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Dear Client:

We are very excited to provide this Medical OSHA Compliance Manual to assist in your efforts to create a strong safety program for your practice.

The manual includes the following sections:

1. Legislation: Pertinent federal regulations are provided which address certain safety and documentation requirements.

2. Exposure Control Plan – This plan addresses the requirements for employers as outlined by the Bloodborne Pathogen Standard. An easy to use post-exposure protocol is included to assist in the event of a blood or body fluid exposure.

3. Infection Control Plan – Patient safety standards related to proper preparation of instruments for reuse are addressed in this section. Also included, is the Tuberculosis (TB) Control Plan as recommended by the CDC, to ensure the safety of patients and employees if they are in contact with a patient with suspected or active TB.

4. Hazard Communication Plan – Workers have the “right to know” which substances they may come in contact with that may pose a threat to their health or safety. This plan clearly communicates your practice’s process for communication of hazards and reflects the most current updates of the Hazard Communication standard to align with the Globally Harmonized System of Classification and Labeling.

5. Emergency Procedures – Plans in the section address: fire safety, electrical safety, and work-place violence.

6. State regulations – State specific regulations related to employee safety and waste disposal can be found in this section.

7. Forms – Documentation of compliance efforts are critical to the success of your program. Specific tools to document Hepatitis B vaccination or any medical evaluations, exposure incident reports, and tools to document consideration, evaluation, and selection of safety equipment are a few of the forms provided in this section.

8. Training documentation – Training attendance rosters and continuing education documentation are included to complete your documentation.

9. Supplemental Material – This section provides a wide variety of information including letters of interpretation of OSHA standards, CDC guidance documents on infection control, and information about pertinent vaccinations.

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Follow the instructions below for completion of your manual to reflect current processes in place for your specific practice environment.

EXPOSURE CONTROL PLAN

ECP 1 o Fill in the appropriate information regarding policy review and the Safety Officer. o Under Exposure Determination, check all appropriate job classifications which are at risk of

occupational exposure to blood or body fluids. ECP 2 – Check the tasks which are performed regularly in the facility. ECP 6

o Check all PPE which is available for workers. o List all products utilized for surface disinfection. Products must be an EPA approved hospital

level disinfectants. ECP 8 – Check all areas where regulated waste containers/biohazard bags are found. ECP 11

o Identify and list where the SOURCE patient will be sent for testing. Testing must include a RAPID HIV test as recommend by the CDC.

o Test results must be made available to the WORKER’S treating physician, therefore document where the SOURCE patient testing will be sent.

o Include the appropriate address for bills related to the care of the source patient. This is considered a practice/facility level expense.

ECP 12 – Document address for any expenses involved in care of the worker. This is a practice level expense.

INFECTION CONTROL PLAN

ICP 4 – If performing SPORE testing select the process utilized for testing. ICP 5

o Select the type of packaging utilized to wrap packages for the sterilization process. o Select the process adopted for safe storage of instruments.

ICP 9 o At the top of the page select the statement which best reflects the current status of potential

exposure to possible suspect or confirmed ACTIVE TB. o Document the person who will review the TB plan, including date of review. o Select screening process for all NEW HIRE employees.

ICP 10 o Check whether initial screening for patients is or is not provided.

ICP 12 o Document the number of cases of ACTIVE TB reported in your County and State for the

previous year, as well as suspect or confirmed cases in your practice. o Select if the practice has a triage plan in place.

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o If there has been a cluster of TB patients in the practice in the previous year, a more extensive TB plan will need to be completed. The Plan is located on the TMC website in the Client Portal.

ICP 13 o Determine RISK category. If any boxes under the Classification Chart are checked as above, a

more extensive Plan will need to be developed. ICP 14

o List any problems noted during the plan review and document corrective actions in sections 1 and 2.

o Circle and date identified risk category based on the completed assessment. ICP 17

o Select vaccination recommendations for workers. o Select process for evaluation of employee who may have communicable disease.

ICP 18 – Select type(s) of hand hygiene products in use. ICP 19

o Select type of dispenser in use for hand hygiene products. o Record number for local Health Department.

ICP 20 – Document name of Infection Control officer and review date.

HAZARD COMMUNICATION PLAN

HC 1 - Fill in the name of the practice, name of Safety Officer, and review date. HC 2

o Record location of MSDS/SDS. o If satellite offices are involved, document location of MSDS/SDS.

HC 3 o Select MSDS/SDS format. o If utilizing electronic formats, document back-up process if electronic formats are not available. o Select process for retention of MSDS/SDS.

HC 7 – After review of NIOSH list of hazardous drugs and package inserts on current medications, check this box if hazardous drugs are NOT in use in the facility. Skip to Emergency Procedures.

*The following is for practices/facilities which utilize hazardous drugs.

HC 8 o List additional resources utilized in the development/management of the Hazardous Drug Safety

and Health Plan. o Select appropriate information related to proper ventilation when handling these drugs.

HC 9 o Select all PPE in use. o Identify location where hazardous drugs are prepared.

EMERGENCY PROCEDURES

EP 2 – Complete the Fire Prevention Plan. MUST be in writing if 10 or more employees. EP 3 – Complete the Fire Emergency Plan. MUST be in writing if 10 or more employees. EP 22 – Complete the Inspection Checklist to Identify Potential Workplace Violence Problems.

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FORMS – The forms section is provided to assist with documentation of your compliance efforts. We recommend at a minimum the completion of the following forms in all practices/facilities

ECP 101 – Hepatitis B vaccine documentation of declination. SHA 501 – Annual Review of Sharps Safety Program - provides documentation on an annual basis of

your review of safety equipment/processes as well as employee feedback on safety practices in place to reduce the likelihood of a sharps injury.

SHA 503 – 504 – Utilized for the evaluation of safety devices as required by the Needlestick Safety Act. Evaluation is required to be performed by non-managerial staff.

DOC 101 –Hazard Assessment - Select all procedures applicable to your clinical environment. DOC 102 – Complete the Cleaning Schedule as required by the Bloodborne Pathogen Standard.

TRAINING DOCUMENTATION

Personal Protective Equipment Training Record (PPE) – Review the Hazard Assessment Form with all employees utilizing PPE. Review the location of, proper use and disposal of PPE and have employee sign the PPE training record. This should be completed on an annual basis.

For additional assistance you may contact the TMC Client Services Center at 888.862.6742. You can also join TMC for a complimentary webinar for Safety Officers the first Wednesday of each month. Additional details can be found on the TMC website www.TotalMedicalCompliance.com.

HAZARD ASSESSMENT CERTIIITCATION . MEDICAL

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POST EXPOSURE PROTOCOL

Source Patient Testing and Counseling:

The source patient will be immediately sent for blood tests to

The following tests will be ordered for the source patient unless they are already known to be positive forinfection:

1. Obtain patient consent based on state law utilizing form ECP 107 Source Patient Consent forBlood Test.

2. HIV Antibody. Rapid HIV test will be used if available. If rapid HIV is not available, expeditethe HIV test.

3. Hepatitis B Surface Antigen (HBsAG).

) Source patient testing is not indicated if exposed worker has documented serologic evidenceof hepatitis B immunity.

4. Anti-Hepatitis C virus (Anti-HCV).

The results of the source patient tests will be forwarde d to to n Ce nlYq ,6r"physician providing treatment to the exposed employee. Additionally, forward the results to any physicianas requested by the source patient.

Exposed Employee Treatment and Counseling:

The exposed employee will immediately be offered a confidential medical evaluation by:

Con ce nlva (P hys ic ian/P rac t ic e pr ov id in g c ar e)

The following information will be forwarded to the treating provider:

,/ Medical records relevant to the appropriate treatment of the employee including the informationon Hepatitis B vaccinations and titers.

{ A description of the employee's duties as they relate to the exposure incident.

/ Documentation of the exposure incident. May use form ECP105 or OSHA 301.

r' A copy of the OSHA 1910.1030- Bloodborne Pathogen Standard - page 12-19 in the Legislationsection of the TMC OSHA Compliance manual.

,/ A copy of form ECP 108 Physician Written Opinion. This form is to be completed by the treatingphysician and a copy must be provided to the employer/employee within 15 days of examination.

Baseline bloodwork - Employee:

. Obtain consent or declination from the exposed employee for treatment and blood tests usingform ECP 106 Post Exposure Medical Evaluation. If exposed employee declines HIV testing,offer the option to draw and hold blood for 90 days.

o If source patient test results are negative for infection, no further testing of employee will beindicated.

o Conduct baseline testing of employee

tr For all bloodborne exposures with either known or unknown source patient:

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o HIV Antibody

o "*:'n1"*;H:ffi:::::illicated,

ir documented serorogic evidence indicatesimmunity to hepatitis B.

o Anti-Hepatitis C Virus (Anti-HCV)/

M Test only if source patient testing indicates disease:

o HIV Antibody

o "*:""1:i;T::ffi:[::ff]icated,

ir documented serorogic evidence indicatesimmunity to hepatitis B.

o Anti-Hepatitis C Virus (Anti-HCV)

Provide counseling to employee

On counseling for HBV and HCV, the CDC guidelines say; "HCP exposed to HBV or HCV infectedblood do not need to take any special precautions to prevent secondary transmission during the follow upperiod."

On counseling for HIV, the guidelines say; "Exposed HCP should be advised to use precautions toprevent secondary transmission during the follow up period. For exposure for which PEP is prescribed,the HCP should be informed about possible drug toxicities and the need for monitoring and possible druginteractions."

Forward the bill for services for so.urce patient and employee to:

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Treating Physician Written Opinion to Employer

As required by OSHA 1910.1030(f)(5), a letter must be sent to the employer of the exposed employeewithin l5 days of the initialtreatment.

Allother findings or diagnoses shall remain confidential and shall not be included in the written report tothe employer.

Additional Resources for Post Exposure Management

PEP Hotline - National Clinicians Postexposure Prophylaxis Hotline

888-448-491I

ECP 12

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R - routinel) - potential for blood or other bodl' tluids

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DOC102 (Rcv Dec 2012)

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usE oF SHARPS tOG

Type/Brancl(s) of sharp, BD iCalPel bt adeS

'l-his sharp.is used for the sc procedures:

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Complete for each sharp used in tltc tacility.

Progress in implementing the use of sharps rvith engineered sharps in.lury protection

is reflectcd in the regular revierv and updating oi'thc inforntation below'

Maintain with the Exposure Control Plan.a

Estimated frequencl.' of use: I times per {@. V.,nth, Year).

This sharp docs / rlo"rnot havc an cnginecreclsharps injury protection feature'

lf it does not, this olfice uses tlte following cxccption.o -fhis type of sharp rvith an engineered sharps injury protection feature is not

available in thc rnarketplacc.

t/Ur. of sharp *'ith an cngineered sharps injury protection fbature .ieopardiz.espatientsafety'clrthcsucccssof'theprocedurc.'l'hishasbeendenronstratedby:

€valvthon of 'afcl^l

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O Use of sharp rvith an engineered sharps injury protection l'eature is not more

effective in preventing exposurc incidents as detnonstrated by:

t:l No reasonable spccific ancl reliable safetl, pertbnnance inlbrmation is availablefcrr the sharp witlr an cnginecred sharps iniury protcction fcature. 'l'his office is

actively determining by nreans of ob.iectivc product evaluatiott criteria rvhether it

will rcduce the risk of exposulc inciclents.

lf rhis type of sharp is available with arr engineered sharps injury protcction l'eature:

Namc ol'l3rancl(s):

SL|A502 (Rev. Jan 20 | l)

USE OF SHARPS LOG

Type/Brand(s) of sharp: BD €cli Prc qeeolle t

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Complete for each sharp used in the facility.Progress in implementing the use of sharps with engineered sharps injury protection

is reflected in the regular review and updating of the information below.

Maintain with the Exposure Control Plan.

This sharp is used for these procedures:

Estimated frequency of use: to times per @,*onh,

Year).

This sharp / do"r- does not have an engineered sharps injury protection feature.

If it does not, this office uses the following exception.B This type of sharp with an engineered sharps injury protection feature is not

available in the marketplace.

O Use of sharp with an engineered sharps injury protection feature jeopardizes

patient safety or the success of the procedure. This has been demonstrated by:

D Use of sharp with an engineered sharps injury protection feature is not more

effective in preventing exposure incidents as demonstrated by:

tr No reasonable specific and reliable safety performance information is availablefor the sharp with an engineered sharps injury protection feature. This office isactively determining by means of objective product evaluation criteria whether itwill reduce the risk of exposure incidents.

If this type of sharp is available with an engineered sharps injury protection feature:

Name of Brand(s):

SHA502 (Rev. Jan 201 l)

2.

1.

ANNUAL RE,VIEW SHARPS SAFETY PROGRAM - MEDICAL

Review Use of Sharps (SHA502) andHazard Assessment Certification (DOC101D) forms to ensure

current inventory of sharps meets the needs of the practice/facility.

Review of the sharps injury log or incident reports.

3. Request feedback on sharps safety program from front line clinical staff.

Ef Staff meetins. Date: l,q.f t Ftcall>acb qttached

tr Committee Meetins: Date:

*See attached document for stafffeedback.

4. The following journals, periodicals, websites, catalogs were reviewed and/or the following vendors werecontacted:

bit.lv/I&D3ivC Link to a great sourceforfull list of safety devices.

fialt onql nwrses (ltr+octahon 4nnt)al conFerenoc

5. Product evaluation (Check one of the following boxes)

tr No products were evaluated for implementation at this time based on employee input, review of sharps

injuries, and new product review.

Ef ttre following product(s) were evaluated for implementation. Use SFIA504B and/or SHA505 todocument the evaluation process.

Name of Device Times involved in incident Safetv device? Yes or NoBD ecliosO '7- Yel

J*enrq Sohoi ^

- 5wo ah€r

Name of Device lmplemented?Yes/No

lfno, reason for not selecting the product

B o 1a(c\ et,dc Mrutr lhejeopardizes patient safety or the success ofthe procedure6fls not more etfective in preventing exposure incidents

E Use jeopardizes patient safety or the success ofthe procedureE ls not more eflective in preventing exposure incidents

E Use jeopardizes patient safety or the success ofthe procedureE ls not more effective in preventing exposure incidents

Tbtnw ConPbarncc

Signature OSHA Compliance Officer

SHA5O| (Rev Aug 2014)

Date

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SAFIITY FIIATI.]RE EVAT,I ]A1'ION FOIIMS;\FETY SYRTNG E/DEVICF: - )InDICAL

Date: t,Nq,lt DepartnrentiOUlcc:r

Number of times used:

Please circle the most appropriate ansrve r for each qucstiott. Not applicable (N/A) may be used

if the question docs not apply to this particular product.

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1

DURING USE:The safety f'eature can be activated Lrsing a one-hlndcdtechnique.The saf'ety l'eature does not obstruct vision of the tip o1-the

sharp.

Use of this product requires you to use the sal"ety leature.

This product does not require rnore time to use tlran o non-sa{'ety

device.'I'he sal'ety li:ature rvorks rvellwith a rvidc variety <lf lrartd sizes.

l'he device is easy to handle u,hile u,earing glovcs.

The device does not intert'ere r.vith uscs that do ttot rcquire a

needle,'l'his device ofters a good vier.v o1'any aspirated tluid. I

'l'his device rvill rvork with all required syringe artd treedle sizes. I

This device provides a better alternative to traditional recapping. I

AFTIIR USE:Therc is a clcar and unmistakable change (audible or visible) I

that occurs rvhen the safety t'eature is activated.The saf'ety lbature operates reliably. I

'flre exposed sharp is perrnanentl,v- bluntcd or covcred alier use I

and prior to disposal.This device is no rnole difflcult to process alier use tltan non- I

Agree ....Disagreet2 3os Ni^

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15. 'l'he user tloes not need cxtensive t"rairtirtg lbr colrect operation. | 2

16. 'l'he design ol'the device suggests proper use. | 2

17. lt is not easy to skip a crucial step in proper use ol'thc dcvice. | 2

Ol'the above questions. which three are the rnost important to your sat'ety rvhen using thisoroduct'j tf'rt1J t tI

Are there otlrer questions rvhich you f'eel should be asked regarding the sat'etyiutility of thisproduct'.)

Non€

StlA50+\l (Rer' .lan l0l I)

Employcc:Product:

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STERTLIZER LOGand time of treatment.

Temperatures & pressure monitoring discs or chemical integrators may be attached

INSTRUMENT

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RESULTS OF EFFECTIVENESS CALIBRATION OR MAINTENANCE

DOCIO5 (Rev. April 2015)

DATE TIME OPERATORBEGIN

TEMPRR,ACHF:,I)

PRESSUREREA(lHF:,I)

AMOUNTOF'TIMF:,

OPERATORR,NI)

2.L.tE q.q 5DA harul. n, cZcs ^,:r\UY KVO9- to l ot ',oW 554lo-; t {Y br 5DAt2-l €tA11 PPC

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