Beverly Hills Pediatrics

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #2, the laboratory failed to verify the accuracy of its nasal smear for eosinophils testing at least twice annually for two (September 2022 to September 2024) of two years reviewed. Findings include: 1. A review of the laboratory's verification of accuracy records revealed one event was performed on 9/5/24. No other verification of accuracy events were present between September 2022 and September 2024. 2. An interview on 9/5 /24 at 1:10 pm with Technical Consultant #2 confirmed the laboratory had not verified the accuracy of its nasal smears for eosinophils testing at least twice annually. 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. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with Technical Consultant #2, the laboratory failed to follow its specimen labeling policies for one patient specimen 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 -- observed. Findings include: 1. The surveyor observed the laboratory's ABX Micros 60 Complete Blood Count (CBC) analyzer on 9/5/24 at 12:57 pm with a lavender microtainer in the sample chamber with blood in it and no label or patient identifier on it. 2. A review of the laboratory's "CBC Patient Sample" policy revealed a section stating, "Label Safe-T-Fill with patient last name or patient initials." 3. An interview on 9/5/24 at 12:57 pm with Technical Consultant #2 confirmed the specimen observed had not been labeled in accordance with the laboratory's policy. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel #7, the laboratory failed to label its Minotrol hematology control materials with expiration dates to reflect the open stability for three of three opened control materials observed. Findings include: 1. The surveyor observed a box with four sets of three Minotrol hematology control vials in the refrigerator on 9/5/24 at 1:03 pm. None of the vials included and expiration date. 2. An interview on 9/5/24 at 1:03 pm with Testing Personnel #7 revealed the laboratory had recently opened the box and had opened the first set of three control vials. She also revealed that, once opened, the vials are only stable for two weeks. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. -- 2 of 3 -- This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #7, the laboratory failed to perform calibration verification for its Complete Blood Count (CBC) testing at least every six months for three (3/24/23, 10/18/23, and 6/27/24) of four calibration verification events in the previous two years. Findings include: 1. A review of the laboratory's Horiba CBC analyzer's calibration records revealed the following dates when calibration verification was performed less frequently than every six months: a. 7 /9/22 to 3/24/23, 8 months. b. 3/24/23 to 10/18/23, 7 months. c. 10/18/23 to 6/27/24, 8 months. 2. A review of the laboratory's "Calibration Procedure" revealed a section stating, "CBC machine to be calibrated bi-yearly using S-Cal from Beckman Coulter." 3. An interview on 9/5/24 at 2:04 pm with Testing Personnel #7 confirmed the laboratory had not performed calibration verification at least every six months. 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 record review and interview with Technical Consultant #2, the laboratory failed to ensure testing personnel were qualified. Refer to 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: . Based on record review and interview with Technical Consultant #2, the laboratory failed to ensure testing personnel were qualified for 4 (Testing Personnel 11-14) of 14 testing personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's personnel qualification records revealed a lack of documentation for the following laboratory personnel performing moderate-complexity hematology testing: a. Testing Personnel 11 b. Testing Personnel 12 c. Testing Personnel 13 d. Testing Personnel 14 2. The surveyor requested the four testing personnel's qualification records on 9/5/24 at 2:51 pm and they were not made available. 3. The laboratory was granted 7 days to provide the missing records and none were received. -- 3 of 3 --

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #4 and the Technical Consultant (TC), the laboratory failed to have a documented electronic request for patient testing from an authorized person for 1 (patient #9) of 20 patient charts reviewed. Findings include: 1. A review of patient charts revealed for 1 (patient #9) of 20 patient charts reviewed there was no electronic order for the hematology complete blood cell count (CBC) that was performed and resulted on 4/19/2022 in the patients electronic medical record (EMR). 2. An interview on 8/29/2022 at 11:00 am, TP4 and the TC confirmed there were no orders documented in the patients EMR for the CBC performed and resulted on 4/19/2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory 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 record review and interview with the Technical Consultant, the laboratory failed to report SARS-Co-V-2 test results as required for 91 tests performed with a negative result since the laboratory started testing. Findings include: 1. A review of laboratory's testing records from two patients having SARS-CoV-2 testing with their BD Veritor system revealed the laboratory had not reported the results to the health department. 2. An interview with the Technical Consultant on 5/10/21 at 11:29 am revealed the laboratory is not reporting negative SARS-CoV-2 results from their BD Veritor system to the health department. 3. An interview with the Technical Consultant on 5/10/21 at 11:48 am revealed the laboratory had tested 91 patients with negative test results since the laboratory started testing on 10/27/20. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. 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 -- This STANDARD is not met as evidenced by: . Based on observation and interview with the Office Manager, the laboratory failed to label a secondary container with the identity and expiration date for methyl alcohol used in nasal smear preparation for the current container in use. Findings include: 1. During a tour of the laboratory on 5/10/21 at 9:25 am, the surveyor observed a glass bottle with clear liquid inside that did not have the identity of the liquid or the expiration date. 2. An interview on 5/10/21 at 9:25 am with the Office Manager revealed the liquid inside the container was methyl alcohol that is used in the preparation of nasal smears and confirmed it did not contain the identity or expiration date. -- 2 of 2 --

Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory 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 record review and interview with the Technical Consultant, the laboratory failed to report SARS-Co-V-2 test results as required for 91 tests performed with a negative result since the laboratory started testing. Findings include: 1. A review of laboratory's testing records from two patients having SARS-CoV-2 testing with their BD Veritor system revealed the laboratory had not reported the results to the health department. 2. An interview with the Technical Consultant on 5/10/21 at 11:29 am revealed the laboratory is not reporting negative SARS-CoV-2 results from their BD Veritor system to the health department. 3. An interview with the Technical Consultant on 5/10/21 at 11:48 am revealed the laboratory had tested 91 patients with negative test results since the laboratory started testing on 10/27/20. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. 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 -- This STANDARD is not met as evidenced by: . Based on observation and interview with the Office Manager, the laboratory failed to label a secondary container with the identity and expiration date for methyl alcohol used in nasal smear preparation for the current container in use. Findings include: 1. During a tour of the laboratory on 5/10/21 at 9:25 am, the surveyor observed a glass bottle with clear liquid inside that did not have the identity of the liquid or the expiration date. 2. An interview on 5/10/21 at 9:25 am with the Office Manager revealed the liquid inside the container was methyl alcohol that is used in the preparation of nasal smears and confirmed it did not contain the identity or expiration date. -- 2 of 2 --

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 College of American Pathologists (CAP) final proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the hematology analyte hematocrit (HCT). Findings include: Review of the CMS database and the CAP graded proficiency testing reports showed unsatisfactory performance for five of eight proficiency testing events for the hematology analyte: HCT. 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 College of American Pathologists (CAP) final proficiency testing reports, the laboratory failed to achieve satisfactory performance in five of eight consecutive proficiency testing events for the following hematology analyte: hematocrit (HCT). Findings include: Unsatisfactory performance in five out of eight consecutive proficiency testing events constitutes subsequent unsuccessful proficiency testing performance. HCT PT Event Score 2nd event 2016 60% 1st event 2017 0% 3rd event 2017 0% 1st event 2018 60% 3rd event 2018 20% 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 review of the College of American Pathologists (CAP) proficiency testing reports, the laboratory director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: 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) 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 review of the CMS database and review of the College of American Pathologists (CAP) proficiency testing reports, the laboratory director failed to ensure the laboratory successfully participated in a proficiency testing program as required under subpart H. Findings include: The laboratory failed to achieve satisfactory performance for the analyte hematocrit in the speciality of hematology. Refer to D2016 and D2130. -- 2 of 2 --

Summary Statement of Deficiencies D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on document review and interview, the laboratory failed to have the final nasal smear for eosinophils report maintained as part of the patient's electronic medical record (EMR) for one (#2) of 16 patient charts audited. Findings include: 1. On October 8, 2018 at 12:50 PM, document review for one (#2) of 16 patient charts audited revealed the final test report for the nasal smear for eosinophils was not maintained in the patient's EMR. 2. During the interview on October 8, 2018 at 12:50 PM, the technical consultant and testing personnel #12 as listed on the CMS-209 confirmed the final nasal smear for eosinophils was not included in the patient's EMR . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 submitted results for proficiency testing event FH2-C in 2017 under another CLIA number. Refer to D2013. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory director and testing personnel failed to attest to the routine integration of the hematology proficiency testing samples into the patient workload for three (A, B, and C in 2017) of six events reviewed in 2016 and 2017. Findings include: 1. On February 5, 2018 at 11:00 a.m., record review 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 -- of the College of American Pathologists (CAP) hematology proficiency testing program documents revealed the laboratory director and the testing personnel did not sign the attestation statement sheets for three of six events in 2016 and 2017. 2. During the phone interview on February 5, 2018 at 4:39 p.m., testing personnel #15 confirmed the attestation statement sheet was not signed. D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory submitted results for event FH2-C in 2017 hematology complete blood cell count proficiency testing samples under another CLIA 23D0950408 (CAP# 7205731-01) number. Findings include: 1. On February 5, 2018 at 11:00 a.m., record review of event FH2-C 2017 in the proficiency testing binder revealed the final graded results for CLIA# 23D0950408 CAP# 7205731-01. The report showed the facility crossed out the address and the the CAP# and hand wrote the Bingham Farms, Mi 48025 and the CAP # 6299401-01 on the report. 2. On February 5, 2018 at 11:00 a.m., record review revealed the results sent into CAP for evaluation for CLIA# 23D0950408 CAP# 7205731-01 were the results from the five instrument generated print outs from CLIA# 23D0362690 CAP# 6299401-01. 3. During the phone interview on February 5, 2018 at 4:39 p.m., testing personnel #15 as listed on the CMS-209 confirmed the results from their facility were entered incorrectly into the CAP proficiency testing system for their other facility. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to review and evaluate the hematology proficiency testing results for five (A and C in 2016 and A, B, and C in 2017) of six events reviewed in 2016 and 2017. Findings include: 1. On February 5, 2018 at 11:00 a.m., record review of the College of American Pathologists proficiency -- 2 of 3 -- testing CMS summary report revealed for five of six events reviewed in 2016 and 2017 the following: a. event A in 2016 - no testing personnel review b. event C in 2016 - no laboratory director review c. events A and B in 2017 - no laboratory director and testing personnel review d. event C in 2017 - missing two of three testing personnel review 2. During the phone interview on February 5 2018 at 4:39 p.m., testing personnel #15 confirmed the CMS summary report were not reviewed or evaluated. 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) 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 record review and interview, the laboratory failed to maintain a record system that included the identity of the testing personnel performing the College of American Pathologists hematology proficiency testing for five (A, B, and C in 2016 and B and C in 2017) of six events reviewed in 2016 and 2017. Findings include: 1. On February 5, 2018 at 9:20 a.m., record review for five of six hematology proficiency testing events in 2016 and 2017 revealed the laboratory did not have a record system in place that included the identity of the testing personnel who ran the specimen on the hematology analyzer as follows: a. event B in 2017 only on specimens FH-06 and FH-07 b. events A, B, and C in 2016 and event C in 2017 2. During the interview on February 5, 2018 at 9:20 a.m., testing personnel #15 confirmed a record system was not in place to identify the testing personnel performing the hematology complete blood cell count testing. -- 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 College of American Pathologists (CAP) final graded proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the overall performance of the specialty of hematology and the following hematology analytes: Cell Identification (ID) or White Blood Cell (WBC) Differential (Diff), Red Blood Cell (RBC), Hemoglobin (HGB), White Blood Cell (WBC), Platelet (PLT), and Hematocrit (HCT). Findings include: 1. Review of the CMS database and CAP proficiency testing reports showed unsatisfactory performance for two of three consecutive proficiency testing events for the overall performance of 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 2 -- specialty of hematology and the following hematology analytes: WBC Diff, RBC, HGB, WBC, and PLT. 2. Review of the CMS database and CAP proficiency testing reports showed unsatisfactory performance for three of five consecutive proficiency testing events for the hematology analyte: HCT. Refer to D2130 and D2131. 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 CMS database and review of the College of American Pathologists final graded proficiency testing reports, the laboratory failed to achieve satisfactory performance in two out of three consecutive proficiency testing events for the following hematology analytes: Cell Identification (ID) or White Blood Cell (WBC) Differential (Diff), Red Blood Cell (RBC), Hemoglobin (HGB), White Blood Cell (WBC), and Platelet (PLT) and three out of five consecutive testing events for Hematocrit (HCT). Findings include: 1. Unsatisfactory performance in two out of three proficiency testing events constitutes initial unsuccessful proficiency testing performance. WBC diff PT Event Score 1st event 2017 0% 3rd event 2017 0% RBC PT Event Score 1st event 2017 0% 3rd event 2017 0% HGB PT Event Score 1st event 2017 0% 3rd event 2017 0% WBC PT Event Score 1st event 2017 0% 3rd event 2017 0% PLT PT Event Score 1st event 2017 0% 3rd event 2017 0% 2. Unsatisfactory performance in three out of five proficiency testing events constitutes subsequent unsucccessful proficiency testing performance. HCT PT Event Score 2nd event 2016 60% 1st event 2017 0% 3rd event 2017 0% 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 CMS database and review of the College of American Pathologists final graded proficiency testing reports, the laboratory failed to achieve satisfactory performance for the overall testing event in the specialty of hematology in two out of three consecutive testing events. Findings include: Hematology PT Event Score 1st event 2017 0% 3rd event 2017 0% -- 2 of 2 --