Advanced Care Emergi Center & Occupational Health

Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 27, 2023. Advanced Care Emergi Center and Occupational Health Clinic Inc clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, observation of patient specimens, and interview, the laboratory failed to ensure the positive identification of a patient's specimen at the time of collection for 1 of 1 patient specimen collected during the survey. Findings: Review of the procedure titled, Routine Venipuncture read, "Label each tube. Each tube the patient's full name as it appears on the reference lab requisition, date and time of collection, initials of phlebotomist." Observation on 09/27/2023 at 11:13 AM, of a patient's blood collection tubes (one purple top tube and three red top tubes) showed only the last name of the patient was written on the tubes of blood. On 09/27/2023 at 11:15 AM, Testing Personnel B acknowledged she did not write the patient's full name, date or collection time on the tubes. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of patient's test reports, the procedure manual and interview, the laboratory failed to establish a written procedure for correcting the specimen collection time for three of three patients' (#1, #2, #3) test reports. Findings: Review of three patient's hematology test results showed the collection time on the reports was after the analysis time. Patient #1's hematology test report indicated the specimen was analyzed on 01/24/2022 at 9:32 AM, and collected on 01/24/2022 at 9:37 AM. Patient #2's hematology test report indicated the specimen was analyzed on 02/06/2023 at 11: 19 AM, and collected on 02/06/2023 at 11:27 AM. Patient #3's hematology test report indicated the specimen was analyzed on 06/08/2023 at 12:25 PM, and collected on 06 /08/2023 at 1:34 PM. Observation on 09/27/2023 at 11:05 AM, of a patient specimen run on the hematology analyzer showed the analyzer automatically added a collection time that was after the analysis time. Review of the procedure manual revealed there were no directions on how to change the collection time from the hematology analyzer to the correct collection time of the patient's specimen. On 09/27/2023 at 11: 12 AM, the Technical Consultant acknowledged the collection times on the test reports were incorrect and there were no directions in the procedure manual on how to change the collection time from the hematology analyzer to the correct collection time of the patient's specimen.. 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 review of the Laboratory Personnel Report, personnel records, and interview, the laboratory failed to verify the educational qualifications (degrees) for 1 of 3 Testing Personnel, (A). (See 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 This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of the Laboratory Personnel Report, personnel records, and interview, the laboratory failed to verify the educational qualifications (degrees) for 1 Testing Personnel (A) out of 3 Testing Personnel (A, B, C). Findings: Review of the Laboratory Personnel Report, signed by the Laboratory Director on 09/19/2023, showed there were three employees listed as moderate complexity testing personnel. Review of the laboratory personnel folders showed there was no documentation of the educational degree for Testing Personnel A available for review. On 09/27/2023 at 11: 30 AM, Technical Consultant stated Testing Personnel A could not find her degree. -- 3 of 3 --

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 record review and interview, the laboratory failed to enroll in proficiency testing for 1 out of 3 endocrinology analytes tested for the 2nd and 3rd events of 2018 and the 1st event of 2019. Findings:t Review of the laboratory's proficiency testing with American Proficiency Institute (API) showed that the laboratory failed to enroll in proficiency testing for Free Thyroxine (FT4) for the 2nd and 3rd events of 2018 and the 1st event of 2019. During an interview on 5/15/19 at 11:17 AM, Technical Consultant stated they started endocrinology testing on 4/4/18 and that the laboratory failed to enroll in proficiency testing for FT4. D2123 HEMATOLOGY CFR(s): 493.851(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) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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 record review and interview, the laboratory failed to participate in proficiency testing (PT) that resulted in a score of zero (0) percent on the Hematology /Coagulation third event in 2017. Findings: Review of the American Proficiency Institute (API) records for the 2017 Hematology/Coagulation 3rd event showed the laboratory received a score of 0% for all analytes to be tested. Notes on the API "Performance Summary" sheet stated "Failure to Participate". During an interview on 5/15/19 at 11:15 AM, the Technical Consultant acknowledged that the laboratory failed to get the test results submitted on time. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document annual competency assessment on 1 out of 3 testing personnel for 2018. Findings: Review of the competency records showed that the laboratory failed to have document the annual competency assessments for 1 out of 3 testing personnel in 2018. During an interview on 5/15/19 at 1128 AM, the Technical Consultant who is also a testing personnel stated that she didn't have a competency evaluation performed on herself. 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 record review and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the analytic system and correct identified problems. Findgins: Cross Reference D5403. Based on record review and interview, the laboratory's written procedure manual was incomplete. Cross Reference D5413. Based on observation, record review, and interview, the laboratory failed to store frozen Chemistry control material at the correct freezer temperatures from 1/01 /18 to 5/15/19. Cross Reference D5421. Based on record review and interview, the instrument verification for the Beckman Coulter Access 2 installed in July 2017 was -- 2 of 9 -- incomplete. Cross Reference D5469. Based on record review and interview, the laboratory failed to perform quality control lot to lot comparison from 5/15/17 to 5/15 /19. Cross Reference D5481. Based on record review and interview, the laboratory failed to have the 2 levels controls within acceptable range for CBC's (Complete Blood Count) prior to testing patients on 1 testing date (5/29/17) in 2017 and 2 testing dates (4/02/18 and 12/03/18) in 2018. 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 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)