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esources Rfor Women’s Health

Volume 1, Number 1, October 1997 Endometrial Sampling Technologies for the Office or Clinic Forrest C. Greenslade, Ph.D.; José David Ortiz Mariscal, M.D.; Marian Abernathy, MPH

he health care gy for resolving some by a non-physician for most women. By con- provider working in or circumstances provider), increases accessi- trast, D&C requires an oper- T private practice has related to a woman’s health bility as well as acceptability ating room which increases a wide range of health care that can arise at different technologies from which to times during her life. Table 1: Comparison of Vacuum choose in diagnosing and Aspiration and Sharp Curettage (D&C) managing obstetrical and Endometrial sampling can for Endometrial Sampling gynecological problems. be performed to determine Access to a variety of tech- the potential causes of infer- Sharp Curettage nologies has the potential to tility, to evaluate abnormal help health care providers uterine bleeding, to diagnose Uses flexible plastic or Requires a sharp curette offer better, more appropri- or hyper- metal cannulae ate reproductive health care; plasia, and to monitor the effects of hormone replace- Does not require cervical Mechanical dilation often however, it can also lead to performed the overuse of some costly ment therapy. dilation technologies, such as ultra- or analgesia Paracervical anesthesia or sound, that may only be Vacuum aspiration is a sim- optional, depending on parenteral analgesic often available from specialists or ple, safe technology that can patient’s need administered in hospital settings. Other be used for endometrial sam- technologies provide innov- pling, and that, in many More convenient for — ative applications that can cases, can be used as an patient and provider be utilized in a wide range of alternative to sharp curet- settings. For example there tage or dilation and curet- Lower rate of complications — tage (D&C), a surgical pro- (uterine hemorrhage, are many occasions when infection and perforation) endometrial is appro- cedure that requires facilities with operating rooms (Table priate or requested for either Approximately 1/10 the cost — diagnostic or sampling pur- 1). Using vacuum aspiration of D&C per procedure poses. An endometrial sam- as an alternative to D&C pling technique using vacu- offers advantages for both Specimens consist of strips Specimens fragmented um aspiration can be per- the patient and provider. A of tissue with little blood and mixed with blood formed in an office or simple vacuum aspiration proce- clinic setting. This publica- dure, performed as an ambu- Office or outpatient Usually needs operating procedure room tion focuses on endometrial latory procedure in an office sampling: a useful technolo- or primary clinic (potentially Ipas Resources for Women’s Health 1 the cost of care; furthermore, um aspirator. By the early Suarez et al., 1983; Marik used to monitor the effect of the woman usually receives 90s, vacuum aspiration had and Tatarun, 1984; Hulka, hormone replacement thera- general anesthesia, increas- become the standard tech- 1988), so that Asherman’s py (Kaunitz, 1995). ing both her risk and recov- nology for endometrial biop- syndrome (associated with ery time. sy in the United States intrauterine adhesions and Vacuum Sources although sharp curettage is traumatic amenorrhea) may Endometrial sampling Technologies still used (Hulka, 1991). be less likely following vacu- devices achieve suction in Report um aspiration (Grimes, one of three ways: a vacuum Endometrial sampling Safety 1982). syringe, an internal piston, devices employing vacuum The safety advantage of vac- or a vacuum pump (Table aspiration provide in-office, uum aspiration over sharp Effectiveness 2). The Ipas MVA syringe diagnostic and monitoring curettage is supported by Histologic analyses of features a locking valve services minimizing the need research on vacuum aspira- endometrial tissue provide which allows the provider to for procedures requiring tion for a variety of indica- health care providers with establish a vacuum before D&C. tions. This body of research important information con- beginning the aspiration spans 30 years, encompasses cerning adenocarcinoma, procedure. Internal piston The use of vacuum aspira- over 80 studies, and involves atypical hyperplasia, polyps, devices generate suction that tion for more than 500,000 patients submucosal myomas, chron- draws a column of tissue into has been well established (Greenslade et al., 1993). ic inflammation, and proges- the tube when the piston is since Grimes’ 1982 analysis Vacuum aspiration removes tational effect in anovulatory withdrawn. Both mecha- of 13,598 sharp curettage less of the basal layer of the cycles (Baughan, 1993). nisms may be manual or procedures and 5,851 proce- than sharp Aspiration endometrial sam- electrical and are reusable. dures using the Vabra vacu- curettage (Hale et al., 1976; pling devices can also be

Table 2: Endometrial Sampling Devices for the Office or Clinic

Vacuum Source

Locking-valve Syringe Internal Piston Electric or Mechanical Pump

Characteristics Flexible cannulae, reusable Entire device is disposable Cannulae and collection of Use or disposable; reusable chamber disposable syringe

Sampling Plastic (2-7mm) Cannulae Plastic (2-3mm) Plastic or stainless steel (2-7mm) (external diameter)

60 cc syringe collects large, Slim flexible device Sample chamber collects Endometrial diagnostically adequate sam- collects small but specimen; compares favor- Samples ple with a high ratio of diagnostically ably with those obtained by endometrial tissue to blood adequate sample diagnostic D&C clot.

Ipas Gynecologic Aspiration Examples Pipelle, Z-Sampler, Tis-U-Trap, Vabra Aspirator, Kits with Cannulae & Syringe Gynosampler, Pipet Masterson Endometrial Biopsy System Curette

2 Resources for Women’s Health Ipas Cannula better quality than sharp cancer (Suarez et al., 1983) Endometrial samples Ipas 4mm flexible plastic curettage samples, as there and, when performed with obtained with MVA are par- cannulae for endometrial were larger strips of tissue , superior to ticularly valuable for biopsy have two whistlecut and a higher ratio of tissue sharp curettage (Goldrath research because large sam- apertures near the distal end. to blood clot in the speci- and Sherman, 1985; Suarez ples can be obtained to pre- Novak’s 2-4mm cannulae men, facilitating pathologic et al., 1983). pare endometrial cells for tis- and Randall’s 4mm cannula diagnosis (Hale et al., 1976; sue cultures. Examination of for endometrial biopsy are Suarez et al., 1983). Mateo Sanez et al. found cell cultures derived from reusable and made of stain- 92.2% of samples obtained such samples yields valuable less steel. These cannulae Furthermore, MVA was with MVA were adequate, as insights into various aspects attach to the syringe via found to be as good a diag- compared with 84.4% of of reproductive physiology, Luer-Loks. Internal piston nostic tool as sharp curettage samples obtained with including certain types of devices are plastic and usual- in detecting endometrial Novak’s cannula. . ly 3mm in external diameter. Pump vacuum sources use stainless steel or plastic can- nulae ranging from 2-7mm What is MVA? in diameter. MVA is a simple yet effective vacuum aspiration technique. This innovative technology consists of a flexible plastic cannula that is connected to a Endometrial manual aspiration syringe with a locking valve to perform an endometrial Sampling biopsy or a uterine evacuation. MVA is a very effective method and safer with Ipas MVA than sharp curettage. With the MVA instruments, a qualified health care Instruments provider may perform a wide range of ambulatory surgical procedures A number of studies evaluat- using the capabilities already available in the office or treatment room. ing endometrial biopsy per- Thus, the patient is not forced to be admitted to a hospital and instead can formed with MVA demon- undergo a safe and effective procedure in a private setting. strate it to be an effective and safe technology for col- lecting endometrial samples MVA Instruments Characteristics (Hale et al., 1976; Ladipo, ◆ Manufactured with high quality standards. 1976; Suarez et al., 1983; Goldrath and Sherman, ◆ Easy to learn: Each instrument kit contains detailed and illustrated 1985; Mateo Sanez et al., instructions to facilitate learning the operative technique. 1994). ◆ High level of effectiveness, safety and patient acceptability. Tissue samples collected with MVA were consistently ◆ Of practical use in the medical office, clinic and hospital. adequate for histologic diag- nosis (Hale et al., 1976; ◆ May be used with local anesthesia (paracervical block) so that the Ladipo, 1976; Mateo Sanez patient avoids the risk of epidural or general anesthesia. et al., 1994). Hale found MVA superior to sharp ◆ Of great application in ambulatory surgery. curettage in sampling the cornual regions of the . ◆ Portable, not electric. In Suarez’ study, 82% of MVA samples were adequate for diagnosis compared to Combining all these characteristics, MVA yields a significant benefit for both 76% of those obtained with the provider and the patient. sharp curettage. MVA sam- ples were judged to be of

Ipas Resources for Women’s Health 3 Use of MVA for endometrial Contraindications biopsy requires little if any and Precautions What are the pain control medication. There are few contraindica- applications of MVA? The procedure generally is tions to office endometrial completed in less than one aspiration. Endometrial MVA’s applications in gynecology and minute (Ladipo, 1976; biopsy is contraindicated obstetrics include the following: Suarez et al., 1983; Mateo with known or suspected Sanez et al., 1994), with pregnancy. If cervical, uter- women reporting minimal ine or pelvic infection (e.g. Endometrial Sampling pain (Ladipo, 1976; Suarez acute pelvic inflammatory et al., 1983; Goldrath and disease, chlamydial cervici- ◆ Primary or secondary infertility Sherman, 1985; Mateo tis) is present or suspected, Sanez et al., 1994). In the endometrial biopsy ◆ Abnormal uterine bleeding Ladipo’s study, no pain med- should be delayed until ication was administered, antibiotic cover is estab- ◆ Amenorrhea and 10% of the women lished. When cervical experienced light or moder- stenosis is present, dilation ◆ Hyperplasia ate discomfort. Mateo Sanez may be required. The proce- et al. found that the women dure should not be done ◆ Endometrial cancer screening reported less pain with MVA without emergency backup than with Novak’s cannula. for women with a history of ◆ Chronic endometrial infections Studies with MVA also doc- blood dyscrasia because of ument its safety for endome- the risk of hemorrhage. ◆ Monitoring in hormone trial biopsy, with no major replacement therapy complications reported. Conclusion Ladipo (1976) reported Modern vacuum aspiration ◆ Intrauterine neoplasia some incidence of transient technologies for endometrial syncope. sampling are valuable tools for diagnosis and monitor- International ing. They can be used safely Uterine Evacuation Experience and effectively by trained Ipas has supported programs health care providers, ◆ Inevitable abortion to introduce the use of MVA including nurses or nurse for endometrial biopsy in midwives, to provide care in ◆ Infected abortion many countries. This office or clinic setting. experience shows that shift- Because typically no anes- ◆ Missed abortion ing from sharp curettage to thesia or operating room MVA improves patient care facilities are needed, vacuum ◆ Hydatidiform mole and reduces resource use. In aspiration can be used in one country, for example, more decentralized settings ◆ Incomplete abortion—retained rather than admitting that are more accessible to products of conception patients overnight for D&C, more women. A variety of MVA was performed in an technical approaches to in- ◆ early elective abortion through the outpatient treatment area office endometrial sampling first trimester and the women were able to are available and useful. Ipas leave the hospital shortly MVA instruments provide a afterwards. convenient, effective and safe alternative for delivering these important women’s reproductive health services.

4 Resources for Women’s Health Ipas Examination and Assessment Preparing Ipas Cannulae and Syringes Screening of patients should include a medical history, physi- Instruments need to be sterile when they are inserted through cal exam, and laboratory tests as indicated. In post- the . If sterility is not possible, high-level disinfection menopausal women, cervical stenosis may make outpatient (HLD) is the only acceptable alternative. Before being insert- sampling more difficult. If the working diagnosis is infertility, ed, the parts of dilators or cannulae that will enter the uterus the patient should be in the premenstrual (luteal) phase of should not touch objects or surfaces that are not sterile or her cycle. It is preferable to perform endometrial biopsy when treated with HLD, including the vaginal walls. the patient is not bleeding. A Pap smear may also be done at the time of endometrial biopsy. 1. Have ready a 4mm cannula and a single-valve syringe.

General Physical Exam 2. Inspect the syringe. To be effective, a syringe must be able Check and record the patient’s vital signs (temperature, pulse, to hold a vacuum. Discard syringes with any visible cracks respirations and blood pressure). Note the general health of or defects, or ones that do not hold a vacuum. the woman (whether she is malnourished, anemic, or in gen- 3. Check the plunger and valve. The plunger should be posi- eral poor health). Examine her lungs, heart, abdomen, and tioned all the way into the barrel and the pinch valve extremities, as indicated by the clinical presentation. should be open, with the valve button out. Bimanual Pelvic Exam The purpose of the pelvic exam prior to endometrial biopsy is 4. Close the pinch valve by to establish the size, consistency, and position of the uterus, pushing the button down and and to check for adnexal tenderness or other signs of infec- forward toward the syringe tion. Careful assessment of the uterus and cervix is essential tip. When closed, the valve Closing the Pinch Valve to the procedure. Prior to the bimanual exam, explain the will lock into place. purpose of the exam to the patient. She should empty her 5. Prepare the syringe by grasping the barrel and pulling back bladder and assume the lithotomy position on an examina- on the plunger until the arms of the plunger snap outward tion table. Drape the patient to protect her privacy. The prac- at the end of the syringe barrel, holding the plunger in titioner should wear clean, undamaged examination gloves. place. Check the stable posi- tioning of the plunger arms. Speculum Exam Both plunger arms must be fully Insert the speculum to expose the cervix. Note any abnormal- extended to the sides and smelling discharge. Check for signs of cervical infection or secured over the edge of the sexually transmitted diseases as well as pelvic inflammatory barrel. With the arms snapped disease (PID). Any suspected infection should be treated with in this position, the plunger appropriate antibiotics before aspiration. will not move forward and the vacuum is maintained. Pain Control Creating the Vacuum Assess the woman’s need for pain-control medication and Incorrect positioning of the administer as needed. Generally, because no arms could allow them to slip back inside the barrel, possi- is necessary for endometrial biopsy, analgesia and/or mild bly pushing the contents of the syringe or air into the anti-anxiety medication is sufficient to ease uterine cramping uterus. Never grasp the syringe by the plunger arms. during the procedure. If cervical dilation is required, paracer- 6. Check the syringe for vacuum tightness before use. vical block may ease the discomfort of dilation. Leave the syringe for several minutes with the vacuum Patient Preparation established. Open the pinch valve by releasing the button. Air will rush into the syringe, indicating that there was a Extensive preparation of the perineal area is not necessary. vacuum in the syringe. If there is not a rush of air, lubri- Ask the patient about any allergic reactions to antiseptics cate the o-ring with silicone and test the vacuum again. before selecting an antiseptic solution. Swab the cervical and Replace the o-ring or use another syringe if the syringe still vaginal areas with a water-based (not alcohol-based) antisep- will not hold a vacuum. tic solution, using sponge forceps and gauze or cotton wool. Wait 1-2 minutes before beginning the procedure, to allow 7. Repeat steps 3 through 6 to reestablish the vacuum at the the antiseptic to dry. time of the procedure. Steps for Endometrial Biopsy

3. Insert the cannula gently through the cervix into the just past the internal os, while hold- ing the cervix steady. Rotating the cannula with gentle pressure Inserting the Cannula often helps ease insertion.

4. Push the cannula slowly into the uterine cavity until it touches the fundus. Note the uterine depth by the dots visible on the cannula. The dot nearest the tip of the can- nula is 6cm from the tip, and the other dots are at 1cm intervals.

After measuring the uterine size, withdraw the cannula slightly.

6cm

Measuring Uterine Depth with Cannula

5. Attach the prepared syringe (vacuum established) to the cannula. With the index and thumb of one hand, hold the Any instruments or parts of instruments that enter the uterus end of the cannula, and with the other fingers the tenacu- must be sterile or high-level disinfected. Observe a No-Touch lum. Hold the syringe with the other hand. Make sure that Technique throughout the procedure: do not contaminate the cannula does not move forward into the uterus as you the cannula or allow the tip to touch objects or surfaces attach the syringe. before being inserted through the .

1. With speculum inserted, hold the cervix steady with a tenaculum and gently apply traction to straighten the cer- vical canal.

2. Dilate the cervix (if required). When performing endome- trial biopsy, cervical dilation is rarely necessary to allow passage of the 4mm cannula, although it may be required in some instances. In some older women, particularly post- menopausal patients, the cervix may be so stenotic that Attaching the Syringe to the Cannula dilation and passage of a cannula may not be possible in the outpatient setting. Some providers prefer to attach the syringe to the cannula before inserting the cannula through the cervical os. 6. Release the pinch valve on the syringe to transfer the vacuum through the cannula to the uterus. Blood, tissue and bubbles should begin to flow through the cannula into the syringe. Releasing the Pinch Valve 7. Movement of the cannula inside the uterus may vary according to the purpose of the biopsy. Detaching Syringe Aspirate tissue sample by moving the cannula gently and slowly back and forth within the anterior uterine cavity, If the cannula is detached from the syringe immediately without going beyond the internal os. Then rotate the following withdrawal, empty the contents of the syringe cannula and reinsert it until it touches the uterine fundus into a fixitive solution by opening the valve and pushing and aspirate the tissue sample from the posterior cavity in the plunger to eject aspirated tissue. If the cannula is not the same manner. In the case of hemostatic curettage detached immediately following withdrawal from the (biopsy), move the cannula gently and slowly back and uterus, the cannula may be used to draw fixative into the forth within the entire uterine cavity, rotating the syringe syringe, mixing the fixative with the aspirated tissue. as you do so. Then the cannula is detached from the syringe and the aspirated tissue is emptied into a specimen bottle It is important not to withdraw the cannula apertures containing fixative. beyond the cervical os during the procedure. Prepare and deliver specimen in accordance with local laboratory requirements. (Do not reinsert the cannula into the uterus after flushing with fixative.)

9. Decontaminate and process all instruments appropriately.

Manual vacuum aspiration is a procedure that involves minimal trauma to the uterus and cervix. However, in a small Aspirating Endometrial Tissue Sample percentage of cases, one or more of the following complications may occur: uterine or cervical perforation, hypotension, vagal While the vacuum is established and the cannula is in the reaction, pelvic infection, or air embolism. Some of these uterus, never grasp the syringe by the plunger arms to conditions can lead to secondary infertility or other serious ensure that they do not move from their locked position injury, or, in some cases, death. on the rim of the barrel. Accidentally allowing the plunger to slip back into the syringe may push tissue or air back into the uterus, possibly causing complications.

8. Complete the procedure. The procedure may be quicker and produce less discomfort than biopsy with metal curettes, and is complete as soon as an adequate amount of tissue is obtained for pathological examination. Withdraw the cannula from the uterus. References Resources for Women’s Ipas MVA instruments are Health is an occasional publica- Baughan, D.M. Office Endometrial tion of Ipas. It addresses issues available through these Aspiration Biopsy. Family Practice related to women’s health Recertification, 15(5): 45-55, 1993. including: introduction of distributors: appropriate technologies, quali- in order by country Goldrath, M.H. and Sherman, A.I. ty of care, women’s perspec- Office Hysteroscopy and Suction tives, research results, and expe- Curettage: Can We Eliminate the riences from Ipas’ programmatic SEMINA Industria e Femope, Ltd. Hospital Diagnostic Dilation and work. Comercio Ltda. 87, Palm Avenue Curettage? American Journal of Rua Vergueiro, 2994 P.O. Box 1543, Mushin Obstetrics and Gynecology, 152(2): Ipas is dedicated to improving CEP 04102-001 Lagos, NIGERIA 220-229, 1985. women’s health through a focus Vila Mariana, São Paulo, SP, Tel: (234-1) 4522016 on reproductive-health care. We BRAZIL Greenslade, F.C. et al. Manual believe that every woman has Tel: (55-11) 575-2452 DAROAN Ltda. Vacuum Aspiration: A Summary of the right to safe reproductive Pietro Mascagni No. 240 Clinical & Programmatic Experience choices and high-quality care. Trimedic Supply Network San Borja, Lima 41, PERU Worldwide. Carrboro, N.C.: Ipas, Ipas concentrates on preventing 40 Viceroy Road, Unit 6 Tel: (51-14) 476-0548 1993. unsafe abortion, treating its Concord, Ontario L4K 2L8 complications, reducing its con- CANADA LOZON (S) Pte. Ltd. Grimes, D.A. Diagnostic Dilation and sequences, and increasing Tel: 905-738-7272 5611 North Bridge Road Curettage: A Reappraisal. American women’s access to a broad Eng Cheong Tower #04-01 Journal of Obstetrics and Gynecology, range of reproductive-health Logix Egypt SINGAPORE 0719 142(1): 1-6, 1982. services. 54, Road 261, New Maadi Tel: (65) 299-9123 Ipas strives: Cairo, EGYPT Hale, R.W. et al. Histopathologic • to influence health policy and Tel: (20-2) 518-6981 SA Biomedical (Pty) Ltd. Evaluation of Uteri Curetted By programming decisions P.O. Box 4044 Flexible Suction Cannula. American through research, technical Ghana Social Marketing 22 Golf Course Road, Journal of Obstetrics and Gynecology, assistance and communica- Foundation Sybrand Park 125(6): 805-808, 1976. tions; 8 Gowa Close, Roman Ridge Cape Town, SOUTH AFRICA P.O. Box C1847, Cantonments Tel: (27-21) 696-5202 Hulka, J.F. . In • to enhance health-care Accra, GHANA Sciarra, J.J., ed. Gynecological providers’ expertise through Tel: (233-21) 772-823 Bright Trading Co. Ltd. Obstetrics. New York: Harper and Row, clinical and management 7-1 Fl., No. 25, Jen-ai Road, 1988. training; and Goodman Medical Sec. 3 • to improve services through Supplies Ltd. Taipei, TAIWAN ______. Endometrial Sampling in increasing availability of 335, Nathan Road, 8th Floor Tel: (886-2) 771-1539 Sciarra, J.J., ed. Gynecological appropriate reproductive- Kowloon, HONG KONG Obstetrics. New York: Harper and Row, health-care technologies. Tel: (852) 2332-4455 REMED Medikal 1991. Muhurdarbaki Cikmazi No. 5/4 Ipas Andrew Gold Ltd. 81300 Kadikoy Kaunitz, A.M. Endometrial Sampling 303 E. Main Street P.O. Box 8487 Istanbul, TURKEY in Menopausal Patients. Menopausal P.O. Box 999 Kingston CSO, JAMAICA Tel: (90-216) 347-7224 Medicine, 1(4): 5-8, 1993. Carrboro, NC 27510 USA Tel: (809) 929-1471 Tel: (919) 967-7052 Tecnomed J. Trapp, C.A. Ladipo, O.A. Outpatient Diagnostic Fax: (919) 929-0258 Johnson & Johnson Peligro a Puente República Curettage. Journal of the National Email: [email protected] (Kenya) Ltd. Edif. 142, P.B. Av. Este 2 Medical Association, 68(5): 389-390, P.O. Box 47591 La Candelaria, Caracas, 1976. © Ipas, 1997 Nairobi, KENYA VENEZUELA Design/layout by Beth Rimmer Tel: (254-2) 559830, 555571 Tel: (58-2) 575-2422 Marik, J.J. and Tatarun, I.V. Dilation, Fractional Curettage, and This document may be repro- Duke Medical Corporation Phamatech Nonpregnant Vacuum Aspiration. In duced in whole or in part, for CPO Box 3560 288/11B Nam Ky Knoi Nghia, Symonds, E.M. and Zuspan, F.P., eds. educational and/or non-profit Seoul, KOREA Quan 3 Clinical and Diagnostic Procedures in purposes upon notification of Tel: (82-2) 277-4274 Ho Chi Minh City, VIETNAM Obstetrics and Gynecology. New York: Ipas. If parts of this document Tel: 84-8-442-775 Marcel Dekker, 1984. are to be quoted or reproduced, Farma Institucional S.A. the author(s) names, document Durango No. 104-404, Col. Phamatech Mateo Sanez y cols. Biopsia endome- title, series title, Ipas, and the Roma 9265 Activity Road, #112-#113 trial por aspiración. Ginecología y date must be clearly cited. México, D.F. 06700, MEXICO San Diego, CA 92126 USA Obstetricia de México, 62: 395-398, Tel: (52-5) 208-2398 Tel: 1-619-635-5840 1994. Forrest C. Greenslade, Ph.D. President Dr. Fidel Rocha Cortes Suarez, R.A. et al. Diagnostic Ann H. Leonard, RN, MSPH Apartado Postal 566 Also available Endometrial Aspiration with the Executive Vice President Guaymas, Sonora, MEXICO direct from Ipas Karman Cannula. The Journal of Tel: (52-622) 21990 303 East Main Street Reproductive Medicine, 28(1): 41-44, Judith Winkler, MEd P.O. Box 999 1983. Vice President Hospital and Allied Ltd. Carrboro, NC 27510 USA 1, Carter Street Tel: 919-967-7052 or Ipas is an international not-for- Ebute-Meta, Lagos, NIGERIA 800-334-8446 (in the US) Ipas profit non-governmental orga- Tel: (234-1) 864052, 837703 Fax: 919-929-0258 nization based in Carrboro, North Carolina, USA. 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