Er Quickcare Pl

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at ER QUICKCARE PL on March 26, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 record review and interview, the laboratory failed to have the two out of seven testing personnel (TP) rotate through the testing of Proficiency Testing (PT) for Mycology and Parasitology specialties in 2 out of 2 years reviewed. Findings included: 1-Review of FORM CMS-209 signed and dated by the Laboratory Director (LD) on 03/02/2025 revealed the laboratory had seven TP listed (TP#1, TP# 2, TP#3, TP#4, TP#5, TP#6 and TP#7). 2-Review of KOH control log for 2023, 2024 and 2025 revealed that TP#2, TP#6 and TP#7 performed the controls for the testing of reference. 3-Review of American Proficiency Institute (API) PT records for 2023 (first and second event), 2024 (first, and second) and 2025 (1st event) revealed that TP#2 signed all events for the Vaginal Wet Prep, Vaginal Wet Prep (KOH) and Urine Sediment. TP#6 and TP#7 did not participate in the events of reference. 4-During an interview on 03/26/2025 at 01:30 PM, the Consultant confirmed that the laboratory failed to rotate the PT between TP#2, TP#6 and TP#7 for the period of reference. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory records review and staff interview, the laboratory failed to do competency evaluation for one out of seven Testing Person (TP) Findings included: 1- Review of FORM CMS 209 signed by the Laboratory Director (LD) on 03/02/2025 revealed that the LD was Clinical Consultant (CC), Technical Consultant (TC) for Mycology, Chemistry and Hematology specialties and TP#6, the 209 listed 6 more TP (TP#1, TP#2, TP#3, TP#4, TP#5 and TP#7). 2- Review of personnel records revealed that TP#7 that performed the KOH test during 2023 and 2024, did not have record of competency evaluation for those years. 3-During an interview on 03/26/2025 at 2:30 PM, with LD, he confirmed that TP#6 failed to have competency evaluation for 2023 and 2024. 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 observation, record review and interview, the laboratory failed to follow manufacturer's instructions for storage temperature of the control material for D- Dimer, Troponin and Creatine Kinase MB (CK-MB) tests on the Quidel Triage for 9 months reviewed from September 2023 to March 2025. Findings included: 1-During the laboratory tour on 03/26/2025 at 11:00 AM, the surveyor found stored in a freezer one open box of Quidel Triage Total 5 Control Product level 1 lot number C4080AN, one unopen box of Quidel Triage Total 5 Control Product level 1 lot number C4087AN and one open box of level 2 with lot number C4089AN. 2-Review of the required storage temperatures as per manufacturer showed a storage requirement in a non-defrosting freezer at -20 Celsius Degrees (C) or colder. 3-Review of the temperature log revealed an acceptable temperature range of -15C or less DEGC. The range does not meet the storage requirements. 4-Review of documented temperature log for the following months: September 2023, May 2024, July 2024, August 2024, September 2024, October 2024, December 2024, January 2025 and March 2025, revealed that the temperature has not reached the requirement of -20 or colder. The freezer temperatures were documented at levels of -14.4 C to -19 C. 5-During an interview on 05/02/2023 at 10:30 PM, Testing Person #1 confirmed that the controls listed above were stored outside of the acceptable range as per manufacturer instructions in the months of reference. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at ER Quickcare PL on 07 /18/23. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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 observation, record review, and interview with Testing Personnel #C, the laboratory failed to follow the laboratory's procedure for centrifuging urine sediment specimens at the correct speed and time for two out of two years reviewed (2021 - 2023). The laboratory had performed 2,391 patients urine sedimenation tests from April 16, 2021 to July 18, 2023. Findings included: On 07/18/23 at approximately 9: 20 am, observation revealed the laboratory was using a designated centrifuge that did not adjust for time and centrifuge speed when spinning blood and urine specimens. Interview with the Testing Personnel #C at time of observation revealed the centrifuge was used for blood specimens and urine specimens for urine sedimentation testing . Review of the "Operator's Manual Drucker Diagnostics" revealed "General Specifications for the Model 642E Centrifuge... Nominal speed (horizontal): 3380 (=/- 100 ) RPM " Review of the laboratory's policy "Routine Urinalysis" revealed "If microscopic is warranted, centrifuge urine in the conical tube for 5 minutes." On 0718 /2023 at 9:45 AM, Testing Personnel #C confirmed that the centrifuge was being used for blood and urine specimens, but the laboratory used a separate timer that was set at 3 minutes and 30 seconds for urine specimens instead of using the centrifuge timer that was set at 10 minutes for bloood specimens. 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 D0000 An announced CLIA recertification survey was conducted at ER Quickcare PL on 04 /15/2021. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 the lack of record review and interview with Testing Personnel #B, the laboratory failed to verify the quality control manufacturer's recommended range for the Urinalysis (for the Urisys instrument) , Serum HcG ( manual testing), Chemistry (for the Triage Meter Pro), and Hematology controls ( for the Coulter ACT Diff 2 Hematology Analyzer) for two out of two years (2019-2021). Findings included: Review of Urinalysis, Serum HcG, Chemistry and Hematology quality control records revealed the lack of quality controls records for verification of quality control manufacturer's recommended ranges for the new lot of Kovac ( for Urinalysis and Serum HeG), Chemistry controls (CKMB, D Dimer, Troponin and Brain Natriuretic 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 -- peptide) and Hematology controls for two out of two years (2019-2021). Interview on 04/15/2021 at 12:45 PM, Testing Personnel #B stated that the laboratory had discontinued performing verification of quality control manufacturer's recommended ranges because the previous laboratory consultant had told them the laboratory did not have to verify quality control manufacturer's recommended ranges. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director, the Laboratory Director failed to follow the laboratory's procedure for Quality Assurance (QA) review for 2 (April - December 2019, January - December 2020, and January - March 2021) out of 2 years reviewed. Findings Included: Review of the Laboratory procedure "Lab Staff Job Description Moderate Complexity" revealed " 4. Perform all Quality Assessment activities assigned to this position and document these activities for periodic review by the Laboratory Supervisor and/or the Laboratory Director." Review of laboratory documentation revealed that the Testing Personnel #B was documenting she reviewed all laboratory QA monthly. for 2 (2019 - 2021) out of two years and the Laboratory Director had not documented reviewing QA for 2 (April - December 2019, January - December, and January - March 2021) years. Interview on 04/15/10 at 02:00 PM, the Laboratory Director stated he did not know he was suppposed to review the monthly Quality Assessment activities performed by Testing Personnel #B. -- 2 of 2 --

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, there was no documentation to indicate that the technical consultant conducted a semiannual performance evaluation of one of two new personnel. Findings include: The surveyor reviewd the competency evaluations for all testing personnel on 03/20/19, and found that one of two testing personnel who started since the last survey did not have a semiannual evaluation. During an intrview with testing person B. at 12:10 p.m. on 03 /20/19, she said that she thought one had been done, but she did not see it in the file or the training certificate book. 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 --