Posted by Sten Westgard, MS

Articles by the Cleveland-Plain Dealer, as well as a 333 page CMS inspection report, have detailed major laboratory failures at several Cleveland Clinic facilities.

Sloppiness, lax oversight revealed at Cleveland Clinic's Marymount lab; overhaul includes firings

CMS report on Cleveland Clinic's Marymount Hospital lab details systemic problems

Here's an example of the violations detailed in the CMS report:

"Review of the PT documentation for the chemistry PT event title 'K-B 2014 Ligand Assay - General' found the laboratory initially analyzed PT samples K-06 and K-07 on 07/23/2014. Instrument printouts and handwritten notes on the printouts then demonstrate the laboratory reanalyzed PT samples K-06 and K-07 on 07/27/2014 multiple times on both Cobas 6000 analyzers as follows:

"Cobas 6000 Instrument Printouts: K-B2014: Sample K-06:

"a) Date: 07/23/2014 13:27:52

Handwritten notes stated:
"K-06"
"K-06"
"TP #7" first name"
Folate, Seru 1.72 ng/mL

b) Date: 07/23/14 13:27:52
Handwritten note stated:
"K-06"
Quant Beta H 10:18 H mIU/mL

c) Date: 07/23/14 13:27:52
Handwritten note stated:
"K-06"
Ferritin 12.70 L ng/mL
Free T4 0.580 L ng/mL
TSH 0.074 L uIL/mL

d) Date: 07/23/14 13:27:52
Handwritten note stated:
K-06"
Vitamin B12 56.50 L pg/mL
T4 3.22 L ug/dL
FT3 III 3.63 L pg/mL

e) Date: 07/27/14 12:54:53
Handwritten notes stated:
"COBAS 1"
"RERUN"
The ID number 6 and date and time were circled.
The word rerun was underlined twice. Each numeric results listed below had a checkmark to left.
Folate, Seru 1.50 ng/mL
Ferritin 12.67 L ng/mL
Free T4 0.591 L ng/dL
Quant Beta H 10.40 H miU/mL
TSH 0.077 L uIU/mL
Vitamin B12 66.07 L pg/mL
T4  3.32 L ug/dL
FT3 III 3.82 pg/mL"
and it goes on and on and on.

This is a MAJOR scandal, one that reveals persistent endemic problems with how the laboratory conducts itself. If there is a culture present at Cleveland Clinic labs where cheating on Proficiency Testing is a routine and accepted practice, how can patients and clinicians trust any result produced by that laboratories?

There's no doubt there will be many many stories on this in the news.

This isn't just a "Maryland General" - this is an example of what happens when you cut the laboratory to the bone and impose a culture where producing results is more important than protecting patients.