- 1 - A STUDY OF THE HOSPITAL UTILIZATION LABORATORY TESTS OF CLINICAL MARTIN HOWARD FLAX A.B., Cornell University (1946) Ph.D., Columbia University (1953) M.D., University of Chicago (1955) and MICHAEL JOHN DINNIS BRAND B.Sc., University of Bristol (1964) Ph.D., Imperial College of Science and Technology (1968) SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE at the MASSACHUSETTS INSTITUTE OF TECHNOLOGY Signature of Author(s) Date Sloan School of ManagcS ntg, . Certified by ............. . a . Accepted by ........ "" UK;HIVES2 Lt~i.: ·: Date *i•a The•sis Supervisor - 2 A STUDY OF THE HOSPITAL UTILIZATION OF CLINICAL LABORATORY TESTS by MARTIN HOWARD FLAX and MICHAEL JOHN DINNIS BRAND Submitted to the Sloan School of Management on May 11, 1979 in partial fulfillment of the requirements for the Degree of Master of Science ABSTRACT A study has been made of the utilization of laboratory testing in a major teaching hospital. Two measures of laboratory utilization were considered: 1) the total number of tests performed in the chemistry laboratory over the past ten years and 2) tests used in the management of a group of patients with a diagnosis of uncomplicated acute myocardial infarction over a period of fifteen years. In each case, test volume data was compared with technological, environmental and cultural change within the hospital and laboratory. Both groups of data showed an approximately exponential growth in chemistry test utilization over the past decade. Over 90% of the total test volume in each year comprised a group of 23 tests. Although there was a dramatic increase in the number of different tests utilized, from 100 to over 600, during the period studied, new tests contributed little to the increase in test volume. Significant changes in laboratory technology occurred during the period studied, in particular the introduction of automated and multichannel analyzers. There was evidence that these technological changes caused a small increase in laboratory test growth rate, but the effect was predominantly in the facilitation of increased demand. Clear evidence was obtained of a change in physician behavior; there was a marked reduction in the average interval between tests and a greater tendency to use tests for monitoring as opposed to diagnosis in more recent years. Name and Title of Thesis Supervisor: Edward B. Roberts, David Sarnoff Professor of the Management of Technology - 3 - TABLE OF CONTENTS Page No. Chapter 1. INTRODUCTION 1.1 The Cost of Health Care 1.2 Laboratory Medicine . 1.3 The Clinical 1.4 Laborato ry 1.3.1 Clinical Labor ato ry 1.3.2 Clinical Labor ato ry Cost Factors Contributing Clinical 1.5 I to ea sea Chemistry Te ........... Objectives .......... Chap ter 2. ............ METHODOLOGY 2.1 The Hospital 2.2 Study of Total ........ 2.3 Myocardial 2.4 Technological Chemistry Chem istry Clinic al Laboratory Testing 2.5 ................ (1969-1 978)........ Infarction Study Change Within Laboratory ..... (1963-1978). the .. e......... Enviro nment 2.5.1 Chapter 3. Malpractice Costs TOT AL CHEMISTRY LABORATO 3.1 Total 3.2 Distri bution of Tests 3.3 Chemis try Test Costs ZAT Tests Performed ..... ... ..... •... ...... -4Page No. Chapter 4. MYOCARDIAL INFARCTION STUDY 4.1 Chemistry Test Utilization ................. 52 4.2 Intervals Between Tests ............. 57 4.3 Frequency of Abnormal Tests ................ 62 4.4 Test-Ordering Patterns 4.4.1 4.5 ....... (Grouping) Frequency of Test Combinations 62 Comparison of the Frequency of Diagnostic and Monitoring Functions Chapter 5. ................. 66 ................ 73 DISCUSSION 5.1 Laboratory Test Utilization 5.2 Factors 5.3 ...... Influencing Laboratory Utilization 5.2.1 Patient Factors....................... 75 5.2.2 Technological 5.2.3 Physician Related Factors Factors ............... ........... 76 77 Determination of Appropriate Levels of Laboratory Utilization .................. REFERENCES ....................................... 83 . 87 - 5 - Chapter 1.1 The Cost I INTRODUCTION of Health Care Health care expenditure creased exponentially in 1975. the United States has from $4 billion in 1940 to $118 billion The increase in Gross Na tional same interval has been from $100 Produ ct during the b illion to $1 520 billion. Thus the fraction of GNP spent on health care creasing, as shown in Table 1.1. increase has been a technological medicine which has an d scientific life itself. as health care costs continue to r ise, (1). in- re volution in thr ee decades. Increased costs were justified bec ause of the between medical has been A major caus e o f this cost taken place in the last placed on health, and even in- ver y high value It is ap parent that choices mu st be made care and other des irable goods an d services As a result, in recent years the costs a nd resulting benefits of health ca re have come under cri tical examina t ion and are a major publi c policy most other issue in the United States and industrial ized nations. Health care con sumers annually sp end about 25% total expenditures on pharmaceuticals, medical other products; the other non-product remaining 75% items as shown suppl their and is spent on wages, fees and in Figure 1.1 (2). Hospital care and physicians services are the two largest sectors of health care costs and together account for almost two thirds -6 TABLE - 1. I1 HEALTH CARE EXPENDITURE AS A FRACTION OF GNP Year Health Care Expenditure Fraction of GNP $ billions 1940 3.86 3.87 1950 12.03 4.22 1960 25.86 5.13 1965 38.89 5.69 1966 42.11 5.61 1967 47.88 6.03 1968 53.77 6.22 1969 60.62 6.52 1970 69.20 7.08 1971 77.16 7.31 1972 86.69 7.49 1973 95.38 7.37 1974 104.03 7.36 1975 118.50 7.82 Source: Social Securi ty Administration FIGURE FIGURE 1.1 Sectoral Analysis of Health Care Expenditures, 1975 Product Analysis of Health Care Expenditures, 1975 (Consumer Expenditures) 1.2 Billion $ $10.0 3.5 2.5 2. 1.2 0.9 9.0 25% Dental Car $ 7.5 Billic Medicine $ 10.6 Bil Total: $ 117.6 Billion Source: Arthur D. Little, Inc. estimates Source: Division of Health Insurance Studies, Security Administration Social - 8 of total expenditures Not unexpectedly, hospital (Figure 1.2). services have shown the fastest rising costs care are a and it has hospital costs (3). policy in the health been suggested that the is now the central rapid growth of problem of U.S. The rapi d ris e in hospital costs health care reflects the in- creasing sophisticat ion a nd complexity of the care provid ed. The cost of clinical among the labo ratory services was ing elem ents of thes e acc elerating hospital c osts. 1ead- Patie nts admitted to hospital s toda y expect and receive a battery o f diagnost ic tests and are als o used to mo ni- proc edures which tor thei r progress d uring Neither patients nor the been satisfied medical with less the course of their physicians who care hospital st ay. for them hav e than technical excellence in care. 1.2 Laboratory Medicine The practice of medicine has changed substantially during this century, largely as a result of diverse and continuing technological innovation (4). It can be argued that physicians' ability to alter the outcome of the disease was almost non-existent until the development of twentieth century pharmaceuticals. Successful application of these powerful therapeutic agents is dependent on accurate diagnosis which is increasingly achieved through sophisticated technological means. Diagnostic laboratory methods used in modern medicine - 9 include: (a) visualization: ultrasonic imagin endoscopy, x-ray, nuclear and g, (b) phy sio l ical me asurements pulmon- (c) inic al laboratory hematol- ary function, EKG EEG and ogy, microbiology immunolo g Y, biochemistry. Laboratory medicine can be c haracteriz ed by I) high imp act 2) increasing use and 3) incre asing costs. is a growing not surprising th at there of benefit analysis interest laborat ory medicine is focus ed on the studies have been cli nical it is, therefore, inte re st in the cost/ Much of this (5) laborat o0 y although .g . x-ray made of some other areas, There are a pproximate ly 15,000 clinic a the U.S. (7,8). not incl uding smal I p hysicians' of f while the remaind er are 1.3 are hospital in ce laboratories laboratories, independent. The Clinical L aboratory Laboratory medicine has participated the technological revolution. transformed this itive "cottage Significant industry" of producing anal ytical Among the innovations have capacity, capable data at a very rapid rate and quan- innovations that have brought about this (9): The introduction of quality control to the clinical in into a highly sophisticated, highly transformation are the following (1) in a major way branch of medicine from a relatively prim- automated system of impressive analytical tity. (6). aboratories f About hal f of the total of technology, laboratories in the 1950s procedures in- providing the essen- - tial 10 - element of reliability and confidence (2)The introduction of multichannel in the early 1960s permit ted in results automatic analyzers the rapid generation of large volumes of re latively rel iable data with minimal manpower (10). tec hnical (11) (3)The itating the int roduction of electronic data process ing facilinte rnal from the clini cal hand ling and transfer of labora tory data laborato ry to the clinicians. 1.3.1-Clinical Laborat ory Development These technolog ical devel opments have permitted the clinical laboratories to clinical demands for remarkable increase i over the past 20 year the period respon d effectively to the aboratory services. the util ization of (7,8); clinical atory tests. laboratory services Accord ing to national rate of 13.8% in surveys, hospital Figures from Engl and and Wales pat terns. tests were performed while In 1961, this laboratories labor- indicate similar 21 million laboratory figure rose to 46 million and reached over 90 mi llio n by accelerating rate of growth for laboratory tests chemi tries com prise about 30% of all laboratory growth 1971 There has been a 1970-1975, the n umbe r of clinical increased at an annua increased 1976, in showing again an Laboratory utilization at the teaching hospital of the Un iver sity of Minnesota tripled in volume from 1963-1976 , desp ite little change in the number of patients or other patient-related factors. In another study - II - from the teach ng hospital of the University of Rochester in 1971, Griner ly 40% ( 2) found chemistries accounted for approximate- of all bill; between atory tests aboratory charges and 965 and 1970, However, incr ease in growth in use of laboratory tests masks for patients w th different diseases. have also demonstrated accelerated cardial conditi ons increase in laboratory for acute my infarction bet wee n 1939 and 1969 sho wed exponential as well as x-ray a nd b•ctprinlnni examinations witho ut significant changes of hospitalization or pat ient mortality There are also tient populations treated in the duration (13) sign ificant differences utilization by diffe rent patients in hospitals A study of patients hospitaliz ed increased chemistry te sts cal hospital the number of chemistry labor- studies of se lected medical utilization. of the total in reased by 95%. The overall variability 10% in aboratory physicians treating com arable in a cl inic setting (14), for imilar in diffe rent teaching hospi tals (15) a teaching hospital compa red to a community hospital 1.32 Clinical pa- and (16). Labora tory Costs As indicated a bove, increasing clinic al have been a major contributor to the hospital services. This does not laboratory costs increasing costs of reflect labor atory ine ffic- iencies, but rathe r the greater utilization of services and expansion of new s ervices; only 50% of the 13% increase in - costs in 1975 was due to 12- increased unit costs. increase in the cost of services probably reflects is remarkably This 6.5% low, and laboratories increased effici ency of the related to automation. 1.4 Factors Contributing to Testing Increa sed Clinical These factors may be divided Chemistry into three major categor- ies: Laboratory factors Patient factors Physician factors I. Laboratory factors: (a) Increased capability and reliability of results, with development of automated multichannel (b) Advances in medical knowledge, analysis. particularly in the discovery of new relationships between biochemical alterations and disease. There has been a remarkable able laboratory tests from 100 tests at present. increase in 1950 to more than 600 One contributing factor is that old technology is replaced but not completely increased test pool retired, resulting in an size. (c) Perceived need to keep up with the ogy, in avail- in part necessitated by the latest technol- increased demands on the laboratories by the clinicians. 2. Patient factors: (a) The method of payment has changed, with increase in - 13 - third party payments for health care through private ance carriers, Medicare and Medicaid providing broader ance coverage. insurinsur- These are associated with decreased out-of- pocket expenses, particularly as a consequence of their ability as a fringe benefit as well as avail - the deductibility of health insurance costs from income taxes. (b) Local pital. factors such as "ca se mix" and type of hos- The introduction of increas ingly complex technology and sophisticated services, such as intensive care units has also stimulated laboratory utilizat ion. 3. Physician factors: (a) The type and location of training of the physicians has a major influence on laboratory utilization. Most physi- cians are trained in university tea ching hospitals, which tend to utilize the laboratories community hospitals ical research (16), into the laboratory tests. to a greater extent than and which are the location of clin- introduction and evaluation of new Furthermore thei r role-models are spec- ialists who, as a group, tend to us e laboratories to a greater extent; tended physicians who were found to be members of groups to be high users in which the leadership exhib- ited this characteristic. (b) Pressure by superiors and peers on house officers to do comprehensive work-ups and avoid missing diagnosis,and to avoid failure to monitor and detect changes in the - 14 - patient's condition. The type of practice also has (c) an influence. With increasing specialization, the attending physicians become less comfortable with medical problems ou tside of their area of expertise and are more reluctant to cr iticize and constrain laboratory usage by house officers in these relatively unfamiliar areas. (d) Increase response to in the practice of defensive medicine, less sign ificant in radiology. concept of frequent, to the hea lthy individual, regu ar systematic evaluation including multiphasic laboratory in which chemistry testing plays a significant screen ing (f) clinical is much The increased emphasis on preventative medicine has (e) of the tests laboratory areas such as in the clinical clinical chemistry, than led The con- increased threat of malpractice suits. sequent increased tendency to order additional in Relatively inadequate physician education laboratory medicine, giving rise to an role. in insufficient awareness of particular test characteristics such as reliability, or the diagnostic implications of various levels of test sensitivity and specificity. (g) hospitals. The initiation of quality assurance programs in These seek to establish minimal standards of care - 15 - for various diseases, and monitor conformance with these standards. these programs are not a In quantitative terms in recent significant factor tory utilization, incr eases since they are in clinical labora- concerned with minimal standards of laboratory usage rat her than the issue of excess utilization. 1.5 Objectives The objective of the present study was to examine depth the increase teaching hospital. excellence and n laboratory utilization This hospital in in a university has a reputation for serv e s as a model for the examination of factors contributin g to increasing laboratory test volumes. The approach we have taken is to examine both the laboratory as a whole and as utilized in a well-defined group of patients having a common principal each case we have reviewed the changes over an extended diagnosis. in laboratory testing period, ten years for the laboratory as a whole, and fifteen years for the patient group. technological, hospital environmental In In addition, and cultural changes within the have been documented where possible. This set of data allows us to evaluate the relative importance of factors affecting the utilization of laboratory tests. - Chapter 2 16 - METHODOLOGY 2.1 The Hospital The hospital with an is a 452-bed volunta ry, international reputation in the non-profi t hospital fields of ca rdiology, oncology, endocrinolog y, hematology and k i dney d isease, among others. It pioneered miany of the radiolog y techn ques standard use throughou t the world, and ha s been pediatrics and in the to insure survival teaching hospital medical development of immu n ologic now in leader in techniques of transplanted organs It i s a major in w hich patient care is integ rated with student, gradu ate and post-gradua t e phys ician train- ing and health-related research. The hospital adm its 14,000 inpatien ts annu ally, with an additional ambulatory and emergency case patients. Al 1 major specialities and sub-specia lities with the exception of ma ternity The med ical physicians. post-doctoral load of 235,000 inpatient servi ces are available. staff has a core of 240 full-t ime salaried They are augmented by 400 ho use off icers and fell ows and more iate, consult ing, than 500 m embers of the assoc- special and scientific staffs, and over 750 nurses. The n ursin g complement comprises registe red nurses, licensed pract ical nurses, aides, technici ans and hundred fifty students rotate from the medi cal and dental others. Four two health school s eac h year, and mo re than 800 students participate annual ly in a broad range of associated health profes- sions training programs. - 17 - Much of the daily activity at the hospital the health-related research vital medical organizations, over 300 to to the continued growt h of knowledge and improved patient care. largely by government agencies and is tied Supported private foundations a nd research programs budgeted at $8 million are conducted annually. During the period of hospital building was completed 96 adult beds, which the current study, one major new in 1973, adding approxim ately including a four-bed coronary care unit became operational in March 2.2 Study of Total Clinical ( CCU), 1973. Chemistry Laboratory Testing F1969-1978) The data on the numb ers of tests ical performed by the clin- chemistry laboratory was obtained from monthly computer print-outs which enumerate d the frequency of all formed during that period. initiated in 1972, Aggre gate data on the total chemistry tests beginning source; This computer program was first so that earlier data was not available through this source. hospital tests per- number of in 1969 was available from another these fig ures for total tests from 1972 on- ward corresponded very wel 1 with figures obtained from the computer print-outs. The monthly frequency of each of 23 major tests was determined for the period tests constitute over 90% the c linical 1972-1978. These of the total testing performed by chemistry labora tory. Data on admissions, tota 1 patient days and length of 18 - - stay were obtained from summary monthly reports of hospital activity. The interpretation of the aggregate 1 aboratory utili- zation data is somewhat complicated by chan ges which could con tribute to shifting patterns of laboratory utili zation. Su ch shifts are evident Table 2.1 which to service in t:his hospi tal, in recent year s. in 1973, ther e have also been r"elative o ccupancy levels on different services. For example, thiere has b een a progressive patients: adul t surgery , in 1970-71 to 25,60 0 increased only in surgical surgery grew from abo ut 15,600 patient in 1977-79, while adult medicine from 31,4 00 to 35,360 during Orthopedic surg ery also grew significantly 2.3 Myocardial i ncrease thoracic surgery and dental (combined in ea rl ier rec ords) days While there has increa se in patient days, associated with expansion of thie bed cap acity in the from a n examination of indicate s the number of pat ient days according been some overa Jll shifts in patient mix Infarctio n St udy (1963 - the same period. during this period. 1978) The purpo se of thi s po,rtion of the study was to compare the utilization of clini cal chemistry laboratory testing, a comparable gr oup of pa tien ts, during the last in 15 years. We selected acute myocardia 1 infarction because these patients generally requi re a subs tant ial and have benefi tted from volume of laboratory testing, inc reasingly sophisticated and spec- ialized care. Patients w ith uncomplicated myocardial tion were selected infarc- from among a larger group of patients with 0 0 TABLE 2.1 THE DISTRIBUTION OF PATIENT DAYS ACCORDING TO CLINICAL AREAS DEPARTMENT 1970-71 ADULT Medicine 31,430 Surgery Thoracic Surgery715,627 Dental Otolaryngology 1,349 1971-72 1972-73 1973-74 1974-75 1975-76 1976-77 1977-78 29,168 33,021 35,842 15,037 17,086 19,278 38,305 19,676 3,674 1,729 6,880 3,291 7,913 4,415 4,288 507 2,089 7,473 2,576 9,757 4,461 5,299 431 35,048 15,939 3,207 532 1,999 7,469 2,714 12,211 4,669 5,038 447 1,547 7,963 3,188 11,918 5,777 4,913 469 34,465 21,535 4,778 491 1,797 6,825 3,127 12,413 5,668 5,063 317 35,361 20,328 4,625 652 2,151 6,495 2,525 11 ,446 5,774 5,184 400 89,273 98,016 96,479 94,941 14,818 832 3,131 3,300 1,338 421 146 2,164 4,633 15,426 767 2,813 3,104 1 ,282 469 15,637 14,197 1,335 Gynecology 5,738 Urology Orthopedics Neurosurgery Neurology Opthalmology 3,622 7,488 2,241 3,137 414 1,703 5,893 3,167 8,606 2,924 4,171 362 72,046 71,031 79,130 87,206 13667 283 14,229 13,536 14,752 2,086 3,039 5,204 536 168 2,194 2,920 2,098 1,057 226 4,743 4,348 4,391 427 165 386 164 1,949 1,899 3,726 228 1,582 1,063 257 441 180 2,186 4,385 1,072 937 230 28,353 27,530 29,047 31,613 Adult Total PEDIATRIC Medicine -13667 Psychiatr Infectious Disease Surgery5,0 Thoracic Sur ger Otolaryngology Dental Urology Orthopedics Neurosurgery Neurology Ophthalmology Pediatric Total 3,341 1,389 1,059 586 80 1,088 2,137 3,758 1,503 389 93 2,888 4,161 1,419 335 105 274 4,863 1,901 4,336 243 2,693 4,155 1,151 700 187 226 2,034 164 32,836 32,827 32,871 32,753 940 870 898 905 978 - that discharge diagnosis. 20 - For the period 1963 through 1968 the study group was finally selected from among those with myocardial Starting infarcts by direct review of hospital charts. in 1970, the discharge diagn oses (in the form of International Classification of Disea se Adapted -ICDA-8) stored in a computer program, so that were a print-out of all patients with the discharge diagnosis of acute myocardial infarction could be obtained. From t hese data, cases with uncomplicated acute myocardial infarc ts were selected and their hospital charts were reviewed. cardiac arrythmias, congestive heart Only cases without failure or other compli- cations were selected for further ana lysis of laboratory utilization. For each patient studied, the hospi tal ined and all c linical on a daily bas is. ting 2.3. chemistry determina tion s were t abulated This yielded a comprehensive chart all chem istry tests hospital day. for the admission according Examples are tests were also tests were des ignated as abnorm al limits set by the cated with an asterisk [*] to if the values laboratory. desi gnation recor ded; fell in the study. outside (These ar e indi- in the example s.) Tables 2.4a and b compare some of the general of the patients tabula- illustrated on Tables 2.2 and The freq uency of abnormal of the normal record was exam- features The average age of the pat ents and the frequency of males to fema les did not change sign f- icantly throughout the study. on The re was a gradual reduct TABLE TEST 8/ TEST 7 8 2 .2 -- 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 SMA-6 - 1 (6 tests) + + + Sodium Potassium Chloride + CO2 BUN + Creatinine + (3 tests) Enzymes (4 tests) Patient: +' SGOT + + +, Glucose Bloodgases +- + + + +' +9 + Age: SGPT +, +, Dates of Hospitalization: CPK Isoenzymes LDH CPK 8/7/63 - 8/25/63 19 Days II (6 tests) Total Tests - 20 Calcium Phosphate Total protein + Test(s) reported * Abnormal result Albumin Bilirubin Cholesterol + Alkaline phosphatase Others Digoxin Pronestyl TOTAL 79 Hospital #158-110 LDH SMA-6 - G,M. 4 3---3 - 2 1 - - - - 6 - 1 - - - 22 - TABLE 2.3 ,Patient: A,E. Age 60 Hospital #99 87 39 Dates of Hospitalization: 2/16/77 - 3/2/77 - 15 days Total tests - 118 TEST 16 17 18 19 20 21 22 23 24 25 26 27 28 3/ 1 2 + + 2/ SMA-6 - I (6 tests) Sodium Potassium Chloride C02 BUN Creatinine Glucose Bloodgases Enzymes + + + + + + + + + + + + + + +, + + + + +, + + + + +* , + + + +, + - , + -, + (3 tests) (4 tests) SGOT ++ +* +* SGPT ++ + ++ +, LDH CPK + +, ++ +, +, Isoenzymes LDH ++ +, +, CPK SMA-6 - II (6 tests) Calcium Phosphate Total protein Albumin Bilirubin Cholesterol Alkaline phosphatase Others + + + Uric Acid +. +- Amylase + T5 Uptake T4 Free T4 TOTAL + + , , 5 5 +, + + + + + 27 23 12 6 4 1 4 6 7 5 6 5 - 23 - TABLE 2.4a YEAR NAME SEX 1963 C,R. C,A. D,M. F,A. AGE (years) LENGTH OF STAY M 54 15 days M 48 16 F F 56 72 17 27 G,A. F 69 24 G,B. G,M. L,F. M F F 63 79 70 19 19 23 M,F. F 62 21 " 32 M,D. M 68 33 " 71 S,R. M 62 21 " 37 P,J. W,A. F F 52 45 22 22 " " 19 28 Y,J. M 69 29 " 23 Average 1967 H,H. M,J. M,F. 59 73 41 Average 1968 1970 " 22 days 19 days 18 " 17 " 58 72 59 15 days 27 21 G,J. M 57 23 H,J. L,J. M,E. M M F 60 68 55 22 25 19 S,A. F 61 23 Z,L. M 76 24 Average 63 41 36 60 34 67 41 " 32 56 22 days 52 74 32 54 52 61 43 55 25 days 19 20 28 23 " 18 " 16 " 60 yrs. 47 47 67 64 " 63 yrs. 49 50 81 68 40 72 60 30 18 days M F M M M M F M F F 95 52 20 53 B,V. F,A. G,J. B,F. C,N. F,F. M,A. P,S. S,G. V,C. 26 23 67 58 yrs. Average 12 " 62 yrs. M M M TOTAL TESTS 21 days - 24 TABLE 2.4b AGE (years) LENGTH OF STAY F 80 15 days M 64 11 G.E. G,E. H,H. L,M. L,G. F M F M M 70 54 67 75 65 16 15 21 15 25 N,M. M 64 16 R,M. S,H. W,A. M M F 71 72 66 16 24 12 YEAR NAME SEX 1973 B,F. F,J. Average 1975 M M F F F 68 73 76 78 92 P,C. M 55 Average 1977 F F M M M M M 60 60 55 69 58 59 34 W,H. M 70 Average 1978 Average 24 90 106 59 66 95 " 121 51 106 76 17 days 14 days 21 " 15 " 14 " 18 " 21 88 17 days 15 days 19 16 18 19 22 12 17 63 75 58 17 days 20 10 M,M. F 61 15 M,R. M,M. M F 70 62 17 13 yrs. 84 17 days M M M 65 87 118 179 286 143 80 160 69 " 59 yrs. A,L. E,A. G,E. 75 76 87 101 75 92 " 74 yrs. A,E. F,H. F,R. L,G. M,F. P,S. S,K. 39 " 62 yrs. B,H. D,L. G,E. G,R. K,B. TOTAL TESTS 139 165 179 85 " 139 207 245 15 days 170 -25in the average leng th of stay of these patients (from about 21-22 days to about 15-17 days) and a remarkable increase in total 1963 clinical c hemistry to the present in utilization will laboratory determinations from The detailed analysis of the changes be provided in Chapter 3, and constitute a major element of the study. 2.4 Technological Change Within the Chemistry Laboratory The chemistry laboratory of the progressively study. incre ased automation du ing the period of this The timing of the instruments is outl ined were performed individual introductio man ual ly before blood urea n itrogen introduced (TP), (BUN), (AA) were introduced for for the determination of to tal (Alb), calcium (Ca), and alkal ine phosphatase analyses using an Instrumentation In the same year (1972), in automation were SMA 4+2 was NA, K, Cl, carbon dioxide (Creat.) and serum protein phosphate (Alk. Phos.). (P04 ) , The next i n 1968 of blood gas La bor atgry, This was supplement ed by a Corning changes (CI), c rea tinine major change was the introduction 1972. determinations In 1 964, additional aut oanalyzers were serum albumin uric acid All 1963; at which time dedicate d Technico n AutoAnalyzers glucose (GI). of various new in Table 2.5. the determination o f serum chloride (C02), hospital underwent 165 Inc. (IL-ll3). i nstrument oth er si gnificant introduced. A Technicon introduced for the simultaneous determination of C0 2 , BUN and Creatinine. Serum glucose and the 0 TABLE Year 63 Na 67 4 # K' Cl02 AA CO2 A AA DBlkl """ MANUAL 0-- - MANUAL 10 SMA 4+2 TP -4 Alb. -o MAN SMA 4+2 )Pp- P_.,i SMA 4+2 SMA 4+2 __ _ ABA- 100 4 Bilirubin -( SMAklIIAI . __ Amylase SGOKAAL SGPT LDH q - 4 -• SGPT' 4 - CPKL '" ALK. Phos•-*- MAN SNA -C I-1.L 113 Il . SSMA. MANUAL ABG II SMA .. ~ Uric Acid -MAN 0' SMA "''" SMA "e -- MAN -M P04 SCMA Pý] 4 MAN -I-- ,• -SM - MAN -P- - 0 > SMA 4+2 AA Glucose-' )- SMA 4+2 •- AA- 4 Ca 75 "AA - CREAT 2.5 -- CORNING 165 -.- AA po S*) MANUA ABA-100 --4- ABA-100 ABA-100 -- MANUAL .- *-- ABL-2 ABA 100.- - MANUALMNLA )----~ -- ABA-100 GEMSAEC *- GEMSAEC --GEMSAEC-)-- MANUAL AIMAN "AL '~""' - ..0- . A, ill ABA-100 --- ~ GEMSAEC --ABA-100 0---GEMSAEC •-. 4 - major enzymes - 27 (SGOT, SGPT, LDH and utilizing the Abbott ABA-100. determined with this CPK*) were determined Alka line phosphatase was instrument in 1973. The next major technological improvement occurred in 1976 when a second Technicon SMA-6 was introduced for the determination of TP, Alb, Ca, P0 4 , uric acid and A GEMSAEC was also introduced for a 11 at this time; serum cholesterol was 1977, and amylase in 1978. hilirhin enzyme determination determined by ABA-100 Finally , arterial blood gases were determined by the technologica lly superior Radiometer ABL-2 in 1978. A brief description of some of the main these a. features of instruments follows: AutoAnalyzer (Technicon Instruments, The AutoAnalyzer (AA), Inc.) developed by Skeg gs sents a first attempt to introduce automation mechanization) into the clinical chemical (17) (or at , rep re- least labo ratory. I The AutoAnalyzer utilized the principle of continu ous flow: a pump moves the sample blood serum and necessar y reagents along a series of plastic tubes continuously. methods are used * SGOT to separate serum proteins, dilute the is the abbreviation transminase; minase; Appropriate for serum glutamic oxaloacetic SGPT stands for serum glutamic pyruvic transLDH is lactic acid dehydrogenase, and CPK is creati- nine phosphokinase. - sample and add reagents - 28 in controlled proportions. Further details of AutoAnalyzer methodology a re given elsewhere Generally, the method of measurement other detectors can also be used. ments, reage nts product with the are added is photometric, although In photometric measuresample to produce a color req uired of the color is measured component, and the in a photoelectric intens colorimeter. rate of Samples are proces sed by an AutoAnalyzer at the 60 per hour. Each sampl e is placed which is loaded in turn plastic cup The instrument pre- is calibrated replacing samples wit h reference standards of known comThe output of the analyzer is either a chart position. recording of sample peak color heights (which are proportional to intensities) or a printed table of sample concentra- tions. Once the serum s amples a the analyzer can able saving b. SMA-6 run una ttended. loaded hich into the turntable, represents a consider- in operator time over earlier manual (Technicon Inst ruments, The SMA 6/60 (19). Inc.) performs six different chemical tests per sample at a ra te ot bU combinations of the six but the most common methods (Sequiential Mu Itiple Analyzer) is a contin- uous flow analyzer which Cl, in a small into a turntable for sequential sentation to a sampling probe. by (18). tests (t amples per hour. test profile) • - are possible is t he four serum electrolytes C0 2 ) plus two others (BUN, Creat.). Ditterent , (Na, K, Here, Na and K are - 29 - measured with a flam e photometer whil e the other tests utilize a photoelectric colo rimeter, as yzer. Another commo n combination 6 in this hospital) bumin, in a single channel bilirubin and AutoAnal- (in use with the second SMA- is calcium, phosp hate, total protein, al- cholesterol. Operation of t he SMA-6 is not s ubstantiall y different from a single channe 1 AutoAnalyzer. into cups Serum sampl es are loaded in a sampl er turntable and ment operates automa tically. thereafter the on a chart recorder recorder output for which is sufficient for One tec hnician routine operation of the instrument. instru- The result s are obtained is designed to be easi ly read; a single patient sample is s hown the in Figure 2.1. c. ABA-100 (Abbott LIaboratories, Inc. I) The ABA-100 is an automated dis crete sampl e clinical analyzer comprising a spectrophometer , a pipetto r-dilutor, and an electronic da ta-processor and appropriate reagents are dispensed plastic multi-cuvet mounted The is measured for each sample in tu rn by the spectrophotometer; color proportional to required analytical time interval intensity is concentration. The in- repeat measurements at fixed intervals of up to 20 minutes. eration and Th e required reagents to produce a color- intensity of this color strument can be programmed to S amples and into wells of a disposable in a wate r bath. sample compo nent reacts with the ed product. printer. Depending on the mode of op- selected, the instrument is capable j '-~-~--'~~~~ ~ - 30 - FIGURE 2.1 SMA 6/60 SERUM ANALYSIS Na± meq/liter 160 + K meq/liter 10 CI- COn meq/liter 9 o' dr meq/liter 40-- - CHART BUN mg/dl 100 Creat. mg/dL 15 14 150 9- 120- 90 - 140 13 130 8- 110- 80 - 12 - 30 120 11 7- 110- 70 100 10 100 6- 90- 60- - 9 90 B_ 8 20-- 80- 5 80- 50 - 7 - B- 70- - 40" - 70- 60 6 - 5 10- 50 3- 30 -- 4 40 30 2. 20 1 10 3 20 C- 10 0 Na + 0 K+ n. -0 - CI- CO, BUN BUN 0 Creat. - of up to 31 - 150 measurements per hour, about 5-20 times the rate for equivalent manual d. GEMSAEC procedures. (Electro-Nucleonics, Inc.) The GEMSAEC anal yzer, which was developed by Anderson (20), rep resents an alt ernate approach to laboratory instrumen- tation f rom the ubiqui tious continuous flow analyzers. GEMSAEC is one of five comme rcially available centrifugal analyzers which operate by pho tometric measurement of color samples contained in s eparat e chambers rapidly rotating disc. Befo commenci and reag ents are preme asured nto appro into the disc. ted and During an an a lytical centrifugal develops in the periphery of a accommod ated in mples te well chined in the sample. reagents outwar ds co ncentration of t he Sixteen samples can be a disc and a photometric ab sorption is made on each sample is rot a- Here mixing occurs and color in proportion to th e analytical required component nalysis cycle, the disc fo rce mov es samples and into a c orresponding c uvette in reading durin g each revoluti on of the disc. The meth od offers particular advantages in kinetic assays which are u sed to determine enzyme activities in blood serum Kinetic met hods of analysis relate the rate of formation of color to an alytical concentration. Centrifugal analyzers generate la rge amounts of data - a consequence of the high speed rotat ion of the disc. effect data reduction. A computer is therefore used to . - 32 e. Blood Gas Analyzers Arterial blood gas analysis (ABG) conventionally re- quires measurement of pH and the partial (PC0 2 ) dissolved in the sample. (P02 ) and carbon dioxide Practical pressures of oxygen electrochemical sensors had been d eveloped for measurement of these thre e parameters by the late 1950s. The represents an IL 113 (Instrumentati on Laboratory Inc.) early example of a blood gas analyzer. It c omprises two units: a thermostat bath contain ing the three elect rode sensors and an analog meter provided with three differen t scales for each measurement. scale in In operatio n, it was necessary to select each turn by means of The Corning Model a switch. 1 65 represents a second generation of It incorporates a d igital blood gas anal yzers. in addition to the basi c pH also calculate total P0 2 and PCO dial. This requires a knowle dge of the sample tion, which measurements, will 2 ca rbon dioxide conce ntration, bicarbonate ion concentrat ion and b ase excess. meter display and, is entered into the Model latter derived parahemoglobin concentra- 165 through a calibrated Push bu ttons are pro vided to allow any one of the six parameters to b e displayed. The ABL- 2 (Radiometer) is a second generation of the first computerized blood pH, made. b l ood gas analyzer. P0 2 a nd PCO 2 , a direct measurement of hemoglobin Derived parameters are: dioxide, base excess, In addition to measuring bicarbonate, standard base excess, total carbon standard bicar- is - 33 bonate and oxygen saturation. of pH, P0 2 and PCO displays. All 2 The three bas ic measurements are shown simultaneously on three digital measured and derived parameters are printed on a strip printer. The ABL-2 also di rectly measures ambient barometric pressure which is necess ary for automatic calibration of the instrument, another uni que feature. calibration occurs every two hours or at This feature is particularly effect ive the users' initiation. in improving the reliability of blood gas analysis - earlier instruments had required the technician to obtain a barometric atmospheric pressure, calculate the Automatic partial reading of pressures of the standard gas mixtures and then perf orm several calibration adjustments to the analyzer. 2.5 Environment 2.5.1.Malpractice Insurance Rate Changes As a consequence of the cost of malpractice ably high rate changes increased malpractice litigation, insurance has in recent years. in premium rates between increased at a remark- Table 2. 6 indic ates the 1965 and classes of physicians in Massachusetts While some rate increase s began between ticularly in higher risk classes), went into effect in 1972 increase through 1974. 1977, for five (100/300 limits). 1968 and the major 1972 (par- in creases and continued at this h igh rate of Further increases contin ued up to TABLE 2.6 MALPRACTICE COSTS PHYSICIANS & SURGEONS RATES 100/300 LIMITS CLASS YEAR A B C E D 1965 $ 87.00 $109.00 $ 208.00 $ 276.00 1966 103.00 130.00 272.00 408.00 1968 95.00 167.00 284.00 396.00 494.00 1969 119.00 210.00 357.00 497.00 622.00 1972* 138.00 242.00 522.00 726.00 907.00 1972 209.00 368.00 794.00 1,104.00 1,380.00 1973 288.00 506.00 1,092.00 1,518.00 1,898.00o 1974 403.00 708.00 1,529.00 2,125.00 2,657.00 1975 469.00 824.00 1,757.00 2,447.00 3,060.00 1976 548.00 ,250.00 2,081.00 3,010.00 3,810.00 1977 552.00 ,425.00 2,556.00 3,644.00 4,158.00 * Rates - 25/75 Limits --- - 35 the present, but not at the approximately 30% increase seen in 1972-1974. rate of - 36 TOTAL CHEMISTRY LABORATORY UTILIZATION Chapter 3. 3.1 Performed Total Tests Durin g the period performed p er year creased 1969-78, the total num ber of tests in the analyzed chemistry 1 aboratory in- fro m 270 thousand to over 930 thousand . volumes for intermediate years are shown trend curve for test volumes is shown Total in Ta ble 3.1 in Figur e 3.1. test and a Total test volume s grew exponentially from 1969 unti 1 1974. rate slowed briefly recurred in 1976 and Table 3.1 s hows in 1975, but the rate in 1978. in tests as a % ove r the previous year and as an absolute rate volume with increased growth rate 1977, moderating somewhat the growth The (first derivative of total respect to time). test It may be noted that the growth is slightly higher during the period 1972-74 than during 1975-77. Changes changes in total laboratory utilization may reflect in the utilization of the hospital in its entirety, as well as utilization of chemistry tests in patient care. We, therefore, calculated the average number of tests per hospital admission and per patient day of admission for each year during the period compared with the total 3.2 and Table 3.2. 1969 to 1978. These results are number of tests per year The general in Figure shape of the curves showing tests per day and tests per admission is very similar to that of the total tests. We conclude that hospital - 37 TABLE GROWTH Year 3. 1 IN TOTAL CHEMISTRY TESTS Total Tests % Increase Over prior year (thousands) Absolute Growth Rate (Tests/year) (thousands) 1969-70 268.9 1970-71 272.3 1 20.3 1971-72 309.5 13 85.2 1972-73 442.80 38 139.3 1973-74 588.20 33 98. 1 1974-75 639.00 9 83.8 1975-76 755.70 18.2 126.7 1976-77 892.30 18 89.5 1977-78 934.77 5 - 38 - FIGURE 3.1 LAB TOTALS Ir\~h r-- 900 ALL TESTS 1 800 700 - 600 - 500 - 400 - 300 200 100 SMA6-I (LBC) - - - I 1970 I 71 I 72 I 73 I 74 YEAR I 75 I 76 I I 77 78 - 39 - FI GURE 3.2 Total Chemical Tests Performed per Year t•'0" I r I,UUU0UUU, Ihr\ F IuU TOTAL TESTS 90 80 - TESTS/ ADMISSION 70 TESTS/ ,TIENT DAY - zo0 60 (, C, -03 500,000 N 50 E C,, -, w 40 30 200,000 - 20 10 - - 9 YEAR - 40 TABLE 3.2 GROWTH IN TOTAL CHEMISTRY TESTS PER ADMISSION OR PATIENT DAY Total Admissions Tests/ Admission Total Patient Days Tests/ Pt. Day 1969-70 10,671 25.2 117,280 2.30 1970-71 11,089 24.7 114,041 2.39 1971-72 11,608 26.7 112,941 2.74 1972-73 11,459 38.5 121,828 3.63 1973-74 12,295 47.8 132,839 4.42 1974-75 13,426 47.7 135,786 4.71 1975-76 14,012 54.0 147,184 5.14 1976-77 13,164 67.6 142,879 6.24 1977-78 13,366 69.9 140,952 6,56 Year - - 41 total occupancy has had some effect on tests ordered, However, importance. that other factors are of greater but interpretation of these results must be made cautiously because, as will later in the myocardial be shown is not uniform over the study, the distribution of tests length of hospital stay. Figure 3. 1974-75. yearly total is a greater test use immedi- There immediately prior to discharge. ately following admission than The test data shows an anomalously presented in Table 3.1 and low growth rate during In order to obtain furt he r in ht reasons fo r this variance, we exa mi ned into the monthly total 1976 and compared chemistry test performed from 197 3 until them with the monthly hospital oc cupancy r ate Monthly va riations were in some c ases extr eme, of 10-20%. and total (patient days). in the range Some correlation betw een month ly patient days test volume was apparen t; Table correlatio n coefficient for each year. correlatio ns exist for 1973, but for 1975, was found. infarction 1974 and 3.3 shows the Mo derate positive 1976 (r = 0.55 to 0.85) a moderate negative correlat ion (r = -0.44) Little information is obtained by graphical examinatio n of the data until it is smooth ed. Figure 3.3 shows 3-mo nth moving averages as a functio n of time for mont hly to tal are 1975 noted (by tests and patient d ays. narrow arrows) Pos itive correlation in mid 1974 a nd at the end of S In the first quarter of 19 75, there is a peak in TABLE 3.3 CORRELATION BETWEEN MONTHLY TOTAL TESTS AND PATIENT DAYS Year - - Average Length of Stay ± 1 s.d. (days) Average Monthly Total Tests (thousands) Average Monthly Patient Days Correlation Coefficient 1973 10.71 + 0.28 36.8 10.3 0.553 1974 10.79 + 0.32 49.3 11.1 0.845 1975 10.19 + 0.57 51.1 11.5 -0.435 1976 10.74 ± 0.27 63.1 12.1 0.743 - 43 FIGURE 3.3 Monthly Total Chemistries and Occupancy (Patient Days) 12 MONTHLY PATI ENT DAYS (000's) -IV A ýj • InLVUV I 9 -, , 7U 60 MONTHLY TOTAL LAB TESTS 50 (000's) r- )- E 40 E 30 E- I I I I I I MONTH: 3s YEAR: 1973 1974 1975 * All data points are 3-month moving averages. 1976 - 44- TABLE 3.4 AVERAGE LENGTH OF STAY IN THE HOSPITAL UNDER STUDY Month Year 1973 Jan 1974 1975 1976 11.50 11.13 10.52 Feb 11.07 10.89 10.63 10.4 Mar 10.57 10.72 10.48 10.68 Apr 10.39 11.08 9.92 10.5 May 10.47 10.63 9.60 10.46 June 10.42 10.55 9.30 10.77 July 11.00 10.63 9.57 10.79 Aug 10.68 10.72 9.8 10.8 Sept 10.53 10.98 10.18 10.9 Oct 10.66 10.55 10.5 11.4 Nov 11.24 10.95 10.2 10.9 Dec 10.75 10.22 10.9 10.8 - 45patient days of ho spital with the tot al occupancy which correlates tes ts performed (thick arrow). the average length of stay of a patient significantly lower than in 1974 or Also, negatively in 1975, in the hospital 1976 (Tables 3.3 and 3.4). It is concluded that there was a short-term change in hospital utilization during this period, particularly from April August, to 1975; associated with the admission of a group of length of hospitalization. patients with reduced 3.2 is Distribution of Tests The frequency of use of 23 major tests over the period 1972 to Here, in Table 3.5. 1978 is shown grouped according to the technology used year, tests have been in 1978. In each these tests account for over 90% of the tests performed. The percentage fraction of total tests not included in this set of 23 tests shows some variation from year to year, but there is no clear growth trend. While the introduction of new tests undoubtedly contributes to the total in the it is not a significant factor increase test volume, in chemistry laboratory utilization. The BUN, so-called "LBC"* group of tests (Na, K, Cl, C0 2, Creatinine) represents slightly over half of the total tests performed. This fraction has been 1971 onwards, as shown in Table 3.6. parallels the growth in total in LBCs remarkably constant from The growth in LBCs tests performed; see Figure during the period 1972-74 is greater 3.1 Growth *LBC is an acronym standing for 'Lectrolytes, BUN, Creatinine 0 TABLE 0 3.5 TESTS 1972 1973 1974 1975 1976 1977 1978 TOTAL 309.5 442.8 590.2 639.8 755.7 892.3 934.8 SMA6-1* 166.0 236.7 337.7 370.6 437.3 506.3 524.8 Enzymes 38.2 49.6 59.8 67.0 75.0 91.4 94.8 SMA6-11 + 40.4 55.59 66.5 75.9 81.5 94.5 95.0 Glucose 21.4 29.2 34.8 36.3 45.3 47.8 49.0 Alkaline Phosphatase 8.6 10.9 13.4 15.9 16.6 21.3 20.8 Blood Gases 8.1 16.6 23.9 26.3 35.6 43.01 44.6 Cholesterol 3.4 4.0 5.4 5.9 5.9 7.52 Amylase 3.0 4.79 5.94 7.3 8.1 12.5 14.0 851.0 Subtotal % of Total Tests Unaccounted 289.2 407.4 547.5 605.2 705.3 824.3 6.6 8.0 7.2 5.4 6.7 7.6 *SMA6-1: Na,K,C1,CO2,BUN,Creatinine 8.4 9.0 +SMA6-11: Ca,P04,Total Protein,Albumin,Bilirubin,Uric Acid 0 0 TABLE 3.6 GROWTH IN LBC AND ENZYMES YEAR TOTAL "LBC" 1971-72 166,030 .52 38,190 .12 1972-73 236,700 .53 49,640 .12 1973-74 337,690 .57 59,830 .10 1974-75 370,600 .58 65,980 .11 1975-76 437,330 .58 74,960 .10 1976-77 506,310 .57 91,380 .10 1977-78 524,880 .56 94,770 .10 % INCREMENT OVER PRIOR YEAR LBC/TOTAL TOTAL ENZYMES % INCREMENT OVER PRIOR YEAR ENZYMES TOTAL - 48 than during There wa 1975-77. labo ratory technology for LBCs was a substantial adva nce accelerated t he growth the two years followi ng its in 1972 when the first SMA-6 in LBC include the labora tory was promptly. No formal attempt w as made of the SMA-6. main ing tests for whi ch annual growth Figure in enz ymes and but SMA-6 - realization by hous e to publicize the 3.4 show s trends arri val reg ion between 1974 Mechanisms for report in g LBC data more staf f that b lood gases, tests performed duri ng introducti on. the technology diffus ion could glucose and in it is poss ible tha t this technological introduced; anomalo us change re- were available. totals and in the 1975 is apparent for 1ess so for enzymes. II tests The The is accelerated from 1976 to 1977, again following major te chnological advances in the 3.3 laboratory for both test methodologies. Chemistry Test Costs The relative direct cost of the was determined summarized From for each year of the study; (FTE) test volumes the data are in Table 3.7. 1972 to the present, there has been an increase in the productivity of the technical laboratory. increased Total increased tests/full from 12.1 staff of the chemistry time equivalent empl oyees in 1972 to 20.7 in 1978, an increase - 49 - FIGURE 3.4 LAB TOTALS IuU MA6 - II NZYMES 90 80 70 60 50 + m ;LUCOSE 3LOOD GAS 40 30 ALKALINE PHOSPHATASE -AMYLASE 20 10 - CHOLESTEROL I I I I I I .... 1972 73 74 75 I YEAR I 76 ~-''I 77 78 0 0 0 · TABLE 3.7 RELATIONSHIP OF CHANGES IN TOTAL CHEMISTRY TESTING TO STAFF AND COST DATA COSTS STAFF Year Total Tests x 103 FTE* Tests/FTE Payroll $ x 103 NonPayroll $ x 103 Ratio Total Tests Total Costs 69 1.21 .83 Rat io Cost ($) Tests 1972 320 26.5 12.08 196 1973 443 27.5 16.11 263 108 1.19 .84 1974 588 33.2 17.71 322 129 1.30 .77 1975 615 34.2 17.98 404 152 1.11 .90 1976 756 39.0 19.38 540 240 0.97 1.03 1977 892 44.4 20.09 664 324 0.90 1.11 1978 935 45.4 20.69 746 370 0.84 1.19 *FTE = Full Time Equivalent Employees - 51 of 71%. At the same time, there has been a very significant increase in both payroll a net cost reduc tion in the (from an average o tests/dolla r in 1978. inflation and non-payroll costs resulting mber of tes ts produced per total 1.21 tests/ dollar in 1972 to .84 is c ange reflects a significant and in both payro non-pa yroll costs. For has ncreas ed from $7400 in 1972 in 1978 refl ting increa ses fr inge benefit (inc uding example, th e cost/F.T.E to $15,270 tion and - retirement) . social security and Cos s show ed an even more remark- Non-payro able six-fo Id increase in direct compensa- ring this p eriod, v volume incr eases and hia her reagent cated and expensive tests. predominantly reflects the The net reflecting both costs for more sophisti increase in cost/test inflationary factors, and real dollars probably reflects a modest increase ductivity related to automation. in in pro- - Chapter 4. 4.1 MYOCARDIAL INFARCTION STUDY Chemi stry Test Utiliza tion The a verage num ber of in the study grou ps from 1963 52 - to 1978 chemi st ries performed on patients (described in s ection 2.3), is illustrated at in Figure 4.1 intervals The & 4.2. creases in total chemistries seems b roadly divisible into several phases. An early growth ph a se from 1963 to 1967 in- (phase I) during which the average n umber of tests per hospital stay increased from about 30 to 50 t ests, an ximately 66% duri ng this four year (or an average exponential There was rate little p eriod of growth of appro x imately 14% growth the averages in 1977. rate of increase of approximately in 1975, and to 1 6% per year durina v I • is even m ore rema rkab e considering that the average length of hosp ital has this period. reduced over (phase 2) This co n stituted an exponential aDDroximatelv 140 This gro wth rate 1973 rose to a p proximately 75 tests/admission in 1973, about 90 t e sts period. per year). in testing f rom 1967 through 1970, but a second majo r growth spurt is e vident by during which increase of appro- These data are stay this i 1 - 53 4.1 FIGURE Average Number of Tests per Hospital Stay ('95%confidence limits) 200 + 150 E- U) U) LL 0 IO G 100 H z 50 B~tr _ I I I I I I I I I I I I I I I 1963 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 YEAR - 54 - FIGURE 4.2 Average Number of Tests per Hospital Stay (- 95% confidence limits) 200 100 50 20 191 191 YEAR * SEMI-LOG PLOT - 55 - increase indicative of a marked laboratory usage in for the nations also increase parallels the is no t Figure "LBC" group These almos t ident ical is not to surpris stitu te a ve ry larg 1972 to 1977 infarction the myocardial t determina tions of the early in hospital- in the evident 4.3 summari zes creat inine) This as from platea u observed The anom a ous study wide rise phase 2 of (corresponding to study). a rel ati ve plateau a rapid followed 1970s Those determi- as a whole. hospital sho wed intensity of these patients. The overal l pattern of behavior the in BUN, (electrolye data revea 1 a pattern that seen ng e so-called e data for for f growth chemistries. tot the and since t his group o tests con- to 1 clinical proportio n of the In contrast, the changes chemi stry te sts per ormed. the a verage numbers of serum enzyme determinations did not s how the case of the same m arked LBCs.. in the evident marke dly different in this group of patients, testing waIs not under the indicates that, enzymes This growt h rate same pattern the growth serum stimulating _I r - 56 FIGURE 4.3 Average Number "LBC s" and Serum Enzymes per Hospital Stay I ^' II 10 "LBC" ---SERUM ENZYMES - 9 8 7 6 5 4 2 I \9 \9~96: .Ik \41' :1\ - 57 influences observed with the LBC or in the hospital population at and might provide some increased intriguing observation, This is an large. insight into the causes of the laboratory utilization, since, in this group of patients, the enzymes are used for diagnostic purposes to the monitoring functions of the (in contrast LBC determinations - see In the period below). before the application of serum iso- enzyme techniques in 1977 (which permit the differenti- ation of isoenzyme patterns of serum enzymes that are characteristic of different diseases and which might cause elevations and in their overall levels), multiple serial enzyme determinations were required clearly establish the characteristic sequential to pattern of serum enzyme increase and decline associated with acute myocardial infarction. Thus, the pattern and frequency of serum enzyme analysis was not as susceptible to variation as were other varieties of tests, particularly the "LBCs". 4.2 Intervals Between Tests Ordering patterns of clinical tests have undergone significant changes during the period of study. A major - 58 increase in the frequency of testing resulting change is an in progressively shorter intervals between consecutive tests. is evident This shift cy of various from Figure 4.4 which shows the frequen- intervals between consecutive tests, for electro- BUN and creatinine determinations. Although the most lytes, intervals between tests frequent in 1963 is one day, very sig- nificant numbers of tests were ordered at some with intervals, intervals greater than 6 days. As a consequence the average interval between tests in 1963 was 4.2 days. The tervals between consecutive tests fell the subsequent periods of study, with requests for daily determinations. By were requested at daily interval in- progressively during increasingly frequent 1978, almost all intervals, with an additional tests signifi- requested on the same day. The cant number of repeated tests average longer between tests is reduced to .87 days in 1978. The patterns obtained for the serum enzymes exhibited some differences (Fig.4.5). The tendency to orde r these tests pre- dominantly at daily or 2-day intervals was 1963, but there was a slower progression already evident in in the direction of daily ordering of these tests. The average interval between individual 1.7 days in 1963, but the serum enzyme determinations was interval shortened to 1.1 It should be noted that the days by increase 1978 (Table 4.1). in daily testing was not solely a consequence of the availab ility of automated instrumentation, since a significant number of instances of i-- - 59 4.4 FIGURE INTERVALS BETWEEN CONSECUTIVE TESTS Electrolytes, BUN, Creatinine la-CE 1963 ) w O., z C L 40 WJ 40 40 1ir ni- ci 30 u-LL 30 Li > 20 - z 20 1-J 0 l1, LLJto I 2 3 4 5 6 >6 INTERVAL (DAYS) 0 1973 £o 70 I-- ,) oz 50 Lu w C3 Lu w I- L- C', u, 30 ir 1978 60 z M I 2 3 4 5 6 >6 INTERVAL (DAYS) 40 + - w Lu I-. Ui -J W ui- B IwU IC W 0 I 2 3 4 5 6 >6 INTERVAL (DAYS) II I1 0 -U- I 2 3 4 5 6 >6 INTERVAL (DAYS) FIGURE 4.5 INTERVALS BETWEEN CONSECUTIVE TESTS Serum Enzymes (SGOT, SGPT, LDH, CPK) -rr` IOU -- r- IOU 7 1963 1973 1968 100 00 50 50 1978 100 E- 50 0I II. 2 34 - m 5 6>6 0 . I. 1234 INTERVAL (DAYS) SI 56>6 I 0 1 2 3 4 5 6>6 - 61 - TABLE 4. 1 WEIGHTED INTERVALS BETWEEN TESTS Year 1978 "LBC" (Electrolytes, BUN, Creatinine) Intervals (Days) .87 Serum Enzymes Intervals (Days) 1.1 1975 1.6 N.D. 1973 1.7 1.5 1970 2.9 N.D. 1968 2.9 2.0 1963 4.2 1.7 - to this - observed in 1963 (admittedly less frequen- daily testing was tly than 62 in 1973). Thus although the laboratory could respond intensity of demand in 1963, these daily requests were significantly less common before 1973. 4.3 Frequency of Abnormal Tests number of tests that were found The percent of total be abnormal (Table 4.2). to was determined at each of the intervals studied With respect to the serum electrolytes, creatinine, there was a generally progressive percent of abnormal tests between 1963 and BUN and reduction in the 1977. Comparable changes were not observed for the serum enzyme determinations, since myocardial infarction results of serum enzyme abnormalities and in predictable patterns is consequently not as open to such fluctuation. 4.4 Test-Ordering Patterns (Grouping) With the development of 4.4.1-Frequency of test combinations: multichannel could instruments such as the Technicon SMA-6, which provide simultaneous determinations of multiple differ- ent laboratory tests from a given sample, the question arises whether such instruments stimulate the physicians to request groups of tests (according instruments) merly). rather than to their availability from these individual tests (as was common for- We approached this question by examining the fre- quency with which the combinations of the 6 "LBC" bined in the SMA 4+2) had been ordered tests (com- simultaneously, during - 63 - TABLE 4.2 Percent Abnormal Tests - Electrolytes, BUN, Creatinine Yea r % Abnormal 1963 1968 1970 1973 1975 1977 48 37 39 34 24 28 - 64 the period prior to the acquisition of that and whether the frequency instrument increa sed after this time. the ordering patte rns Figure 4.6 illustrates 1972, fo r ele c- trolytes, BUN and creatinine wit hin the study g roup a t ent periods in the study. The f requency with w hich g roups of either 1-3,4,5 or 6 of these tes ts were ordered is plotted for each year of the study. indicate that, although the simul taneo usly (These figure s are in each sam ple. adjusted for the number of patie nts data dif fer- ) The frequency of o rderin g all inc reased followin g the the six tests simultaneously sition of the multiple determina tion of acqui instrument , this patt ern was already evident as early as 1967 and was we 1 es tablished by 1970, two years before the SM A-4+2 was opera iona I in the laboratory. In 1963, the majority of test tions of 1 to 3 of the for sing le te sts. in six By 1968, requests were for combina- tests; many of these were requests a majority of tests was o rdered group s of 6, with a sign ificant frequency of combi nations of 4 or 5 tes ts. By 1970, the trend has progressed further, with combinat ion o f 4 or more tests now the and the combi nation of all six becoming more common. the prop ortio n of comb inati ons of six tests had further with categori es. only smal I num bers of test B y 1978, a Imost test battery, with tests; all relative ly requests s till rule, By 1973, incre ased in o ther tests are requested a s the six infrequent groups of I or 2 groups of 4 or 5 tes ts had become uncommon. FIGURE 4.6 Group Ordering of "LBC s" CV 15 0 LL a U- 10 5 h. 1963 Ij 1967 1968 l 1970 YEAR 1973 1975 1977 1978 - 66 This clearly indicates that, in this sample, the prac- tice of ordering the combination of six tests dated the availability of the multichannel sion ("LBC") ante- SMA 4+2. to offer a combination of these 6 tests seems an attempt by the instrument manufacturers to be The decito reflect responsive to a pre-existent propensity to order a combination of these tests. While the availability of this combination in a single instrument may have encouraged the ordering of tests bination, the this instrumentation did not in com- initiate the trend, in instance. 4.5 Comparison of the Frequency of Diagnostic and Monitoring Functions The clinical varies within utility and purpose of laboratory tests the hospital stay. During the initial period of hospitali zatio n, the laboratory tests are used predominantly to assist the clinician in the d iagnosis of a In the ca se of acute myocardial certain infarction, serum enzyme abnormaliti es is an patient's illness. evidence of important factor in the diagn osis, and serial determ inations during the first 3 hospital days is common. Other tests are also useful different ial d iagnosis as well a s evaluation of the function of other organ systems which may generally orde red within the fi in the be impaired; these also are ew days of hospitalization. In contra st to this diagnostic zation, tests obtained during the ization tend to serve a "monitoring remainder of the hos function", assistin the eva luation of the - 67 response to therapy. patient's current condition and We have analyzed the laboratory uti ization data respect to the incidence of diagnost c or monitoring with tests ; the data are presented in Figu re 4. 7. of th is comparison, diagnostic all tests For the purpose are d efined to include t ests ordered within th e first 3 days of hospital ization, as we 11 as any test ordered 3-day period. All for the f irst time after this others a re termed "moni toring" tests. As can b e seen, the numbers of both moni torin g and diagnostic tests per hospitalization rose throug hou t Howev er, the proportion of monitoring the test period. test s rose from 1975 to the present, d espite the drop significantly in length of stay. Whi le the ratio of diagnost ic to moni torin g tests varied 1.0 - 1.2 from 1963 to 1973 , the rati o declined and f inally to .60 the i ncreased in 1977 and 1978. The data to .75 from in 1975 indicate that intensity of monitoring activities constitutes a maj or element in the incr eased labo ratory utilization in recent years. Still another demonstratio n of this phenomenon is evi- dent by comparison of the averag e number of tests performed during the first and 4.3). In general, the number of tests present. tests 1978. last 5 days of the hospital stay (Table the data show a progressive increase in these two Considering the in intervals from 1963 to the initia 1 5-day period, increased from an average of 3.8 the number of in 1968 to 21.8 in Similarly, the number of tests ordered during the last ;___ 68 FIGURE 4.7 Average Number of Chemistries per Patient as Diagnostic or Monitoring Functions eUU DIAGNOSTIC TESTS O MONITORING TESTS 150 > 100 90 80 70 60 50 40 30 20 10 LL 1963 r, L 67 68 Y oL 70 73 YEAR Y 75 Y Y 77 78 - 69 - TABLE 4.3 AVERAGE NUMBER OF TESTS FOR FIRST AND LAST FIVE DAYS OF HOSPITAL STAY PER PATIENT Avg.# Tests per day per patient Year 1963 67 68 70 73 75 77 5 days after admission 3.8 4.7 6.2 6.9 9.7 11.0 14.9 5 days prior to discharge 0.25 0.8 0.29 0.49 1.2 1.4 4.1 5.3 7.8 7.9 3.6 4.1 First 5 days Last 5 days 15.1 5.8 21.3 14.1 78 21.8 - 70 - five days of hospitalization increased progressively in l 963 to 5.3 an average of 0.25 tests value in 1978 from (the is anomalous, result ing from a si n gle patient 967 i whom a large number of tests we re ordered ju s t before disc arae) The significant flects the increase f rom large increases period (Figure 4.3). The 1975-1977 predominantly re- in LBCs obse r ved during the rat ios of fir a marked decline, indicati ng that late, s t/last days shows sustained monitoring is progressively increasin g a:s a propor t ion of the total. A third approach to dem(onstrating the changes orderin g pattern from 1963 to the present in test involved the compari son of the average number of tests ordered on each day of the hospitalization. periods are illustrated The data for 4 of the test in Figure 4.8. In 1963 and 1968, the hig hest test frequencies occurred within the first 4-6 days of hospitalization, with averages falling below I test/ day soo n thereafter. By 1973, the initial levels of testing were su bstantially greater and, thereafter, persisted for a longer duratio n, while averages in the range of 2 tests/day were maintai ned throughout most of the period of hospitalization. By 1978 , this pattern had become even more marked; very high levels were maintained for the first week, and moderate levels (in the range of 6 to 8 tests/day) were sustained through out most of the remainder of the hospitalization. FIGURE 4.8 Averaae Number of Th.sts 3 flrdri.rdr I 2 2 2 2 1963 &-- 2 1968 1973 1978 [][ I 3 4 bO IT IU II II IO 1 1I DAY OF HOSPITALIZATION - --- - 72 - This also indicates that early progressively higher of sustained monitoring activity is also evident recent groups (in 1973 and particularly The time after admission required level of testing was calculated This result in the more in 1978). to reach th e average for each of the fou r years; it decreased progressively from 6.9 days in 1978. levels in 1963 to 6.0 days is consistent with an increas ed level of monitoring activity, giving rise to this shift o f the "day of average testing" to an earlier period after admi ssion. - 73 - Chapter 5. DISCUSSION 5.1 Laboratory Tes t Utilization Our study of the total led an exponential growth 1977, chemistry test in tests over the in this medi cal center. able to that obser ved This growth utilization revea- period of 1971p attern is compar- in laboratory testing throughout the (7, 8, 21, United States, dur ing the same period 22). Since most of these stud ies provided aggregate da t a, summarizing the behavior of many h ospitals or of all a given hospital, tors they may be labora t ory tests within influenced by a variety of fac- resulti ng from uncontrolled changes lation. For in the patient examp le, one might argue that increases ar e the result of changes in the some of thes e average seve rity of illness, and th at patients now tend to b e relatively ill than in prior years. What is more like ly patients who had b een admitted in the past work-up, for exa mple) wou Id now obtain popu- more is that s ome (for a diag nostic thes e tests as o ut- patients due to increasin g pressure fr om PS RO organizat ions. One might al so s imp rovement peculate that with in thera py(such patients with chronic dis eases as antibioti cs) seriously are kept ali ve for longe r periods bef ore f inally succu mbing to their ill particularly ness These facilitated the ill pat ien ts terminally intense trea tment and might also s pecu late that have ill 1aborato ry mon since both Medica re and availability of ould require tori ng. One Medi caid health care to two groups - 74 (the elderly and the poor) who might be expected to have more serious health problems, these have affected the case-mix of the hospitals in an adverse way. In order to avoid these sources of variability, we have also elected to study the though small, lab utilization group of patients. uncomplicated myocardial in a well-defined, They were selected as having infarction, and are as close to a homogeneous group of patients as we were able to identify. If" . • selected t his gr oup or patie nts since the diagnosis ment invol ved a substantial utilization of clinical and We treat- laboratory services, partic ularly chemi ry. some expan sion d variety of laboratory tes s the period of this study. or useful in the range in these patients ove Furthermore, there has example, s erum c reatinine ph phokinase came ry into use in this labora in isoenzyme determ ination of s um la and CPK wa s inst ituted t 197 in ab bout serum ic deh ydrogenase (LDH) The also heavil of the hea vy use of serum el ectrolytes and blood gases different Both showe general inc rease on the se patients in beca se (par ticularly p otass un in their the rapeutic monito ring. The data s uggest tion seen enzyme firs 1970, while automation would impac (CPK) been that his define the increased laboratory utili ho spital group wa s not subst ant ia ly the behav or of the general hospital remarkable with exponential increase a- gro wth in the chem istry in the range of po pulat on. tes ting, 14% per year from - 75 1970 to 1977, a figu re which is in general experience throughou t the country. crepancy was evident at a greater ra th an the myocardial inc remental to about the From the ported that the doubled every f (The only significant dis- in 1973 and 1974 when total a consequence o 120% o agreement with the 1972 increases tests grew infarction patients, as in hospitals beds up level). d l 950s through the 1960s, some hospitals re- umb er of laboratory tests ordered per patient e y ears. Typical was Yale-New Haven Hospital if" which in 1954 p rto med 48,000 98,000; and in increase in pat hospital testin 964 approximately 2 bil in 1959, 200,000 associated with only a slight ent census ex laboratory procedures; anded i (23). at on tests a In the 1970s slightly performed the rate of faster in pace. From the 1971 numb r climbed to about 3 b illion in 1974 and to roughly 5 billion (24). 1977 Of these tests, at a cost 5.2 Factors 5.2.1 approximately 30% were clinical chemistry in 1977,of approximately 3 billion dollars. Influenc ing Laboratory Utilization Patient Factor s The major pati ent related fa ctor is the nature of reim- bursement for health care delivery ; namely the increase in third party payment for health car e with t he advent of Medi- care and Medicaid. In 1974, for e xample, 21% bills 18% in of patients' in the hospita 1 under study were rei mbursed by Medicare, by Medicaid, 42% by Blue Cross and onl y 19% themselves or through commercial insurance. by the patients - Technolog Iical 5.2.2 Factors Laboratory factors liability 76 - include increased capabi lity and re- of the results, and the development of automated multichannel analyzers. Two majo )r technological factors may affect laboratory utili zation : th e introduction of new tests without retiring older tests and analyzers, particularly those the impact of automated whi ch perform a profile of tests which the physician wou Id not oth erwise have study of both the total ord ered tests ordered. in the chemistry labora- tory and tests ordered for a grou p of myocardial patients has shown that 23 te sts test volume. The total test utilization chemistry account for over 90% of the ou nted Howe ver, most o 10% represents a growing f the growth in laboratory is d ue to greater us e of established Two major techno logical labora tory d uring ad v ances occurred the test volume for Ilowing LB both event tests. in the analyzed p eriod studied: duction of the f irst S MA6 in 197 2 and GEMSAEC in 1976. infarction lume has, of course, been grow- ing with time so that t he una number of tests. Our the he second intro- SMA 6 and the rate of increase in , SMA6-I I che mistr es and enzymes was slightly greater than wou Id ave been expected rom prior trend data. It may be sugges ted that suc h technolo ical a small, albeit shor t lived of laboratory te sts. LBCs (1-2 year) The te ndency for advances do have effect in escalation physicians to order in groups of six was established before the of the SMA6 in 1972; this introduction profile-ordering pattern certainly - 77 became dominant in subsequent years, which may be attributable to the pre s ence of the SMA6. b asic question which must be a nswered regarding the The impact of t echnology is whether test uti lization expands to the capaci t y of the laboratory or whethe r the laboratory primarily k eeps pace with other word ical s , is laboratory util ization s ubject (inst r ument Our pull. question. induced) push LBCs had apparently to a technolog- (physician demand) is that reached a plateau prior to in 197 2 , but gr ew rapidly afterwards. it may be argued response t o an unmet clusion or a need In data do not provide an unambi guous answer to this introducti o n of the SMA6 However, the d emands of the physician. that the SMA6 was acquired physician demand. test laboratory in Our subjective con- volumes are largely determined by physician need and that new automated technology has a minimal causative effect. 5.2.3 Physician-Related Factors Specialization: play the predominant oratory utilization. The physician-related factors seem to role in the remarkable The effect of a high degree of sub- specialization has already been discussed. hospital used increase in lab- in the study, In the particular the degree of subspecialization is rather extreme, with a high degree of subspecialization in internal medicine, pediatrics and surgery and very few general - 78 internists, pediatricians or surgeons on is essentially full-time (and until employees of the hospital); all the medical school, the staff. The staff recently were salaried have teaching appointments at and many are actively engaged in clinical research. There is a very active house s taf f training program, complemented by extensive fellowship ities tr aining (particularly in internal medi cin e). for ordering of laboratory tests in subspecial- Responsibility res ts predominantly with the house staff; daily rounds are he Id with the attending physician on service for the month, at which status of e ach patient is reviewed. recognized as a n excellent hos pital ical 12 traini ng; Th e hospital is generally in which to obtain clin- several hundred appl ica n ts apply each year for internsh ip p ositions tial time the current in med icine . This implies a substan- degree of independence of the hou s e staff, in whom major responsibil ity for day-to-day patient c are is vested. medical ser vice s are entirely divisions ( e.g. The organize d into subspecialty cardiology, he matology nephrology, endocrin- ology, gast roen terology, etc.) and all patients are assigned to one of t hese , as appropriat e. resence of medical The student "ex tern s" on each serv ice may oratory uti liza tion somewhat, natural cur iosi ty. end to increase lab- in order to satisfy their This degree of subspecialization undoubt- edly contributes to the exceptionally high level of laboratory - 79 testing. lab- Lack of effective interaction/consultation with oratories: is no formal There between clinical laboratory directors and the clinicians/ house officers who utilize the have been made interaction/consultation laboratory data. to intervene or otherwise No attempts influence the order- ing of laboratory tests by clinicians/house officers than attempts to discourage unnecessary "stat" (other [urgent] requests for exceptionally rapid reporting of results). On the contrary, the laboratory has attempted to respond to the increased demands with increased services, automation, and more extensive coverage to almost 24 hour service, seven days a week. Malpractice: physician related factor increasing threat of malpractice suits, is the an Another general resulting in increase in "defensive medicine", a term applied to the use to avoid litigation. of diagnostic procedures felt compelled, testing in cases in some instances, in which Physicians have to carry out laboratory the physical examination and history have already yielded an unquestionable diagnosis. The major increase the in rates began in 1972 and may have contributed to increased laboratory utilization evident at that time. Influence of technology: A much more significiant factor relates to the attitide toward technology shared physician and patient alike. by (For a comprehensive discussion - 80 see Reiser's book "Medicine and the Reign of of this point, Technology"'' [4 ).Reiser notes that the increased reliance technologically-produced data at the expense of the physical I exam inati cine for I D and hi number tory h as be en a matter of concern in medif yea r s. In 1921, Tieken wrote, "For years, phys icans and many of ou r well -known teachers have leaned so much towards la borat ory m ethod s that physical almost become a lost art" (2'5) icantly increas ed si nce t hen. accelerating by the of medicine see med of disease and (4). and clinical and the dependency has signifBeginning in the 1930s and the newer generations of professors 1950s i ntere sted principally in the biochemistry "a nu mber shift ed almost directly from the lab- oratory into pr ofess orial schools" diagnosis has chai rs at hospitals and medical The p hysic ian/s cientist, steeped in laboratory investi gatio n, wa s the model academic physic ians Furthermo re, against which all were measured. a not he r factor in th e increased attachment to machine-prod uced evidence occurring during the 20th century "originated in part from contemporary faith in scien ce and technology, and a belief that a scientific spirit entered clinical practice through technology" provided by means of a sophisticated (4). Laboratory data, instrument,seemed to satisfy the desire of the physician for precisely expressed clinical evidence. Progress in medicine was measured by some according to the degree to which quantitative measurements - 81 replaced qualitative clinical an judgments. At the same time, increasing proportion of health costs were borne by pri- vate and government insurance, which also covered patients for laboratory and x-ray exami nations creasing to almost 75% of the (t he propor populat ion by 1974 is likely that, wi th litt le cos t constrain t, and patient encour age the technology in the both in- 26]). physician incre ased utiliz ation of laboratory det ecti on and evaluation of thermore, as a res ult ion illn ess. of increa sed automat ion, the Fur- labora- tories tend to be increasingly cost e ffect ive, gen erating more tests at a reduced real cost/test. usually addressed, A more crucial is the question of the extent to which the biochemical change s in blood serum re flect the cri tical alterations which a re occurring within the diseased cells. The ready availabi lity of serum shoul d not obscure that which i only -eflects indirectly re more crucial t This h ah expectation of to the older belief the the the fact intra cellular events underst and ing of dis ease. serum is, in some sense, analogous (now discredited) that position of the urine could prov ide major nature of the disease processes the che mical cominsights While in genera of the characterization of serum elements real issue, not into the the value is obvio us, its limitations should also be appreciated. Behavioral factor Most marked changes seem to ref lect behavorial characterist ics of the clinician - particular ly - evident in the myocardial the Most noticeable was levels, but the increased intensity of there a marked increase Not only was istry testing. - 82 infarct study. chemin total intervals b e tween consecutive tests p rogress- ively shortened so that, by 1978, most tests are orde red daily (and the average intervals thermore there are greater i s shortened Fur- to below I da y). l evels of sustained monito ring activity throughout the cou r se of hospitalization. Wh ile there was some shortening of aver a ge days), this does not accoun t for the markedly greater testing levels throughout the hospi t al (CCU ). cardiac status also seems t o in recent years. One facto r The constant monitoring of ead to an u rgency reg t he current other monitoring activities daily orders for "LBCs" stay crisis orientation" evide nt within undoubtedly relates to the the Coronary Care Unit length of stay (from 2 2 to 15 proced ures en zymes for a 11 and pat ient ding nclude (orders are written o n the day of admission). Another remarkable feature of the g rowth in cl nical chemistry tes ts is that the proportion of LBC/total relatively un changed (from about 52% in spite of a n almost 3-fold suggests an in 1972 to 56% emains n 1978) increase in testing. Th s also i ncrease in intensity of test ing, rather than a change in q uality. The increasing "packaging" of the LBC remarkable. Although there to combine BUN & crea tinine is not a strong requests is also rationale,a priori, requests with e lectrolytes (Na, - 83 K, Cl and CO2) ing them. which ment. Thi this is now the preponderant manner of orderpattern antedated the advent of the SMA-6 linked these 6 determinat ons This expec ed linkage is more in a multichannel instru- rema rkable when one considers the rate of change in these two groups of tests. Serum potas ium levels might undergo qiuite rapid shifts, under cer- tain linical circumstances, but expec ed to show relatively under level slow (and predictable) alterations most clinical circumstance s. might require more rapid atini changes. requi different freauencv of different practice of 5.3 BUN and creatinine would be In investigation general,chai nge freau .... vI Consequently, changing K in these 2 groups should s tudy and, s than BUN/cre- consequently, the universally grouping these tests seems to be questionable. Determination of Appropriate Levels of Laboratory Utilization As is evident from the foregoing discussion, there are a great many causes of increased laboratory utilization over the past 30-40 years. We have, thus far, avoided whether this remarkable growth indicative of unneccessary and be vigorously discouraged. some of this growth in utilization is necessarily inappropriate usage and should While most people will agree that is unnecessary, there may be significant differences of opinion on how much of it would fit category. the issue of into that Short of a case-by-case review of hospital records, how can the question of the appropriateness of laboratory - 84 What sort ot evidence migh t be utilized testing be resolved! in establishing evidence of excess unnecessa ry usage? ve, One simple approach would be to determine ' of abnormal and normal tests yielding normal This simple view values, wi th the values were is unfortunately implication that the likely to be unnecessary (15) open to objection. conversion of a test value from a bnormal cate the efficacy of therapy, whi le to normal in other normal Fur thermore, The may indi- instances, required to ascertain that certai n undesirable of therapy had not occurred. the proportion it is side effects in some instances, values are very valuable i n resolving certain diagnos- tic problems (27). For example, if alternative A has a higher incidence of abnormal values with tion B, a normal value provides the given test than condi- ind irect support favoring condition B. At mal the other extreme, an in tests results does not necess oratory utilization. It might al eased proportion of abnorily indicate effective reflect unnecessary lab- lab- oratory testing consequent to exc sively frequent and tious requests were already demonstrably abnormal, for the tests whic and could not reasonabl significantly altered in the inte dition of "necessity" is introduc the data (in terms of its even the abnormality initiati repeti- be expected to have been al. If an additional con- requiring "usefulness" some change of in treatment), of the test result would not guarantee - 85 its "necessity". Another approach to the establishment of appropriate levels of laboratory utili zation is the development of "group norms" which would establi sh some level a co rrect standard. plic ity, but of current practice as This has the advantage of relative sim- it does not ing that the "normal" resolve the difficulty of establish- behavior is actually appropriate. This brief discussion of the problem of establishing an uneq uivocal method of establishing the "proper" level of labo ratory utilization, for different categories of diseases and indicates patients moni toring schemes test 5.4 the problems inherent in any sample (such as determining percent abnormal, or frequency). General Recommendations The best alternative suggested by a number of authors ~I (3, 9,23,28) involves a controllin g role of the clinical oratory directors and clinicians ing of laboratory usage. i n the education and monitor- Educatio nal programs might the appropriate use of particular tests, normal values and relation of test as involve significance of ab- results to disease, as well the costs of laboratory tests; these programs would be directed to medical staff. as lab- There these can programs students, hous e officers and attending is some evidence tha t educational programs such influence laboratory utilization, but these must be repeatedly reviewed to remain effective (29). - 86 Key individuals in the implementation are the directors of the clinical as laboratories, who would need to play an expanded role laboratory consultant, advising on tion of laboratory tests, the use and interpreta- design diagnostic test strategies for different types of disease, and establish a test monitoring system to provide continuing review of current laboratory utilization. The fundamental problem of the consequences of increased dependence of the clinician upon diagnostic technology still remains unresolved. Its use can enlarge the physicians' knowledge of disease, but they may rely too much on such technology, and not enough on diagnostic capability based upon their own ability and experience. "risks becoming merely an and the medical machines" (4). judgments Otherwise the physician intermediary between the patient rendered by technical experts and - 87 - REFERENCES 1. Social 2. 4. 5. Benson, and What Interest, S ummer 40 (1977). Medicine and the Reign of Tech nology, I T Reiser, S.J., (1978). H., Editors, Logic Laboratory Use, Elsevier N.Y. E.S. and Rubin, of Clinical 6. "The High Cost of H ospitals it", The Public Cambridge 1974. (1977). Feldstein, M.S., do About N ew York, "The Twilight Zone", M edical Marketing and R.L., Media, June 17 3. Inc., Basic Books, Choice. Hughes, Health , Economics and Live? 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