Bloom Pediatrics

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 qualified 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 qualified 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 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Technical Consultant (TC), the laboratory failed to monitor the room temperature and humidity for the west laboratory for the hematology testing with the Beckman Coulter AcT diff2 analyzer for 6 (8/09/2022 to 2/14/2023) of 6 months in use. Findings include: 1. During a tour of the west laboratory on 2/14/2023 at 9:08 am, the surveyor observed a Beckman Coulter AcT diff2 analyzer was in use. 2. A record review of the laboratory's temperature monitoring logs revealed a lack of documentation for the room temperature and humidity of the west laboratory for 6 (8/09/2022 to 2/14/2023) of 6 months in use. 3. An interview on 2/14/2023 at 9:18 am, the TC confirmed the laboratory was not monitoring the room temperature and humidity for the west laboratory. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 Technical Consultant (TC), the laboratory failed to calibrate and/or replace the expired thermometer in the east laboratory that monitors the room temperature and humidity for over 2 (expired 1/15 /2021) of 2 years in use. Findings include: 1. During a tour of the laboratory on 2/14 /2023 at 9:08 am, the surveyor observed a Thomas Scientific thermometer in use for the room temperature and humidity with an expiration date of 1/15/2021. 2. An interview on 2/14/2023 at 9:18 am, the TC confirmed the thermometer in the east laboratory had expired and was not calibrated and/or replaced. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 D0000 A recertification survey was completed on June 27, 2019. During the survey, it was determined that Immediate Jeopardy (IJ) existed for the following condition-level deficiencies: Bacteriology- 42 CFR 493.1201 D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on document review and interview, the laboratory failed to meet Bacteriology requirements as specified in 493.1230 through 493.1256. Findings include: 1. The laboratory failed to establish performance specifications for the modified bacteriology FDA approved OSOM Strep A Test kit. Refer to D5423. 2. The laboratory failed to accurately perform the OSOM Strep A Test with an acceptable specimen source and accurately report out patient specimen source on throat culture reports. Refer to D5805. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) 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 -- Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: . Based on document review, manufacturer's instruction review, and interview with the Laboratory Director (LD) and Testing Personnel #1 (TP1), the laboratory failed to establish performance specifications for the modified bacteriology FDA approved OSOM Strep A Test kit for 26 ( #1 - #26) of 34 patient charts audited by using specimen sources (vaginal and anal/rectal) outside the scope of the manufacturer's instructions from June 2017 to present date. Findings include: 1. Document review for 26 of 34 patient charts audited revealed on the "Rapid Strep and Throat Cultures Log Sheet" under the section "Patient Name" documentation of vaginal or anal/rectal written on the log. 2. When queried on June 27, 2019 at approximately 12:00 pm, TP1 acknowledged the specimen source written on the log were the actual specimen used for the waived OSOM Strep A Test kit. 3. The manufacturer's package instructions state "The OSOM Strep A Test should be used only with throat swabs or colonies taken directly from a plate. The use of swab specimens taken from other sites or the use of other samples such as saliva, sputum or urine has not been established. The quality of the test depends on the quality of the sample; proper throat swab specimens must be obtained". 4. When queried on June 27, 2019 at approximately 12:00 pm, TP1 was not able to provide the surveyor documentation to demonstrate the laboratory had established performance specifications for the modification of the strep kit for using specimens outside of the manufacturer's instructions. 5. During the interview on June 27, 2019 at approximately 12:45 pm, the Laboratory Director acknowledged the laboratory had modified the procedure and did not establish performance specifications. 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 document review, patient final electronic medical record (EMR) reports, manufacturer's instructions review, and interview with the Laboratory Director (LD) and Testing Personnel #1 (TP1), the laboratory failed to accurately report out the specimen source for the OSOM Strep A Test for 27 (#1 - #27) of 35 patient specimens reviewed and 2) accurately report out patient specimen source for 14 (#1 - #2, #5, #8 - #10, #12 - #13, #17 - #18, #21 - #23, and #26) of 35 specimen samples reviewed for the throat culture testing. Findings include: 1. Document review of the "Rapid Strep and Throat Culture Log Sheet" revealed for 27 of 35 patient specimens reviewed, the specimen source reported out on the patient's final report for the OSOM Strep A Test did not match the source written on the testing log sheet as follows: a. vaginal - #5 - -- 2 of 3 -- #8, #10, #14 - #15, #17 - #18, #21 - #22, #25, and #27 b. anal/rectal - #1 - #4, #9, #11 - #13, #16, #19 - #20, #23 - #24, and #26 2. Document review for 14 of 34 patient's final test report in the EMR reported the result as a Throat Culture. The specimen source reported did not match the source written on the "Rapid Strep and Throat Culture Log Sheet" as follows: a. vaginal - #5, #8, #10, #17 - #18, and #21 - #22 b. anal/rectal - #1 - #2, #9, #12 - #13, #23, and #26 3. During the interview on June 27, 2019 at approximately 2:55 pm, the LD acknowledged the OSOM Strep A Test and the final throat culture report in the patient's chart did not match the specimen source recorded on the patient log sheet. -- 3 of 3 --