Natl Ctr For Hlth Statistics Nhanes Iv

Summary Statement of Deficiencies D0000 The following deficiencies are the result of a desk review of proficiency testing scores obtained from the national database, verified with the proficiency testing company. The facility was found to be out of compliance with the CLIA program's conditions. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]. D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report, the College of American Pathologists (CAP) 2025, and the American Proficiency Institute (API) 2026 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three testing events (2025 Events 3 and 2026 Event 1) in the specialty of hematology for the Hematocrit (HCT) analyte. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, the College of American Pathologists (CAP) 2025, and the American Proficiency Institute (API) 2026 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three testing events (2025 Events 3 and 2026 Event 1) in the specialty of hematology for the Hematocrit (HCT) analyte. Findings: 1. A review of the CASPER 0155 report revealed the following results: a. CAP 2025 - 3rd Event The laboratory received an unsatisfactory score of 40% for HCT. b. API 2026 - 1st Event The laboratory received an unsatisfactory score of 40% for HCT. 2. A review of CAP and API proficiency testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, the College of American Pathologists (CAP) 2025, and the American Proficiency Institute (API) 2026 proficiency testing records, the laboratory failed to provide overall management and direction of the laboratory services. Refer to D6016. 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: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, the College of American Pathologists (CAP) 2025, and the American Proficiency Institute (API) 2026 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory's -- 2 of 3 -- services. The laboratory director failed to ensure successful participation in an HHS- approved proficiency testing program. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A federal surveyor from the Division of Clinical Laboratory Improvement & Quality CLIA Operations, Centers for Medicare and Medicaid Services (CMS) - Philadelphia CMS Office conducted an announced CLIA Recertification survey at the NATL CTR FOR HLTH STATISTICS NHANES IV laboratory on April 14 , 2021. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. Specific deficiencies cited are as follows: D5781

Summary Statement of Deficiencies D0000 Federal Jurisdictional Survey The laboratory is in compliance with 42 CFR part 493 with standard level deficiencies cited: 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 review of manufacturer's instructions, temperature charts, and interview, the laboratory failed to have defined the correct criteria conditions for proper storage of reagents at room temperature for hematology (DxH 800) as evidenced by: 1. In review of the manufacturer's instructions for reagents it states for Beckman Coulter DxH 800 analyzer: a. Differential pack store at 2-25 degrees C. b. Cleaner store at 2-25 degrees C. 2. In review of the laboratory's temperature charts the laboratory defined a criteria outside of the proper room temperature storage range: 15-30 degrees C. 3. In review of the room conditions temperature graphs for (all day monitoring) May 25th- 27th and June 1st, 8-10, for three days ,the room temperature was above 25 degrees C at certain periods of the day. The temperature graphs show that they are above 25 degrees without a numeric value. The following dates and times were seen above 25 degrees on the chart : a. 6-10-2018 @ 4pm b. 5-27-2018 @12PM c. 5-26-2018 @4 pm The laboratory did not take any remedial actions and was unaware of the storage requirements by the manufacturer. 4. In interview with the Laboratory Director on 3- 18-2019 @1115 am she stated that she was not aware that reagents had a tighter 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 -- storage temperature. She also stated that everything must have changed when they went to the DxH 800 a few years ago. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on record review, manufacturers instructions and interview with staff the laboratory failed to document open vial stability of Coulter 6 C quality control material. as evidenced by: 1. Coulter 6C manufacturers instructions state: " 16 Open Vial days, assumes that the instruction for use section of the package insert is performed a maximum of 18 times within 16 days. 2. Direct observation of current lot of Coulter 6c materiel in the refrigerator( L1 123192490, L2 133182490, L3 143192490) was observed @ 1115 on 0303/18/19 without new expiration date on the vial or documented. 3. In interview with the Director @ 1115 on 03/18/19, she stated : The QC was good for 7 days and they typically run qc 2 times per day during lot rollover and every 4 hours during sessions, , and no means to ensure 18 events in 16 days were not surpassed." D5783