TABLE D.1 Estimated Annual Volume of Laboratory Tests by Laboratory Type and Waived-Nonwaiveda Test Status, 1996
Facility Type |
Number of Laboratories |
Waived Test Volume |
Nonwaived Test Volume |
Total Test Volume |
Hospital |
8,888 |
91,883,111 |
2,886,279,172 |
2,978,162,283 |
Independent |
5,751 |
15,886,008 |
1,529,300,443 |
1,545,166,451 |
Physician |
||||
Physician office |
89,432 |
119,593,903 |
402,642,748 |
522,236,651 |
Community clinic |
5,016 |
15,104,518 |
46,914,077 |
62,018,595 |
Health maintenance organization |
959 |
6,879,396 |
58,602,448 |
65,481,844 |
Other practitioner |
2,135 |
3,353,899 |
34,017,314 |
37,371,213 |
Total Physician |
97,542 |
144,931,716 |
542,176,587 |
687,108,303 |
Other |
11,216 |
64,978,527 |
235,688,932 |
300,667,459 |
Blood bank |
338 |
9,037,496 |
108,378,714 |
117,416,210 |
Insurance |
38 |
953,783 |
88,211,516 |
89,165,299 |
Ambulatory surgery center |
1,160 |
1,892,906 |
24,881,423 |
26,774,329 |
Comp. outpatient rehabilitation facility |
60 |
152,069 |
344,189 |
496,258 |
Ancillary test site in health facility |
2,254 |
21,152,745 |
54,292,331 |
75,445,076 |
End-stage renal dialysis facility |
1,919 |
7,034,302 |
3,698,366 |
10,732,668 |
Health fair |
213 |
452,066 |
8,433,499 |
8,885,565 |
Home health agency |
8,676 |
9,193,602 |
734,261 |
9,927,863 |
Hospice |
596 |
377,998 |
2,020,628 |
2,398,626 |
Industrial |
1,343 |
1,006,668 |
6,516,089 |
7,522,757 |
Intermediate care facility |
626 |
419,097 |
1,570,654 |
1,989,751 |
Mobile unit |
718 |
1,166,534 |
596,277 |
1,762,811 |
Pharmacy |
288 |
150,911 |
142,638 |
293,549 |
School or student health service |
1,175 |
1,072,946 |
3,797,719 |
4,870,665 |
Skilled nursing or nursing facility |
13,933 |
37,638,543 |
5,968,203 |
43,606,746 |
Tissue bank |
29 |
92,580 |
5,519,625 |
5,612,205 |
Rural health clinic or federally qualified health centerb |
||||
Ambulanceb |
||||
Total Other |
44,582 |
156,772,773 |
550,795,064 |
707,567,837 |
Total, All Facility Types |
156,763 |
409,453,608 |
5,508,551,266 |
5,918,004,874 |
aTests are put in the waived category under (CLIA) regulations if they are simple to conduct, highly trained staff is not needed, and the chances for error are small. Facilities that conduct only waived tests do not have to meet the same personnel requirements as facilities that conduct moderate- or high-complexity tests. bNew facility types effective November 1998. SOURCE: 1996 CLIA Provider Files. Health Care Financing Administration. |
TABLE D.2 Estimated Annual Volume of Laboratory Tests by Laboratory Type and Waived-Nonwaiveda Test Status, 1997
Facility Type |
Number of Laboratories |
Waived Test Volume |
Nonwaived Test Volume |
Total Test Volume |
Hospital |
8,766 |
95,533,576 |
2,890,447,242 |
2,985,980,818 |
Independent |
5,246 |
16,010,004 |
1,694,570,874 |
1,710,580,878 |
Physician |
||||
Physician office |
91,979 |
125,431,118 |
531,817,599 |
657,248,717 |
Community clinic |
5,667 |
16,507,804 |
56,348,445 |
72,856,249 |
Health maintenance organization |
872 |
6,139,609 |
59,289,436 |
65,429,045 |
Other practitioner |
2,113 |
3,087,842 |
38,034,249 |
41,122,091 |
Total Physician |
100,631 |
151,166,373 |
685,489,729 |
836,656,102 |
Other |
12,190 |
65,765,571 |
329,945,790 |
395,711,361 |
Blood bank |
341 |
8,984,653 |
112,267,650 |
121,252,303 |
Insurance |
36 |
953,348 |
106,422,639 |
107,375,987 |
Ambulatory surgery center |
1,474 |
1,906,826 |
22,801,571 |
24,708,397 |
Comp. outpatient rehabilitation facility |
86 |
120,763 |
313,722 |
434,485 |
Ancillary test site in health facility |
2,629 |
22,165,830 |
57,195,905 |
79,361,735 |
End-stage renal dialysis facility |
2,343 |
7,916,703 |
7,394,763 |
15,311,466 |
Health fair |
262 |
536,936 |
8,229,977 |
8,766,913 |
Home health agency |
11,202 |
10,594,655 |
759,040 |
11,353,695 |
Hospice |
829 |
301,566 |
1,587,633 |
1,889,199 |
Industrial |
1,375 |
993,481 |
19,482,917 |
20,476,398 |
Intermediate care facility |
700 |
543,964 |
1,658,198 |
2,202,162 |
Mobile unit |
1,074 |
1,403,132 |
2,871,039 |
4,274,171 |
Pharmacy |
677 |
312,452 |
149,426 |
461,878 |
School or student health service |
1,372 |
1,155,195 |
4,430,107 |
5,585,302 |
Skilled nursing or nursing facility |
14,389 |
39,749,678 |
3,916,131 |
43,665,809 |
Tissue bank |
33 |
93,830 |
5,492,474 |
5,586,304 |
Rural health clinic or federally qualified health centerb |
||||
Ambulanceb |
||||
Total Other |
51,012 |
163,498,583 |
684,918,982 |
848,417,565 |
Total, All Facility Types |
165,655 |
426,208,536 |
5,955,426,827 |
6,381,635,363 |
aTests are put in the waived category under (CLIA) regulations if they are simple to conduct, highly trained staff is not needed, and the chances for error are small. Facilities that conduct only waived tests do not have to meet the same personnel requirements as facilities that conduct moderate- or high-complexity tests. bNew facility types effective November 1998. SOURCE: 1997 CLIA Provider Files. Health Care Financing Administration. |
TABLE D.3 Estimated Annual Volume of Laboratory Tests by Laboratory Type and Waived-Non-waiveda Test Status, 1998
Facility Type |
Number of Laboratories |
Waived Test Volume |
Nonwaived Test Volume |
Total Test Volume |
Hospital |
8,644 |
94,196,474 |
2,861,419,809 |
2,955,616,283 |
Independent |
4,871 |
15,272,621 |
1,380,135,459 |
1,395,408,080 |
Physician |
||||
Physician office |
93,763 |
129,153,794 |
363,417,570 |
492,571,364 |
Community clinic |
5,535 |
15,390,658 |
42,097,551 |
57,488,209 |
Health maintenance organization |
751 |
5,042,666 |
30,487,001 |
35,529,667 |
Other practitioner |
2,004 |
2,984,083 |
24,256,184 |
27,240,267 |
Total Physician |
102,053 |
152,571,201 |
460,258,306 |
612,829,507 |
Other |
11,995 |
64,685,709 |
217,678,933 |
282,364,642 |
Blood bank |
316 |
8,595,502 |
96,113,181 |
104,708,683 |
Insurance |
36 |
952,898 |
88,346,869 |
89,299,767 |
Ambulatory surgery center |
1,507 |
1,933,819 |
20,287,811 |
22,221,630 |
Comp. outpatient rehabilitation facility |
91 |
130,747 |
313,462 |
444,209 |
Ancillary test site in health facility |
2,384 |
21,546,469 |
34,021,429 |
55,567,898 |
End-stage renal dialysis facility |
2,386 |
7,742,580 |
5,875,977 |
13,618,557 |
Health fair |
270 |
656,215 |
5,622,353 |
6,278,568 |
Home health agency |
10,859 |
10,245,942 |
423,745 |
10,669,687 |
Hospice |
847 |
305,926 |
1,415,242 |
1,721,168 |
Industrial |
1,363 |
963,861 |
6,030,475 |
6,994,336 |
Intermediate care facility |
665 |
520,100 |
624,787 |
1,144,887 |
Mobile unit |
1,094 |
1,131,722 |
280,678 |
1,412,400 |
Pharmacy |
773 |
447,319 |
110,149 |
557,468 |
School or student health service |
1,379 |
1,214,093 |
3,648,558 |
4,862,651 |
Skilled nursing or nursing facility |
14,008 |
38,971,818 |
3,006,791 |
41,978,609 |
Tissue bank |
31 |
93,830 |
5,416,065 |
5,509,895 |
Rural health clinic or federally qualified health centerb |
||||
Ambulanceb |
||||
Total Other |
50,004 |
160,138,550 |
489,216,505 |
649,355,055 |
Total, All Facility Types |
165,572 |
422,178,846 |
5,191,030,079 |
5,613,208,925 |
aTests are put in the waived category under (CLIA) regulations if they are simple to conduct, highly trained staff is not needed, and the chances for error are small. Facilities that conduct only waived tests do not have to meet the same personnel requirements as facilities that conduct moderate- or high-complexity tests. bNew facility types effective November 1998. SOURCE: 1998 CLIA Provider Files. Health Care Financing Administration. |
TABLE D.4 Estimated Annual Volume of Laboratory Tests by Laboratory Type and Waived-Nonwaiveda Test Status, 1999-Early 2000
Facility Type |
Number of Laboratories |
Waived Test Volume |
Nonwaived Test Volume |
Total Test Volume |
Hospital |
8,560 |
95,931,042 |
2,862,826,492 |
2,958,217,534 |
Independent |
4,936 |
15,057,780 |
1,499,093,551 |
1,514,151,331 |
Physician |
||||
Physician office |
96,357 |
133,563,773 |
347,739,610 |
481,303,383 |
Community clinic |
5,978 |
18,360,107 |
40,200,559 |
58,560,666 |
Health maintenance organization |
717 |
4,768,920 |
79,774,094 |
84,543,014 |
Other practitioner |
2,037 |
3,350,368 |
28,679,024 |
32,029,392 |
Total Physician |
105,089 |
160,043,168 |
496,393,287 |
656,436,455 |
Other |
12,605 |
66,900 |
265,612,004 |
265,678,904 |
Blood bank |
340 |
9,044,389 |
74,538,000 |
83,582,389 |
Insurance |
44 |
961,946 |
79,440,076 |
80,402,022 |
Ambulatory surgery center |
1,943 |
2,239,255 |
19,114,207 |
21,353,462 |
Comp. outpatient rehabilitation facility |
107 |
317,250 |
450,541 |
767,791 |
Ancillary test site in health facility |
2,650 |
22,437,640 |
4,116,747 |
26,554,387 |
End-stage renal dialysis facility |
2,804 |
8,628,068 |
2,386,960 |
11,015,028 |
Health fair |
315 |
501,270 |
12,732,801 |
13,234,071 |
Home health agency |
8,461 |
17,570,371 |
326,868 |
17,897,239 |
Hospice |
897 |
1,028,376 |
1,733,518 |
2,761,894 |
Industrial |
1,428 |
954,110 |
6,224,404 |
7,178,514 |
Intermediate care facility |
696 |
538,212 |
944,477 |
1,482,689 |
Mobile unit |
1,203 |
1,663,769 |
2,140,582 |
3,804,351 |
Pharmacy |
1,450 |
910,779 |
81,794 |
992,573 |
School or student health service |
1,526 |
1,314,250 |
3,666,849 |
4,981,099 |
Skilled nursing or nursing facility |
14,695 |
43,496,738 |
3,056,795 |
46,553,533 |
Tissue bank |
41 |
99,930 |
7,633,868 |
7,733,798 |
Rural health clinic or federally qualified health centerb |
233 |
699,531 |
431,327 |
1,130,858 |
Ambulanceb |
79 |
20,360 |
- |
20,360 |
Total Other |
51,517 |
112,493,144 |
484,631,818 |
597,124,962 |
Total, All Facility Types |
170,102 |
382,985,134 |
5,342,945,148 |
5,725,930,282 |
aTests are put in the waived category under (CLIA) regulations if they are simple to conduct, highly trained staff is not needed, and the chances for error are small. Facilities that conduct only waived tests do not have to meet the same personnel requirements as facilities that conduct moderate- or high-complexity tests. bNew facility types effective November 1998. SOURCE: March 2000 CLIA Provider Files. Health Care Financing Administration. |