All Childrens Pediatric Clinic Pa

Summary Statement of Deficiencies 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 upon review of the laboratory's verification study for the Horiba Micros (Serial number 111CS99869) hematology analyzer (completed May 19,2022), the laboratory's own written policy, the manufacturer specifications, patient test records and interview of facility personnel, the laboratory failed to verify the reference ranges for the parameters of the Complete Blood Count (CBC) were appropriate for the patient population before testing patient specimens. The laboratory reported an annual volume of 36,000 Hematology tests. The findings included: 1. Review of the Horiba Test System Validation form (signed by the laboratory director on 05/19/2024) found written next to Reference Range a note that read In Progress) with no documentation of approval. 2. Review of the laboratory's own written policy titled Validation of a New Test System (signed by the laboratory director with no date) found on page 1: "It is the policy of this lab to validate a new test system prior to using it to report patient results." 3. Review of the manufacturer specifications found on page 11 in Table 1-11 under the heading normal Ranges: WBC ( White Blood Cells): Male 4.7 - 9.6 10 3/ mm3 Female 4.9 - 12.3 10 3/ mm3 RBC (Red Blood Cells): Male 4.7-6.1 10 6/ mm3 Female 4.2-5.4 10 6/ mm3 HGB (Hemoglobin): Male 13.5 - 16.5 g/dl Female 12.0 - 15.0 g/dl Hct (Hematocrit): Male 41-50% Female 37-45% MCV ( Mean Corpuscular Volume): Male 83 - 101 um3 Female 84-96 um3 MCH ( Mean Corpuscular 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 -- Hemoglobin): Male 26-34 pg Female 27 - 34 pg MCHC( Mean Corpuscular Hemoglobin Concentration): 32-35 g/dl RDW( Red Cell Distribution Width): Male 12 - 16 % Female 12 - 14 % Plt ( Platelet): Male 145 - 355 10 3/mm/3 Female 150 - 330 10 3/mm/3 MPV(Mean Platelet Volume) 7.3 - 9.0 um3 Granulocyte %: Male 49 - 74 Female 53 - 79 Lymphocyte%: Male 23 - 47 Female 19 - 41 Monocyte%: Male 3 - 6 Female 2 - 6 3. Review of 4 final patient reports for male and female patients between the ages of 1 and 15 years found the following reference ranges: Male: WBC 3.5 - 10 x10^3 RBC 3.8 - 5.8 x10^6 Hgb 11.0 - 16.5 g/dL Hct 35 - 50 % MCV 6.5 -11 um^3 MCH 26.5.0 - 33.5 pg MCHC 31.5 - 35.0 g/dL RDW 10 - 15 % Plt 150 - 450 x10^3 MPV 6.5 - 11.0 um^3 Gran % 43 - 76 % Lymph% 17 - 48 % Mono% 4 - 6% 4. During interview of the technical consultant conducted March 7, 2024 at 10:21 AM, she confirmed the laboratory had not verified the reference ranges for pediatric populations. She went on to say that the laboratory should have verified 3 different reference ranges for patients between the ages of newborn and 18 years of age. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(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 upon review of the laboratory's verification study for the Horiba Micros (Serial number 111CS99869) hematology analyzer (completed May 19,2022), the laboratory's own written policy, the manufacturer specifications, patient test records and interview of facility personnel, the laboratory director failed to ensure the reference ranges for the parameters of the Complete Blood Count (CBC) were appropriate for the patient population before testing patient specimens. (See D 5421) -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on September 16, 2022 the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the facility failed to achieve successful 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 -- performance in four of four overall consecutive testing events for Hematology in 2021 (events 1, 2, and 3) and 2022 (event 1) resulting in unsuccessful performance (refer to D2131) and failed to achieve successful performance in three or more consecutive testing events for the analytes White Blood Cell Differential, Erythrocyte Count, Hemoglobin, Hematrocrit, White Blood Cell Count, and Platelets resulting in unsuccessful participation (refer to D2130). 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory failed to achieve satisfactory performance for the analytes White Blood Cell Differential, Erythrocyte Count, Hemoglobin, Hematocrit, White Blood Cell Count, and Platelets in three or more consecutive testing events in 2021 and 2022. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory analyte scores (satisfactory is 80% or greater): White Blood Cell Differential 2021 (event 1) 0% 2021 (event 2) 0% 2021 (event 3) 0% Red Blood Cell Count 2021 (event 1) 0% 2021 (event 2) 0% 2021 (event 3) 0% 2022 (event 1) 60% Hemoglobin 2021 (event 1) 0% 2021 (event 2) 0% 2021 (event 3) 0% 2022 (event 1) 60% Hematocrit 2021 (event 1) 0% 2021 (event 2) 0% 2021 (event 3) 0% 2022 (event 1) 60% White Blood Cell Count 2021 (event 1) 0% 2021 (event 2) 0% 2021 (event 3) 0% Platelets 2021 (event 1) 0% 2021 (event 2) 0% 2021 (event 3) 0% Failure to achieve satisfactory performance for the same analyte in two consecutive events or three out of three consecutive testing events is unsuccessful performance. 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory failed to achieve satisfactory performance for the overall specialty of Hematology in four of four consecutive testing events in 2021 (events 1, 2, and 3) and 2022 (event 1). The findings included: 1. Review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for specialty of Hematology in four of four consecutive events: 2021 API 1st event 0% 2021 API 2nd event 0% 2021 API 3rd event 0% 2022 API 1st event 76% 2. Review of the American Proficiency -- 2 of 3 -- Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for specialty of Hematology in four of four consecutive events: 2021 API 1st event 0% 2021 API 2nd event 0% 2021 API 3rd event 0% 2022 API 1st event 76% Failure to achieve satisfactory performance for an overall testing event in two consecutive events or four out of four consecutive testing events is unsuccessful performance. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the specialty of Hematology (refer to D6016). 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the specialty Hematology (refer to D2130 and D2131). -- 3 of 3 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor observation, review of manufacturer's instructions, and confirmed in interview of laboratory personnel, the laboratory failed to follow manufacturer's instructions to discard unused test strips for 1 of 1 vial of True Metrix Blood Glucose test strips observed in the laboratory on September 12, 2022. The findings included: 1. Surveyor observation made on September 12, 2022 at 15:20 hours in the laboratory found 1 vial of True Metrix Blood Glucose test strips available for use in the laboratory. Lot Number: MX4429S Expiration Date: 07-31-2022 2. Review of the manufacturer's instructions for the True Metrix Blood Glucose test strips (RF3TVH03 Rev. 52) stated, "Caring for Test Strips ...Discard all unused test strips in vial after either date printed next to EXP on the test strip vial label or 4 months after date opened, whichever comes first. Using test strips past these dates may cause inaccurate results." 3. The findings were confirmed in interview with the technical consultant on September 12, 2022 at 15:22 hours in the laboratory. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory 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 -- that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's test menu, review of manufacturer's instructions, patient test records, and staff interview, the laboratory failed to provide documentation of reporting 133 SARS-CoV-2 antigen positive results from April 1, 2022 to September 12, 2022 (the day of the survey) as required. The findings included: 1. A review of the laboratory's test menu found the laboratory utilized the Quidel QuickVue antigen SARS-CoV-2 kit for patient testing. 2. A review of the manufacturer's instructions for use for the Quidel Quick-Vue antigen SARS-CoV-2 antigen assay under the section titled "Conditions for Authorization for the Laboratory and Patient Care Settings" stated, "Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 3. A review of laboratory policies found no documentation of a policy or procedure related to SARS-CoV-2 test reporting to public health authorities. 4. Review of patient test records found the following SARS- CoV-2 antigen positive results were not reported to any public health authority (patient alias list provided to technical consultant the day of the survey on September 12, 2022). 5. An interview with testing personnel #1 (as listed on Form CMS-209) on September 12, 2022 via telephone confirmed the findings. Key: SARS-CoV-2 - Coronavirus that causes COVID-19 CMS - Centers for Medicare and Medicaid Services 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 review of the laboratory's test menu, laboratory policies, review of the laboratory's instrument verification records, and staff interview, the laboratory failed to provide documentation of verifying patient normal ranges when it changed hematology analyzers in May 2022. The findings included: 1. A review of the laboratory's test menu found the laboratory placed the Horiba hematology analyzer into use in May 2022. 2. Review of the laboratory's policy titled 'Validation of a New Test System' (no approval date by the laboratory director) stated, "Purpose: The purpose of this policy is to ensure that prior to performing tests on patients, every new test system will have studies performed to validate the accuracy, precision, reportable range of test results, and verify manufacturer's normal values." 3. Review of the verification study performed for the Horiba hematology analyzer in May 2022 found no patient normal verification studies. 4. The laboratory was asked to provide documentation of performing patient normal verification studies for the new analyzer. -- 2 of 4 -- No documentation was provided. 5. An interview with the technical consultant on September 12, 2022 at 1700 hours in the office confirmed the findings. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control records, and staff interview, the laboratory failed to have documentation of verifying 1 of 1 lots of Horiba Minotrol hematology controls. The findings included: 1. A review of the laboratory's quality control records found the following lot number of Horiba Minotrol hematology controls was not verified prior to putting into use. Lot: MX435 Expiration date: 07-25- 2022 2. The laboratory was asked to provide documentation of verifying the lot number of quality control prior to putting it into use. No documentation was provided. 3. An interview with the technical consultant on September 12, 2022 at 1645 hours in the office found the laboratory did not verify the controls. This confirmed the findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on laboratory policy, review of patient test records, and interview with laboratory personnel, the laboratory failed to ensure test reports were complete for 8 of 8 patient results randomly selected from July 23, 2022 to August 30, 2022. The findings included: 1. Review of the laboratory's policy titled, "Policy for handling flagged CBC Differentials" approved by the laboratory director on March 28, 2018 stated, " ...It is the policy of this laboratory to return [SIC] flagged CBC results. If the second run still shows flags, then lab will evaluate flagged differentials according to -- 3 of 4 -- the procedures in the unit's operator manual ..." 2. Review of 8 randomly selected patient test records from July 23, 2022 to August 30, 2022 found the following samples that were incomplete. There was no documentation that the laboratory resolved flags. Therefore, the CBC results were incomplete. Date: 07-23-2022 Patient ID: See patient alias list Flags: M2, G1 Date: 07-23-2022 Patient ID: See patient alias list Flags: M2, G1 Date: 07-25-2022 Patient ID: See patient alias list Flags: G1, G2 Date: 07-25-2022 Patient ID: See patient alias list Flags: M2, G1, G2 Date: 07-25- 2022 Patient ID: See patient alias list Flags: M2, G1, G2 Date: 08-26-2022 Patient ID: See patient alias list Flags: G1 Date: 08-27-2022 Patient ID: See patient list Flags: G1 3. The laboratory was asked to provide documentation of ensuring the CBC results were complete prior to their release to the healthcare provider. No documentation was provided. 4. The findings were confirmed in interview with the technical consultant on September 12, 2022 at 16:09 hours in the laboratory. Key: CBC - Complete Blood Count 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 quality control records, patient test records, technical consultant quality assurance review, and confirmed in interview of laboratory personnel, the laboratory director failed to ensure a quality assurance plan was established and maintained for 20 of 20 patient results for CBCs from August 22, 2022. The findings included: 1. Review of the laboratory's hematology quality control records for August 22, 2022 found the laboratory could not provide documentation of at least two passing levels of hematology quality controls. 2. Review of technical consultant's quality assurance review for August 2022 found she instructed the laboratory to invalidate 20 of 20 patient results performed on August 22, 2022 since there was no passing quality control. 3. Review of the 20 patient charts found the results had not been invalidated and were available for review on their medical record. 4. The findings were confirmed in an interview with the technical consultant on September 12, 2022 at 1715 hours in the laboratory after her review of the records. Key: CBC - complete blood count -- 4 of 4 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor observation, review of manufacturer's instructions, and confirmed in interview of laboratory personnel, the laboratory failed to follow manufacturer's instructions to discard unused test strips for 1 of 1 vial of True Metrix Blood Glucose test strips observed in the laboratory on September 12, 2022. The findings included: 1. Surveyor observation made on September 12, 2022 at 15:20 hours in the laboratory found 1 vial of True Metrix Blood Glucose test strips available for use in the laboratory. Lot Number: MX4429S Expiration Date: 07-31-2022 2. Review of the manufacturer's instructions for the True Metrix Blood Glucose test strips (RF3TVH03 Rev. 52) stated, "Caring for Test Strips ...Discard all unused test strips in vial after either date printed next to EXP on the test strip vial label or 4 months after date opened, whichever comes first. Using test strips past these dates may cause inaccurate results." 3. The findings were confirmed in interview with the technical consultant on September 12, 2022 at 15:22 hours in the laboratory. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory 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 -- that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's test menu, review of manufacturer's instructions, patient test records, and staff interview, the laboratory failed to provide documentation of reporting 133 SARS-CoV-2 antigen positive results from April 1, 2022 to September 12, 2022 (the day of the survey) as required. The findings included: 1. A review of the laboratory's test menu found the laboratory utilized the Quidel QuickVue antigen SARS-CoV-2 kit for patient testing. 2. A review of the manufacturer's instructions for use for the Quidel Quick-Vue antigen SARS-CoV-2 antigen assay under the section titled "Conditions for Authorization for the Laboratory and Patient Care Settings" stated, "Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 3. A review of laboratory policies found no documentation of a policy or procedure related to SARS-CoV-2 test reporting to public health authorities. 4. Review of patient test records found the following SARS- CoV-2 antigen positive results were not reported to any public health authority (patient alias list provided to technical consultant the day of the survey on September 12, 2022). 5. An interview with testing personnel #1 (as listed on Form CMS-209) on September 12, 2022 via telephone confirmed the findings. Key: SARS-CoV-2 - Coronavirus that causes COVID-19 CMS - Centers for Medicare and Medicaid Services 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 review of the laboratory's test menu, laboratory policies, review of the laboratory's instrument verification records, and staff interview, the laboratory failed to provide documentation of verifying patient normal ranges when it changed hematology analyzers in May 2022. The findings included: 1. A review of the laboratory's test menu found the laboratory placed the Horiba hematology analyzer into use in May 2022. 2. Review of the laboratory's policy titled 'Validation of a New Test System' (no approval date by the laboratory director) stated, "Purpose: The purpose of this policy is to ensure that prior to performing tests on patients, every new test system will have studies performed to validate the accuracy, precision, reportable range of test results, and verify manufacturer's normal values." 3. Review of the verification study performed for the Horiba hematology analyzer in May 2022 found no patient normal verification studies. 4. The laboratory was asked to provide documentation of performing patient normal verification studies for the new analyzer. -- 2 of 4 -- No documentation was provided. 5. An interview with the technical consultant on September 12, 2022 at 1700 hours in the office confirmed the findings. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control records, and staff interview, the laboratory failed to have documentation of verifying 1 of 1 lots of Horiba Minotrol hematology controls. The findings included: 1. A review of the laboratory's quality control records found the following lot number of Horiba Minotrol hematology controls was not verified prior to putting into use. Lot: MX435 Expiration date: 07-25- 2022 2. The laboratory was asked to provide documentation of verifying the lot number of quality control prior to putting it into use. No documentation was provided. 3. An interview with the technical consultant on September 12, 2022 at 1645 hours in the office found the laboratory did not verify the controls. This confirmed the findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on laboratory policy, review of patient test records, and interview with laboratory personnel, the laboratory failed to ensure test reports were complete for 8 of 8 patient results randomly selected from July 23, 2022 to August 30, 2022. The findings included: 1. Review of the laboratory's policy titled, "Policy for handling flagged CBC Differentials" approved by the laboratory director on March 28, 2018 stated, " ...It is the policy of this laboratory to return [SIC] flagged CBC results. If the second run still shows flags, then lab will evaluate flagged differentials according to -- 3 of 4 -- the procedures in the unit's operator manual ..." 2. Review of 8 randomly selected patient test records from July 23, 2022 to August 30, 2022 found the following samples that were incomplete. There was no documentation that the laboratory resolved flags. Therefore, the CBC results were incomplete. Date: 07-23-2022 Patient ID: See patient alias list Flags: M2, G1 Date: 07-23-2022 Patient ID: See patient alias list Flags: M2, G1 Date: 07-25-2022 Patient ID: See patient alias list Flags: G1, G2 Date: 07-25-2022 Patient ID: See patient alias list Flags: M2, G1, G2 Date: 07-25- 2022 Patient ID: See patient alias list Flags: M2, G1, G2 Date: 08-26-2022 Patient ID: See patient alias list Flags: G1 Date: 08-27-2022 Patient ID: See patient list Flags: G1 3. The laboratory was asked to provide documentation of ensuring the CBC results were complete prior to their release to the healthcare provider. No documentation was provided. 4. The findings were confirmed in interview with the technical consultant on September 12, 2022 at 16:09 hours in the laboratory. Key: CBC - Complete Blood Count 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 quality control records, patient test records, technical consultant quality assurance review, and confirmed in interview of laboratory personnel, the laboratory director failed to ensure a quality assurance plan was established and maintained for 20 of 20 patient results for CBCs from August 22, 2022. The findings included: 1. Review of the laboratory's hematology quality control records for August 22, 2022 found the laboratory could not provide documentation of at least two passing levels of hematology quality controls. 2. Review of technical consultant's quality assurance review for August 2022 found she instructed the laboratory to invalidate 20 of 20 patient results performed on August 22, 2022 since there was no passing quality control. 3. Review of the 20 patient charts found the results had not been invalidated and were available for review on their medical record. 4. The findings were confirmed in an interview with the technical consultant on September 12, 2022 at 1715 hours in the laboratory after her review of the records. Key: CBC - complete blood count -- 4 of 4 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of manufacturer's instructions, review of maintenance records, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of performing quarterly maintenance on the Sysmex XP-300 as required by the manufacturer for 4 quarters in 2020 and the 1st quarter of 2021. The findings were: 1. Review of laboratory policy "7.001" no laboratory director approval date it stated, "5. Evaluate maintenance schedule, ensure that all of manufacturer's recommendations are followed and that maintenance procedures are being done as required." 2. Review of the manufacturer's instructions for the Sysmex XP-300 (Code No. AU553517) under "12. Cleaning and Maintenance" it stated, "... Every 3 months (or every 4500 samples) - Clean the SRV (see 12.8)." 3. Review of the laboratory's Sysmex XP-300 maintenance records from January 2020 to March 2021 revealed quarterly maintenance (clean sample rotor valve) was not documented as performed for 15 months. 4. An interview with the technical consultant on April 27, 2021 at 15:30 hours in the patient exam room confirmed the findings. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) 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 -- The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of instrument and patient test records and interview with facility personnel, the laboratory failed to provide documentation of having a mechanism in place to ensure the identity of testing personnel performing CBCs (complete blood count) for 10 of 10 patient test records from April 2021. The findings were: 1. Review of the laboratory's policy titled, "Test Records" no laboratory director approval date stated, "...Test Record Logs will provide the following information: the identity of the personnel who performed the tests." 2. Review of 10 patient final reports revealed that each of the 10 reports did not include the identity of the testing person who performed the test. 3. An interview with the primary testing person on April 27, 2021 at 15:00 hours in the patient exam room confirmed the findings. When asked if the laboratory documented the identification of the testing person performing the test any place else such as a testing log, she stated, "No." -- 2 of 2 --

Summary Statement of Deficiencies 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)

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director; moderate complexity Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. 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 CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). 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: 493.803 successful participation in a proficiency testing program 493.1403 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: 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 -- Based on a desk review of proficiency testing records it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, 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 hematology for the all analytes. 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) 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 desk review of 2017 hematology proficiency testing PT results reported to CMS and records obtained from the PT provider, American proficiency Institute, the laboratory failed to participate in 2 out of 3 testing events in 2017 for hematology resulting in unsatisfactory performance. Findings: 1. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for Cell ID/WBC Diff. 2. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for RBC. 3. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for Hematocrit. 4. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for Hemoglobin. 5. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for WBC. 6. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for Platelets. 7. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for Cell ID/WBC Diff. 8. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for RBC. 9. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for Hematocrit. 10. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for Hemoglobin. 11. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for WBC. 12. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for Platelets. ID = Identification WBC = White Blood Cells RBC = Red Blood Cells 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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80 % or greater) for the same analyte in the specialty of hematology in two consecutive testing events or two out of three consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance for the analytes Cell/ID/WBC Diff, RBC, Hematocrit, -- 2 of 3 -- Hemoglobin, WBC and Platelets. Findings: 1. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for Cell ID/WBC Diff. 2. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for RBC. 3. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for Hematocrit. 4. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for Hemoglobin. 5. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for WBC. 6. API 2017 - 1st event laboratory received an unsatisfactory score of 0% for Platelets. 7. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for Cell ID/WBC Diff. 8. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for RBC. 9. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for Hematocrit. 10. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for Hemoglobin. 11. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for WBC. 12. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for Platelets. 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 desk review of laboratory proficiency testing it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. See D6016 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 laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2130 -- 3 of 3 --