Bloom Pediatrics

Summary Statement of Deficiencies D0000 A recertification survey was performed on July 29, 2026 by the State of Michigan Licensing and Regulatory Affairs Department. The laboratory was found to be out of compliance with CLIA regulations (42 CFR Part 493, Laboratory Requirements) for the following condition-level deficiencies: 493.1230 Condition: General laboratory systems. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on record review and interview with the technical consultant, the laboratory failed to perform proficiency testing as it would perform patient testing for two (M2 2025 and FH16-A 2026) of five testing events reviewed. Findings include: 1. A review of the laboratory's proficiency testing records revealed the following events when proficiency testing was not tested by personnel who routinely perform testing or how it would routinely perform patient testing: a. The American Association of Bioanalysis Medical Laboratory Evaluation (AAB-MLE) proficiency testing event M2 2025 included a review of the event's "Proficiency Testing Survey Exception Form". The form included a section stating, "Upon documentation review, the PT samples for this event were run twice initially (one set reported, one set saved)." b. The College of American Pathologists' event FH16-A 2026 included an attestation showing the technical consultant was the testing personnel for this event. 2. An interview on 7/29/26 at 12:30 pm with the technical consultant confirmed patient Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- testing is not routinely performed in duplicate. 3. A review of the laboratory's Form CMS-209, signed by the laboratory director on 7/28/26, did not show the technical consultant was designated as testing personnel. 4. A review of the technical consultant's personnel file revealed a lack of testing personnel training or testing personnel competency assessments. 5. An email received on 7/30/26 at 3:01 pm from the technical consultant confirmed they had not been routinely performing patient testing. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 with the technical consultant, the laboratory failed to ensure testing personnel and the laboratory director attested to the routine integration of its proficiency testing samples into the patient workload for four (Event M1 2025, Event M2 2025, Event M3 2025, and FH16-B 2026) of five testing events reviewed. Findings include: 1. A review of the laboratory's proficiency testing records revealed a lack of attestation statements for the following events: a. American Association of Bioanalysis Medical Laboratory Evaluation (AAB-MLE) Event M1 2025. b. AAB-MLE Event M2 2025. c. AAB-MLE Event M3 2025. d. College of American Pathologists' event FH16-B 2026. 2. An interview on 7/29/26 at 12:30 pm with the technical consultant confirmed the above findings. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to establish competency assessment policies to assess technical consultant competency (refer to D5209 A), failed to follow its competency assessment policies to perform testing personnel competency assessments (refer to D5209 B), and failed to document its evaluations of proficiency testing performance (refer to D5221). D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. -- 2 of 7 -- This STANDARD is not met as evidenced by: . A. Based on record review and interview with the technical consultant, the laboratory failed to establish competency assessment policies to assess technical consultant competency for two (July 2024 to July 2026) of two years reviewed. Findings include: 1. A review of the laboratory's personnel records revealed a lack of documentation of technical consultant competency assessments performed between July 2024 and July 2026. 2. A review of the laboratory's "CBC Maintenance Procedure 2026", approved by the laboratory director without a date of implementation, included a section titled "Bi-annually" stating, "Complete competency checklist for each employee who runs lab tests using the Coulter DxH 500 Analyzer." This section of the maintenance policy did not address how the laboratory assesses competency of its technical consultants. 3. An interview on 7/29 /26 at 12:12 pm with the technical consultant confirmed the laboratory had not established a competency assessment policy to include how it assesses technical consultant competency. B. Based on record review and interview with the technical consultant, the laboratory failed to follow its competency assessment policies to perform testing personnel competency assessments for 16 (testing personnel 3, 6, 10, 12, 14, 16, 17, 23, 34, 37, 40, 47, 48, 49, 53, and 55) of 33 testing personnel competency assessment records reviewed. Findings include: 1. A review of the laboratory's "CBC Maintenance Procedure 2026", approved by the laboratory director without a date of implementation, included a section titled "Bi-annually" stating, "Complete competency checklist for each employee who runs lab tests using the Coulter DxH 500 Analyzer." 2. A review of 33 testing personnel competency assessment records revealed the following 16 testing personnel did not have semiannual competency assessments performed: a. Testing personnel #3 was hired on 9/16/25 and completed their training on 1/23/26. No documentation of competency assessments performed were present. b. Testing personnel #6 was hired on 5/6/25 and completed their training on 8/13/25. No documentation of competency assessments performed were present. c. Testing personnel #10 was hired on 6/17/25 and completed their training on 8/5/25. No documentation of competency assessments performed were present. d. Testing personnel #12 was hired on 9/15/25 and completed their training on 1/13/26. No documentation of competency assessments performed were present. e. Testing personnel #14 was hired on 6/17/25 and completed their training on 8/5/25. No documentation of competency assessments performed were present. f. Testing personnel #16 was hired on 5/6/25 with training completed on 7/17/25. No documentation of competency assessments performed were present. g. Testing personnel #17 was hired on 10/7/24 with training completed on 11/11/24. One competency assessment was present and completed on 7/23/25. h. Testing personnel #23 was hired on 6/14/24 with training completed on 6/14/24 and 7/23/25. The only competency assessment present was dated 8/1/24. i. Testing personnel #34 was hired on 10/16/25 with a training completion date of 11/20/25. No documentation of competency assessments performed were present. j. Testing personnel #37 was hired on 6/17/25 with a training completion date of 8/20/25. No documentation of competency assessments performed were present. k. Testing personnel #40 was hired on 1/21/25 with a training completion date of 2/21/25. No documentation of competency assessments performed were present. l. Testing personnel #47 was hired on 6/18/24 with a training completion date of 7/23/24. The only competency assessment present was dated 12/20/24. m. Testing personnel #48 was hired on 5/6/25 with a training completion date of 7/11/25. No documentation of competency assessments performed were present. n. Testing personnel #49 was hired on 6/17/25 with a training completion date of 8/5/25. No documentation of competency assessments performed were present. o. Testing personnel #53 was hired on 5/6/25 -- 3 of 7 -- with a training completion date of 8/6/25. No documentation of competency assessments performed were present. p. Testing personnel #55 was hired on 5/6/25 with a training completion date of 7/24/25. No documentation of competency assessments performed were present. 3. An interview on 7/29/26 at 11:33 am with the technical consultant confirmed competency assessments for the above testing personnel were not performed in accordance with the laboratory's policy. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: . Based on record review and interview with the technical consultant, the laboratory failed to document its evaluations of proficiency testing performance for three (event M2 2025, event FH16-A 2026, and event FH16-A 2026) of five proficiency testing events reviewed. Findings include: 1. A review of the laboratory's proficiency testing records revealed the following events with unacceptable, outside of the grading range or included an incorrect response: a. The American Association of Bioanalysis Medical Laboratory Evaluation (AAB-MLE) event M2 2025 had the following results outside of the grading range or included an incorrect response: i. Basophil percentage differential sample nine. ii. Monocyte percentage differential sample nine. iii. Hematocrit sample nine. iv. Hemoglobin sample nine. A review of the laboratory's "Proficiency Testing Survey Exception Form" used by the laboratory to evaluate the testing event failed to include how it evaluated the incorrect results obtained for basophil percentage differential sample nine. b. The College of American Pathologists' (CAP) proficiency testing event FH16-A 2026 had the following specimens with unacceptable results: i. Red Blood Cell Count sample three. ii. Hematocrit sample three. The documentation did not include an evaluation of the unacceptable results obtained. c. The CAP proficiency testing event FH16-B 2026 had the following specimens with unacceptable results: i. Hematocrit sample FH16-07. ii. Platelet count sample FH16-08. The documentation did not include an evaluation of the unacceptable results obtained. 2. An interview on 7/29/26 at 12:30 pm with the technical consultant confirmed the above findings. 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 record review and interviews, the laboratory director failed to ensure proficiency testing was performed as the laboratory would perform patient testing (refer to D6016 A), failed to ensure the proficiency testing specimens were integrated into the patient workload (refer to D6016 B), failed to document its evaluations of proficiency testing performance when the laboratory obtained unacceptable results (refer to D6019), and failed to ensure testing personnel performing moderate complexity testing met educational qualification requirements (refer to D6029). -- 4 of 7 -- D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: . A. Based on record review and interview with the technical consultant, the laboratory director failed to ensure proficiency testing was performed as the laboratory would perform patient testing. Refer to D2007. B. Based on record review and interview with the technical consultant, the laboratory director failed to ensure the proficiency testing specimens were integrated into the patient workload. Refer to D2009. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) (e)(4)(iv) An approved

Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with the technical consultant, the laboratory failed to have a qualifed person perform the technical consultant duty of testing personnel competency assessment performance (refer to D6035), failed to perform and document direct observations of test performance, specimen handling, processing, and testing (refer to D6047), and failed to perform and document assessment of problem-solving skills (refer to D6052). D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; AND (b)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical 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 -- oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: . Based on record review and interview with the technical consultant, the laboratory failed to have a qualifed person perform the technical consultant duty of testing personnel competency assessment performance for 57 of 57 total testing personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's testing personnel competency assessments performed in 2024 for 57 testing personnel revealed the assessments were signed by a person not listed on Form CMS-209 as a technical consultant. 2. An interview on 1/23/25 at 9:53 am with the technical consultant confirmed the person who signed the competency assessments was not qualified as a technical consultant. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: . Based on record review and interview with the technical consultant, the technical consultant failed to perform and document direct observations of test performance, specimen handling, processing, and testing for 10 (March 2024 to January 2025) of 10 months reviewed. Findings include: 1. A review of the laboratory's competency assessment records revealed the document used to aid in performing and documenting testing personnel competency assessments was missing direct observations of test -- 2 of 4 -- performance, specimen handling, processing, and testing. 2. An interview on 1/23/25 with at 1:00 pm the technical consultant confirmed the competency assessment documentation used to assess testing personnel competency did not include documentation of direct observations of test performance, specimen handling, processing, and testing. D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) (b)(8)(vi) Assessment of problem-solving skills; and This STANDARD is not met as evidenced by: . Based on record review and interview with the technical consultant, the technical consultant failed to perform and document assessment of problem-solving skills for 10 (March 2024 to January 2025) of 10 months reviewed. Findings include: 1. A review of the laboratory's competency assessment records revealed the document used to aid in performing and documenting testing personnel competency assessments was missing assessment of problem-solving skills. 2. An interview on 1/23/25 at 1:00 pm with the technical consultant confirmed the competency assessment documentation used to assess testing personnel competency did not include documentation of assessment of problem-solving skills. 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 a lack of documentation, the laboratory failed to ensure its moderate complexity testing personnel were qualified to perform Complete Blood Count (CBC) testing using the Beckman Coulter DxH 500 analyzer. Refer to D6035. . 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 (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and -- 3 of 4 -- This STANDARD is not met as evidenced by: . Based on a lack of documentation and interview with the technical consultant, the laboratory failed to ensure testing personnel performing Complete Blood Count (CBC) testing using the Beckman Coulter DxH 500 analyzer were qualified for 9 of 57 total testing personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's testing personnel qualification records revealed the following personnel lacked documentation of meeting the educational requirements at 493.1423: a. Testing Personnel #3 had a bachelor's degree that did not specify the major of study. b. Testing Personnel #11 had a bachelor's degree that did not specify the major of study. c. Testing Personnel #14 had a foreign degree without appropriate equivalency documentation. d. Testing Personnel #15 had an associate degree that did not specify the major of study. e. Testing Personnel #22 had a foreign degree without appropriate equivalency documentation. f. Testing Personnel #24 had a "Cum Laude" certificate for grade point average, not an earned diploma or equivalent. g. Testing Personnel #29 had no education documentation present. h. Testing Personnel #48 had a bachelor's degree in Interdisciplinary Healthcare Services. i. Testing Personnel #57 had a bachelor's degree of Integrative Studies. 2. The surveyor requested additional information for the testing personnel listed above on 1/23/25 at 12:00 pm and it was not made available. 3. The laboratory was provided with an additional seven days after the survey's conclusion to provide additional information for the testing personnel listed above and it was not received. -- 4 of 4 --