Pediatric & Adolescent Care

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/26/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, technical consultant #1, and technical consultant #2 during an exit conference performed at the conclusion of the survey. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1 and technical consultant #2, the laboratory failed to evaluate the accuracy of testing when proficiency result had not been graded by the proficiency testing program for one of three Clinical Microscopy events reviewed in 2022 and 2023. Findings include: (1) A review of Clinical Microscopy proficiency testing records for 2022 and 2023 identified the following for one of three events: (a) First 2023 Event (CM-A 2023) - One of one result had not been graded by the proficiency testing program for Urine Sediment ID (sample USP-02). There was no documentation to prove the laboratory performed a self-evaluation of the non-graded result. (2) The records were reviewed with technical consultant #1 and technical consultant #2 who stated on 10/26/2023 at 10:40 am, the laboratory had not performed a self-evaluation to evaluate the non- graded result. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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 -- A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with technical consultant #1, technical consultant #2, and testing person #3, the laboratory failed to follow their written policy for labeling hematology specimens for CBC for nine of 12 patient specimens. Findings include: (1) On 10/26/2023 at 10:20 am, testing person #3 stated the following: (a) The laboratory performed CBC testing on the Medonic M series analyzer; (2) Observation of the specimen refrigerator on 10/26 /2023 at 10:20 am identified the following: (a) Nine EDTA whole blood specimens in an emesis basin in the refrigerator labeled with the patient's last name and a unique identification number; (3) A review of the policy titled, "Technical Procedures" stated, "All specimens will be labeled with 2 patient identifiers: Patient's legal first and last name, date of birth (DOB). All specimens will be labeled with the date and time of collection. All specimens will be labeled with the phlebotomist's or collectors initials."; (4) Interview with testing person #3 on 10/26/2023 at 10:20 am confirmed the following: (a) Nine of 12 blood samples in the refrigerator were labeled with the last name and unique identifier only; (5) The findings were reviewed with technical consultant #1 and technical consultant #2 who stated on 10/26/2023 at 10:30 am, the laboratory had not followed their policy for labeling the patient specimens. 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 a review of records, manufacturer's instruction manual, and interview with technical consultant #1 and technical consultant #2, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the Medonic M-series analyzer during the review period of 09/01/2022 through 09/30 /2023. Findings include: (1) On 10/26/2023 at 10:30 am, technical consultant #1 and technical consultant #2 stated CBC (Complete Blood Count) testing was performed using the Medonic M-series analyzer; (2) A review of the manufacturer's instruction manual titled, "Medonic M-series User's Manual", Chapter 8, section 8-2 required the following monthly maintenance procedures: (a) Monthly Cleaning (Hypochloride) (b) Clot Prevention (Enzymatic) (3) A review of maintenance logs from 09/01/2022 through 09/30/2023 identified monthly maintenance had not been documented as performed between: (a) 11/02/2022 and 01/04/2023 (b) 03/28/2022 and 05/31/2022 (4) The records were reviewed with technical consultant #1 and technical consultant #2 who stated on 10/26/2023 at 01:26 pm, maintenance procedures had not been documented as performed as stated above. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) -- 2 of 4 -- 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 a review of records and interview with technical consultant #1 and technical consultant #2, the laboratory failed to verify the stated value of control materials before they were put into use for three of six lot numbers. Findings include: (1) On 10 /26/2023 at 10:30 am, technical consultant #1 and technical consultant #2 stated the following: (a) CBC (Complete Blood Count) testing was performed using the Medonic-series analyzer; (b) Three levels of QC (quality control) materials were tested each day of patient testing; (c) The manufacturer's provided ranges were used to determine acceptability of quality control results. (2) A review of records for six control lot numbers identified no evidence the provided ranges were verified before the lot numbers were put into use for three of six lot numbers as follows: (a) Low control lot #2230601, Normal control lot #2230602, and High control lot #2230603 put into use on 07/28/2023. (3) The findings were reviewed with technical consultant #1 and technical consultant #2 who stated on 10/26/2023 at 11:57 am the manufacturer's ranges had not been verified before the above lot numbers had been put into use. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of patient reports, the complete blood count technical procedures manual, and interview with technical consultant #1 and technical consultant #2, the laboratory failed to make appropriate reference ranges available for three of three patient CBC reports. Findings include: (1) On 10/26/2023 at 1:00 pm, technical consultant #1 stated the Medonic M Series analyzer was used to perform CBC (Complete Blood Count) testing, to include mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC) values; (2) A review of the procedure titled "Complete Blood Count" listed the laboratory's acceptable reference ranges for three distinct patient populations; (a) Range 1 - Patients between age two to six months. Acceptable values were as follows, "MCH 26.0-32.0 pg, MCHC 32.0- 36.0 g/dL"; (b) Range 2- Patients between age seven months to two years. Acceptable values were as follows, "MCH 23.0-28.0 pg, MCHC 31.0-36.0 g/dL"; (c) Range 3 - -- 3 of 4 -- Patients between three years to 12 years. Acceptable values were as follows, "MCH 25.0-29.0 pg, MCHC 31.0-35.0 g/dL". (3) A review of one patient test report for each patient age range was reviewed and revealed the following; (a) Range 1 - Patient report stated the normal MCH as 25.0-34.0 pg, and MCHC as 30.0-37.0 g/dL; (b) Range 2 - Patient report stated the normal MCH as 25.0-34.0 pg, and MCHC as 30.0- 37.0 g/dL; (c) Range 3 - Patient report stated the normal MCH as 25.0-34.0 pg, and MCHC as 30.0-37.0 g/dL. (4) The reports and the policy were reviewed with technical consultant #1 and technical consultant #2, who stated on 10/26/2023 at 01:00 pm, the laboratory had not updated the age-specific normal reference ranges in the laboratory's computer information system. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/27/2021. The findings were reviewed with the laboratory director and lead tech during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant 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. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the lead tech, the laboratory failed to use materials that had not expired. Findings include: (1) On 07/27 /2021 at 09:50 am, the lead tech stated to surveyor #1 manual differential testing and slide reviews were performed in the laboratory; (2) On 07/27/2021 at 10:00 am, surveyor #1 observed the bottle of Wright's stain stored in the laboratory cabinet, and identified Healthlink Wright's Stain, lot #0043, with an expiration date of 05/12/2021; (3) Surveyor #1 showed the bottle of Wright's stain to the lead tech and asked if it was currently being used for patient testing. The lead tech stated the stain was currently in use and was not aware it had expired; (4) The surveyor reviewed patient testing records and identified patient manual differential and or slide reviews had been performed using the expired stain on 05/24,28/2021; 06/04,09,11,30/2021; and 07/16, 21,22/2021. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the 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 5 -- 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 a review of records, manufacturer's instructions, and interview with the lead tech, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for 4 of 14 months. Findings include: (1) On 07/27/2021 at 09:50 am, the lead tech stated to surveyor #1 that CBC (Complete Blood Count) testing was performed on the Medonic M-Series analyzer; (2) Surveyor #2 reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for monthly maintenance were as follows: (a) Fill a cup with 10 ml 2% hypochlorite (bleach), certified by Boule, and one cup with 18 ml diluent; (b) Aspirate the hypochlorite as a pre-diluted sample and then repeat; (c) Run 2 blank samples by aspirating diluent as a pre-diluted sample; (d) Perform a background check, in pre-dilute mode, to verify all values are with range. (3) Surveyor #2 then reviewed maintenance records for 14 months (January 2020 through February 2021). There was no evidence the monthly maintenance had been performed: (a) Between 05/28/2020 and 08/08/2020 (b) Between 09/26/2020 and 11 /20/2020 (c) Between 12/28/2020 and 02/14/2021 (4) Surveyor #2 reviewed the records with the lead tech, who stated on 07/27/20201 at 01:50 pm the monthly maintenance had not been performed as required. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the lead tech, the laboratory failed to have control procedures that monitored the accuracy and precision of the testing process for hematology testing for 18 of 18 months. Findings include: (1) On 07/27 /2021 at 10:00 am, the lead tech stated to surveyor #1 CBC (Complete Blood Count) testing was performed on the Medonic M-Series analyzer; (2) On 07/27/2021 at 01:45 pm, the lead tech stated to surveyor #2 that three levels of QC (quality control) materials were performed each day of patient testing; (3) Surveyor #2 requested QC records (i.e., Levey-Jennings data) for the above testing performed from January 2020 though June 2021 to ensure QC had been monitored for variances (i.e. shifts, trends, biases). The lead tech stated on 07/27/2021 at 02:20 pm, there were no records (i.e., Levey-Jennings data) proving the control results had been monitored for variances during the review period because data had not been printed and maintained. Surveyor -- 2 of 5 -- #2 was able to verify that QC had been performed each day of patient testing, however, there was no documentation the data had been reviewed for variances by the laboratory. 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 a review of records and interview with the lead tech, the laboratory failed to verify the stated value of control materials before they were put into use. Findings include: (1) On 07/27/2021 at 09:50 am, the lead tech stated the following to surveyor #1: (a) The laboratory performed routine CBC (Complete Blood Count) testing using the Medonic M-Series analyzer; (b) Three levels of manufacturer control materials were analyzed each day of patient testing; (c) The manufacturer's provided ranges were used to determine acceptability of quality control results. (2) Surveyor #2 reviewed records for 6 control lot numbers. There was no evidence the provided ranges were verified before the lot numbers were put into use for 6 of 6 lot numbers as follows: (a) Low control lot #22012-21, Normal control lot # 22102-22 and High control lot #22102-23 used from 01/21/2021 through 04/26/2021; (b) Low control lot # 22102-31, Normal control lot #22102-32, and High control lot #22102-33 used from 04/27/2021 through 07/13/2021. (3) The findings were reviewed with the lead tech who stated on 07/27/2021 at 01:15 pm the manufacturer's ranges had not been verified before the above lot numbers had been put into use. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY 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 a review of records and interview with the lead tech, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. -- 3 of 5 -- 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 possess qualifications that are equivalent to those required for such certification; 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 one year of laboratory training or experience, or both in non-waived 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 oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the lead tech, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for 1 of 1 competency evaluations performed. Findings include: (1) On 07/27/2021 at 09:45 am, surveyor #2 reviewed records for 2 persons performing moderate complexity testing in 2019, 2020 and to date in 2021. The records showed the evaluations for 1 of 1 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #2 - The 07/31/2020 and 07/20/2021 evaluations had been performed by the lead tech (this person had earned an Associates Degree in Science); (2) Surveyor #2 reviewed the records with the lead tech on 07/27/2021 at 11: 00 am, and explained that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). The lead tech stated to surveyor #2 on 07/27/2021 at 11: -- 4 of 5 -- 10 am, the above evaluations had been performed by an individual who did not meet the educational qualifications of a technical consultant. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 08/19/19. The findings were reviewed with the laboratory lead and the clinic manager at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 a review of records and interview with the laboratory lead and the clinic manager, the laboratory failed to ensure proficiency testing samples were tested by personnel who routinely performed patient testing. Findings include: (1) At the beginning of the survey, the surveyor reviewed the Laboratory Personnel Report (Form CMS-209) completed prior to the survey. The form listed 4 testing persons (Laboratory lead, clinic manager, testing person #3, and testing person #4) as performing the moderate complexity testing in the laboratory; (2) The laboratory lead stated to the surveyor the laboratory performed the following moderate complexity testing: (a) CBC (Complete Blood Count)(i.e. WBC-White Blood Count; RBC-Red Blood Count; Hemoglobin, Hematocrit, Platelet, etc.) testing using the Medonic M Series hematology analyzer; (b) Neonatal bilirubin testing using the Reichert Unistat Bilirubinometer. (3) The surveyor then reviewed proficiency testing records for the Third 2017 Event; the First, Second, and Third 2018 Events; and the First and Second 2019 Events and identified the clinic manager had not performed proficiency testing in 6 of the 6 Hematology proficiency testing events reviewed and 4 of the 4 proficiency testing events for neonatal bilirubin; (4) The surveyor asked the laboratory lead if the clinic manager had been trained to perform CBC and neonatal bilirubin testing. The laboratory lead stated to the surveyor, the clinic manager had been trained 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 -- and would fill in and perform patient testing if necessary; (5) The surveyor reviewed the findings with the laboratory lead and the clinic manager and explained all testing persons who perform, or would perform the moderate complexity patient testing must participate in proficiency testing. 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 a review of records, and interview with the laboratory lead, the laboratory failed to verify the accuracy of KOH prep and urine sediment examinations at least twice annually. Findings include: (1) At the beginning of the survey, the laboratory lead stated to the surveyor KOH preps (for presence/absence of fungal elements) and microscopic urine sediment examinations were performed in the laboratory; (2) The surveyor reviewed proficiency testing records for the Third 2017 Event; First, Second, and Third 2018 Events; and the First and Second 2019 Events. The surveyor identified the laboratory had not participated in proficiency testing during the proficiency testing events reviewed; (3) Since the laboratory had not enrolled in proficiency testing (enrollment and participation in a proficiency testing program is not required for KOH preps and microscopic urine sediment examinations; they are not regulated analytes), the surveyor asked the laboratory lead how the testing was verified for accuracy during 2017 through the date of the survey; (4) The laboratory lead stated 2 patient KOH and 2 urine sediment examinations were performed in office and the results documented. The samples were then sent to a reference laboratory for testing and the results compared. The laboratory director reviewed the results for acceptability; (5) The surveyor then reviewed the accuracy testing for 2017 through the date of the survey and identified during 2018 and 2019, the comparison testing had not been performed twice annually as required: (a) KOH prep comparison testing was performed on 07/19/18 and on 07/19/19; (b) Microscopic urinalysis examination testing comparison was performed on 05/05/18 and on 01/11/19. (6) The surveyor reviewed the findings with the laboratory lead who stated to the surveyor, the laboratory failed to verify the accuracy of KOH prep and urine sediment examinations at least twice annually in 2018 and 2019. 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)