Children's Clinic Of Harlingen, Pa

Summary Statement of Deficiencies 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 review of the manufacturer's instructions for the Sysmex EIGHTCHECK 3WP X-TRA hematology controls, observations, review of policies and procedures and interview of facility personnel,the laboratory failed to document revised expiration dates for one of one opened lot of control materials. The findings included: 1. Review of the manufacturer's instructions for the Sysmex EIGHTCHECK 3WP X- TRA hematology controls (Revision 03/2023) under the section titled Storage and shelf life after first opening: "Opened vials and vials which have been sampled by cap piercing will retain stability for 14 days if stored at 2 - 8C after being recapped." 2. Observations made in the laboratory found one vial each of the low, normal and high controls in the refrigerator with no documentation of the new expiration date after opening. The controls had "hashmarks" to document the number of times used. 3. Review of the Lab Procedure found on page 14 under the heading Reagents: All reagents must be properly labeled with the date of receipt, date placed in service, and expiration date. " 4. During interview of testing person one conducted March 6, 2024 at 10:28 AM, she confirmed that the laboratory did not change the expiration date on the control once it was opened. She went on to say that the hashmarks were made on the controls for each use, and they used the controls 14 times before changing the vials. D5781

Summary Statement of Deficiencies D0000 The laboratory was surveyed on April 7, 2022 and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of laboratory policies, review of the laboratory's American Academy of Family Physicians (AAFP) proficiency testing records and confirmed in interview of facility personnel, the laboratory failed to ensure proficiency testing samples were handled the same as patient samples for 2 of 4 testing events reviewed.. The findings included: 1. Review of the laboratory's policy titled "Procedure for Proficiency Testing" approved by the laboratory director on October 9, 2014 stated, "...Survey material will be handled the same way any routine specimen would be." 2. Review of proficiency testing records from 2021 (events 1, 2, and 3) and 2022 (event 1) found the following testing events were tested on more than one day prior to result submission: Hematology (event 2) Specimen #6 Tested on 06-15-2021 @ 15:30 Tested on 06-15-2021 @ 15:32 (did not meet any laboratory criteria for repeat analysis) Hematology (event 3) Specimen #12 Tested on 10-08-2021 @ 12:51 Tested on 10-13-2021 @ 16:40 Specimen #14 Tested on 10-08-2021 @ 12:43 Tested on 10- 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 -- 13-2021 @ 16:41 3. The laboratory was asked to provide documentation of handling proficiency testing samples the same as patient samples. No documentation was provided. 4. An interview with the primary testing person on April 7, 2022 at 10:15 hours confirmed the findings. She stated that she had repeated them because she was unsure about the flags. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with the CLIA regulations at 42 CFR. Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 A recertification survey was performed on May 17, 2018. The laboratory was found to be IN COMPLIANCE with the CLIA regulations and recertification is recommended. 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 observations, review of manufacturer's instructions, review of maintenance records, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions to clean the strip holder on the McKesson 120 Urine analzyer. The findings were: 1. Surveyor observation made in the laboratory on 05/17/2018 at 1100 hours revealed the strip reader on the McKesson 120 Urine analyzer was discolored. 2. Review of the manufacturer's instructions for the McKesson 120 Urine analzyer (Number: 1150667601, Effective Date: 2012-02- 16) under, "Daily Cleaning" stated, "Clean the Strip Holder." 3. Review of maintenance records from January 2017 to April 2018 revealed no documentation of the facility performing the daily maintenance on the McKesson 120 Urine analyzer 4. Interview with the Operations Manager on 05/17/2018 at 1130 hours in the office confirmed the findings. She revealed she performs the facility's maintenance but has not currently been documenting the maintenance for the urine analyzer. 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 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Sysmex XP300 hematology analyzer, review of the laboratory's maintenance records from January 2017 to April 2018, and staff interview, it was revealed the laboratory failed to have documentation of performing quarterly maintenance as required by the manufacturer. The findings were: 1. A review of the manufacturer's instructions for the Sysmex XP300 hematology analyzer (Revised July 2012) under the section titled "Cleaning and Maintenance" revealed the manufacturer required the following maintenance to be performed every 4500 cycles or every 3 months, whichever occurred first: Clean SRV 2. A review of the laboratory's maintenance records from January 2017 to April 2018 revealed the laboratory failed to have documentation of performing the required quarterly maintenance. Maintenance documentation was as follows: February 2017 December 2017 (10 months later) April 2018 (4 months later) 3. The laboratory was asked to provide documentation of performing the required maintenance. No documentation was provided. 4. An interview with the Operations Manager on 05/17 /2018 at 1030 hours in the office confirmed the findings. -- 2 of 2 --