Omni Laboratory Services

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of manuals, lack of documentaion, and interview, the laboratory director (LD) failed to provide overall management to ensure the establishment of quality assessment (QA) policies and procedures (D6094) and failed to ensure an approved and complete standard operating procedure manual was available to all personnel (See D6106). D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory director (LD) failed to establish and implement quality assurance (QA) procedures which monitor, assess, and when indicated, correct identified problems in the laboratory. Findings include: 1. The laboratory's standard operating procedures manual was reviewed. 2. The LD failed to establish written procedures that provide an ongoing review process that encompasses all facets of the laboratory's technical and non- technical functions for the following phases of the testing process: *Preanalytic - Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- assessing practices/issues related to test requests, specimen submission, handling, specimen acceptance and rejection, and referral. *Analytic - assessing: practices /issues related to test procedures; accurate and reliable test systems; equipment, instruments; reagents; materials; and supplies; specimen and reagent storage condition; equipment/instrument/test/system maintenance and function checks; control procedures; comparison of test results.

Summary Statement of Deficiencies 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 review of CASPER Report 0155D and interview with an American Proficiency Institute (API) representative the laboratory failed to successfully participate in proficiency testing (PT) for the specialty of Hematology (See D2031) and the analytes red blood cells (RBC) and hematocrit (HCT) during PT event 3 of 2020 and event 2 of 2021 (See D2030). D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER Report 0155D and interview with an American Proficiency Institute (API) representative the laboratory failed to successfully participate in proficiency testing (PT) for the analytes red blood cells (RBC) and hematocrit (HCT) in event 3 of 2020 and 2 of 2021, for the specialty of hematology. Findings include: 1. Review of the CASPER 0155D report revealed that the initial unsuccessful PT performance occurred during API PT event 3 of 2020 and event 2 of 2021, as listed below. HEMATOLOGY EVENT -3, 2020 RBC, 0% Unsatisfactory EVENT -2, 2021 RBC, 20% Unsatisfactory EVENT -3, 2020 HCT, 0% Unsatisfactory EVENT -2, 2021 HCT, 0% Unsatisfactory 2. Interview with the API representative on 10-04-2021 at 9:32 AM confirmed the initial unsuccessful PT performance for the analytes RBC and HCT in event 3 of 2020 and event 2 of 2021. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 review of CASPER Report 0155D and interview with an American Proficiency Institute (API) representative the laboratory failed to successfully participate in proficiency testing (PT) for the specialty of Hematology in event 3 of 2020 and 2 of 2021. Findings include: 1. Review of the CASPER 0155D report revealed that the initial unsuccessful PT performance occurred during API PT event 3 of 2020 and event 2 of 2021, as listed below. HEMATOLOGY EVENT -3, 2020 Hematology, 48% Unsatisfactory EVENT -2, 2021 Hematology, 67% Unsatisfactory 2. Interview with the API representative on 10-04-2021 at 9:32 AM confirmed the initial unsuccessful PT performance for the specialty of Hematology for event 3 of 2020 and event 2 of 2021. -- 2 of 2 --

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 an HHS approved proficiency testing (PT) program for tests performed in the subspecialties of Bacteriology and General Immunology during the years of 2019 to 2021. Findings include: 1. Patients' test records from 12/2019 to 08/2021, the American Proficiency Institute (API)-PT documents for the years of 2019 to 2021, manufacturer's package insert, and procedures manual were reviewed. 2. The patients' final reports and manufacturer's package inserts revealed the following: *For 14 out of 14 selected patients, the laboratory performed and reported test results for these analytes: Heliobacter pylori (H.Pylori); Rheumatoid Factor (RF); Hepatitis C antibody (HCV); and Hepatitis B surface Antigen (HbsAg). *The methods used to test for H.Pylori, RF, HCV and HbsAg were all non-waived. 3. The laboratory's PT policy stated the following: "The laboratory will be enrolled in an approved Proficiency Testing for all regulated analytes as specified in Subpart I, Proficiency Testing Programs for Non- waived testing, ...". 4. The API-PT data records showed the laboratory failed to enroll in the subspecialties of Bacteriology and General Immunology for the analytes listed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- in findings #2. 5. On a Recertification survey conducted on 08/26/2021 at 4:00 PM, the general supervisor confirmed the above findings and stated he thought the tests were waived and did not require PT enrollment. 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 review of the American Proficiency Institute (API) proficiency testing (PT) reports and interview, the laboratory failed to successfully participate in their PT program for each Hematology analyte (D2130). D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 record review and interview, the laboratory failed to attain a score of at least 80 percent for SARS-CoV-2 IgM and C-Reactive Protein during the years of 2020 and 2021. Findings: 1. The American Proficiency Institute (API) proficiency testing (PT) Immunology results for the years of 2020 and 2021 and PT policies and procedures were reviewed. 2. The laboratory failed to achieve satisfactory performance scores for the following analytes: GENERAL IMMUNOLOGY *SARS- CoV-2 IgM - Event #3, 2020 = 33% - Unsatisfactory *C-Reactive Protein (qual) - Event #1, 2021 = 50% - Unsatisfactory 3. The laboratory's PT policy instructed the following: "When graded PT results are unsatisfactory, will evaluate the results and take appropriate

Summary Statement of Deficiencies 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 review of CASPER Report 0155D and interview with a American Proficiency Institute (API) representative; the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analytes uric acid and high-density lipoprotein (HDL) cholesterol during PT events in 2020 and 2021. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 review of CASPER Report 0155D and interview with a American Proficiency Institute (API) representative; the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analytes uric acid and high-density lipoprotein (HDL) cholesterol during PT events in 2020 and 2021. Findings include: 1. Review of the CASPER Report 0155D on 08/02/2021 at 10:15 AM, identified the initial unsuccessful PT performance for the specialty of chemistry analytes as indicated below. CHEMISTRY Cholesterol, HDL - EVENT-1, 2021 = 40% - Unsatisfactory Cholesterol, HDL - EVENT-2, 2021 = 60% - Unsatisfactory Uric Acid - EVENT-3, 2020 = 60% - Unsatisfactory Uric Acid - EVENT-2, 2021 = 40% - Unsatisfactory 2. A phone interview with the API PT representative on 08/02 /2020, at 1:10 PM, confirmed the unsatisfactory PT scores for cholesterol, HDL for events 1 and 2 of 2021 and uric acid for event 3 of 2020 and event 2 of 2021. -- 2 of 2 --

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 an interview with the laboratory director (LD), the laboratory failed to enroll in an HHS approved proficiency testing (PT) program for the subspecialty of General Immunology, affecting 9 out of 9 patients. Findings include: 1. The laboratory's patients' test records, PT documents, manufacturer's package insert, and final reports were reviewed. 2. The patients' test logs and manufacturer's package insert showed the following: *The laboratory was performing patient testing for the analytes: antistreptolysin-O (ASO) and C-reactive protein (CRP). *The method used to test for ASO and CRP was non-waived. 3. The America Proficiency Institute (API) PT program receipt showed that the laboratory failed to enroll in the subspecialty of General Immunology for the ASO and CRP testing performed. 4. The final reports of 9 out of 9 patients selected for review, included ASO and CRP test results. 5. On an Initial survey conducted on 08/30/2019 at 2:30 PM, the LD confirmed the above findings and stated he thought the tests were waived and did not require PT enrollment. D3007 FACILITIES CFR(s): 493.1101(b) 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 -- The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on direct observation and an interview with the laboratory director (LD), the laboratory failed to have sufficient equipment for the type and volume of testing it performs. Findings include: 1. On 08/30/2019 at 11:58 AM during a tour of the laboratory, the surveyor observed the following: *A centrifuge seated on the floor, against the wall, by the laboratory's entrance door; *No table or workbench for processing patients' requisitions and specimens; and *No table or workbench to aliquot and prep specimens for chemistry and immunology testing. 2. The LD confirmed the above findings. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on record review, manuals, and an interview with testing personnel (TP2) and the laboratory director (LD), the laboratory failed to ensure the information transcribed or entered into the laboratory's information system (LIS) is transcribed or entered accurately, affecting 9 out of 9 patients. Findings Include: 1. The patients' requisitions, final reports, and laboratory manual were reviewed. 2. The 9 randomly selected patients' requisitions and final reports revealed the following: * 4 (A1, A2, A3, & A4) out of 9 requisitions failed to indicate the sex of the patient; *However, the final reports of patients A1, A2, A3, & A4 included the sex; *The laboratory failed to provide documentation from the provider that confirmed the sex of patients A1, A2, A3, & A4, prior to entering the information into the patients' LIS records. *8 out of 9 patients' requisitions had requests for tests the laboratory did not perform. *The laboratory failed to send 8 out of 8 patients' specimens to a referral laboratory when tests requested were not performed. *1 out of 9 patients' final report had an incorrect collection date; and *1 out of 9 patients' received results that were not requested in their requisition. 3. The laboratory's manual failed to include a policy and procedure which would establish an ongoing process that would ensure the accuracy of manual into the LIS by personnel. 4. On an Initial survey conducted on 08/30/2019 at 2:30 PM, the LD and TP2 confirmed the above findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on record review and an interview with testing personnel (TP2); the laboratory failed to establish written procedures for specimen submission, handling, and referral, prior to receiving patient specimens for Routine Chemistry and General Immunology. Findings include: 1. The laboratory procedures manual was reviewed. 2. The manual failed to include the following written step-by-step procedures: * The laboratory failed to have written details on how specimens are labeled. * The laboratory failed to have written details on how specimens are prepared/processed for chemistry and immunology testing. * The laboratory failed to have written details on how specimens are prepared for transport when referring to another testing laboratory. 3. On an Initial survey conducted on 08/30/2019 at 2:30 PM, the LD confirmed the above findings. 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)