150-03 Physical Examination, Diagnostic Tests and Preventive … · 2018-04-23 · FLORIDA STATE...

FLORIDA STATE HOSPITAL STATE OF FLORIDAOPERATING PROCEDURE DEPARTMENT OFNO. 150-3 CHILDREN AND FAMILIES

CHATTAHOOCHEE, February 7, 2017

Health

PHYSICAL EXAMINATION, DIAGNOSTIC TESTS AND PREVENTIVE MEDICAL CARE

1. Policy: As part of the required physical examination, laboratory tests and other clinical procedureswill be ordered when clinically indicated. Such tests and procedures, as well as subsequent periodicphysical examinations, shall be deemed to be updates of the original statutorily mandated base lineexamination and as such, to be an integral part of that physical examination.

2. Purpose:

a. To identify disease process that may be present or suspected to be present; and

b. To prevent spread of infectious diseases.

3. References:

a. Children and Families Operating Procedure 155-1, Guidelines for Psychiatric, Medical, andNursing Responsibilities with the Use of Psychotherapeutic Medications in State Mental HealthTreatment Facilities

b. Florida’s Mental Health Act, Florida Statute Chapter 394

c. Florida Senate, House Bill 321, HIV Testing, effective date of July 1, 2015

d. Recommendation of the Centers for Disease Control (CDC) Advisory Committee onImmunization Practices (ACIP), Morbidity and Mortality Weekly Report (MMWR) (see Attachment 1)

e. American Cancer society Guidelines for Early Detection of Cancer, American Cancer Society;Cancer Facts and Figures 2003, (see Attachment 2, American Cancer Society (ACS) Cancer DetectionGuidelines – Cancer-Related Check-up)

f. Joint National Committee on Prevention, Detection, Evaluation and Treatment of High BloodPressure VII Report (see Attachment 3)

g. E-Medicine Specialties, Diabetes 1 & 2, May, 2003 and July, 2003

h. National Cholesterol Education Program (NCEP) Guidelines

i. E-Medicine Specialties: Hypercholesterolemia and Hypertriglyceridemia (see Attachments 4and 5)

j. Diabetes--Medical Practice Guidelines, State of Florida Agency for Health Care Administration(see Attachment 6)

This Operating Procedure supersedes: Operating Procedure 150-3 dated December 23, 2016OFFICE OF PRIMARY RESPONSIBILITY: Clinical ServicesDISTRIBUTION: See Training Requirements Matrix

February 7, 2017 FSHOP 150-3

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4. General Information:

a. All findings/reports will be documented and filed in resident’s chart.

b. All forms related to physical/neurological examination will include date, time, stamp andsignature of the person completing the examination.

c. If the resident refuses any treatment, intervention or preventive care:

(1) If the delay of treatment has potential to seriously impair the resident’s health or life,a court order authorizing diagnostic testing and treatment should be obtained if appropriate.

(2) They should be periodically assessed by qualified clinicians as to the individual’smedical urgency and competency to consent/refuse.

(3) The reason for the individual’s refusal must be documented, as well as efforts ofperiodic assessment attempts and counseling. The Treatment Team should also document therapeuticinterventions taken, including, but not limited to, counseling and education efforts in order to obtaincompliance.

d. The physical examination will include the ordering of laboratory tests for analyses and reviewof systems to identify acute or chronic disease processes that will assist in establishing each resident’shealth care needs and treatment.

5. Admission Physical Examination: A Physical Examination includes a Neurological Examination andshall be completed within 24 hours following admission; and will be performed annually thereafter, on orbefore the anniversary date of the resident’s admission.

6. Diagnostic Tests: The following diagnostic tests and assessment will be done as part of theadmission and physical examination and may be repeated when clinically indicated (1 - 4 may beomitted if done within 30 days prior to admission by an approved lab provided copies of such laboratoryreports are made available to the admitting facility at the time of admission):

a. Complete Blood Count (CBC) and Platelet count.

b. Syphilis screening serology.

c. Comprehensive Metabolic Profile including TSH, cholesterol and lipid profile.

d. Urinalysis.

e. PPD (Mantoux)--2 steps for new admission; unless documented to have been done withaccompanying results.

f. Pregnancy test on women in their reproductive years (through age 55).

g. Pap smear and wet prep.--PAP smear may be omitted in the presence of documentednegative report within one (1) year and absence of clinical symptoms.

h. Chest X-ray--May be omitted if performed within 30 days prior to admission withdocumentation of a negative report. The hospital must receive a copy of the last report.

i. EKG--within seven (7) days of admission (earlier if indicated).


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j. Eye Exam (acuity--done in Eye Clinic).

k. Hearing Assessment and audiology referral if needed.

l. Hemoccult on residents over 50 years old.

m. HIV test if indicated, with pre & post-test counseling. (House Bill 321 “provides that aperson’s signature on a general consent form suffices as consent to an HIV test.”

n. Hepatitis panel in identified high risk individuals (B and C).

o. Immunizations--Routine diphtheria and tetanus (should be given every ten (10) years. Unlessthe hospital receives documentation of the date last given, this series will be given upon admission tothe hospital.) Immunizations will be administered by a licensed nurse and documented on theImmunization Record Form. If a resident is readmitted to Florida State Hospital, his/her immunizationrecord forms should be placed in his/her chart. See Florida State Hospital Form 13.

p. Breast examination: an initial breast examination will be performed by the primary physicianon admission and annually thereafter.

(1) Monthly self-breast examinations will be encouraged.

(2) For clinically incompetent female residents, a breast examination will be performedby a clinician every three (3) months at approximately the same time each month.

(3) All breast examinations will be documented.

(4) An admission mammogram will be performed on women age 40 and above, unlessphysically or medically contraindicated.

(5) A mammogram must be done as soon as possible when a breast examinationindicates any suspicion of breast pathology and/or when the resident is identified as high risk fordeveloping breast cancer.

q. Digital rectal examination of prostate on all males over 50 years of age, earlier if indicated.

r. PSA on all males over 50 years of age through 75 years.

s. Eye exam including intraocular pressure (if clinically indicated).

7. Health Education--Each unit will offer ongoing health education and counseling programs thataddress smoking cessation and tobacco use, diet, prevention of sexually transmitted diseases includingHIV/AIDS as relative to resident need, and monthly self breast examinations to women (as applicable).

8. The annual physical examination shall include:

a. Complete blood count (CBC) with platelet count.

b. Comprehensive Metabolic Profile including thyroid-stimulating hormone (TSH) if indicated,cholesterol and lipid profile.

c. Urinalysis.


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d. Pap Smear and wet prep--all women who have been sexually active or who have reachedage 18, should have an annual Pap smear and pelvic examination. After 3 consecutive normal annualpelvic and Pap smear examinations, the Pap smear may be performed less frequently at the discretionof her physician.

e. Chest X-ray (when clinically indicated).

f. EKG (when clinically indicated).

g. Visual Acuity and intraoccular pressure (IOP).

h. A review and documentation of the immunization status (which should include Tetanus andDiphtheria (Td) booster, hepatitis A and B, MMR (measles, mumps, and rubella), and pneumococcal).

i. Mammogram--annually after age 40, unless physically or medically contraindicated. Amammogram may be done earlier and as soon as a breast examination indicates any suspicion ofbreast pathology.

j. Syphilis serology screening.

k. Stools for occult blood X 3 on residents over 50 years old (refer to Cancer Guidelineattachment).

l. Digital rectal examination of prostate on all males over 50 years of age, earlier if indicated(refer to Cancer Guideline attachment).

m. Prostatic specific antigen (PSA) on all males over 50 years of age, (earlier if indicated)through 75 years (refer to Cancer Guideline attachment).

9. Other appropriate laboratory/clinical procedures/referrals should be performed when clinicallyindicated:

a. Individuals with possible HIV retinitis who are symptomatic and have CD4 count of <200should be considered for a referral to the ophthalmologist.

b. Residents with diabetes will be referred annually to the Ophthalmologist.

c. Individuals with diabetes mellitus will be referred to the Podiatrist for foot care when clinicallyindicated.

d. Individuals with obesity or hypercholesterolemia/hypertriglyceridemia will be referred toappropriate clinician including dietitian.

e. Individuals who are HIV positive will be referred to the Medical Screening Clinic/Appropriateclinician for further evaluation when clinically indicated.

f. Individuals with abnormal Viral Hepatitis test results will be referred to Internal Medicine Clinic.

g. Individuals with positive fluorescent treponemal antibody absorbed (FTA-ABS) test andpersistently elevated rapid plasma reagin (RPR) titer and who present symptoms suggestive ofneurosyphilis will be referred to the neurologist.


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10. Training Requirements: A check in the box below indicates which employees within the departmentare required to read this operating procedure and when they will receive training at Florida StateHospital. Employees within identified departments will also be required to review the policy each time itis updated.

DepartmentWorksite

Education

NewEmployeeOrientation

DisciplineSpecificTraining

AnnualUpdate

All EmployeesClericalDentalDieticians, Laboratory, SpecialTherapy, X-Ray Techs

X

Direct CareEmergency OperationsEnvironmental Services (Aramark)Financial ServicesFood ServicesHealth Information ServicesHuman ResourcesInformation SystemsLegalMaterials ManagementNursing XOperations & Facilities (Aramark)PharmacyPhysician/ARNP (Prescriber) XProfessional DevelopmentPsychologyQuality ImprovementRecovery PlanningRehab ServicesResident Advocacy/Risk Mgt.Social ServicesSupervisors/ManagersVolunteer ServicesOther:


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MARGUERITE J. MORGAN Attachments:Hospital Administrator 1. Recommended Adult Immunization Schedule

2. ACS Cancer Detection Guidelines – CancerRelated Checkup

3. Tables for Treatment of Hypertension4. Hypercholesterolemia5. Hypertriglyceridemia6. Diabetes Medical Practice Guidelines

SUMMARY OF REVISED, ADDED OR DELETED MATERIAL

Added Paragraph 9.f.


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Recommended Adult Immunization Schedule for Adults Aged 19

Years or Older, by Vaccine and Age Group1

United States, 2016

Compliant version of the schedule(https://www.cdc.gov/vaccines/schedules/hcp/imz/adult-compliant.html)

Print PDF document of this schedule

8.5"x11" print color[2 pages](https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-

schedule.pdf)

8.5"x11" print black and white[2

pages](https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-schedule-bw.pdf)

These recommendations must be read with the footnotes that follow containing number of doses, intervals

between doses, and other important information.

Vaccine Age Group19-21

years

22-26

years

27-49

years50-59 years

60-64

years≥ 65 years

Influenza *, 2 1 dose annually

Tetanus, diphtheria, pertussis

(Td/Tdap) *, 3Substitute Tdap for Td once, then Td booster every 10 years

Varicella *, 4 2 doses

Human papillomavirus (HPV)

Female *, 53 doses

Human papillomavirus (HPV)

Male *, 53 doses

Zoster 6 1 dose

Measles, mumps, rubella

(MMR) *, 71 or 2 doses depending on indication


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Vaccine Age Group19-21

years

22-26

years

27-49

years50-59 years

60-64

years≥ 65 years

Pneumococcal 13-valent

conjugate (PCV13) *,81 dose

Pneumococcal polysaccharide

(PPSV23) 81 or 2 doses depending on indication 1 dose

Hepatitis A *,9 2 or 3 doses depending on indication

Hepatitis B *, 10 3 doses

Meningococcal 4-valent

conjugate (MenACWY) or

polysaccharide (MPSV4) *, 11

1 or more doses depending on indication

Meningococcal B (MenB) *, 11 2 or 3 doses depending on vaccine

Haemophilus influenzae type b

(Hib) *, 121 or 3 doses depending on indication

*Covered by the Vaccine Injury Compensation Program

Legend

Recommended for all

persons who meet the age

requirement, lack

documentation of vaccination,

or lack evidence of past

infection; zoster vaccine is

recommended regardless of

past episode of zoster

Recommended for persons

with a risk factor (medical,

occupational, lifestyle, or other

indication)

No recommendation

Attachment 1


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Prevention and Early Detection

ACS Cancer Detection Guidelines

CANCER-RELATED CHECKUP

For people having periodic health examinations, a cancer-related checkup should include health counseling anddepending on a person's age might include examinations for cancers of the thyroid, oral cavity, skin, lymphnodes, testes, and ovaries as well as for some non-malignant diseases.

Special tests for certain cancer sites are recommended as outlined below.

BREAST

Yearly mammograms starting at age 40 and continuing for as long as a woman is in good health.

Clinical breast exams (CBE) should be part of a periodic health exam, about every three years forwomen in their 20s and 30s and every year for women 40 and over.

Women should report any breast change promptly to their health care providers. Breast self-exam (BSE)is an option for women starting in their 20s.

Women at increased risk (e.g., family history, genetic tendency, past breast cancer ) should talk withtheir doctors about the benefits and limitations of starting mammography screening earlier, havingadditional tests (e.g., breast ultrasound or MRI), or having more frequent exams.

COLON AND RECTUM

Beginning at age 50, both men and women should follow one of these five testing schedules:

Yearly fecal occult blood test (FOBT)*

Flexible sigmoidoscopy every 5 years

Yearly fecal occult blood test plus flexible sigmoidoscopy every 5 years**

Double-contrast barium enema every 5 years

Colonoscopy every 10 years

*For FOBT, the take-home multiple sample method should be used.

**The combination of FOBT and flexible sigmoidoscopy is preferred over either of these two tests alone.

All positive tests should be followed up with colonoscopy.

People should begin colorectal cancer screening earlier and/or undergo screening more often if they have any ofthe following colorectal cancer risk factors.

a personal history of colorectal cancer or adenomatous polyps

a strong family history of colorectal cancer or polyps (cancer or polyps in a first-degree relative youngerthan 60 or in two first-degree relatives of any age) Note: a first degree relative is defined as a parent,sibling, or child.

Attachment 2Page 1 of 3

a personal history of chronic inflammatory bowel disease


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a family history of hereditary colorectal cancer syndromes (familial adenomatous polyposis andhereditary non-polyposis colon cancer).

CERVICAL

The American Cancer Society recommends:

All women should begin cervical cancer screening about 3 years after they begin having vaginalintercourse, but no later than when they are 21 years old. Screening should be done every year with theregular Pap test or every 2 years using the newer liquid-based Pap test.

Beginning at age 30, women who have had 3 normal Pap test results in a row may get screened every 2to 3 years with either the conventional (regular) or liquid-based Pap test. Women who have certain riskfactors such as diethylstilbestrol (DES) exposure before birth, HIV infection, or a weakened immunesystem due to organ transplant, chemotherapy, or chronic steroid use should continue to be screenedannually.

Another reasonable option for women over 30 is to get screened every 3 years (but not more frequently)with either the conventional or liquid-based Pap test, plus the HPV DNA test.

Women 70 years of age or older who have had 3 or more normal Pap tests in a row and no abnormalPap test results in the last 10 years may choose to stop having cervical cancer screening. Women with ahistory of cervical cancer, DES exposure before birth, HIV infection or a weakened immune systemshould continue to have screening as long as they are in good health.

Women who have had a total hysterectomy (removal of the uterus and cervix) may also choose to stophaving cervical cancer screening, unless the surgery was done as a treatment for cervical cancer orprecancer. Women who have had a hysterectomy without removal of the cervix should continue to followthe guidelines above.

Women who have had a total hysterectomy (removal of the uterus and cervix) may also choose to stophaving cervical cancer screening, unless the surgery was done as a treatment for cervical cancer orprecancer. Women who have had a hysterectomy without removal of the cervix should continue to followthe guidelines above.

ENDOMETRIUM

The American Cancer Society recommends that all women should be informed about the risks andsymptoms of endometrial cancer, and strongly encouraged to report any unexpected bleeding or spottingto their doctors. For women with or at high risk for hereditary nonpolyposis colon cancer (HNPCC),annual screening should be offered for endometrial cancer with endometrial biopsy beginning at age 35.

PROSTATE

Both prostate-specific antigen (PSA) testing and digital rectal examination (DRE) should be offered annually,beginning at age 50 years, to men who have at least a 10-year life expectancy. Men at high risk should begintesting at age 45 years. Information should be provided to men regarding potential risks and benefits of earlydetection and treatment of prostate cancer. Men at even higher risk, due to multiple first-degree relatives affectedat an early age, could begin testing at age 40. Depending on the results of this initial test, no further testing mightbe needed until age 45. Information should be provided to men regarding potential risks and benefits of earlydetection and treatment of prostate cancer.


Men who choose to undergo testing should begin at age 50 years. However, men in high-risk groups,


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such as African Americans and men who have a first-degree relative diagnosed with prostate cancer at ayoung age, should begin testing at 45 years. Note: a first-degree relative is defined as a father, brother,or son.

Men who ask their doctor to make the decision on their behalf should be tested. Discouraging testing isnot appropriate. Also not offering testing is not appropriate.

Testing for prostate cancer in asymptomatic men can detect tumors at a more favorable stage (anatomicextent of disease). There has been a reduction in mortality from prostate cancer, but it has not beenestablished that this is a direct result of screening.

An abnormal Prostate-Specific Antigen (PSA) test result has been defined as a value of above 4.0 ng/ml.Some elevations in PSA may be due to benign conditions of the prostate.

The Digital Rectal Examination (DRE) of the prostate should be performed by health care workers skilledin recognizing subtle prostate abnormalities, including those of symmetry and consistency, as well as themore classic findings of marked induration or nodules. DRE is less effective in detecting prostatecarcinoma compared with PSA.

REFERENCES

American Cancer Society. Cancer Facts and Figures 2003. Atlanta, GA: American Cancer Society; 2003.

Smith RA, Saslow D, Sawyer KA, et al. American Cancer Society Guidelines for Breast Cancer Screening:Update 2003. CA Cancer J Clin. 2003;53:141-169.

Revised 5-14-03



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eMedicine – Hypercholesterolemia, Polygenic: Article by William Isley, MD Attachment 4http://ww.emedicine.com/med/topic1073.htm Page 1 of 6

The risk factors for CHD, other than LDL-C, in the NCEP screening and treatment algorithm are as follows:

Age/sex

o Men aged 45 years or older

o Women aged 55 years or older

Family history of premature CHD (male first-degree relative <55 y; female first-degree relative <65 y)

Current cigarette smoking

Hypertension - Blood pressure greater than or equal to 140/90 mm Hg or taking antihypertensive drugs

Low HDL-C concentration - Less than 40 mg/dL, but subtract 1 risk factor if HDL-C concentration is morethan 60 mg/dL (This level has been increased from <35 mg/dL compared to the NCEP ATP II.)

DIFFERENTIALS Section 4 of 11

Author Information Introduction Clinical Differentials Workup Treatment Medication Follow-up MiscellaneousPictures Bibliography

Anorexia NervosaBiliary ObstructionChronic Renal FailureHypopituitarism (Panhypopituitarism)HypothyroidismNephrotic SyndromePorphyria, Acute Intermittent

Other Problems to be Considered:

Biliary cirrhosis

Coronary heart disease

WORKUP Section 5 of 11


Lab Studies:

The NCEP ATP III suggests screening asymptomatic individuals with a fasting lipid panel every 5 years.

Practically speaking, performing a risk factor analysis prior to obtaining screening blood test results ispreferable. Patients can have risk factors for CHD other than LDL-C (see Causes).

o A full lipid profile is obtained with the patient fasting for 9-12 hours.

o Chylomicrons must be absent and the total triglyceride level must be less than 400 mg/dL in orderto use the Friedewald formula to calculate LDL-C, ie, LDL-C = total cholesterol - (HDL-C +


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triglycerides/5).

o Direct LDL-C measurements do not offer any greater utility, except in patients with markedhypertriglyceridemia. Direct LDL-C measurements can be performed while the patient is in thenonfasting state.

Take a careful medication history, and perform evaluations of serum thyroid stimulating hormone levels,liver function, creatinine level, and urinalysis results to rule out secondary dyslipidemias.

TREATMENT Section 6 of 11


Medical Care: During the 1990s, the cholesterol revolution occurred, with numerous studies documenting theefficacy of LDL-C reduction in reducing CHD events and, in some situations, reducing both CHD and totalmortality rates. Medical therapy involves lifestyle modification and pharmacologic therapy.

Goals for LDL-C and cut points for dietary and drug treatment (see Table 1)

o For patients with known atherosclerosis, the LDL-C goal is less than 100 mg/dL.

o For patients with 2 or more risk factors, the LDL-C goal is less than 130 mg/dL.

o For patients at low risk, the LDL-C goal is less than 160 mg/dL.

o The LDL-C goal for patients with CHD equivalent risk, including patients with diabetes mellitus,should also be less than 100 mg/dL.

Table 1. NCEP Treatment Based on LDL-C Levels

Treatment Patient CategoryInitiation LDL-C

Level,mg/dL

LDLGoal,mg/dL

Dietarytherapy

Without CHD and with fewer than 2 otherrisk factors*

160 <160

Without CHD and with 2 or more otherrisk factors

130 <130

With CHD >100 <100

Drugtreatment

Without CHD and with fewer than 2 otherrisk factors

190 <160

Without CHD and with 2 or more otherrisk factors

160 <130

With CHD 130 <100

*See Causes

The evaluation generally begins by forming a risk factor analysis. Patients are then categorized accordingto CHD or CHD risk equivalents (particularly diabetes), ie, those with multiple risk factors and those at lowrisk (<2 risk factors). Patients with CHD or CHD equivalent risk have a greater than 20% 10-year risk forCHD events. Low-risk patients generally have a 10-year CHD risk of less than 10%. Patients with multiplerisk factors may or may not be at high risk.


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The new NCEP ATP III guidelines recommend calculating a Framingham risk score to quantify risk andset LDL-C goals. The Framingham score calculator is available through the NCEP and the US NationalHeart, Lung, and Blood Institute (see Risk Assessment Tool for Estimating 10-year Risk of DevelopingHard CHD).

o Patients with CHD or CHD equivalent are prescribed drug therapy simultaneously withtherapeutic lifestyle changes if their LDL-C concentration is greater than or equal to 130 mg/dL.Drug therapy is optional for patients whose LDL-C value is 100-129 mg/dL.

o For patients with multiple risk factors, the LDL-C goal depends on the Framingham score. Forpatients with multiple risk factors and a 10-year risk of greater than 20%, the treatment should besimilar to those patients with CHD. For patients with a 10-year risk of 10-20%, the LDL-C goal isless than 130 mg/dL, with therapeutic lifestyle changes and possibly drug therapy begun for thosewith higher values.

o For patients at low risk, the LDL-C goal is less than 160 mg/dL, with therapeutic lifestyle changesbegun for those with higher values and drug therapy considered at LDL-C levels of greater thanor equal to 190 mg/dL.

The new NCEP guidelines also recommend trying to identify patients with the metabolic syndrome. Thesepatients have at least 3 of the following criteria: (1) abdominal obesity (waist >40 in for men, >35 in forwomen), (2) high triglyceride level (>150 mg/dL), (3) low HDL-C value (<40 mg/dL for men, <50 mg/dL forwomen), (4) high blood pressure (>130/85 mm Hg), and (5) impaired fasting glucose value (plasmaglucose 110-125 mg/dL). Such patients should be particularly targeted for therapeutic lifestyle changes.

All patients should be screened with a fasting lipid profile every 5 years beginning at age 20 years.Patients with CHD should have a lipid profile determination at least yearly. Patients with multiple riskfactors should have a lipid profile determined at least every other year.

Recheck the lipid profiles of patients treated with therapeutic lifestyle intervention in 3 months. Recheckthe lipid profiles of patients treated with drugs in 6-12 weeks.

Liver function testing is indicated periodically for patients taking statins or fibrates, although the risk forhepatotoxicity is very low. Liver function abnormalities are more common at the highest doses of each ofthe approved statins

Table 2. Dosage and Approximate LDL-C Lowering of Various Statins

Drug Dose LDL-C Lowering

Atorvastatin 10-80 mg qd -39% to -60%

Fluvastatin 20-80 mg qhs, 40 mg bid -22% to -36%

Lovastatin 20-40 mg every pm, 40 mg bid -24% to -42%

Pravastatin 10-80 mg qhs -22% to -34%

Simvastatin 20-80 mg qhs -38% to -47%

Diet: The NCEP has created dietary guidelines for all people older than 2 years. The reduction of saturated fatintake is vitally related to reduced LDL-C levels. In general, replacing fat with complex carbohydrates is helpful.Because carbohydrates are less calorically dense than fat, this substitution also may help prevent obesity.Adopting an appropriate diet may help patients reduce their LDL-C value by approximately 10-15%. However, inreal world studies, a 5% reduction is more likely. Reduction in trans fat intake also helps reduce LDL-C levels andmay help raise HDL-C levels.


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NCEP dietary guidelines are as follows:

o Total fat - Less than 30% of calories

o Saturated fat - Less than 7% of calories

o Polyunsaturated fat - Less than or equal to 10% of calories

o Monounsaturated fat - Ten to 15% of calories

o Cholesterol - Less than 200 mg/dL

o Carbohydrates - Fifty to 60% of calories

Extreme fat and cholesterol restriction has been achieved with vegetarian diets, as demonstrated bystudies performed by Ornish and colleagues (1990). This type of dietary restriction has resulted in amarked reduction in LDL-C levels and improvement in CHD symptoms. Whether these dietary restrictionsare realistic for most Americans is debatable. Moreover, such a diet also reduces HDL-C and raisestriglyceride levels.

Stanol esters can be included in the diet and may reduce LDL-C values by approximately 14%.Commercial preparations are available as margarine substitutes (eg, Benecol, Take Control).

After years of lay promotion, recent small short-term studies have suggested that high-fat low-carbohydrate diets (eg, the Atkins diet) may facilitate weight loss without adversely affected serum lipidconcentrations. However, the long-term effects of such a diet remain to be determined.

Therapy with estrogen alone in women without a uterus is still being studied in clinicaltrials.

Statin therapy rather than estrogens should be used for primary lipid modification and forCHD prevention in women who are postmenopausal, particularly in women withatherosclerosis.

o Patients with diabetes

The post hoc analysis of the 4S trial in patients with type 2 diabetes mellitus showeddramatic event reduction in patients who received simvastatin. Unfortunately, this trial didnot include patients with high triglyceride levels, which is a common lipid abnormality inpersons with type 2 diabetes mellitus.

The HPS (using simvastatin 40 mg/d) showed similar reduction in CHD event rates inpatients with type 2 diabetes mellitus compared to those without diabetes.

Recent epidemiologic work suggests that the risk for CHD events and mortality is thesame in patients with diabetes who have not had a previous known myocardial infarctioncompared to patients without diabetes who have had a previous coronary event. Thesedata led the American Diabetes Association to advocate an LDL-C level of less than 100mg/dL for patients with diabetes (see Table 4).

The NCEP ATP III now considers diabetes mellitus a CHD risk equivalent, with the sameLDL cholesterol goal (<100 mg/dL) as patients with known CHD.


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Table 3. American Diabetes Association Treatment Based on LDL-C Levels

Treatment Patient CategoryInitiation Level,

mg/dLLDL-C Goal,

mg/dL

Medical nutrition therapyWithout CHD, PVD*, or CVD† >100 <100

With CHD, PVD, or CVD >100 <100

Drug treatmentWithout CHD, PVD, or CVD >130‡ <100

With CHD, PVD, or CVD >100 <100

*Pulmonary vascular disease

†Cardiovascular disease

‡For patients with diabetes who have multiple CHD risk factors (eg, low HDL-C, hypertension,smoking, family history of CVD, or microalbuminuria or proteinuria), some authorities recommenddrug therapy for LDL-C levels of 100-130 mg/dL. Age and sex are not risk factors becausewomen and men have equal CHD risk.


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Implications of Recent Clinical Trials for the National Cholesterol Education Program … Page 19 0f 34

For high-risk patients, the recommended LDL-C treatment goal remains at <100 mg/dL. However, a

target of <70 mg/dL represents a therapeutic option, ie, a reasonable clinical strategy, for persons

considered to be at very high risk, on the basis of emerging clinical trial data. TLC is recommended in

high-risk patients whenever the LDL-C level is 100 mg/dL. Furthermore, any person at high risk who

has lifestyle-related risk factors (eg, obesity, physical inactivity, elevated triglycerides, low HDL-C, or

metabolic syndrome) is a candidate for TLC to modify these risk factors regardless of LDL-C level. As

before, whenever the baseline LDL-C concentration is 130 mg/dL, simultaneous initiation of an LDL-

lowering drug and dietary therapy is recommended. If LDL-C is 100 to 129 mg/dL, the same now holds.

If baseline LDL-C is <100 mg/dL and the patient is considered to be at very high risk, initiation of an LDL-

lowering drug to achieve an LDL-C level of <70 mg/dL is a therapeutic option that has clinical trial

support. For those high-risk patients who have elevated triglycerides or low HDL-C levels, addition of a

fibrate or nicotinic acid to LDL-lowering therapy can be considered.

For patients at moderately high risk (10-year risk 10% to 20%), the LDL-C goal remains <130 mg/dL.

However, a goal of <100 mg/dL represents a therapeutic option on the basis of evidence of efficacy in risk

reduction from primary-prevention trials. TLC should be initiated in all such persons whose LDL-C level is

130 mg/dL. Again, any person at moderately high risk who has lifestyle-related risk factors (eg, obesity,

physical inactivity, elevated triglycerides, low HDL-C, or metabolic syndrome) is a candidate for TLC to

modify these risk factors regardless of LDL-C level. If the LDL-C concentration is 130 mg/dL after TLC,

consideration should be given to initiating an LDL-lowering drug, to achieve and sustain the LDL-C goal of

<130 mg/dL. For LDL-C levels of 100 to 129 mg/dL at baseline or on lifestyle therapy, initiation of an

LDL-lowering drug to achieve an LDL-C level <100 mg/dL is a therapeutic option on the basis of clinical

trial evidence of additional efficacy.

When initiating LDL-lowering therapy in a person at high risk or moderately high risk, the efficacy of

therapeutic lifestyle change both to lower LDL-C levels and to reduce risk through other mechanisms

must not be overlooked. Lifestyle change must be an integral part of risk reduction therapy. When an

LDL-lowering drug is employed in a person at high risk or moderately high risk, a reduction in LDL-C

levels of at least 30% to 40% beyond dietary therapy should be achieved if feasible. For people in lower

risk categories, there are no proposed changes to the treatment goals and cutpoints.45

Footnotes

This statement was approved by the National Heart, Lung, and Blood Institute in April 2004, by the

American Heart Association Science Advisory and Coordinating Committee in May 2004, and by the

American College of Cardiology Foundation Board of Trustees in May 2004. A single reprint is available

by calling 800-242-8721 (US only) or writing the American Heart Association, Public Information, 7272

Greenville Ave, Dallas, TX 75231-4596. Ask for reprint No. 71-0292. To purchase additional reprints: up

to 999 copies, call 800-611-6083 (Us only) or


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eMedicine – Hypertriglyceridemia: Article by Elena Citkowitz, Md, PhD, FACP Attachment 5http://ww.emedicine.com/med/topic2921.htm Page 1 of 3

Type I hyperlipoproteinemia (pure hyperchylomicronemia)

o To make a definitive diagnosis of type I hypercholesterolemia, deficiency of either LPL or apo C-IImust be confirmed. The presence of LPL activity may be measured in plasma followingintravenous heparin administration (50 IU of heparin per kg body weight) or by analysis of muscleor adipose tissue biopsy samples.

o Defective or absent apo C-II must be determined at a lipid center that performs 1 of the 3following assays: (1) gel electrophoresis, (2) radioimmunoassay, or (3) confirmation that LPLadded to the patient's plasma is not active.

Other Tests:

Rule out secondary causes of hTG, including diabetes mellitus and hypothyroidism.

Procedures:

If the diagnosis of eruptive xanthomas is in doubt, obtaining a biopsy of the suspicious lesions will revealaccumulations of fat (not cholesterol).

TREATMENT Section 6 of 11

Author Information Introduction Clinical Differentials Workup Treatment Medication Follow-up Miscellaneous Pictures Bibliography

Medical Care:

When hTG is diagnosed, secondary causes should be sought out and controlled.

o Direct treatment of elevated TGs should be undertaken after aggravating conditions, such asuncontrolled diabetes mellitus, are controlled as well as possible.

o In some cases, hTG will resolve completely when the other condition(s) are managedsuccessfully. These conditions include obesity, a sedentary lifestyle, and smoking. Thus, theinitial management of hTG should include weight reduction, increased physical activity, andelimination of ingesting large concentrations of refined carbohydrates.

o The latest Adult Treatment Panel guidelines (ATP III) have reclassified serum triglycerides asfollows:

Table 1. Classification of Triglycerides

Classification TG Level (mg/dL)

Normal TG level <150

Borderline-high TG level 150-199

High TG level 200-499

Very high TG level >500

If the secondary conditions that raise TG levels cannot be managed successfully and if TGs are 200-499mg/dL, the non–HDL-c becomes the initial target of drug therapy using LDL-lowering medication. The


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non–HDL-c is the sum of the LDL-c and the VLDL cholesterol (total cholesterol – HDLc). The goals fornon–HDL-c levels, similar to the goals for LDL-c levels, are dependent on risk and are 30 mg/dL higherthan the corresponding LDL-c goals. The classification of LDL-c and non–HDL-c is as follows:

Table 2. Classification of Low-Density Lipoprotein Cholesterol and Non–High-Density LipoproteinCholesterol

ClassificationLDLGoal

(mg/dL)

Non-HDLGoal

(mg/dL)

CHD* and CHD risk equivalent,diabetes mellitus, and the following:

10-year risk forCHD >20%

<100 <130

Two or more risk factors and thefollowing:

10-year risk<20%

<130 <160

0-1 risk factor <160 <190

*Congestive heart disease

If secondary conditions are not present, no specific care is required other than treatment to improve hTG.

The importance of obesity, a sedentary lifestyle, and a deconditioned state should not be underestimatedin the treatment of hTG. Instituting a program of progressive aerobic and toning exercise along withdietary management of obesity can cause TG levels to decrease several hundred points (in mg/dL).

During pregnancy, severe hTG is an unusual complication and may cause pancreatitis.

o Many case reports have been published describing interventions to manage this condition.

o Most commonly, a very low-fat diet was sufficient to control TGs and prevent pancreatitis.

o Intermittent and, in persistent cases, continuous total parenteral nutrition has been used—usuallyin the third trimester.

o Reports also have been published describing plasma exchange or apheresis, as well as earlythird trimester termination of pregnancy by cesarean section.

Consultations:

If the primary care physician cannot control a patient's TGs, referral should be made to a lipidologist orendocrinologist with expertise in treating severe and difficult-to-manage lipid disorders.

Diet:

Total fat intake should be restricted if this intervention assists in weight loss. If TG levels are greater than 1000

mg/dL, allowing no more than 10% of total calories from fat usually will lower TGs promptly and dramatically.

Chylomicrons and VLDLs normally undergo rapid metabolism via the action of LPL, hepatic lipase, andcholesterol ester transfer protein. The normal half-life of chylomicrons and VLDLs is about 10 minutes and 9hours, respectively. During catabolism, TGs are hydrolyzed, free fatty acids are released to the plasma, and

cholesterol is transferred from HDL to VLDL.

Any disturbance that causes increased synthesis of chylomicrons and/or VLDLs or decreased metabolicbreakdown will cause elevations in TG levels. That disturbance may be as common as dietary indiscretion or asunusual as a genetic mutation of an enzyme in the lipid metabolism pathway.


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Frequency:

In the US: If hTG is defined as fasting TGs greater than 200 mg/dL, the prevalence in the United Statesis approximately 10% in men older than 30 years and women older than 55 years.

Prevalence of severe hTG, defined as TGs greater than 2000 mg/dL, is estimated to be to be 1.8 casesper 10,000 adult whites, with a higher prevalence in patients with diabetes or alcoholism.

The frequency of LPL deficiency is approximately 1 case per 1 million population, and that of apo C-IIdeficiency is even lower.

Internationally: The frequency of LPL deficiency in Quebec, Canada is significantly higher than the 1case per 1 million population reported in the United States.

Apo C-II has a worldwide distribution but is infrequent in all population studies to date.

Mortality/Morbidity:

Hypertriglyceridemia is correlated with an increased risk of cardiovascular disease (CVD), particularly inthe setting of low HDL cholesterol (HDL-c) levels and/or elevated LDL cholesterol (LDL-c) levels. Whenlow HDL-c levels are controlled for, some studies demonstrate that elevated TGs do not correlate with riskof CVD. However, other studies suggest that TGs are an independent risk factor. Because metabolism ofthe triglyceride-rich lipoproteins (chylomicrons, VLDL) and metabolism of HDL are interdependent andbecause of the lability of TG levels, the independent impact of hTG on CVD risk is difficult to confirm.However, randomized clinical trials using TG-lowering medications have demonstrated decreasedcoronary events in both the primary and secondary coronary prevention populations.

An understanding of lipoprotein catabolism provides an explanation for the absence of increased risk ofCVD in patients with the most severe form of hTG, type I hyperlipoproteinemia. The atherogenicity of TGsis thought to be secondary to increased levels of chylomicron and VLDL remnants. Remnants aresmaller, richer in cholesterol, and more readily taken up by macrophages, which are converted to plaque-forming foam cells. Patients with type I disease cannot convert chylomicrons to remnants; rather, thechylomicrons have not undergone metabolic transformation and remain large and nonatherogenic.


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Attachment 6DIABETES MEDICAL PRACTICE GUIDELINES

Page 1 of 4

DEFINITIONS(AACE) American Association of Clinical Endocrinologists.

(ADA) American Diabetes Association - is the not-for-profit national voluntary health agency concerned withdiabetes.

Board-Certified Adult Endocrinologist - refers to a physician who has completed a residency program ininternal medicine and a fellowship program in endocrinology, diabetes and metabolism and passed thecertification examinations of the American Board of Internal Medicine to become board certified in endocrinology,diabetes and metabolism.

Board-Certified Pediatric Endocrinologist - refers to a physician who has completed a residency program inpediatrics and a fellowship program in pediatric endocrinology, diabetes, and metabolism and has passed thecertification examinations of the American Board of Pediatrics to become board-certified in PediatricEndocrinology.

Certified Diabetes Educator - refers to a health care professional who has passed the certification exam of, andis currently certified by, the National Certification Board for Diabetes Educators and meets the criteria set forth bythe American Association of Diabetes Educators (AADE) and has passed the national exam established by theAADE.

Diabetes - is a chronic disorder characterized by abnormalities in the metabolism of carbohydrate, protein andfat. Types of diabetes include:

Type 1 Diabetes - Beta-cell destruction usually leading to absolute insulin deficiency. This form ofdiabetes is usually immune mediated.

Type 2 Diabetes - Ranges from predominantly insulin resistance with relative insulin deficiency to apredominately secretory defect with insulin resistance.

Diabetes Outpatient Self-Management Training - is a program designed to help individuals to learn to managetheir diabetes in an outpatient setting. They learn self-management skills and making lifestyle changes toeffectively manage their diabetes and to avoid or delay the complications associated with this illness.

The diagnosis of diabetes is made with test results of:

A1C ≥6.5%. The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.*

OR

FPG ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.*

OR

2-h PG ≥200 mg/dL (11.1 mmol/L) during an OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.*

OR


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In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose≥200 mg/dL (11.1 mmol/L).

In the absence of unequivocal hyperglycemia with acute metabolic decompensation confirmation should be madeby repeat testing on a different day. Fasting plasma glucose is the recommended method for clinical diagnosis ofdiabetes. It is easier for the patient and much less expensive to perform.

Gestational Diabetes - occurs in women who manifest glucose intolerance during pregnancy.

Impaired Fasting Glucose - occurs when a person’s fasting blood glucose level is above normal but fails to meetcurrent diagnostic criteria for diabetes. This condition is treated through nutrition, exercise, and weight loss. Thesepatients have increased cardiovascular risk factors. Impaired fasting glucose is 110 – 125 mg/dl.

Impaired Glucose Tolerance - occurs when a person’s blood glucose level is above normal and fails to meetcurrent diagnostic criteria for diabetes. This condition is treated through nutrition, exercise, and weight loss. Thesepatients have increased cardiovascular risk factors. These individuals have a 2 hour postprandial glucose level of140 – 199 mg/dl.

Licensed Registered Dietitian - refers to a health care professional who meets the criteria set forth in FloridaStatute 468.501-Part X and is licensed by the state of Florida.

Nutrition Counseling - (medical nutrition therapy) includes an individualized assessment and self-managementtraining sessions designed to assist persons with diabetes to make changes in nutrition and lifestyle (i.e., eatinghealthier, beginning exercise) habits that will lead to improved metabolic control).

(PCOS) polycystic ovarian syndrome.

Oral Diabetes Medications

Biguanides

Metformin (Glucophage)Metformin liquid (Riomet)Metformin extended release (Glucophage XR, Fortamet, Glumetza)

Metformin: usually taken twice a day with breakfast and evening meal.

Metformin extended release: usually taken once a day in the morning.

Decreases amount of glucose released from liver.

May cause bloating, gas, diarrhea, upset stomach, and loss of appetite (usually within the first few weeks ofstarting). Take with food to minimize symptoms. Metformin is not likely to cause low blood glucose. In rare cases,lactic acidosis may occur in people with abnormal kidney or liver function.

Sulfonylureas

Glimepiride (Amaryl)Glyburide (Diabeta, Micronase)Glipizide (Glucotrol, Glucotrol XL)Micronized glyburide (Glynase)

Take with a meal once or twice a day.


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Stimulates the pancreas to release more insulin, both right after a meal and then over several hours

May cause low blood glucose, occasional skin rash, and irritability.

Meglitinides

Repaglinide (Prandin)Nateglinide (Starlix)

Both of these medications should be taken with meals. If you skip a meal, skip the dose.

Stimulate the pancreas to release more insulin right after a meal.

Effects diminish quickly and they must be taken with each meal; may cause low blood glucose.

These work quickly when taken with meals to reduce high blood glucose levels.

However, they are less likely than sulfonylureas to cause low blood glucose.

Thiazolidinediones

Pioglitazone (Actos)

Usually taken once a day; take at the same time each day.

Makes the body more sensitive to the effects of insulin.

May cause side effects such as swelling (edema) or fluid retention.

Do not cause low blood sugar when used alone.

Increased risk of congestive heart failure in those at risk.

Increases the amount of glucose taken up by muscle cells and keeps the liver from overproducing glucose; mayimprove blood fat levels.

DPP-4 Inhibitors

Sitagliptin (Januvia)Saxagliptin (Onglyza)Linagliptin (Tradjenta)

Take once a day at the same time each day.

Improves insulin level after a meal and lowers the amount of glucose made by your body.

May be associated with stomach discomfort, diarrhea, sore throat, stuffy nose, and upper respiratory infection.

Do not cause low blood glucose.

Can be taken alone or with metformin, a sulfonylurea or Actos.

Alpha-glucosidase Inhibitors

Acarbose (Precose)


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Miglitol (Glyset)

Take with first bite of the meal; if not eating, do not take.

Slows the absorption of carbohydrate into your bloodstream after eating.

May cause gas, diarrhea, upset stomach, and abdominal pain.

Take with meals, to limit the rise of blood glucose that can occur after meals; these do not cause low bloodglucose.

Side effects should go away after a few weeks.

Combination Pills

Pioglitazone & metformin) (Actoplus Met)Glyburide & metformin (Glucovance)Glipizide & metformin (Metaglip)Sitagliptin & metformin (Janumet)Saxagliptin & metformin (kombiglyze )Repaglinide & metformin (Prandimet)Pioglitazone & glimepiride (Duetact)

Prediabetes

Prediabetes is the precursor stage before diabetes mellitus in which not all of the symptoms required to diagnosediabetes are present, but blood sugar is abnormally high.

The progression to type 2 diabetes mellitus is not inevitable for those with prediabetes. The progression intodiabetes mellitus from prediabetes is approximately 25% over three to five years.

Diagnosis

Usually, prediabetes is diagnosed with a blood test: Fasting blood sugar (glucose) level of:

o 110 to 125 mg/dL (6.1 mM/L to 6.9 mM/L) - WHO criteriao 100 to 125 mg/dL (5.6 mM/L to 6.9 mM/L) - ADA criteria

Two hour glucose tolerance test after ingesting the standardized 75 Gm glucose solution the blood sugarlevel of 140 to 199 mg/dL (7.8 to 11.0 mM)

Glycated haemoglobin between 5.7 and 6.4 percent

Management

There is evidence that prediabetes is a curable disease state. Intensive weight loss and lifestyle intervention, ifsustained, may improve glucose tolerance substantially and prevent progression from IGT to type 2 diabetes. TheDiabetes Prevention Program (DPP) study found a 16% reduction in diabetes risk for every kilogram of weightloss. Reducing weight by 7% through a low-fat diet and performing 150 minutes of exercise a week is the goal. Inobservational studies, individuals following vegetarian diets are about half as likely to develop diabetes, comparedwith non-vegetarians. The ADA guidelines recommend modest weight loss (5-10% body weight), moderate-intensity exercise (30 minutes daily), and smoking cessation.

For patients with severe risk factors, prescription medication may be appropriate. This may be considered inpatients for whom lifestyle therapy has failed, or is not sustainable, and who are at high-risk for developing type 2diabetes. Metformin and acarbose help prevent the development of frank diabetes, and also have a goodsafety profile. Evidence also supports thiazolidinediones but there are safety concerns.


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In 2008, the American Diabetes Association (ADA) began recommending the drug metformin for some cases ofprediabetes — specifically, for people under age 60 with a very high risk of developing diabetes, for people whoare very obese (with a body-mass index, or BMI, of 35 or higher), and for women with a history of gestationaldiabetes. The ADA also said that health-care professionals could consider metformin for anyone with prediabetesor an HbA1c level (a measure of long-term blood glucose control) between 5.7% and 6.4%. In one study,metformin was administered as one 850 mg tablet, titrated to 850 mg twice daily after 1 month depending ontolerability.


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Name_____________________________D.O.B. ____________________________

Patient Chart Flow Sheet No. ______________________________

Type of Diabetes ____________________Date of Diagnosis ___________________

Diabetes Mellitus Management Based on Florida’s Medical Practice GuidelinesMeasure Frequency Status 1stvisit 2nd visit 3rd visit 4th visit

DATE of VISIT

Review of Self-Monitoring GlucoseLog

q visit Signature

Complete History and Physical(including risk factors, exercise anddiet)

q visit Signature

Weight q visit Result

Height Result

Foot Exam (visual inspection forlesions calluses, and infection withoutshoes and socks)

q visit Result

Dental Inspection q visit Result

HbA1c Target value: <7% q 3 months Datecompleted

Result

Microalbuminuria (random urine formicroalbuminuria or urine abnormals(< 30 mg/24 hrs)

q 1 year DateCompleted

Result

Eye Exam 1 year DateCompletedResult

Education/Nutrition Counseling Initial, then asindicated

DateCompletedSignature

Lipid ProfileTarget Values:

TG<200 mg/dL

LDL<100 mg/dL

HDL>35 mg/dL

q 1 year DateCompleted/Result

Influenza Vaccination q 1 year DateCompleted

Pneumococcal pneumonias(generally provided once)

Initial DateCompleted

Self-Management Education/Plan- Diabetes Overview- Medication- Monitoring and Use of Results- Nutrition; Exercise- Prevention, Detection & Treatment of Acute

and Chronic Complications- Stress and Psycho-social adjustment- Foot, Skin, and Dental Care- Use of Healthcare Systems and Community

Initial andupdates

DateCompleted

Result Codes: O = Ordered N = Normal A = Abnormal R = Refused E = Done ElsewherePlease initial when completed.


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QUICK REFERENCE

Florida Diabetes Practice Guideline Algorithm

Critical Parameters for the Treatment of Diabetes

Measure Frequency Recommended

HbA1c (measure of blood glucose levels over a three-month period)

Proportion w/HbA1c within 1% of normal

Quarterly

Eye Exam by an Ophthalmologist or Optometrist One time per year

Foot Exam Every visit

Blood Pressure Frequency Proportion w/reading<130/80 mm Hg

Every visit

Urine Protein Measurement One time per year

Lipid Profile One time per year

Self-Management Education (including Self BreastExamination)

Annual*

Medical Nutrition Therapy Annual*

Self-Monitoring of Blood Glucose Document status

Tobacco Status and Counseling Referral Document status

Immunization Evaluation for Influenza andPneumococcal Polysaccharide Vaccines

Document status

Annual implies that the service could be delivered in more than one session during a 12-month period.

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