Summary:
Summary Statement of Deficiencies D0000 An entrance conference was held 06/22/2018 with testing personnel one. The survey process was discussed. An opportunity for questions and comments was given. The laboratory was found out of compliance with the CLIA (Clinical Laboratory Improvement Amendments) regulations. Immediate jeopardy findings were identified. The conditions not met were: D2000 - 42 C.F.R. 493.801 Condition: Enrollment and Testing of Samples (proficiency testing) D5016 - 42 C.F.R. 493.1210 Condition: Routine chemistry; D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D5800 - 42 C.F.R. 493.1290 Condition: Postanalytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; An exit conference was held by telephone on 06/22/2016 with the laboratory director, the clinical operations supervisor, and the laboratory supervisor. The exit conference attendees were advised the laboratory was out of compliance and advised of conditions and deficiencies found during the survey. An opportunity for questions and comments was provided. On June 25, 2018 the laboratory director submitted a letter stating the laboratory would not voluntarily cease testing at this time. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- This CONDITION is not met as evidenced by: Based on direct observation, review of the laboratory's submitted test menu, review of the CMS (Centers for Medicare and Medicaid Services) 155 report, review of manufacturer's "Technical Bulletin for Proficiency Testing on the i-STAT System, attempted review of laboratory proficiency testing records, and interview of facility personnel it was revealed that the laboratory failed to enroll in a proficiency testing program for each of the specialties and subspecialties for which it seeks certification (chemistry) for 2017 and 2018. The findings were: 1. Review of the laboratory's submitted test menu on June 22, 2018 revealed the laboratory performs arterial blood gas testing using the Abbott i-STAT point of care analyzer. 2. Based on surveyor observation on 06/22/2018 at 0915 hours in the laboratory refrigerator during the initial tour of the laboratory revealed the following test cartridges available for use in patient testing. Abbott i-STAT G3+ arterial blood gas 3. Review of the CLIA FDA Database revealed that Abbott i-STAT G3+ test cartridges for arterial blood gas are labeled as moderate complexity. 4. Review of the CMS 155 report revealed that no proficiency testing scores had been reported to the Centers for Medicare and Medicaid Services (CMS). 5. Review of Abbott i-STAT Technical Bulletin Proficiency Testing on the i-STAT System (Art. 714262-00AD, Rev. Date: 12-Feb-15) stated under "CLIA Requirements for Proficiency Testing": "Moderate Complexity Tests: CLIA regulation Subpart H - Participation in Proficiency Testing requires a laboratory to enroll in a proficiency testing program approved by the Centers for Medicare and Medicaid Services (CMS) for its primary test system or that system used at its primary site. The laboratory must participate successfully as defined by the criteria defined in Subpart I - Proficiency Testing Programs." and; "For CLIA regulated analytes, proficiency (PT) programs must provide three separate shipments during the year that include five challenges for each analyte or test. Laboratories must comply with the CLIA requirements and those of their accrediting organization when testing PT samples" 6. Attempted review of proficiency testing records during the onsite survey on June 22, 2018 revealed no records were available for review that would document the laboratory being enrolled in a proficiency testing program in 2017 or 2018 for chemistry. 7. Review of patient test results revealed that laboratory performed 157 arterial blood gas patient tests since from December 2016 to June 22, 2018 (the date of the survey). 8. An interview with testing person number one (as listed on Form CMS-209) who is also the laboratory supervisor on June 22, 2018 at 0910 in the laboratory during the initial tour of the laboratory confirmed the findings. She revealed that the instrument manufacturer told them they did not have to perform proficiency testing. Key: CLIA - Clinical Laboratory Improvement Amendments FDA - Food and Drug Administration D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observations, review of laboratory policy, review of manufacturer's instructions, review of patient test records, review of environmental records, and confirmed in interview of facility personnel, the laboratory did not meet the requirements for routine chemistry as evidenced by: 1. The laboratory failed to have a -- 2 of 16 -- policy that was approved and signed by the laboratory director that instructed testing personnel on all aspects of the testing procedure. (refer to D5403-A and D5403-B) 2. The laboratory failed to follow the manufacturer's instructions to verify the transit temperature of Abbott i-STAT G3+ test cartridges. (refer to D5411) 3. The laboratory failed to have a mechanism in place to monitor the room temperature and humidity of the laboratory. (refer to D5413) 4. The laboratory failed to perform verification studies on the Abbott i-STAT point of care analyzer used for arterial blood gases prior to patient testing in December 2016. (refer to D5421) 5. The laboratory failed to have a policy that would monitor quality control to detect immediate errors and errors over time. (refer to D5441) 6. The laboratory failed to perform at least one level of quality control each eight hours of patient testing or to develop an IQCP (Individualized Quality Control Plan) to reduce the frequency of quality control testing. (refer to D5537) 7. The laboratory failed to have a policy that would identify and correct errors in the analytic systems. (refer to D5791) D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observations, review of laboratory policy, review of manufacturer's instructions, review of patient test records, review of environmental records, and confirmed in interview of facility personnel, the laboratory failed to monitor and evaluate the overall quality of its analytic systems as evidenced by: 1. The laboratory failed to have a policy that was approved and signed by the laboratory director that instructed testing personnel on all aspects of the testing procedure. (refer to D5403-A and D5403-B) 2. The laboratory failed to follow the manufacturer's instructions to verify the transit temperature of Abbott i-STAT G3+ test cartridges. (refer to D5411) 3. The laboratory failed to have a mechanism in place to monitor the room temperature and humidity of the laboratory. (refer to D5413) 4. The laboratory failed to perform verification studies on the Abbott i-STAT point of care analyzer used for arterial blood gases prior to patient testing in December 2016. (refer to D5421) 5. The laboratory failed to have a policy that would monitor quality control to detect immediate errors and errors over time. (refer to D5441) 6. The laboratory failed to perform at least one level of quality control each eight hours of patient testing or to develop an IQCP (Individualized Quality Control Plan) to reduce the frequency of quality control testing. (refer to D5537) 7. The laboratory failed to have a policy that would identify and correct errors in the analytic systems. (refer to D5791) D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic -- 3 of 16 -- examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)