repeated laboratory tests Select this box, and complete section X on visit form for the date the specimen was collected.
Sexually transmitted infections (STIs) Complete section VII.					Other laboratory tests, including HIV ART resistance tests Select this box, and complete section XI on visit form for date the specimen was collected.

IV. AIDS DEFINING OPPORTUNISTIC ILLNESSES (AIDS OI)
Is there documentation of any new or existing diagnoses of AIDS defining opportunistic illnesses (AIDS OI) during this visit? Yes Select all that are documented below. No
1	Candidiasis, bronchi, trachea, or lungs
2	Candidiasis, esophageal
3	Carcinoma, invasive cervical
4	Coccidioidomycosis, disseminated or extrapulmonary
5	Cryptococcosis, extrapulmonary
6	Cryptosporidiosis, chronic intestinal (>1 month duration)
7	Cytomegalovirus disease (other than in liver, spleen, or lymph nodes)
8	Cytomegalovirus retinitis (with loss of vision)
9	Herpes simplex: chronic ulcer (>1 month duration) or bronchitis, pneumonitis, or esophagitis
10	HIV encephalopathy
11	Histoplasmosis, disseminated or extrapulmonary
12	Isosporiasis, chronic intestinal (>1 month duration)
13	Kaposi’s sarcoma
14	Lymphoma, Burkitt’s (or equivalent term)
15	Lymphoma, immunoblastic (or equivalent term, IBL)
16	Lymphoma (primary in brain)
17	Mycobacterium avium complex or M. kansasii, disseminated or extrapulmonary
18	M. tuberculosis, pulmonary
19	M. tuberculosis, disseminated or extrapulmonary
20	Mycobacterium, of other species or unidentified species, disseminated or extrapulmonary
21	Pneumocystis jiroveci pneumonia (PCP)
22	Pneumonia, recurrent in 12 month period
23	Progressive multifocal leukoencephalopathy (PML)
24	Salmonella septicemia, recurrent
25	Toxoplasmosis of brain
26	Wasting syndrome due to HIV

V. CONDITIONS OTHER THAN AIDS OI
Is there documentation of any new or existing diagnoses of conditions other than AIDS OI during this visit? Yes Select all that are documented below. No
1 Abscess	19 Erythema multiforme		37 Hypogonadism (gonadal deficiency)	55 Prostatitis
2 Alcoholism	20 Erythroderma		38 Hypothyroidism	56 Psoriasis
3 Anxiety disorder	21 Fatty liver		39 Ischemic heart disease	57 Psychosis, including schizophrenia
4 Arthritis (osteoarthritis)	22 Fever, unexplained, >100F for 2+ weeks*		40 Lactic acidosis	58 Pulmonary hypertension
5 Asthma	23 Gastroesophageal reflux disease (GERD)		41 Lipoatrophy	59 Rash, drug-related
6 Avascular necrosis	24 Guillain-Barré syndrome		42 Lipodystrophy	60 Renal failure
7 Buffalo hump	25 Hearing loss, acquired		43 Malignancy	61 Respiratory infection, upper
8 Bronchitis	26 Hepatic (liver) failure		44 Metabolic syndrome	62 Respiratory infection, NOS
9 Cardiomyopathy, due to HIV or unknown cause	27 Hepatitis, alcohol-induced		45 Myelopathy (spinal cord disease/disorder)	63 Seborrheic dermatitis
10 Cellulitis (skin infection, bacterial)	28 Hepatitis, drug-induced		46 Myopathy (muscular weakness or changes)	64 Stevens-Johnson Syndrome
11 Depression, diagnosed by physician	29 Hepatitis, infectious, not drug-induced		47 Nephrolithiasis (kidney stone)	65 Stroke, ischemic, non- hemorrhagic
12 Diabetes mellitus (DM), type 1	30 Hepatitis, NOS		48 Nephropathy (kidney damage)	66 Suicide attempt
13 Diabetes mellitus (DM), type 2	31 Hodgkin’s lymphoma (Hodgkin’s disease)		49 Neuropathy, cranial	67 Thrombocytopenia, idiopathic (ITP)
14 Diabetes mellitus (DM), NOS	32 Human papillomavirus (HPV) infection		50 Neuropathy, peripheral	68 Vision loss, moderate or severe; blindness
15 Diarrhea, allergic/colitis	33 Hypercholesterolemia		51 Neuropathy, NOS	69 Warts, anal or genital
16 Diarrhea, infectious	34 Hyperglycemia		52 Oral candidiasis (thrush)	70 Warts, non-anal, non- genital
17 Diarrhea, NOS	35 Hypertension (high blood pressure)		53 Osteopenia or osteoporosis	*in absence of a known cause
18 Erectile dysfunction	36 Hypertriglyceridemia		54 Pneumonia
71 Other, specify:
72 Other, specify:
73 Other, specify:
74 Other, specify:
75 Other, specify:
76 Other, specify:
77 Other, specify:
VI. PROPHYLAXIS
Is there documentation of prescription for prophylaxis of Pneumocystis jiroveci pneumonia (PCP) during this visit? 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) during this visit? 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)

VII. SEXUALLY TRANSMITTED INFECTIONS (STIs)
Is there documentation of any new or existing diagnoses* of sexually transmitted infections during this visit? Yes Select all that are documented below. No
1 Cervicitis	5 Lymphogranuloma venereum (LGV)		9 Syphilis, NOS		13 STI not specified
2 Chancroid	6 Pelvic inflammatory disease (PID)		10 Urethritis, gonoccocal		*For this section, abstract only the medical provider’s explicit documentation of any of these conditions as a clinical diagnosis.
3 Epididymitis	7 Proctitis / proctocolitis		11 Urethritis, non-gonococcal (non-gonococcal urethritis, NGU)
4 Genital Herpes	8 Syphilis, primary or secondary		12 Urethritis, NOS
14 Other, specify:
15 Other, specify:
16 Other, specify:
17 Other, specify:
VIII. ANTIRETROVIRAL THERAPY (ART)
Is there documentation of prescription or continuation of antiretroviral therapy (ART) during this visit? Yes Select all that are documented below. No
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 (ETR, Intelence, formerly TMC125)		21 Raltegravir (RAL, Isentress, formerly 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:
32 Other, Specify:
33 Other, Specify:
34 Other, Specify:

IX. OTHER MEDICATIONS
Is there documentation of prescription or continuation of medications other than ART during this visit? Yes Select all that are documented below. No
1	acarbose	48	esomeprazole
2	acetominophen/hydrocodone	49	ethambutol
3	acetominophen/oxycodone	50	ethionamide
4	acyclovir	51	famotidine
5	adefovir	52	fexofenadine
6	albuterol	53	filgrastim
7	albuterol/ipratropium	54	folinic acid
8	aldesleukin	55	fluconazole
9	alprazolam	56	fludrocortisone
10	amikacin	57	fluoxetine
11	amitriptyline	58	fluphenazine
12	amitriptyline/chlordiazepoxide	59	fluticasone
13	amoxicillin	60	fluticasone/salmeterol
14	amoxicillin/clavulanate	61	fluvastatin
15	aspirin (ASA)	62	foscarnet
16	atenolol	63	gabapentin
17	atorvastatin	64	gatifloxacin
18	azithromycin	65	gemfibrozil
19	baclofen	66	hydrochlorothiazide (HCTZ)
20	bupropion	67	hydrochlorothiazide (HCTZ)/methyldopa
21	buspirone	68	hydrochlorothiazide (HCTZ)/metoprolol
22	butalbital/aspirin	69	hydrochlorothiazide (HCTZ)/triamterene
23	butalbital/aspirin/caffeine (BAC)	70	imiquimod
24	calcitrol	71	insulin (inhaled or injectable)
25	capreomycin	72	interferon alphacon-1
26	cetirizine	73	interferon alfa 2a
27	chlorpropamide	74	interferon alfa 2b
28	cimetidine	75	iodoquinol
29	ciprofloxacin	76	isoniazid (INH)
30	citalopram	77	isoniazid (INH)/pyrazinamide (PZA)/rifampin
31	clonazepam	78	isoniazid (INH)/rifampin
32	cromolyn	79	kanamycin
33	cycloserine	80	lansoprazole
34	cyclosporine	81	lansoprazole/amoxicillin/clarithromycin
35	dapsone (DDS)	82	levofloxacin
36	darifenacin	83	levothyroxine
37	dexamethasone	84	lisinopril
38	diphenhydramine	85	lithium
39	doxorubicin	86	loxapine
40	doxorubicin lipsomal	87	megestrol
41	doxycycline	88	metformin
42	dronabinol	89	methadone
43	enalapril	90	metoclopramide
44	enalapril/hydrochlorothiazide (HCTZ)	91	metoprolol
45	entecavir	92	mirtazapine
46	epoetin alfa (EPO)	93	moxifloxacin
47	escitalopram	94	nalbuphine

IX. OTHER MEDICATIONS cont’d
95	niacin						121	rifampin
96	nifedipine						122	rifapentine
97	nizatidine						123	rosiglitazone
98	octreotide						124	rosiglitazone/glemepiride
99	olanzapine						125	rosuvastatin
100	omeprazole						126	sertraline
101	oxycodone						127	sildenafil
102	p-aminosalicylate						128	somatropin
103	palonosetron						129	streptomycin
104	pantoprazole						130	tadalafil
105	paroxetine						131	tamsulosin
106	peginterferon alfa 2a						132	telbivudine
107	peginterferon alfa 2b						133	testosterone
108	penicillin						134	tinidazole
109	phenytoin						135	trazadone
110	pioglitazone						136	triamcinolone nasal
111	podofilox topical						137	trichloracetic acid (TCA) topical
112	podophyllin topical						138	trimethoprim/sulfamethoxazole (TMP/SMZ)
113	pravastatin						139	valacyclovir
114	prednisone						140	valproic acid
115	propranolol						141	vancomycin
116	propranolol/hydrochlorothiazide (HCTZ)						142	vardenafil
117	pyrazinamide (PZA)						143	venlafaxine
118	ranitidine						144	warfarin
119	ribavirin						145	zanamivir
120	rifabutin						146	zolpidem
1 47 Other, Specify:
1 48 Other, Specify:
1 49 Other, Specify:
1 50 Other, Specify:
1 51 Other, Specify:
X. LABORATORY TESTING – FREQUENTLY REPEATED TESTS
Is there documentation of any of the following frequently repeated laboratory tests done at this visit? Yes Enter all that are documented below on the visit form for the date the specimen was collected. No
CD4 & HIV Viral Load
		Pos(+)	Neg(-)	Indeterminate	Undetectable	Value			Units (select one, where applicable)
1 CD4 cell count									Cells/ mm3 or µL Other, specify: __________________________	Units not documented
2 CD4 cell %									%	Units not documented
3 HIV viral load									Copies/mL Other, specify: __________________________	Units not documented
		Lower Limit of Detection for HIV Viral Load Test Used: Lower Limit NOT documented

X. LABORATORY TESTING – FREQUENTLY REPEATED TESTS cont’d
glucose regulation tests
	Pos(+)	Neg(-)	Indeterminate	Undetectable	Value	Units (select one, where applicable)
4 FBG (FBS, Fasting blood glucose)						mg/dL Other, specify: __________________________	Units not documented
5 Hemoglobin A1c (HbA1c)						%
hematology Tests
	Pos(+)	Neg(-)	Indeterminate	Undetectable	Value	Units (select one, where applicable)
6 WBC (White blood cell Or Leukocyte count)						Thousands/ mm3 or µL (x103 / mm3 or µL) Other, specify: __________________________	Units not documented
7 RBC (Red blood cell Or Erythrocyte count)						Millions/ mm3 or µL (x106 / mm3 or µL) Other, specify: __________________________	Units not documented
8 Hemoglobin (Hgb, Hb)						g/dL Other, specify: __________________________	Units not documented
9 Platelet count (PLT, Thrombocyte count)						Thousands/ mm3 or µL (x103 / mm3 or µL) Other, specify: __________________________	Units not documented
lipid levels
	Pos(+)	Neg(-)	Indeterminate	Undetectable	Value	Units (select one, where applicable)
10 Cholesterol, HDL (HDL-C)						mg/dL Other, specify: __________________________	Units not documented
11 Cholesterol, LDL (LDL-C)						mg/dL Other, specify: __________________________	Units not documented
12 Cholesterol, Total						mg/dL Other, specify: __________________________	Units not documented
13 Triglycerides (TG, TRIG)						mg/dL Other, specify: __________________________	Units not documented
Liver function tests (LFTs)
	Pos(+)	Neg(-)	Indeterminate	Undetectable	Value	Units (select one, where applicable)
14 Albumin (ALB)						g/dL Other, specify: __________________________	Units not documented
15 ALT (SGPT)						Units /L Other, specify: __________________________	Units not documented
16 AST (SGOT)						Units/L Other, specify: __________________________	Units not documented
17 Bilirubin, total						mg/dL Other, specify: __________________________	Units not documented
Renal function Tests
	Pos(+)	Neg(-)	Indeterminate	Undetectable	Value	Units (select one, where applicable)
18 Creatinine (Creat, Cr)						mg/dL Other, specify: __________________________	Units not documented
19 Urine protein, dipstick						mg/dL Other, specify: __________________________	Units not documented
XI. LABORATORY TESTING – OTHER TESTS
Is there documentation of any of the following other laboratory tests done at this visit? Yes Enter all that are documented below on the visit form for the date the specimen was collected. No
CHEMISTRY Tests
	Pos(+)	Neg(-)	Indeterminate	Undetectable	Value	Units (select one, where applicable)
20 Urine protein, 24 hour						mg/24 hours Other, specify: __________________________	Units not documented
21 Urinary hCG (Urine pregnancy test, UPT)

XI. LABORATORY TESTING – OTHER TESTS cont’d

INFECTIOUS DISEASE TESTS: Hepatitis A, B, C

Pos(+)

Neg(-)

Indeterminate

Undetectable

Value

Units (select one, where applicable)

22 Anti-HAV IgG (HAV Ab IgG)

23 Anti-HAV IgM (HAV Ab IgM)

24 Anti-HAV total (HAV Ab total)

25 Anti-HBc IgG (HBc Ab IgG)

26 Anti-HBc IgM (HBc Ab IgM)

27 Anti-HBc total (HBc Ab total)

28 Anti-HBe (HBe Ab)

29 Anti-HBs IgG (HBs IgG Ab)

30 Anti-HBs total (HBs Ab)

31 HBeAg (Hepatitis B e-antigen)

32 HBsAg (Hepatitis B surface antigen)

33 HBV DNA (PCR)

IU/mL Other, specify: _________________________

Units not documented

Lower Limit of Detection for HBV DNA (PCR) Test Used: Lower Limit NOT documented

Pos(+)

Neg(-)

Indeterminate

Undetectable

Value

Units (select one, where applicable)

34 Anti-HCV, EIA, or RIBA

35 HCV genotype

36 HCV RNA qualitative

37 HCV RNA quantitative (PCR)

IU/mL Other, specify: ________________________

Units not documented

Lower Limit of Detection for HCV RNA (PCR) Test Used: Lower Limit of Detection NOT documented

INFECTIOUS DISEASE TESTS: Human Papillomavirus (HPV), Syphilis, Toxoplasma

Pos(+)

Neg(-)

Indeterminate

Undetectable

Value

Units (select one, where applicable)

38 HPV DNA (PCR)

IU/mL Other, specify: ________________________

Units not documented

Lower Limit of Detection for HPV DNA (PCR) Test Used: Lower Limit of Detection NOT documented

39 Dark field microscopy (Immunofluorescent stain for T. pallidum / syphilis)

40 FTA-ABS (FTA, Treponemal syphilis test)

41 RPR (Non-treponemal syphilis test)

titer

42 TPHA (TP-PA, MHA-TP, Treponemal syphilis test)

43 VDRL (Non-treponemal syphilis test)

titer

44 Anti-Toxoplasma IgG

XI. LABORATORY TESTING – OTHER TESTS cont’d

INFECTIOUS DISEASE TESTS: Chlamydia, Gonorrhea, Trichomonas

45 Chlamydia Tests (CT, C. trachomatis tests)

Result

Site of Specimen Collection (select one for each test performed)

Pos(+)

Neg(-)

Indeterminate

Anorectal

Cervical

Lymph node

Ocular

Pharyngeal

Urethral (swab)

Urine

NOS

1

Culture

2

DFA*

3

EIA (ELISA)†

4

NAAT‡

5

Nucleic acid probe║

6

Test not specified

46 Gonorrhea Tests (GC, N. gonorrhoea tests)

Result

Site of Specimen Collection (select one for each test performed)

Pos(+)

Neg(-)

Indeterminate

Anorectal

Cervical

Lymph node

Ocular

Pharyngeal

Urethral (swab)

Urine

NOS

1

Culture

2

Gram stain

3

NAAT

4

Nucleic acid probe

5

Test not specified

47 Trichomonas Tests (T. vaginalis tests)

Result

Site of Specimen Collection (select one for each test performed)

Pos(+)

Neg(-)

Indeterminate

Anorectal

Cervical

Lymph node

Ocular

Pharyngeal

Urethral (swab)

Urine

NOS

1

Culture

2

EIA / other molecular assay

3

Wet mount

4

Test not specified

*DFA = Direct fluorescent antibody †EIA (ELISA) = Enzyme-linked immunoassay ‡NAAT = Nucleic acid amplification test (usually done on urine specimen, sometimes on cervical /urethral swabs) ║Nucleic acid probe – Also known as DNA probe assay, direct hybridization probe test

INFECTIOUS DISEASE TESTS: Drug Resistance

Pos(+)

Neg(-)

Indeterminate

Undetectable

Value

Units (select one, where applicable)

48 Resistance test for INH (TB drug)

49 Resistance test for Rifampicin (TB drug)

50 Genotypic ART resistance test (Select one below)

Select all ART classes documented with resistance and/or possible resistance:

1 Resistance reported

FI PI NRTI NNRTI ART classes not specified

2 Possible resistance reported

FI PI NRTI NNRTI ART classes not specified

3 No resistance reported

4 Indeterminate result

5 Test result not documented

6 Documented that genotypic resistance testing was not done

7 Genotypic resistance testing not documented

51 Phenotypic ART resistance test (Select one below)

Select all ART classes documented with resistance and/or intermediate resistance:

1 Resistance reported

FI PI NRTI NNRTI ART classes not specified

2 Intermediate resistance reported

FI PI NRTI NNRTI ART classes not specified

3 No resistance reported

4 Indeterminate result

5 Test result not documented

6 Documented that genotypic resistance testing was not done

7 Phenotypic resistance testing not documented

XI. LABORATORY TESTING – OTHER TESTS cont’d
52 Virtual phenotypic ART resistance test (Select one below)
		Select all ART classes documented with resistance and/or possible / intermediate resistance:
	1 Resistance reported	FI PI NRTI NNRTI ART classes not specified
	2 Possible/intermediate resistance reported	FI PI NRTI NNRTI ART classes not specified
	3 No resistance reported
	4 Indeterminate result
	5 Test result not documented
	6 Documented that genotypic resistance testing was not done
	7 Virtual phenotypic resistance testing not documented

OPTIONAL - FOR LOCAL USE ONLY

M MP SPVF v7.1.0

Abstraction

MMP Participant ID: Facility ID:

(ID of the facility where abstraction is being conducted)

Date of Visit:

XII. REMARKS

Page 19 of 19

OMB 0920-0740 - Surveillance Period Visit Form