Medical Health Laboratory Inc

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a 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 -- proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was determined the laboratory has not successfully participated in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the analyte Uric Acid. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2020, it was determined the laboratory failed to attain a score of 80% or greater for the analyte Uric Acid for 2 of 3 chemistry testing events in 2020. Findings were: 1. A review of the CMS national proficiency testing database from 2019-2020 revealed the laboratory failed to attain a satisfactory score of 80% or greater for Uric Acid in 2 of 3 Chemistry testing events in 2020. 2020 AAB 3rd event - 0% 2020 AAB 1st event - 0% 2. A proficiency desk review of the AABB proficiency testing records from 2020 confirmed that the laboratory received the following Uric Acid score for 2 of 3 consecutive Chemistry testing events in 2020. 2020 AAB 3rd event - 0% 2020 AAB 1st event - 0% D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2018 - 2020, it was revealed that the laboratory failed to participate in the 1st and 3rd chemistry events of 2020 for the analyte Uric Acid. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the analyte Uric Acid in the specialty of Chemistry on the 1st and 3rd of 2020 for this facility. 2. A proficiency desk review of AAB PT records revealed the laboratory received a 0% for Uric Acid in the 2020-1st and 3rd Chemistry event PT for "Failure to Participate." The PT summary was rated by the provider as unsatisfactory performance for Uric Acid for testing events 2020-1 and 2020-3 Chemistry. -- 2 of 4 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2020, it was determined the laboratory failed to achieve satisfactory performance for the analyte Uric Acid for 2 of 3 consecutive testing events in 2020. Findings were: 1. A review of the CMS national proficiency testing database from 2019-2020 revealed the laboratory failed to attain a satisfactory score of 80% or greater for Uric Acid in 2 of 3 Chemistry testing events in 2020. 2020 AAB 3rd event - 0% 2020 AAB 1st event - 0% 2. A proficiency desk review of the AAB proficiency testing records from 2020 confirmed that the laboratory received the following Uric Acid score for 2 of 3 consecutive Chemistry testing events in 2020. 2020 AAB 3rd event - 0% 2020 AAB 1st event - 0% 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 a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Findings were: 1. A review of the laboratory proficiency testing results revealed that the laboratory director failed to ensure that the laboratory participated successfully. (refer to D6016) By not providing overall management and direction of the laboratory, the laboratory director could not ensure the accuracy or reliability of all laboratory services provided by the facility. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the -- 3 of 4 -- laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an approved proficiency testing program. (refer to D2087, D2096) -- 4 of 4 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Review of American Proficiency Institute (API) proficiency testing (PT) records from 2018 and 2019, patient test results and confirmed with interview, the laboratory failed to verify the accuracy of Glycated hemoglobin (HgbA1c) twice annually either through enrollment in proficiency testing or method comparison studies. Findings were: 1. Review of the API testing records revealed the laboratory enrolled in proficiency testing records for the 2019 test events for the test HgbA1c. 2. Review of the verification studies for HgbA1c revealed the laboratory performed method comparison in 03/2018. No documentation was available for review of the second assessment in 2018. HgbA1c patient testing began in April 2018 with an annual volume of 1700 tests. 3. An interview with the primary testing person on 2/26/19 at 1100 hours confirmed the above findings. She stated that since they missed the cutoff to enroll for PT, they were unable to perform the PT and they were unaware they should perform twice annual the accuracy assessment. This is a repeat deficiency from the survey with date 04/26/17. D5400 ANALYTIC SYSTEMS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 review of laboratory policies, review of quality control records, review of patient final reports, and confirmed in interview, the laboratory failed to monitor and evaluate the overall quality of its analytic systems. Refer to D5421, D5439 D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of the chemistry verification studies, and verified by interview the laboratory failed to perform a complete verification study for Glycated Hemoglobin (HgbA1c) on the Roche integra 400 plus chemistry analyzer. Findings were: 1. A review of the Roche Integra 400 plus chemistry analyzer verification studies revealed no documentation of a normal patient ranges study for the analyte HgbA1c. 2. An interview with the primary testing person on 02/26/19 at 1100 hours confirmed the above findings. This is a repeat deficiency from the survey with date 04/26/17. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control -- 2 of 5 -- materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of chemistry records and interview of facility personnel, the laboratory failed to document every 6 month calibration verifications on all required analytes for Roche cobas e411 and cobas integra 400 plus. Findings were: 1. Review of chemistry records revealed no documentation of calibration verification studies in 2018 on the following analytes performed on the Roche COBAS e411 clinical chemistry analyzer and calibrated with fewer than 3 calibrators: TSH, TT4, TU 2. Review of chemistry records revealed no documentation of calibration verification studies in 2018 on the following analytes performed on the Roche Integra 400 plus clinical chemistry analyzer and calibrated with fewer than 3 calibrators: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Total Bilirubin, Calcium, chloride, Total Cholesterol, HDL Cholesterol, Creatinine, Glucose, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid. 3. Interview of the primary testing person on 02/26/19 at 1300 hours in the laboratory confirmed the above findings. This is a repeat deficiency from the survey with date 04 /26/17. key: TSH - Thyroid Stimulating Hormone TT4 - Thyroxine TU - Thyroid hormone uptake D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory verification records, calibration records, and confirmed in interview, the laboratory quality assessment policies and procedures failed to to monitor & evaluate the overall quality of the analytic systems. (refer to D5421, D5439). D5817 TEST REPORT CFR(s): 493.1291(i) If a laboratory refers patient specimens for testing-- (i)(1) The referring laboratory must not revise results or information directly related to the interpretation of results provided by the testing laboratory; (i)(2) The referring laboratory may permit each testing laboratory to send the test result directly to the authorized person who initially requested the test. The referring laboratory must retain or be able to produce an exact duplicate of each testing laboratory's report; and (i)(3) The authorized person who orders a test must be notified by the referring laboratory of the name and address of each laboratory location where the test was performed. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on review of laboratory test reports and confirmed in interview with the laboratory director, the laboratory report for the Glycated Hemoglobin (HgbA1c) did not identify the laboratory facility where the tests had been performed for 5 of 10 test reports sent to the reference lab. Findings include: 1. A random review of the HgbA1c from February 2019 sent to a reference lab revealed 10 HgbA1c tests were sent to the reference laboratory for testing. For 5 of 10 patient test reports for the HgbA1c, the report did not identify the laboratory facility where the testing was performed. Accn# 52578 52582 52583 52584 52587 2. An interview with the primary testing person on 2 /26/19 at 1345 in the office confirmed the above findings. She acknowledged that the final report should have the name and address of the reference laboratory. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, test list and confirmed in interview, the laboratory did not have an established and written policy/procedure for verifying and documenting their LIS (laboratory information system) calculated test result as it is interfaced with their Roche Integra 400 plus chemistry analyzer to ensure accuracy. Findings included: 1. The laboratory's procedure manual did not include a policy/procedure for verifying calculated test results from the LIS as it was interfaced with the Roche Integra 400 plus chemistry analyzer. 2. The laboratory's test list included the following calculated test results obtained from the test menu: LDL (calculated); vLDL; Chol/HDL ratio. 3. An interview with the primary testing person on 2/26/19 at 1340 hours acknowledged that "There is not a policy or procedure for checking the calculated test results." She was unaware that she needed to verify the calculated results. According to records, the laboratory's patient total test volume was 12000 tests annually. 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 laboratory's policies and procedures, quality control records, quality assessment records and staff interview, the laboratory director failed to provide overall management and direction of the laboratory. ( Refer to D6013, D6021) D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of -- 4 of 5 -- 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of the laboratory's test system records and interview of facility personnel it was revealed that the laboratory director failed to ensure verification studies were complete for chemistry testing on the Roche Cobas chemistry analyzer before reporting patient test results. (Refer to D5421) D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's records and staff interview, it was revealed the laboratory director failed to ensure a quality assurance program was developed to prevent repeat deficiencies. Refer to D5217, D5421, D5439 -- 5 of 5 --