Heritage Labs Dba Ion Diagnostics Laboratories

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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, It was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the specialty of hematology. Findings include: Review of the CMS database and the API proficiency testing reports revealed the laboratory failed to achieve satisfactory performance for the specialty of hematology. Refer to D2121 and D2130. **Repeat deficiency form 2/10/2020** D2121 HEMATOLOGY 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 -- CFR(s): 493.851(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 of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve at least 80 percent for hematology cell identification or white blood cell differential for 3 (1st and 3rd events in 2019 and the 1st event in 2020) out of 4 consecutive testing events. Findings include: 1. A record review of the CMS database and API proficiency testing reports revealed the following scores for 3 out of 4 consecutive proficiency for cell identification or white blood cell differential: Cell Identification or White Blood Cell Differential PT Event Score 1st event 2019 32% 3rd event 2019 0% 1st event 2020 32% D2130 HEMATOLOGY CFR(s): 493.851(f) 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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the hematology cell identification or white blood cell differential for 3 (1st and 3rd events in 2019 and the 1st event in 2020) out of 4 consecutive testing events. Findings include: 1. A record review of the CMS database and API proficiency testing reports revealed unsatisfactory performance for 3 out of 4 consecutive proficiency for cell identification or white blood cell differential: Cell Identification or White Blood Cell Differential PT Event Score 1st event 2019 32% 3rd event 2019 0% 1st event 2020 32% **Repeat deficiency from 2/10/2020** 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 CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: 1. Failure to ensure that the proficiency testing samples were tested as required under Subpart H. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- 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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory director failed to ensure the laboratory successfully participated in a proficiency testing program as required under Subpart H for 3 (1st and 3rd events in 2019 and the 1st event in 2020) out of 4 consecutive testing events. Findings include: 1. A record review of the CMS database and API proficiency testing reports revealed unsatisfactory performance for 3 out of 4 consecutive proficiency for cell identification or white blood cell differential: Cell Identification or White Blood Cell Differential PT Event Score 1st event 2019 32% 3rd event 2019 0% 1st event 2020 32% -- 3 of 3 --

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 the CMS database and review of the American Proficiency Institute (API) final proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the specialty of hematology for 2 (1st and 3rd) of 3 testing events in 2019. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 2 of 3 proficiency testing events for the specialty of hematology. Refer to D2130. . D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) 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 the CMS database and review of the American Proficiency Institute (API) graded proficiency testing reports, the laboratory failed to achieve satisfactory performance for the hematology white blood cell differential for 2 out of 3 consecutive testing events. Findings include: Unsatisfactory performance for 2 out of 3 consecutive proficiency events constitutes unsuccessful performance for white blood cell differential: White Blood Cell Differential PT Event Score 3rd event 2019 0% 1st event 2019 32% -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on procedure manual review and interview with General Supervisor #2 (GS2), the Laboratory Director (LD) failed to approve, sign, and date 3 ("Reflex Testing Policy, To Whom So Ever It May Concern, and Urinalysis Grading Chart") of 6 new polices before put into use. Findings include: 1. Review of the procedure manual revealed for 3 of 6 new polices submitted with the Allegation of Compliance (AoC) were not approved, signed, and dated by the LD. When queried on 6/26/19 at approximately 11:45 am, GS2 was unable to provide the surveyor with the newly adopted and signed policies. 3. During the interview on 6/26/19 at approximately 11: 45 am, GS2 acknowledged the newly adopted polices were not accessible. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: . Based on procedure review and interview with General Supervisor #2 (GS2), the laboratory failed to provided 6 ("Proficiency Testing, Proficiency Testing Failures, Temperature & Humidity, Test Report, Calibration Verification, and CBC Calibration") of 6 newly adopted, signed, and dated procedures for the surveyor. Findings include: 1. Procedure manual review revealed for 6 of 6 new procedures 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 -- submitted with the Allegation of Compliance (AoC) were not provided in the procedure manual as follows: a. "Proficiency Testing" b. "Proficiency Testing Failures" c. "Temperatures & Humidity" d. "Test Report" e. "Calibration Verification" f. "CBC Calibration" 2. On 06/26/19 at approximately 11:45 am when interviewed, GS2 was not able to provide the surveyor with a copy of the newly adopted procedures. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and interview, the laboratory failed to meet the requirements for the specialty in Chemistry as specified in 493.1230 through 493.1256, 493.1267, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to ensure the procedure contained all the required information for reflex testing. Refer to D5403. 2. The laboratory failed to monitor and document the room temperature. Refer to D5413. 3. The laboratory failed to perform and evaluate the chemistry calibration verification. Refer to D5439. 4. The laboratory failed to perform valid quality control testing in chemistry. Refer to D5481. 5. The laboratory failed to provide accurate and reliable patient test results. Refer to D5801. 6. The laboratory failed to identify the name and address of the facility performing the sendout testing. Refer to D5805. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on procedure review and interview with the Technical Supervisor (TS), the 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 -- laboratory failed to perform and follow a written procedure for the "XN450 Procedure," for 5 of 5 (11/8/19 to 4/15/19) months. Findings include: 1. Procedure review of the "XN450 Procedure" section titled "Retained Patient Controls" revealed patient controls were not run as follows: a. "Within Day Precision" stated random patient bloods are run every 4 hours. b. "Day to Day Precision" stated the same random blood used for within day precision are kept and run the following morning after instrument start-up. 2. Interview with TS on 4/15/19 at 10:05 am acknowledged the laboratory does not perform "Within Day Precision" and "Day to Day Precision" according to the "XN450 Procedure." 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)