Acme Pediatric Provider, Pllc

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of the patient test records from January 1 - 18, 2023, and staff interview, it was revealed the laboratory failed to have documentation of the notification of 6 of 6 patients with critical values. The findings include: 1. A review of the laboratory's policy titled "Critical Values" (approved on 11 /26/2018) revealed: "The Laboratory Personnel will immediately notify the requester or user about lab results in the 'Critical Value' or 'Panic Range." The laboratory then defined the following critical values: WBC under 2.0 or over 20.0 HGB under 7.5 or over 18 HCT under 25 or over 55 PLT under 50 or over 800 2. A review of the laboratory's policy titled "Reporting Critical Values" (approved on 11/26/2018) revealed: "It is the policy of this laboratory to document the reporting of Critical Values. Document: 1. Who was notified 2. When was the person notified 3. By whom was the person notified" 3. A review of patient test records from January 1 -18, 2023 identified 6 patients with critical values which the laboratory failed to have documentation of the notification to the provider. They were: Date Sequence Critical Value 1/3 5361 WBC: 21.0 1/7 5424 WBC: 22.7 1/11 5485 WBC: 20.9 1/13 5518 WBC: 24.3 1/16 5544 HCT: 20.0 HGB: 7.2 1/16 5552 WBC: 26.2 4. An interview 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 -- with the technical consultant on 01/18/2023 at 1420 hours in the break room - after his review of the records- confirmed the findings. Key WBC - white blood cell HGB - hemoglobin HCT - hematocrit PLT - platelet -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. 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 surveyor observation, review of manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to monitor revised expiration dates for the current open vials of Boule Con-Diff controls. The findings included: 1. Surveyor observation on September 21, 2021 at 11:15 hours found three vials of Boule Con-Diff controls for used for quality control testing for the Medonic M-series hematology analyzer. Level: Low Lot 22107-01 Manufacturer Expiration date (unopened): 11-23-2021 Level: Normal Lot 22107-02 Manufacturer Expiration date (unopened): 11-23-2021 Level: High Lot 22107-03 Manufacturer Expiration date (unopened): 11-23-2021 2. Review of the Boule Con-Diff manufacturer package insert (201043L R03.31.15) stated, "Open vial stability 14 days after opening when returned to refrigerator after each use." 3. Without documenting the revised expiration date, the laboratory does not have a mechanism in place to ensure controls are not used beyond the 14 day open manufacturer date. 4. An interview with Testing Personnel #1 (as listed on Form CMS-209) on September 21, 2021 at 11:15 hours in 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 -- the laboratory confirmed the findings. When asked when the controls were opened, she stated, "September 15th," and when asked if it was documented anywhere, she stated, "No." CMS - Centers for Medicare and Medicaid -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor observation, review of manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions to ensure kit packing is not opened until ready to use. The findings were: 1. Surveyor observation at 13:40 hours in the laboratory revealed two (2) BD Veritor test cartridges opened and removed from their foil packaging and located on the counter. 2. Review of the manufacturer's instructions for the BD Veritor System (8087667(13)) under, "Prepare for Testing" it stated, "Remove one RV Reagent D tube /tip and one BD Veritor System Flu A + B device from its foil pouch immediately before testing." 3. At the time of the observation, there were no patients with pending tests to be performed. 4. Interview with testing person #1 (as listed on Form CMS 209) on March 5, 2019 at 13:48 hours in the laboratory confirmed the findings. Key: BD - Becton Dickinson CMS - Centers for Medicare and Medicaid Services D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory policies, review of quality control records, and 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 -- confirmed in interview of facility personnel, the laboratory's policy for "Quantitative Control Validations" failed to reflect the laboratory's current practice. The findings were: 1. Review of laboratory policy titled, "Quantitative Control Validations" approved by the laboratory director on November 26, 2018, stated, "Method: New controls shall be run at least once a day for 5 days along with current controls ..." 2. Review of quality control records revealed that the laboratory's practice was to perform a 3-event (all ran on the same day) verification of new lots of controls. 3. The laboratory's policy did not reflect its current practice. 4. According to the CMS-116, the laboratory performed 21,600 hematolgoy (CBCs) tests annually 4. The findings were confirmed in interview of the technical consultant on March 5, 2019 at 14:30 hours in the break room. Key: CMS - Centers for Medicare and Medicaid Services 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 surveyor observation and confirmed in interview of facility personnel, the laboratory failed to ensure each reagent was labeled with identification of contents, lot numbers, and expiration dates. The findings were: 1. Surveyor observation made in the laboratory on March 5, 2019 at 14:15 hours found two Medline containers (Reference #RL16CN1) filled with clear liquid. The containers were not labeled with content identification, lot number, or expiration dates. 2. The findings were confirmed in interview with testing person #1 (as listed on Form CMS 209) on March 5, 2019 at 14:15 hours in the laboratory. She confirmed that one was bleach but was unsure of what the other container was. She stated that it might be, "Something one of the nurses left in the laboratory." Key: CMS - Centers for Medicare and Medicaid Services -- 2 of 2 --