Jefferson Community Health & Life - Fairbury

Summary Statement of Deficiencies 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. This CONDITION is not met as evidenced by: Based on staff interviews, on date of survey, the laboratory failed to enroll in an approved proficiency testing program for Blood Glucose. The laboratory director and testing personnel confirmed the laboratory performed Blood Glucose testing in 2018. The laboratory was not enrolled in an approved proficiency program for 2018 and 2019. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, laboratory's procedure manual, and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- interview with laboratory personnel the laboratory failed to follow manufacturer's instructions for the Bayer Contour Blood Glucose Meter. Findings are: 1. In review of the manufacturer's instructions for Bayer Contour Blood Glucose Meter states, "The Contour blood glucose monitoring system is intended for self-testing by people with diabetes and by healthcare professionals to monitor glucose concentrations in whole blood. The Contour system is not intended for the diagnosis of or screening for diabetes mellitus." 2. In review of the laboratory's procedure manual the procedure indicates clinical purpose as a "screening test for gestational diabetes mellitus." 3. Interview with testing personnel #5 and laboratory director on 11/25/2019, confirmed the laboratory was using the Bayer Contour Blood Glucose Meter as a screening test for gestational diabetes mellitus. 4. Testing personnel confirmed two of two patients reviewed were screened for diabetes mellitus with the Bayer Contour Blood Glucose Meter in 2018. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the laboratory director the laboratory failed to perform performance specifications on the Bayer Contour Blood Glucose Meter. Findings are: 1. At time of survey no documentation was presented indicating performance specifications performed on the Bayer Contour Blood Glucose Meter. 2. Interview with laboratory director on 11/25/2019 confirmed the laboratory did not perform performance specifications on the Bayer Contour Blood Glucose Meter. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Bayer Contour Blood Glucose Meter package insert, laboratory's procedure manual, and lack of documentation the laboratory director failed to fulfill laboratory director responsibilities. Refer to D5411 and D5423. D6168 TESTING PERSONNEL CFR(s): 493.1487 -- 2 of 4 -- The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on interview with testing personnel #5 a high complexity Blood Glucose testing was performed by unqualified testing personnel. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the -- 3 of 4 -- factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of patients tested in 2018 and 2019 with the Bayer Contour Blood Glucose Meter and interview with testing personnel #5, high complexity Blood Glucose testing was performed by unqualifed testing personnel. Findings are: 1. Review of two out of two patients tested with the Bayer Contour Blood Glucose Meter in 2018 and 2019 revealed Blood Glucose testing was performed by unqualifed testing personnel. 2. Interview with testing personnel #5, on 11/25/2019, confirmed testing personnel was unqualified to perform high complexity testing. -- 4 of 4 --

Summary Statement of Deficiencies D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of 2017 and 2018 competency records and lack of approved procedure manual the laboratory director, who is filling the role of technical consultant, failed to provide technical oversight and failed to fulfill technical consultant responsibilities. Refer to D6030, D6031, and D6033. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of testing personnel listed on the CMS-209, review of 2017 and 2018 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- testing personnel competencies, and interview with Lab Manager, not listed on CMS- 209, the laboratory director (who is filling the role of technical consultant) failed to perform competencies on personnel performing moderate complexity testing. Refer to D6046. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on lack of procedure manual and interview with Lab Manager, not listed on CMS-209, the laboratory director failed to have an approved procedure manual available to personnel. Findings are: 1. No approved procedure manual was available on day of survey. 2. Interview with Lab Manager, not listed on CMS-209, on 7/17 /2019 at 11:00 AM confirmed no approved procedure manual was available to personnel. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of competency records and review of quality control records the technical consultant failed to provide technical oversight and failed to fulfill technical consultant responsibilities. Refer to D6046 and D6049. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of testing personnel listed on the CMS-209, review of 2017 and 2018 testing personnel competencies, and interview with Lab Manager, not listed on CMS- 209, the laboratory failed to have technical consultant perform competencies on personnel performing moderate complexity testing. Findings are: 1. Review of the CMS-209 personnel form presented by the laboratory at the time of survey on 7/17 /2019 revealed five testing personnel performing moderate complexity testing. 2. Review of 2017 and 2018 annual competencies for the five testing personnel revealed -- 2 of 4 -- the Lab Manager, not listed on CMS-209, had signed off on competencies. The Lab Manager is not qualified as a technical consultant. 3. Interview with the Lab Manager, not listed on CMS-209, on 7/17/2019 at 1:00 PM revealed the technical consultant did not perform competencies on the five testing personnel performing moderate complexity testing. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of hematology quality control records and an interview with testing personnel #3, as listed on the CMS-209, the laboratory failed to document the review of hematology quality control records for 2019. Findings are: 1. Review of hematology quality control records for 2019 revealed laboratory director, who performs the function of the technical consultant, did not review hematology quality control records. 2. Interview with testing personnel #3, as listed on the CMS-209, on 7 /17/2019 at 1:15 PM revealed testing personnel #3, who is not qualified as a technical consultant, reviewed hematology quality control records for 2019. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on lack of documentation the laboratory failed to have proof of education on testing personnel #5, as listed on the CMS-209, performing moderate complex testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with testing personnel #5, as listed on the CMS-209, on 7/17/2019 at 12:15 PM the laboratory failed to have proof of education on one out of five testing personnel performing moderate complexity testing. Findings are: 1. No proof of education documentation for testing personnel #5, as listed on the CMS-209, performing moderate complex testing was presented. 2. Interview with testing personnel #5, as listed on the CMS-209, confirmed no documentation was available. -- 4 of 4 --