Pathology Associates Of Lexington, P.A.
Pathology Associates Of Lexington, P.A.
Pathology Associates Of Lexington, P.A.
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        Pathology Programs/Activities
The following activities, creations, and programs have all been implemented, maintained, and constantly improved upon since 1983. These are a mere fraction of the total projects (I have a five drawer file, each drawer 3 feet long; & about two drawers contain just MY memos since 1975) and chosen as examples. Since this list was initially produced for a specific presentation, except for items 46 and higher, this list begins in 2003 and proceeds chronologically backwards toward 1971 when our group began with (in 1971) Lexington County Hospital.
  1. Urine cytology observations and reporting details revised 12/03 to maximize thoroughness (to include medical info in hematuria cases) and smooth out reporting terminology to continue to enhance the LMC image of being maximally helpful to our urologists. Beginning in 2004, significant efforts to contain all info as one-page reports.
  2. Capable and poised for development of an LMC independent blood center if needed, from 2004 forward (requires hugely valuable leadership talent). In the meantime, we have positioned ourselves as strongly as possible with American Red Cross. And we created (about 2002) our emergency "walking emergency donor pool" among the LCHSD employees (see below).
  3. We devised the Foreign Missions Medical Program to work (1) immunizations for short-term church mission trips through the Gilbert CMC...through Connie Watson...idea launched 10/23/03…has not been supported and currently stalled. (2) It was hoped to include a network of referral sources who would work with missionaries returning stateside with health issue s to be addressed, including routine screenings. But then, Dr. Shaw met Dr. Barney Davis in early August 2007 & hopes we can work with his missionary medical support effort newly relocated to Columbia.
  4. We were trying to get Marketing/Information Services/Medical Records to activate "My e-EMR" on line, by FAX, or by toll-free telephoning of outside-contributed, important medical history notes and updates to LMC’s EMR for patients (and potential patients) in our catchment area. First case e-mailed to LMC Oct. 2003. Hopeful help to LMC-ED. 11/04 Pete Hankins and "My 911" for county EMS may be a similar fit. In late May 2005, this need may have been neutralized by a national on-line EMR effort, iHealthRecord (now defunct). By July 2005, another option (by subscription) is (now defunct). There, nevertheless, is a great need for area patients to be able to add info into the LCHSD EMR about their critical health information from doctor visits and expert referral visits so that the info can be available should they end up in our ER (1) from an accident & unconscious or (2) unable to communicate as a result of a disease complication. As of 2012, this may be possible when the new Epic EMR program is launched.
  5. Supported and launched (closely with Shirley Hilton & Ann Beamon) the LMC Medical Technology School in 2003 (now one of only 3 Medical Technologists schools in S.C.). Since 1984, under our leadership, the LMC lab has related to local community phlebotomy training programs (such as at Midlands Tech), MUSC’s medical technologist training program, and provided OJT histotechnologist training and OJT pathologist assistant training. As of 2012, a number have gone to become certified.
  6. Mutual help: We used our private LML resources in 3/2003 to R&D, staff, and perform HC2 (Digene) on Pap smear samples (the only Midlands lab at that time doing HPV in-house) for which LMC charges patients and derives the income (reimbursed LML only for hourly and direct expenses)…upgrade opportunities (CISH) currently being investigated, beginning 11/2003...stalled due to contract status. As of August 2005, we had hoped to change to CISH by end of 2005 (and, by summer of 2006, another possible marker)...a potential real advantage [HPV testing]  to doctors & patients (but supervisor's husband's death, testing space limits, & then concerns about national advertizing that Digene was the only FDA approved test threw things on hold). The CISH hope has come & gone by 2012.
  7. Created Lab Tests on Demand, a unique, patient-requested (patients can order their own tests) lab testing service, in early 2003, a concept developed by Carter & Shaw in 1973 and first implemented at LMC in 1986. In order to jumpstart delays, PAL created the LTOD website & prepaid a year’s hosting of the website...2/04 received criticism for allowing the LMC logo to "ride" on the website...and then we were asked to allow the Lab Tests On Demand website to be absorbed into the LMC website (no offer to purchase or even give credit). Finally just got our own website. Highly positive LMC image producer and added revenue to LMC.
  8. Emergency Blood Reserve Program (an in-house LMC employee "walking" donor pool) launched in early 2002 (after discussions since 1980 of emergency donor registry within LMC) but proved too unwieldly. Have advised LMC of fozen blood program (done in Chicago in 1977) and our own county blood service (both would be difficult to impliment & need LMC backing & approval).
  9. Breast Cancer Program:
    • 1987, next-day Fax of breast core biopsy diagnoses, HERE.
    • 1990, breast fine needle aspiration began. HERE.
    • 1997, breast nurse navigator began (Deirdre Young, R. N. as Nurse Coordinator for Breast Health Services)
    • 1997 launch of program: Because of our history of rapid reporting of core biop[sies, LMC launched its "Five Days Detection to Diagnosis" comprehensive multidisciplinary breast cancer program. This added a high quality LMC image.
    • about 2000, to help offices scanning records, we got a high percentage of all reports into one-page reports which included an orderly, briefly synoptic diagnosis area which was highly popular in the treating physician arena.
    • 2001, Kelly Jeffcoat, R. N. became the Nurse Coordinator and Deirdre became Manager for Cancer Programs & headed the entire LMC Oncology Program toward CoC accreditation
    • May 2005, breast program = the featured underpinning of LMC just (May 2005) having won "accreditation with commendation" for its cancer program (American College of Surgeons...ACOS...Commission on Cancer [CoC] accreditation program), HERE.
    • about 2006, we instituted rapid fixation processing (new automated progessor set-up) of lumpectomies to reduce turn around times below one week.
    • August 2010, initial accreditation of breast program by NAPBC.
    • 2012, our pathology reports, co-ordinating with conversion to EMR's and CoC demands for research-level synoptic formatting of pathology reports, we transitioned to full-fledged synoptic reporting.
  10. Node dissections: Additionally unexcelled cancer-cases lymph node evaluation ("agar depth stick"intense node protocol) system (especially for breast cancer and malignant melanoma) launched in October 2002 (on top of already unexcelled node program begun about 1999)…cost-effective maximized thoroughness in this life-saving procedure. In process of publication. We already had an outstanding process to recover and process nodes in all cancers; and we audited 2004 colonic cases and found that 80% of our cases recovered 12 or more nodes (an average of 23...Dr. Daniel's report of 3/21/05).
  11. PAL leased, in 2002, the FocalPoint robotic, computerized (artificial intelligence Pap smear screening image-analysis instrument, providing comprehensive service to LMC patients at a current cost (can’t yet be recouped in billing) to our pathology group of about $4,000 per month…the 1st S.C. lab to do so in S.C. Administration declined to acquire the service. We took an additional financial blow in doing this because (as of 5/18/05) BC-BS has still not made good on a large number of claims from 2002! This now provides both robotic and expert cytotechnologist screening of all Pap smears…maximum thoroughness. Now, with on-site HPV testing, our spectrum of Pap and surgical (biopsies and hysterectomies) examinations and interpretations allows the ultimate in patient-specific interpretation so as to address issues of false positive or negative concerns as to both tissue and HPV testing. This is a combined value far greater than the charge sum of the components. As with the case of "split billing", it would be a colossal demonstration of institutional ignorance of integrity of quality assurance were the LCHSD to seriously entertain the idea of "bidding out" any or all components of this Pap/GYN package to other labs [item: one of my non-medical college classmates recently proudly told me how his county "bid out" forensic autopsies...showing his complete layman ignorance of the importance of credentialing, capabilities in medical examination and interpretation, and medical "point of service"]. Beginning April 2007, we began real-time (rather than delayed QA reviews) Pap-biopsy slide reviews for concordance [e. g., S-07-4719]. Paps became the business of LMC (not PAL) in 3/2011.
  12. Dr. Armstrong joined us (PAL) in 2001. He has broadened on-site offerings in Coagulation & Hemostasis Testing (with recognition of a special niche in bariatric surgery cases) to the point that LMC is the regional referral source for special tests & especially and personally directed workups of odd bleeding and clotting cases.
    • Calculated to direct/attract an increased share of South Carolina Oncology Associate’s (SCOA’s) Greystone Blvd. discretionary testing to LMC…revenue and "affinity" for LMC.
    • Is thought to have application toward decreased morbidity and mortality in bariatric, orthopedic, and other "big" elective surgery cases, and renal dialysis cases.

    As of 2012, the incoming of cardiac surgery has required great changes in our coagulation testing and blood banking under Dr. Carter's leadership.

  13. Developed, in 2000, this area of LMC’s website with links to the medical information resources developed within PAL’s website…publicly available "consumer" info.
  14. Fine-needle aspirate breast cytologies: We began FNAs via Radiology in 1989 & Dr. Daniel did our first superficial FNA [S90-650] on Betty Shaw. Our final reports are FAXED the same day of specimen receipt from surgeon’s offices, 98% of the time, since 1995. 2003 revision of procedure-regarding report terminology & focus on limiting reports to one page.
  15. AND, beginning in 1994, we have consistently published NewsPath, a topical & periodical lab letter for our medical staff & ancillary personell…how to more effectively use our lab services.
  16. Lab test accuracy verification: Standard process in quality labs is to verify that an instument actually performs as claimed, that a test method/kit performs as claimed, and that each testing batch in the lab performed correctly. There have been numerous challenges from our dedicated clinical doctors over the years that have given us the opportunity to (1) detect flaws in test systems that our routine QA testing failed to detect and to (2) prove to the concerned doctor that our result is the dependable result rather than the dissimilar result on the same patient when tested in a distant commercial lab. A very few examples:
    • serum potassium test on the ACA: In 1989, we were able to use a chemistry instrument free for almost year because the company could not make it replicate the CV claimed for this test (hospital accounting paid for the instrument prematurely because they failed to check with Dr. Carter that the contract had been fulfilled).
    • acute myocardial infarction (AMI) profile: In 2000, cardiologists claimed that our profile was too sensitive and too many false positives. We studied 500 normal specimens without finding any "positives". We then saw the national "medical community" begin to more widely recognize ACS (acute coronary syndrome).
    • the SUDS HIV test: In 2003, this valuable rapid test was only reliable (and highly reliable) when it was negative. But the poor "positive performance" of the kit lead to the company discontinuing the product because labs in the USA could not properly use & defend the rapid & highly strong negative predictive value as being highly valuable.
    • serum pregnancy test: Since about 1990 & then 2006-2007, we have found this test to have a number of manufacturer problems that included heterophile antibodies causing false positives; then other problems that lead to us using two different methods and only reporting results when the two agreed. Even that has not solved the latest problem (7/07) which was an instrument mechanical problem we reported to the FDA.
    • testosterone test: October of 2006 an endocrinologist physician expressed reservations about our testosterone assay...that our values were off by as much as 25-45 ng/ml when compared to Quest laboratories. We did a study comparing both male and female samples run in duplicate with the Quest assay. Our values were lower, but our reference range is lower also. We had better precision than Quest who had some duplicate samples that showed a 50-80 ng/dl difference. The first low (7.6 ng/dl) sample we sent for LS/MS/MS (the gold standard assay) had a Quest report of a value of 234 ng/ml, but their immunoassay results were <20 ng/ml. When informed of this they filed a corrected report of 7 ng/ml. Our testosterone assay is sufficiently accurate and precise in our population. Any abnormally low samples could be sent for LS/MS/MS testing.
    • molecular testing: we detected a Factor V Leiden test positive control flaw defect that lead to a product recall...first half of 2008.
  17. Birthing & placentae: LMC has 2nd highest birth volume in SC. We began to examine more placentae after a CME course given by Dr. Doug Shanklin in Gatlinburg, Tenn. & taken in by Dr. Shaw 1978. Our Placenta Program became part of the basis for placental pathology exam excellence, a status widely known to be an effective defense against unreasonable OB/peds malpractice claims against hospitals. By 1990, we had a customized "green sheet" requisition (regularly updated since then) to assure our having some relevant clinical information and had a standard dictation and observation format for recording pertinent gross findings. In May of 1994, the lab became one of only a small number of labs in the United States who, in order to maximize the benefit to the mother and the newborn baby, perform a gross and microscopic examination on the placenta from every birth (but, the exam of every placenta was caused to be discontinued after four months). A national concensus conference concerning pathology examination of the placenta was held in Atlanta in 1997, & our Drs. Shaw & Carter were 2 of about 5 attendees from S. C. From 2005 to the present, we have been working on a standard approach for assuring appropriately full & pertinent microscopic observations. It is reasonable to have a gross & microscopic surgical pathology exam on every placenta from a gestation with any antepartem, intrapartem, or postpartum abnormality. HERE is this website's TOC as to placental pathology. In May of 2010, we discovered that L&D was discarding all placentae, unlabled, which were not "ordered" for a pathology exam. Hence, we could not respond to an urgent request fo consult concerning the placenta in a case of severe neonatal thrombocytopenia [CN10-15]. An urgent request was forwarded to the VP of nursing to have L&D at least attach identification to all stored placentae. In the fall of 2010, we devised (at the urging of Dr. Sharada Pai) and instituted a way to do frozen sections on placentae in formalin but not yet processed. In Dec. 2010, we instituted the Acute Chorioamnionitis protocol for cases with green sheet info making ACA likely.
  18. Comprehensive bone marrow examinations program: Our laboratory approach to bone marrow examination and interpretation is one of a small percentage of laboratories nationwide who routinely performs a maximally comprehensive examination. This has led to one of our pathologists being a co-author of a nationwide Q-Probes survey of bone marrow performance (during late 1994) throughout the United States, under the auspices of the College of American Pathologist. As of the second half of 2010, we have two Board certified hematopathologists in our group. In early summer of 2011, we began to report flow cytometry, ISH probes, and analytic molecular mutations in Hemepath, adding in-house flow cytometry in later 2011.
  19. Since 1994, an on-going, "full-court-press" for breast cancer workups which will address all of the details likely to be required for surgical oncology, medical oncology and radiation oncology, as well as patient AND doctor user friendly path reports…to include amplified thoroughness of exam for margin status and multifocal neoplasia using staged specimen processing and the in-the-lab Faxitron specimen X-ray machine [pathology component process]. The "yellow sheet" used for communication between the Breast Center & Pathology continues to evolve; and in 12/06, we began to include findings of calcific arteriopathy because that may have implications as to patient's cardiac status [L06-9885]. Next-day reports (initially by FAX) have been key to Breast Program success. In August 2009, we began to assign molecular type to breast cancers and to issue a "riskiness" statement, potentially in lieu of the $3200 commercial lab risk analyses such as Oncotype Dx & Insight Dx. By the end of Sept. 2009, we'd discovered the Magee prognosis formula & were able to calculate a recurrence risk score [L09-10475] and devise an on-line "calculator" for the Magee formula. In early 2010, we funded a 3-year audit of our breast cases as a basis for filing for a July 2010 NAPBC inspection for specialty-accreditation of the LCHSD Breast Cancer Program for which we got a 3 year certificate in August 2010. One of our first clinical trial cases was in June 2010 [L10-6305].
  20. Conceived and launched in 1994 the in-lab Hemochromatosis Registry of patient diagnosis and treatment of iron overload disorders -- the first, and now one of two (?), such programs in S.C. It was started after Dr. Carter (1) was called to the OR by Dr. Givens to see a black liver (wedge biopsy loaded with iron) and encounter a few other routes to the diagnosis of iron overload. Prior to then, medical school teaching dogma in the USA was that hemochromatosis was a rare disease. The patient management and treatment is directed/overseen by the pathologists (JBC).
  21. We organized the radiologist-performed, pain/comfort/safety controlled, outpatient liver biopsy program (includes a current liver profile and submission of clinical information from the office and access to the LMC EMR); this was one of the few, if not only (at that time), such programs in South Carolina (there were very few in the USA) since June 1993. When needed, the reserved serum can be reflexly tested for supplimentary information without need of another patient visit. In the summer of 2009, we added a member (MJS) to our group with special expertise in hepato-pancreatic pathology.
  22. Active civic/community participants: The laboratory works closely with law enforcement officials, including the Medical Examiner autopsy cases of the Lexington County Coroner, the Lexington County PTI (Pre-Trial Intervention) Program, and drawing of blood alcohols for the SLED program (since about 1993). Devised by & under the direction of Dr. John Carter, this effort has lead to measurable local improvement in AMI diagnostics and infant protection from sudden death (SIDS). Our pathology group was commended by JCAHO (their last inspection) for this unique and creative use of coroner’s autopsy information. A brief summary of this unique-in-the-USA quality and safety improvement program was published in the hospital's internal letter, the April 2012 issue of Stethoscoop.
  23. Prostate cancer diagnosis: Conceived and implemented (unexcelled anywhere in the USA) the precisely correlated and accurate prostate biopsy (with e-coil MRI matching capability) program in August 1992 (serving almost all urologists in the greater Columbia, S. C. area)…results/performance having been presented & published. Next-day reports have been key to Prostate Cancer Program success. We have continued to refine and expand reporting information while keeping the reports highly organized and benign ones limited to one page and malignant ones in orderly fashion to one or two pages. New urologists give rave reviews. In late 2006, LMC moved toward a nurse navigator approach. By April 2007, we began additional cancer characterizations in the path reports, including information from on-line tools. Reporting speed (TAT) impact on treatment choices. Sadly, by March of 2009, all but one of our urologists were having biopsies processed in another state by a commercial lab.
  24. Clinical laboratory results (early morning draw...early testing...program): Ours was the first and still one of only a few labs in South Carolina which is able to draw specimens, perform tests, and report over 90% of test results to the hospital nursing stations by 8:30 a.m. the same day (since 1988)…huge efficiency and cost savings to LMC. Emory University published this type of move on their part in 2004 as "ground-breaking". This has long had a favorable impact toward reducing length of stay (LOS).
  25. Dr. McMaster officially organized and created policies and procedures for the Employee Health Program in 1992; and, until 2003, he was the unpaid Employee Health Physician/Medical Director. And, Drs. McMaster and Carter have been Infection Control Committee advisors (an input for which other area hospitals have had to pay the local infectious disease internists groups) since 1990, Dr. McMaster being committee chair since 1990, Dr. Carter being chair 1986-1990; Dr. McMaster retired at the end of 2010.
  26. Radiologist-obtained deep fine needle aspirate (FNA) & biopsies: greater than 90% cytopathology diagnostic rate, significantly better than a national benchmark of excellence, 85%, as of 1990 (meets/exceeds Mayo Clinic). Begun about 1985, Dr. Shaw required that the radiologists also obtain core biopsies when at all possible. And, the FNA room being that the ER work, he directed that we make naked-eye assessment as to specimen adequacy rather than the much more proceedure-time-lengthening microscopic determination of adequacy. This was highly successful. Around the USA, howeve, most cytology departments tried to prove that cytology could be just as good as biopsy in making accurate diagnoses. But, by May 2006, Nationally recognized FNA expert, Dr. Jan Silverman, announced in a CME course in Pittsburgh that the contest was over and that the best for the patient was the obtaining of both cytology aspirates AND biopsy cores (see related). In the summer of 2009, we responded to our endocrinologist MSO practice in order to optimize reporting of thyroid FNAs among our 8 pathologists from diverse training backgrounds & age ranges. In August 2011, the onslaught of interest in moleular testing guidance of cancer therapies brought sudden challenges in proper stewardship of these tiny FNA samples.
  27. Heart-attack diagnosis: First in the Midlands (1994), STAT 24/7/365 Acute MI rapid lab diagnosis program for the 2nd busiest ER in SC (see related), having previously been the first in the Midlands to use cardiac isoenzymes in ER AMI diagnosis (about 1979). Yet, as of the end of 2008, competitor hospitals and the state DHEC have refused to allow our hospital to perform emergency, myocardium-saving emergency coronary stents. In 2009, our hospital exceeded the DHEC requirements & filed a CON.
  28. Blood Bank: Conceived and launched the Only S. C. hospital-based Preoperative Autologous Blood Donor Program in 1988…a great patient convenience to excellently support orthopedic and other elective surgical programs. We have since been in cooperation with cell-saver technology in 1992 and then intra-operative hemodilution in 1995. We ceased the autologous program summer 2010 due to scant utilization.
  29. Skin cancer, non-melanoma: We organized the Doctors-office-based, staged removal of skin cancers (without frozen section) so as to further maximize the conservation of normal skin (such as with cancers of the ears, face, and nose)...used primarily with Dr. Fred McElveen & some with Drs. Thompson & Clemenz. This is one of the few such programs in South Carolina. Hundreds of cases treated since 1987. This is a much more time-effective and less expensive alternative to the very expensive & time & OR-space consuming Mohs surgery (and obviates the need of the Mohs technique about 98% of the time). We have also taught this procedure in 2003 to Dr. Brett Carlin as a way for plastic surgeons to avoid prolonged hospital OR time. These doctors know that permanent section results with mapping (when needed) is available by noon the next day.
  30. Rapid breast and prostate biopsy diagnosis: ours is the only lab we know of where the actual results of both prostate biopsies (since early 1992…see) and breast biopsies (since October 1987) are reported to the surgeon’s office initially by FAX by noon the next day.
  31. Support Group Network: we conceived of & worked hard & successfully to influence the hospital to begin a support group network in 1986/87 (to the present) through the hospital library to help link patients up with various support groups.
  32. Medical School Teaching by PAL: From 1986-2009, from one to three of the eight (as of 2009) pathologists on staff are actively involved in instructing medical students in the pathology department at the USC Medical School…an unpaid, voluntary effort which reflects a high quality image of LMC to soon-to-be primary care doctors who might consider locating in our community.
  33. Immuno-techniques testing: Our special lab testing being available since early 1985, LMC was and is one of the few hospitals in the USA, of around 300 beds, supported by a laboratory program with rapid acute infectious disease immunological diagnosis (at next-door Lexington Medical Laboratories...LML) at a skill level associated with active on-going research. Dr. and Mrs. Carter invented the nationally-marketed test for mycoplasma infections; they continue to be consultants to at least one national test manufacturer. For over 10 years, Dr. and Mrs. Carter were among a handful of national experts who taught the technical and professional aspects of immunoserology testing at national meetings of pathologists and medical technologists. Includes influenza ("flu") and West Nile Virus. 
  34. New test appraisal & intellect-intensive testing: We launched LML privately in early 1985 at the direction of LMC’s CEO, who urged us to buy space in and do a private lab in LMOB because of his decision that there was not any LMC in-house priority due to space shortages and his perceived lack of likely utilization of projected immunology testing (though there was a top quality track record by Doctor & Mrs. Carter from Chicago). It has there-after functioned as an R&D-like new-techniques lab primarily serving the LMC/LCHSD. As tests become useable 3 shifts per day, we tend to transfer them to the hospital. Such a lab...including the intellect-intensive tests...must be mangerally nimble.
  35. RUSH/STAT skin biopsy diagnosis: LMC is the only hospital in South Carolina (and one of just a few few in the southeast) with STAT emergency skin biopsies for fluorescent testing of office-based, ER, or ICU/inpatients (by way of LML and PAL) with dramatically serious skin disorders.
  36. Have directed the proliferating CMC Labs since 1985 on a waived $12,000 per year contract (for Irmo only), essentially having little administrative support and minimal supporting authority. Lab directorate ceased for CMCs and Occupational Health, August 2004. But, wse have maintained influence through our lab liaison medical technologist.
  37. Program of Pre-med student training and work experience in specimen procurement service, now w/ at least 2 physician "alumni", 3 in med school and 4 pre-med currently PRN in program. (Began about 1985)…a link to soon-to-be primary care doctors (allowing them an inside and attracting view of LMC’s quality).
  38. Generally rapid surgical pathology diagnosis program: our lab is the only lab team in S.C. who provide routine surgical pathologist services throughout the weekend (since 1971...partially at our group's expense)…has had a long-term positive effect of rapid diagnosis and treatment turn-around-times, reducing length of stay.
  39. Lab Outreach Program launched in about 1988 and now brings in an estimated 450 tests per day (rate of added revenue to LMC as of 3/04).
  40. Coroner’s Autopsies, since 1971 (from the Lexington County Coroner) have allowed us to see a few inadequacies in our LCHSD system. Since the 1970s, inpatient autopsies have become scarce, nationwide. In the 1980s following the death ofthe spouse of an area pathologist in which the cause of the natural death was never pinpointed, we became more determined to place greater effort in pinpointing causes of natural deaths in our coroner's cases. These coroner's autopsies data have served to constantly help us refine the lab support for our ER/ED in diagnosis of acute MIs. We think that the integration of cause of death QA information from a Coroner's or Medical Examiner's system into the local medical staff QA program is highly unusual, perhaps unprecedented in the USA. And, these autopsies have been the basis to help publicize the problem with, and prevention of, SIDS (see item) and other issues.
  41. Agar pre-embedding was introduced by PAL at LMC in about 1978 and has been a key to several quality advancements in the diagnosis and surgical treatment of various cancers, to even include en block processing. Additionally of great importance is the fact that agar pre-embedding has allowed multiple small, separately clinically identified specimens to be confidently and accurately embedded in the same block. Our current annual block count is nearly 61,000 blocks per year. I estimate that the block count would be 2.5x higher had we not instituted agar pre-embedding (and the operational expenses would have been significantly greater). This technique underpins items lymph node processing and prostate biopsy processing.
  42. PAL has gradually been assigned responsibilities for other lab testing situations in the hospital and/or the Lexington County Health Services (Respiratory Therapy, Occupational Health, MSOs, and CMCs) District, having rescued the Respiratory Therapy blood gas analysis service following two (2) JCAHO inspection failures. The CMC responsibility went to CMC medical directors in about 1999, so we established the job of "lab laison technologist" in about the same period to indirectly support quality for the peripheral labs of the LCHSD.
  43. The wasted commandeering of LMC MSO employee time: PAL, through the main lab, is poised to direct (a) that all CMC and MSO reference lab work come to the main hospital lab and void revenue leakage to competitor reference lab sales reps who instruct those points of service that certain tests must go to their laboratories; and (b) save MSO and CMC staff time dealing with instrument, test, and reference lab representatives who should be directing their product and service solicitations through the PAL-directed talent at LMC and LML. We would capture now-lost revenue. More importantly, we would capture lab result information in case the patient shows up at a CMC or the hospital ER. Such would insure that peripheral points of service are properly synchronized with the hospital central lab and also insure that decisions are made by our top talent. May hospital's Aug. 2005.
  44. POC/Bedside Glucose testing: This is only one example of a large number of important single-issue testing situation stories. PAL has been dealing with this issue since around 1985 when we had to resist switching tests to nurses because the concept did not match a local or nationwide nurse culture prepared at that time for the necessary QA/QC rigor (Roper Hospital had just been served with a multi-million dollar lawsuit [societal impact of such lawsuits] based on improper nurse bedside glucose detection of a hypoglycemic infant). Our interim alternative was a highly reliable STAT testing service executed by the lab and the "early morning draw program". After weathering through many LMC cost-containment efforts, etc., we agreed to re-look at the issue in about 1992 when the i-STAT system came onto the market but was rejected @ LMC due to reagent costs except for some uses at LMC Extended care; bedside glucose testing by laboratory personnel was launched. We were able to smooth this out, achieving a high degree of success. Upon further exploration & availability of dependable technology, the time seemed "right" to further decentralize bedside glucose testing to the nursing staff in 2003. Not only was Dr. Carter a critical element of the "when" of this evolution of bedside glucose testing, he was able to effect several crucial features as to "how" the effort would be done and sustained. We expect this to bring in an even more significant revenue increment to the hospital. And (publications are coming out as of 2004) this testing holds significant potential to have a major effect on the bettering of morbidity and mortality statistics related to the inpatient care of all truly ill patients, especially those in the intensive care units. There should be significant reduction in LOS in the ICU, as well as total LOS. Continuing, Dr. Carter notified nursing on 7/5/05 of publications suggesting reduction of adverse outcomes with tight glycemic control intra-operatively...and an organizational meeting was held by him with nursing. LMC adopted a type of tight glycemic control program, forming a team in March 2006. By March 2009, our MEC approved a complex, nursing-enthusiastically-approved tracking form for subcutaneous basal bolus weight-based insulin orders & titration with bedside glucose monitoring.
  45. Congestive heart failure (CHF) BNP test: This is only one example of a large number of important single-issue testing situation stories. For over 5 years, CHF has been nationally targeted disease for diagnostic and therapeutic improvement. Plasma BNP is the first STAT-available blood test with an excellent chance of being able to separate CHF from all other entities causing shortness of breath, having a huge potential for causing ER triage to be safer and more efficient. Dr. Carter and the Chemistry section had to go through an intense process (even dealing with the president of the vendor company) before we could finally add this test in 2003. And, not only will this test help the ER, it has great potential for monitoring safety of decisions to manage and discharge from ICU and ultimately to discharge from the hospital. There are even developing indications that there may be some real value of BNP as a screening test (of potential MSO office significance). January 2007, Dr. Carter trying to offer pro-BNP which has advantages.
  46. A not-unusual current Part A day: On April 26, 2004, (1) Dr. Pai called Dr. Carter upstairs (on a moment’s notice) to meet with her and a vendor having to do with newborn metabolic screening. (2) Dr. Shaw met with President Mike Biediger concerning the controversy as to specialist vs. primary-care-doctor-performed colonoscopies at LMC. (3) Dr. Shaw made a presentation to Mr. Biediger (and gave him a printed outline for) a new proposed "center for excellence" of Back Pain Diagnosis and Treatment (a program essentially entirely unrelated to pathology and laboratory medicine). A typical Part A day contains innumerable lesser examples of these types of issues and other lesser…but still very important…issues akin to the above other 40+ items.
  47. *** Continuing 2004 and forward, from here on ***

  48. Prevention of universal leukoreduction of all blood products: From about 2002 into 2003, Dr. Will Armstrong originated a protest (at a huge personal expense of weekend and after hours effort) which lead locally, and then to the State Medical Association, to the College of American Pathologists, and then to the AMA which lead to defeat of a national effort to require leukoreduction of all blood products. There were many subtle financial and business situations in America with a great incentive to make this happen (not the least of which was the American Red Cross and the American Blood Commission), and it would have probably increased the cost of products between 20 and 35% per unit. This has resulted in a huge national savings, the maintaining of medical discretion in ordering, and significant annual savings for LMC.
  49. Website development: The group has put considerable effort into the development of the Lab area of the LMC website, has produced a website for Lab Tests on Demand (see this item), and has developed a PAL group website with significant information of always-available use to patients and healthcare workers in the LMC catchment area (the website information is not password protected…it is not advertised for use…but is available for use of those who seek laboratory information).
  50. Intense glucose management: PAL obtained information about January 2004, researched the information, contacted and met with Nursing, produced a lab letter on the topic, continued to work with Trudy (Seybt) Wales, and then made a presentation before the Intensive Care Committee on November 23, 2004 in instigating the initial beginning launch into this effort for the benefit of patients in general (reduced length of stay, reduced complications, and reduced death rate). We continue to take any opportunity to promote this effort (see this item). By 2007, a Tight Glycemic Control Protocol is available in the ICU & elsewhere & even being used by some anesthesiologists in surgury. But, there is still a lack of focused clinical leadership.  
  51. Liability defense: Laboratory direction has always contained a strong undercurrent of intentional efforts to assure that, through laboratory excellence of performance, policy & procedures, and autopsy results, the hospital and it’s medical staff would be strongly represented. One of the initial cases in memory was the patient back in the 1980s who filed a $50 million lawsuit naming the ARC and LMC over HIV being acquired during massive emergency transfusion prior to the national institution of specific HIV testing. Our placenta program has been geared especially with malpractice situations in mind. Involvement in the coroner’s cases has helped us shore up situations such as AMI detection in the Emergency Department.
  52. We think that the integration of cause of death QA information from a Coroner's or Medical Examiner's system into the local medical staff QA program is highly unusual, perhaps unprecedented in the USA.

    Yet, with a case tried in 2006, we found that a clever plaintiff's attorney in front of a weak judge could even cause a set of autopsy findings to be excluded (there were no DNA tests to prove that the slides were actually from the deceased) from a malpractice trial!!! The pathology group must avoid being successfully sued by limiting its practice to ethical situations.

    The group practice must protect itself by having a sufficient limit of medical malpractice insurance coverage (watch out!..there are big differences in "occurance" [covering a contested event happening during a particular year of insurance policy coverage] types and "claims made" [covering the event based on insurance coverage when the claim is filed] types).

    Since it is always unclear as to exactly what is a "med mal" issue and what might be a " directors & officers " issue, D&O liability coverage protection is also needed. This is a more obscure coverage . In connection with Credentials Committee, Dr. Shaw has been urging the LCHSD Admin. since 2003 to assure proper coverage of the LMC medical staff. A client might assure you that you are covered "under a $21 million dollar policy". But the client's Board of Directors may have 21 members. So, is the coverage actually sufficient? Are defense costs covered "inside the limit" or "in addition to" the claimed limit of coverage? Does it just cover damages or damages and penalties? If not, does the client entity have bylaws stipulating that it will reimburse you for expenses suffered in defense? Also there are laws that may prevent reimbursement for certain penalties. To be safe, you must additionally purchase your own insurance to cover this gap..."civil money penalty" coverage. Lastly, does any of this coverage have a "hammer clause"...a forced settlement clause...that the insurance company can use to limit their time and involvement?

    As of 2011/12, our medical staff is implimenting FPPE/OPPE monitoring systems of our practitioner performance. This system is loaded with risk of being a med mal "goldmine"; and we (EBS) have been in touch with CAP about such.

  53. Patients dealing with 3rd party payors: The above PAL website contains considerable information for the use of patients as they deal with 3rd party payers. Our group has been heavily involved in billing and coding issues since the 1980s, and we feel this has been a strong factor in accuracy of pathology and laboratory coding. In addition, for anatomic pathology, PAL billing is subcontracted to a highly experienced, pathology-only billing company for purposes of providing extra expertise in both accuracy of filing of clean claims and secondarily in dealing with patients as they run into problems with 3rd party payers. On the "front end" of billing, we have independent contractors who continually assure that complete information is received from doctors offices and from the EMR in order that the "clean claims" rate be as high as is possible. All of this extra effort and expense is applied by PAL in the hopes of having an LMC catchment area of patients who have been spared large numbers of negative experiences through our group's medical billing.
  54. Pathology and laboratory results reporting: Through telephone calls, e-mails, faxes, and extremely carefully crafted pathology & laboratory reports, information needed for the next step in patient care is provided to the physicians of the LMC catchment area. This is done in a fashion such that we have always received rave reviews of our performance, such performance having been a foundation upon which certain programs are developed (for example, the early morning drawing and reporting of lab tests and the rapid pathology diagnosis [ & #36] which underpin the breast program). This excellence has had a positive impact on bringing additional doctors on the LMC staff. While we attempted after-hours finalization of pathology reports through Sunquest in about 2000 for a year, March 13, 2007 [L-07-2188] saw us bring this on line through Citrix so that we can have an official access to the EMR and sign cases out from anywhere in the world that is on-line. [extended commentary]
  55. Medical staff committee work: Committee work is unpaid work. Unlike many hospital based physicians groups we have heard of elsewhere, PAL has been deeply and long-term involved in key hospital committees spanning many changes of both medical staff leadership and hospital administrative leadership. The strength of the pathology leadership in the Infection Control Committee allowed this hospital to remain independent of being orchestrated by the infection control internists downtown. The Institutional Review Board has functioned smoothly and at an ever more busy pace with the varied research interests of our medical staff. The Credentials Committee has operated in such a way that potential disasters over the years dealing with turf credentialing & other issues have been handled (beginning way back with the nurse midwife issue) such that the medical staff has been able to remain collegial and highly inter-cooperative. The intense review of physician applicants…many instances of sub-par applicants have been handled in such a way that the problem just disappeared (they never became medical staff members in the first place)…has excelled so that there have been no lawsuits related to sub-par credentialing; and only a few people in 30+ years had to subsequently be removed from having medical staff privileges at LMC.
  56. Bariatric Program: Dr. Armstrong, expanding from the considerations of possible hypercoagulability investigations prior to bariatric surgery, has put forth quite an effort to help LMC provide a more global-approach program to the treatment of obesity, a situation proclaimed advisable by the AMA, 11/04.
  57. Coagulation consultations on patients: Dr. Armstrong has instigated & slowly grown this service as our breadth and depth of coagulation testing has expanded. He currently manages most of the Midlands coagulation consultations on ambulatory patients which are considered unusually perplexing by the Midlands hematology/oncology specialist community. These consultations provide significant increased income for LMC & form a basis for keeping the scope of testing at LMC active in behalf of our ICU and ED...adding to the image of excellence of LMC.
  58. Heparin-induced thrombosis (HIT-II): Following the death of a bariatric patient possibly from this syndrome, Dr. Armstrong has expanded on his efforts through the appropriate hospital committees for heparin monitoring to now include consideration of a unique & cost effective protocol for the early detection of HIT-II. This issue will have safety impact in cardiac & peripheral interventional vascular, ICU, extensive surgeries, and in patients at risk for DVT. The rapid ability of a negative test rule out of the onset of HIT-II will avoid the un-needed emergency institution of incredibly expensive anti-HIT-II medication therapy. In 2011/12, Dr. Carter did serious upgrading of our ability to handle questions as to this daignosis.
  59. One page anatomic pathology reports: We had previously (about 1998) begun to push our cancer reporting into diagnostic templates. Especially since offices are beginning to store their copies of our reports by optical scanning and computerized storage, we began a significant "push" in 2004 to have the highest possible percentage of anatomic pathology reports become 1-page reports which are compact and rich in the information desired by the treating physicians. This additionally has the advantage of ease of handling a 1-page report in a physician’s office and represents a sort of "marketing effort" towards having all of our physicians increasingly happier with LMC. But, accreditation demands for bulkier documentaion have lengthened reports. In 2012 (with our CoPath upgrade), we will change the formatting so that diagnoses come first. [note about pathology report content] [extended commentary]
  60. Pathologist-performed superficial FNAs: Our pathologists support ENT, medical oncology and Radiation Oncology with pathologists-performed superficial needle (FNA) biopsies. Dr. Daniel began this in about 1990 on Dr. Shaw's wife, Betty.
  61. Pathologist-performed bone marrows: Until Dr. Tripp Jones came on staff (retired in 2011) as medical Oncologist in about 1979, doctors Calvert & Shaw performed all of the bone marrows. Currently, Dr. Armstrong has responded since 2001 to occassional requests from oncologists to perform bone marrows on some of their patients (sometimes while they are coincidentally under anesthesia in the OR for other surgeries).
  62. Lab "hotline": In about 1985, we dedicated a voice-mail as a 24/7/365 available way for medical staff & hospital personell to tip the lab or pathologists off to problems or requests. Each office was provided with "stickies" for their phones and for the physician’s automobiles and homes; and stickies were placed on all phones at the hospital nursing stations. Amazingly, we received almost insignificant utilization of this system; and it was discontinued. The current pace of workup indicates a need for a means of 24/7/365 lodging of requests from those physicians referring to the LMC lab. Within the past 5 years, we began having a Daily Operations Supervisor (DOS) who is in a position to solve all urgent problems/communications coming into the lab 24/7/365 (independently and/or in consultation with the on-call pathologist). For situations less urgent, and to be sure that we hear of suggestions, questions, or problems ASAP, we are re-instituting (as of 3/2005) a series of telephone voicemails, the 24/7/365 live line (803-791-2400)...backed by the daily operations supervisor beeper (DOS beeper) known to techs on all shifts.  Additionally, we have both FAX and e-mail points of input for the medical staff and nursing to utilize in dealing with the department of pathology and laboratory medicine. In the fall of 2008, we added another line (803-791-2015) in surgical pathology as a voice mail to take additional case information (clinical info, requests for additional biopsy reviews, etc)...went "live" 1/2009 [L09-38].
  63. Extramural support: We manage the liaison activities with the MSO office lab’s liaison (Karla Davis). Our Cytology section has always provided data on all abnormal Paps to our originating referral physicians. We have been involved with our referring urologists and gastroenterologists on some investigative studies coordinated through USC. We are currently involved in a program of data reporting with SC Endoscopy which will be coordinated through the Dartmouth Medical School. All of these activities either accrue toward additional patient safety or to the enhancement of the greater LMC image within the Midlands community. Shadowing within our department by highschool, college, medical students, and working with college, medical student, or medical & pathology residents with electives or medical projects are also activities we are involved in which add to the LMC image of leading-edge, outstanding quality.
  64. Lung lesion (CLEAT) program: Our rapid TAT has firmly underpinned the work-up of lung lesions in a manner quite similar to the LMC Breast program. The CLEAT program of several years ago stalled for uncertain reasons. We have continued the outstanding pathology foundation for such workups and have even added on in-procedure cytotechnologist support for Wang needle biopsies by Pulmonologists. Pathology is poised to be an active and positive component of any future reactivation of the CLEAT program (this is stirring again as of 2/2005). By early 2009, we benefit from the efficiencies exerted on these cases by the hospital's nurse navigator.
  65. Example, focus on OB-GYN issues: In the 3rd quarter of 2004, following an experience of rapid institution of the new Herpes type-specific test, we have started a "demonstration project" of an assembling of all OB-GYN issues which have come to our attention in 2004 and preemptively prepared to address these with our medical staff members of that specialty. This was addressed in writing to the appropriate medical staff in January 2005. We hope that this turns out to be an excellent supplement to our deliberate efforts to discover opportunities to enhance service through contacts in the Doctor’s lounge, through our group members' participation in medical center & medical society activities, & through our policy of having the pathologists of the Pathology group working on-site within the Medical Center at all times.
  66. ER Pneumonia patients and blood cultures issue: This issue came up in the 2nd half of 2004 and is an example of some of the types of issues which we pathologists end up being pulled into after the effort has already been launched by a clinical department.
  67. American College of Surgeons Cancer Program Accreditation for LMC: Dr. Shaw has served on the LMC Cancer Committee and coordinates the weekly Breast Cancer Conference & chairs the associated advisory committee. Dr. Moffatt coordinates the pathology component of the weekly (previously twice-monthly) Oncology Conference (a conference in place since the early 1980s). The effectiveness of both of these conferences is a significant key to being accredited by ACOS (and then maintaining accreditation). The excellent medical direction & pathologist performance of the Department of Pathology and Laboratory Medicine at LMC also impacts heavily on the chances of accreditation and maintaining accreditation. The January 2005 "mock survey" report was very positive...even recommending that we attempt the accreditation status of "accreditation with commendation". We were notified of successful "accreditation with commendation" about 25 May 2005. ACOS's NAPBC Breast Program 3-year accreditation was won August 2010.
  68. Prevention, early detection, and treatment of hematomas: by memo of 7 January 2005, Dr. Carter agreed that lab would work a joint hospital effort with nursing on this issue.
  69. Lab Expansion: As with every expansion and renovation since 1978, we have had to put in extensive planning time (including trips to other states) and "watchdog effort" to deal with the in-progress huge LMC expansion that will about double our lab space between 2005-2007. There are many competing interests, and  we (especially Dr. Carter) have had to be ever vigilant to secure proper space for this growing operation. As we go through this, we will do so with increasing lab volume and intensity of effort. Our most talented efforts at medical direction of all areas of the lab have been needed! 
  70. Protection of community quality: Drs. Shaw, Carter, & Armstrong put in significant effort during 2004 to help S. C. rid itself of AMA-unethical and Medicare/TriCare/Medicaid-illegal "split billing" of anatomic pathology (a form of "fee splitting"). "Split billing" is where a lab performs pathologist services for a clinical physician and then bulk- or client-bills that practice at a low rate (usually in exchange for the clinical pathology testing business). Then the non-pathologist practice uses pathologist CPT codes to bill the patient at full charges. That is, the referring physician bills for doctor services that they did not perform. Those who did perform them are not credentialed (as are over 600 physicians) on our hospital medical staff and may not even be licensed to practice medicine in S. C.! This practice has been fairly widespread in S. C. and had, at times, been widespread in Lexington County (but much less so since the formation of the hospital MSO). Some nonpathologists tried to characterize this split billing as simple subcontracting of services. A proposed law (H3891) passed, was vetoed by Gov. Sanford; and the legislature over-rode the veto on 13 January 2005 (Title 44 Chapter 132 SECTION 44-132-10) so that split billing became illegal in S. C. In 2006, we were approached about the in-vouge but unethical fee kick-back arrangement called "pod labs" (and Dr. Shaw attended a national meeting on these unethical fee-dividing schemes at the October 2006 national meeting of the ASCP).
  71. Protection of community supply of medical practitioners: Drs. Shaw, Carter, & Armstrong have put in significant effort during 2004-5 to help influence that S. C. legislate changes in malpractice laws so that practitioners won't "early retire" or stop providing "risky" but vitally needed services. The legislature unanimously passed a new medical liability reform law (S.83) in late March 2005, signed by Gov. Sanford 4/4/05.  
  72. POC AMI profiling at LMC-Lex and LMC-I...maybe even main ER: Working with Dr. Shuler, Dr. Carter began masterminding (2/2005) the implementation of this important heart testing at some of the outlying service sites, LMC-Lexington & LMC-Irmo (implemented several months later). [see Jan. 2008 memo]
  73. Coagulation & Thrombosis Committee: In March 2005, Dr. Armstrong was able to broaden the scope of this Inter-disciplinary committee (of which he is chair) from the narrow focus of Heparin Committee to that of how LMC deals with all such issues. A first effort was to institute a process to detect devastating heparin induced thrombosis...HIT (a patient had died of HIT) See here & here.
  74. ACT POC testing in OR: Since about 1998, we have discussed & explored doing this with Dr. Bill Moore. As of Dr. Armstrong's 16 March 2005 memo to Dr. Moore, we are "into" the start of making this POC activated clotting time happen. A similar set up is likely to follow this for the cardiac cath. lab; nearly in place as of end of May 2005.
  75. Photo reports: After Dr. Carter joined the group in 1984, he introduced the new communication element of photographic supplements to LMC pathology reports (1) in the form of "polaroids" pasted to heavier gauge paper and on which one can type or hand-write notations. He had, between 2002-2004, added on the aspect of color copies of such reports (the use of which often enhanced case presentations at oncology conferences). During 2004, many labs started locally to produce routine but sloppy reports with case photos in them...printed out from computers and arranged in the report. On 1 April 2005, we became able to do (2) special photo reporting through the pathology transcription system, CoPath. And, Dr. Shaw issued our first (3) website-based photo/sketch supplemental report on case LMC-05-2582, a nurse with bilateral breast cancer. So, we now have 3 routes to help add to excellence in pathology visual communication. [extended commentary] We may even be able to adapt this web-based report as a same-day, distant expert consult format. We look to that and pathology case photo contribution to the radiology Picture Archiving and Communication Systems (PACS) for purposes of complete tertiary referral and in-house conference support in 2007.
  76. Alert values: Since the opening of our hospital in late 1971, the question of when lab workers must pick up the phone and notify a doctor of a highly abnormal lab value (then and now often referred to as "panic values") changes with the times and situations. Dr. Carter has been caught up into bringing reason to the process, once again in 2005 [1st 2005 memo] [next 2005 memo].
  77. Deep vein thrombosis prophylaxis: See above. With much help from Dr. Bill Moore, Dr. Armstrong and the committee have established a page of selections of routine postoperative orders for heparin therapy selection & monitoring in addition to leg compression and ambulatory measures. Approval by the MEC for General, Vascular, & Thoracic Surgery on 15 August 2005. Since late 2004, Drs. Carter & Armstrong have explored various approaches to enhance ambulatory exclusion of DVTs with such as D-dimer. And, after discussions in 2005 with Mike Biediger about the topic, Dr. Armstrong chaired an effort to select patients by risk levels for postoperative thrombosis prophylaxis (there is no national practice standard); a proposed study went before the LCHSD's IRB. The study was withdrawn from IRB in Dec. 2020 due to lack of funding.
  78. Vitros 5.1 Chemistry Analyzer: Continuing leadership going back to about 1973 with Dr. Calvert's (LMC founding pathologist) influence in getting the first DuPont ACA in S. C. in 1975, Dr. Carter & Mickey Floyd lead LMC to be the first in S. C. & one of the first 16 labs in the USA to get this revolutionary 40-tests instrument which tests plasma, serum, urine, & CSF. Came on-line April 13, 2005 & published in LMC's "Stethoscoop" of Summer 2005.
  79. Parathyroid surgery: In early 9/2005, we began to again look at intra-operative PTH testing for parathyroid surgery. Implimented program 10 Oct. 2005. In 2009, we responded to our endocrinologists and instituted PTH analysis of juice from possible parathyroid adenoma aspirates.
  80. Endocrinology support: Many years ago (late 1970s), Dr. Wayne Cartee was next door as the local endocrinologist (he left in the early 80s). Now that Dr. Eric Klett has joined the staff locally (Sept. 2005), Dr. Carter has begun to revisit & amplify our onsite testing capabilities. A number of aspects of endocrine diagnosis have dramatically changed since the early 1980s (especially the specialized nuclear medicine scans). As of 2009, our MSO has two endocrinologists; and we focused on optimizing the reporting of thyroid FNAs.
  81. Rheumatology support: Dr. Nicole Klett had joined the staff locally (Sept. 2005) as our first MSO rheumatologist (she left about 2008). Dr. Carter has begun to revisit & amplify our onsite testing capabilities (our lab has an unusually strong foundation in immunology testing by way of transfer of Dr. & Mrs. Carter's expertise from Chicago). The Kletts moved on. In 2009, Dr. Bruce Goeckeritz became the MSO rheumatologist & has grown that group.In 2014, Dr. John & Sara Carter were resonsible for bringing the Image Navigator Automated Microscope for morphological ANAs, one of the first community hospital labs in the USA.
  82. Pre-term labor detection: In about 2001, Carole Belding, former L&D nurse @ LMC, became the sales rep for a reference lab test for "fetal fibronectin". A negative result means the mother is not in preterm labor & can be safely sent home. We promptly set this test up at LML at a much faster TAT than the California reference lab; but it was seldom ordered. In October 2006, in the midst of a space crisis in LMC OB, we have been asked to resurrect this service. But we were in the midst of lab renovation and a move in the fall of 2007 & some space decompression in OB. The need came forward again in August 2007; the LMC laboratory is now offering testing for fetal fibronectin, in house, 24/7 as of 10/8/07. [Jan. 2008 test performance memo]
  83. Colon cancer: Beginning in 2005, we began to attempt to integrate some idea of the malignant pathway in colorectal cancer cases as to familial or sporadic pathway of origin AND as to subtle findings that might indicate a need for adjuvant systemic or local therapy (still working on this as of 10/2006). We had already instituted highly specialized & focused node dissection in the late 1990s & thereafter often found cases with only one node positive. In 10/2006, we were approached by an oncologist requesting ("Your reports are already the best we have ever seen anywhere; so, I hate to ask anything else.") that we have a regularly orderly presentation of the gross dissection. As of an ASCP workshop in October 2006, we looked into instituting molecular testing or H&E molecular grouping on resections to help guide chemotherapy decisions (H&E-based molecular group designation began on some cases 11/21/06 [L06-9679]). And we began adding (Jan 2007) comments into reports concerning advisability of consult for systemic (chemo) or local (radiation) control, this case being at conference [L07-6294] & affirming that nonsurgeons pick up on these suggestions in behalf of patient.
  84. Prostate cancer: Since the early 1990s, we have reported great detail in our biopsy reports so that exact number of benign & malignant cores are known, composite cancer length is calculable, composit benign tissue length is calculable, Gleason pattern components are known & percentaged, and evidence of perineural space invasion or capsule boundary invasion are reported. "Expectant management" is a way to deal with cancer cases not thought to be aggressive in patients older than age 60 (as of late 2005). By early 2007, we are exploring ways to use nomograms to help produce some guiding opinion expressed in the pathology reports to aid in adequate determination of tumor aggressiveness risk for treatment selection. In early 2009, financial matters drew this biopsy material away from our program from all but Dr. Morrow. The LMC radiologists stand able & ready to perform biopsies.
  85. Calculated GFR: In about 2005, a nephrologist asked that we calculate these on routine chemistry profiles because congress was considering a law to mandate it if the medical community failed to do so. The formula recommended & used has since been discredited as having way too many false positives which have hamperted the use of radiology contrast materials in patients thought possibly to have renal disease. This issue was taken to MEC and reviewed in the August 2007 lab letter.
  86. Blood typing: In about 2006, a national movment (generated possibly by sellers of Rhogam) suggested that labs quit testing for weak Rh (Du). Unfortunately, our lab medical director had this come to our attention (a change had not been approved by Director of Labs) when an alert patient complained, frightened that her blood type had either changed or the lab was sloppy/erroneous. Policy was rectified (7/07) in that one should not change the way of determining something as important & publically known as blood typing in the absence of truly compelling reasons to do so. We typed everyone & Rhogam decisions to be made in the classical way until 2011 when we changed.
  87. Blood irradiator: Connected to the issue of leukoreduction is the classical method of irradiation of just those units of concern. As of July 2007, our hospital Blood Bank nows runs its own irradiator & can now deal with the issue on site 24/7/365. We verified its killing ability with both film & cell cultures.
  88. C-reactive protein (CRP): Since 1984, we have tried to promote the use of quantitative CRP for infection treatment monitoring. In around 2000, high sensitivity CRP testing was offered on Monday-Friday on first shift only with the interest being mostly for cardiac risk analysis. Finally, we received a request from one of our neonatologists about May 2007, Dr. Kirk Bass, to offer the test more frequently for our newborns for serial measurements in the diagnosis and treatment of sepsis in the newborn & as a guide for the duration of antibiotic therapy. And, we expanded the testing to Saturday and Sunday and into 2nd shift; and, by 10/10/07, we are usually 24/7/365 & by 3/08 fully available to all patients. As to neonates, we also added STAT placenta exams in April 2010.
  89. Melanoma skin cancer: we began to template important melanoma parameters into reports in about 2000. Our group's website carries a huge amount of melanoma info for practitioners and patients (prognosis info, etc.). In late 2006, based on one case, we co-ordinated making available a radiation approach to cases showing perineural space invasion. Though quite difficult sometimes, we attempt to at least review path reports of melanoma cases diagnosed in other labs and sent here for sentinel node biopsy, etc. In summer of 2007, for cases from non-dermatologists, we began to either incorporate a nurse navigator statement with phone number into path report [S07-9985] or to FAX practitioner with note advising of availabilty of nurse navigator @ LMC.
  90. Malignant-tissue banking: responding to LMC cancer committee and Radiation Oncology, we set up and began specimen acquisition for tissue banking through the University of SC (The S. C. Biorepository System) medical school [L07-5971] July 2007 & are the state's top contributor as of March 2008.
  91. Fighting "Helter-Skelter": in August of 2007, we became aware that the LCHSD was invaded in early 2007 by a fee "kick-back" lab which took two practices from us. In September 2007, we discovered that a huge mistake had happened; and this brought our attention sharply toward the problem of primary biopsies interpreted elsewhere, followed by radical surgery in the LCHSD's hospital. Through the LCHSD Sentinel Event process, we have spent great effort toward notifying key leaders in the LCHSD of the dangers of "Helter-Skelter" and failure to emphasize "point-of-service" practices for the MSO.
  92. Histologic-serologic correlations: via LML, in early 2008, we added (S08-1663) celiac disease serology testing and reflex correlations with prior biopsies, we having been less frequently able to add ANA and anti-skin antibody correlations to H&E and DIF skin biopsy interpretations and ANCA interpretations with maybe lung biopsies and atypical IBD colitis cases.
  93. Molecular Coagulation Testing: via LML, in 2008 we added testing for Factor V Leiden defects, the Prothrombin gene test, and the Coumadin Sensitivity Profile.
  94. ER STAT lab: Having watched the I-STAT for years (and proposed incorporation for ER in 1994 but we were vetoed higher up), we instituted POC testing in summer 2008 for creatinine to enhance rapidity of renal status determination for Radiology imaging using certain contrast dyes. By end of 2008, we are in plans for a small on-site STAT lab in the ER. This "pocket lab" went live in 2009, and we have very selectively added to the offerings (including PT/INR in June 2010).
  95. Molecular test expansion & addition of flow cytometry: brought in second half of 2011.
  96. Cardiothoracic surgery program & coagulation testing support: brought in first quarter 2012 to support the surgery which is to begin late March 2012.
 (posted 22 December 2004; latest addition 22 February 2015)
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