Alabama Pediatrics

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 a lack of Proficiency Testing (PT) records and an interview with Testing Personnel 1 (TP1), the laboratory failed to enroll in an approved Microbiology Urine Culture Colony Count (UCCC) PT program from the date of the last survey, 07-25- 2024, through the date of the current survey, 05-19-2026. The findings include: 1. A review of PT records revealed the laboratory had no evidence of PT enrollment for the Microbiology UCCC test performed in the laboratory for approximately 22 months. 2. TP1 confirmed the above findings during the exit conference on 05-19-2026 at 2:30 PM. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 -- This STANDARD is not met as evidenced by: Based on a review of API (American Proficiency Institute) Proficiency Testing (PT) records, the lack of Quality Assurance (QA) Policies and Procedures (P&P), and an interview with Testing Personnel 1 (TP1), the laboratory failed to: (I) enroll in an approved PT program for the Microbiology Urine Culture Colony Count (UCCC); (II) implement a QA policy specifying the evaluation of Microbiology UCCC to ensure accuracy of testing. This surveyor noted missing enrollment and documentation occurred from the date of the last survey, 07-25-2024, through the date of the current survey, 05-19-2026. The findings include: 1. A review of PT records revealed the laboratory had no documentation of the PT enrollment for the Microbiology UCCC. 2. A review of the QA policy and procedure manual revealed no written documentation on how the laboratory ensures the accuracy of the Microbiology UCCC test. 3. TP1 confirmed the above findings during the exit conference on 05-19-2026 at 2:30 PM. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 reviews of the Monthly Room Temperature (RT) and Humidity logs, the Medonic M-Series Hematology analyzer User's Guide, patient testing logs and an interview with Testing Personnel 1 (TP1), the laboratory failed to record the RT and Humidity 9 of the 26 testing days in March 2025. The findings include: 1. A review of the RT and Humidity logs revealed TP did not record RT and Humidity for the following days when the Medonic M-Series Hematology analyzer was operated. A) March 21-22, 2025 B) March 24-29, 2025 C) March 31, 2025 2. A review of the Medonic M-Series User's Guide revealed on page 83 the following specifications. A) Temperature - 64 - 90 degrees Fahrenheit (18 - 32 degrees Celsius) B) Humidity (noncondensing) - Up to 80% 3. A review of the patient testing logs revealed 93 Complete Blood Count (CBC) were performed when the RT and Humidity were not documented. 4. TP1 confirmed the above findings during the exit conference on 05- 19-2026 at 2:30 PM. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on surveyor's laboratory tour observation, review of manufacturer's package insert and confirmed in an interview with the Testing Personnel 1 (TP1), the laboratory failed to label Boule Hematology Quality Control (QC) materials with revised expiration dates for 3 of 3 control vials upon opening. Findings Included: 1. During the laboratory tour of the facility with the TP1 on 05-19-2026 at 8:13 AM, the surveyor observed the following Boule Hematology controls for Medonic M-Series analyzer, stored in the laboratory refrigerator. Levels Low, Normal, High Lot Number: Expiration Date: 22602-5K:07-13-2026 Open Expiration Date: Not written The surveyor inquired if the above QC vials were currently being used prior to patient testing. TP1 confirmed the QC vials were currently in use. 2. Review of manufacturer's package insert for the Boule Hematology Control revealed the following instructions, "Storage and shelf life after first opening Opened and recapped vials ... will retain stability for 14 days if stored at 2-8 C after being recapped." 3. TP1 confirmed the above findings during the exit conference on 05-19-2026 at 2:30 PM. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of the pipette maintenance records, the Policy and Procedure (P&P) Manual and an interview with the Testing Personnel 1 (TP1), the laboratory failed to perform and document the annual pipette check for the Piccolo Minipet, a 100 microliter fixed-volume micropipette. This was noted for one out of one pipette being used from the date of the last survey, 07-25-2024 to the date of the current survey, 05-19-2026. The findings include: 1. A review of the 2024-2026 pipette maintenance records revealed the Piccolo Minipet had no documentation of the annual pipette check . 2. A review of P&P manual revealed the laboratory's instructions for an annual check of the pipette. 3. TP1 confirmed the above findings during the exit conference on 05-19-2026 at 2:30 PM. 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. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a review of the Piccolo Total Bilirubin (TBil) Quality Control (QC) records and an interview with the Testing Personnel 1 (TP1), the laboratory failed to monitor the shifts and trends of test performance over time. The surveyor noted there was no documentation of Levey-Jennings (L-J) charts or peer group data for approximately 22 months from the date of the last survey, 07-25-2024 through 05-19-2026. The findings include: 1. A review of the Piccolo TBil QC records revealed no evidence of L-J charts or peer group data being available for review for the following months. A) 2024 - July - December B) 2025 - January - December C) 2026 - January through May 2. TP1 confirmed the above findings during the exit conference on 05-19-2026 at 2:30 PM. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel 1 (TP1), the Laboratory Director failed to ensure the laboratory was enrolled in an approved PT program for the Microbiology Urine Culture Colony Count (UCCC), moderate complexity test. The surveyor noted no documentation of the PT enrollment for the Microbiology UCCC test from the date of the last survey, 07-25-2024, through the date of the current survey, 05-19-2026. The findings include: 1. A review of the API PT records revealed a lack of enrollment and documentation for the Microbiology UCCC test for approximately 22 months. 2. The TP1 confirmed the above findings during the exit conference on 05-19-2026 at 2:30 PM. -- 4 of 4 --

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the USP (Urine Split Plate) QC (Quality Control) log, the USP patient log, and an interview with Testing Personnel #1, the laboratory failed to document media lot numbers and expiration dates for every lot number prior to use for patient testing. This was noted for 58 days of 16 months reviewed in 2023 through 2024. The findings include: 1. A review of the USP QC log revealed no documentation of media from when the last lot expired to when the new lot was put into use for the following: a) Lot# 517460 was put into use 1/4/23 and expired 2/12 /23; 24 days later, b) Lot# 521291 was put into use 3/8/23 and expired 4/24/23; 9 days later, c) Lot# 524542 was put into use 5/3/23 and expired 6/14/23; 25 days later, d) Lot# 621077 was put into use 2/3/24 and expired 4/30/24. 2. A review of the patient log revealed 36 patient urine cultures were performed on the 58 days of no media documentation. 3. During an interview on 7/25/2024 at 2:41 PM, TP #1 confirmed media documentation was missed. 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 D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Chemistry QC (Quality Control) records, the Piccolo IQCP (Individualized Quality Control Plan), and an interview with Testing Personnel #1, the Laboratory failed to ensure testing personnel performed the Piccolo QC every 30 days as per the IQCP. The surveyor noted four out of eighteen months in 2021 and 2022 when QC was not performed as required by the IQCP. The findings include: 1. A review of the Piccolo Chemistry IQCP revealed, "Perform external Quality Control at least every 30 days." 2. A review of the Piccolo records revealed the laboratory exceeded the 30-day requirements for external serum Bilirubin QC, as follows: a) 4/7 /2021 to 5/13/2021; 6 days overdue. b) 7/7/2021 to 8/10/2021; 3 days overdue. c) 6/3 /2022 to 7/14/2022; 11 days overdue. d) 9/1/2022 to 10/4/2022; 3 days overdue. 3. During an interview on October 7, 2022, at 12:38 PM, Testing Personnel #1 confirmed the above findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, 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 -- manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Hematology Quality Control (QC) records and an interview with Testing Personnel #1, the laboratory failed to ensure the Medonic Hematology QC was within the manufacturer's acceptable ranges before patient testing began one day in 2021. The findings include: 1. A review of the Medonic Hematology QC records revealed two levels of QC failed on October 2, 2021. One patient CBC (Complete Blood Count) was run on this date. 2. During an interview on October 7, 2022, at 12:38 PM, Testing Personnel #1 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of the 2018 - 2020 American Proficiency Institute (API) proficiency testing records and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory director and/or testing personnel failed to sign attestation statements for three of nine proficiency testing events reviewed by the surveyor. The findings include: 1. A review of the API proficiency testing records revealed the Laboratory Director failed to sign attestation statements for the following events: Immunology (Mycoplasma) Event #1, 2019; and Microbiology Event #2, 2019. The testing personnel failed to sign the following attestation statements: Immunology (Mycoplasma) Event #1, 2019; Chemistry Event #3, 2018; and Microbiology Event #2, 2019. 2. In an interview on 10/20/2020 at 4:25 PM, TP #1 confirmed the missing signatures of the laboratory director and/or the testing personnel on the above mentioned testing events. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, 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 -- traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the 2019 -2020 calibration records for the Medonic Hematology analyzer for Complete Blood Count (CBC) testing, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to perform the calibration at least every six months, between August 2019 and August 2020, and according to the manufacturer's guidelines. This affected one of four possible opportunities to perform the calibration. The findings include: 1. A review of the Medonic Users' Manual revealed the manufacturer recommended the calibration be performed at least every six months. 2. A review of the calibration records for the Medonic revealed the laboratory performed calibrations on 3/01/2019, 8/30/2019 and not again until 8/22/2020, exceeding the six month time frame, recommended by the manufacturer. 3. During an interview on 10/20/2020 at 4:25 PM, TP #1 stated she was not able to find a calibration record for the Medonic for February of 2020, and added she was not aware what happened to the report. When the surveyor asked with what frequency the Medonic should be calibrated, TP #1 stated the laboratory usually calibrated the instrument at least every six months. . D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Individualized Quality Control Plans (IQCPs) for Mycoplasma, total-Bilirubin (performed on a serum sample on the Piccolo) and throat and urine cultures (Microbiology), a review of quality control records, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure the IQCPs included Quality Assessment (QA) Plans. Additionally, each year from 2018 - 2020, the laboratory started with a new IQCP for each test, neither including a QA plan. This affected 3 of 3 IQCPs developed by the laboratory. The findings include: 1. A review of the IQCP plans for Mycoplasma (discontinued at the beginning of 2020), total-Bilirubin and media for throat and urine cultures, revealed the plans included risk assessments and quality control plans, but no evident quality assessment plans. 2. In an interview on 10/20/2020 at 2:30 PM, the surveyor asked TP #1 to review and explain the plans, as well as indicate the QA plan, a requirement for a complete IQCP. The QA plan should consist of the laboratory's written policies and procedures for monitoring the effectiveness of the IQCPs. TP #1 stated all the plans were done in the same manner, and the last survey (2/07/2018) was the first time one was done and reviewed. 3. During a second interview regarding the IQCPs, on 10/20/2020 at 3:00 -- 2 of 3 -- PM, the surveyor asked why there was an IQCP for each test for each year, 2018, 2019 and 2020. The surveyor asked if the plans were established each year. TP #1 stated she was not aware she did not need to establish a plan each year, but confirmed that she did for each year, since the last survey in 2018. The surveyor inquired of the testing frequency of the quality control for total-Bilirubin. TP #1 stated the IQCP indicated the external quality control should be run at least every thirty days. 4. A review of the total-Bilirubin control testing record revealed no quality control testing between July 24, 2019 and September 10, 2019 and between November 25, 2019 and January 27, 2020. During the interview on 10/20/2020 at 3:00 PM, TP #1 reviewed the quality control records and confirmed the laboratory had missed performing the quality control testing at least every thirty days, according to the direction of the QCP (Quality Control Plan). The surveyor explained if the laboratory had established a QA plan to monitor the effectiveness of the IQCP implementation, there would be no need to develop a plan each year; but to revise portions needing revision, based on effective monitoring. -- 3 of 3 --

Summary Statement of Deficiencies D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing records and an interview with Testing Personnel #1 (TP #1), the surveyor determined the Laboratory Director failed to ensure Immunology results for one of three surveys performed in 2017 were submitted within the timeframes specified by the proficiency testing program. The findings include: 1. A review of the results from 2017-Event #3 Immunology survey revealed 0% (percent) scored for Mycoplasma Antibody due to failure to participate. 2. During an interview conducted on 2/7/2018 at 2:30 PM, TP #1 stated the proficiency testing for Mycoplasma antibody was performed, but failed to submit the results by the deadline. 3. This is a previously cited deficiency. Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor 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 --