Diagnostic Laboratory Services Inc - Fhp

Summary Statement of Deficiencies D0000 Federal Surveyors from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted a recertification survey on 7/16/2025 and 7/22/2025. The following standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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: A. Based on review of the laboratory's procedures, review of the laboratory's patient mean study records, and interview with technical supervisor #1, the laboratory failed to follow its own procedures and document normal patients used for the patient mean study (2024) changed of innovin for 1 of 1 studies reviewed with the Dade CA 620 coagulation analyzer as evidenced by: 1. In review if the laboratory's procedure G405. 20.03.01 under 5.1 Patient mean study states, "Perform before switching to new lot of PT thromboplastin (innovin) or APTT reagent. Obtain citrated specimens from at least 20 normal patients. These samples can be taken from any of the following patient coming to the laboratory for blood test: patients coming for pre-operation/pre-surgery testing, patient know to be non-coumadin users, patients coming in for immigration testing, non-pregnant women, Patients with no know pathological condition (for annual physical), patient should not be taking any medication, including aspirin, patients should span the adult range." 2. In review of the laboratory's patient mean record effective 12/14/2024 for lot #564632, the laboratory could not identify the 20 patients used for the study. They had no record to determine if the patients met their procedure's criteria. 3. In an interview with technical supervisor #1 on 7-16-2025 at 1119 stated that he didn't know who the normal patients were when they did the study 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 -- in December 2024. 38555 B. Based on the review of laboratory procedures, lack of quality control records, and an interview with the technical supervisor (TS), the laboratory failed to establish a manual microscopic urinalysis procedure from July 2023 to July 2025 (24 of 24 months). 1. Review of laboratory QC on July 16, 2025 at 10:00 am, the laboratory was unable to provide a documented QC for manual microscopic urinalysis. 2. The laboratory was requested to provide a manual microscopic urinalysis procedure by July 22, 2025. 3. By interview, on July 22, 2025 at 9:30 am, the TS confirmed the laboratory did not have a procedure for manual microscopic urinalysis. 4. In 2024, 2,297 manual microscopic urinalysis examinations were performed. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, direct observation of testing personnel #4, and interview with technical supervisor #1, the laboratory failed to follow manufacturer's instructions for reconstituting the Dade Ci-Trol coagulations controls with distilled water as indicated by the manufacturer as evidenced by: 1. In review of the Dade Ci-Trol coagulations control manufacturer's instructions states under preparing reagents, "Add exactly 1 ml of distilled water, gently tilt the vial and allow 15 minutes for reconstitution of the plasma in the close vial." 2. In direct observation of testing personnel #4 at 1405 on 7-16-2025, testing personnel demonstrated that for the coagulation controls they use the Deionized (DI) water from their chemistry instrument to reconstitute the Dade CI-Trol controls. 3.In an interview with technical supervisor #1 at 1407 on 7-16-2025 he confirmed they were using deionized water rather than distilled for reconstitution of the controls. 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 of the patient draw area, lack of temperature records and interview with the technical supervisor, the laboratory failed to monitor the room temperature of the patient draw area where 6 of 6 boxes of blood collection tubes were stored. Finding Included: 1. Observation of the laboratory patient draw area on July 16, 2025, at 11:30 am revealed the following blood collection tubes were stored -- 2 of 4 -- below the countertop in the patient draw area with 4-25 degrees Celsius storage requirements: a. BD Vacutainer Blood Collection tubes - Green top - one box - Lot#4198165. b. BD Vacutainer Blood Collection tubes - Red Top - one box - Lot#4289899. c. BD Vacutainer Blood Collection tubes - Lavender Top - two boxes - Lot#5019856. d. BD Vacutainer Blood Collection tubes - Yellow Top - two boxes. 2. The laboratory was unable to provide room temperature monitoring documentation for the patient draw area. 3. By interview, the TS confirmed on July 16, 2025, at 12:00 pm, that temperatures were not monitored in the patient draw area where collection tubes were stored. 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. This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, lack of records, and interview with technical supervisor #1, the laboratory failed to indicate the new kit stability expiration date when opened on July 1, 2025, and stored at room temperature for the Becton Dickinson (BD) Affirm kit as evidenced by: 1.In direct observation of the laboratory at 1021 on 7-16-2025 the following kit (that was opened on July 1st, 2025) did not have the new vial stability expiration date indicated and was stored at room temperature: a. BD Lysis lot#4309083 b. BD Affirm VP III L lot #4291399 c. BD Affirm VP III H lot # 4337824 2. In review of the BD Affirm kit manufacturer's instructions states, "Alternatively, store at room temperature (up to 30 degrees C) no more than 3 months." 3.In an interview with technical supervisor #1 at 1022 on 7-16-2025 confirmed that the kit didn't have the new expiration date of 3 months written on the kit or documented in the laboratory's records. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation, and interview with Technical consultant#1, the laboratory failed to ensure Remel blood sheep agar did not exceed its expiration date with one of one patient cultured as evidenced by: 1.In direct observation of the laboratory on July 22, 2025 at 1015 the following media was expired and used to streak a patient strepococcus throat culture: a. Remel Blood sheep agar expired 7/21 /2025, lot #271260, patient XF51919960 was streaked for culture on the expired blood sheep agar plate. 2.In an interview with technical consultant #1 at 1020 on 7/22/2025, he stated that no, the policy of the lab is not to use expired media. D5473 CONTROL PROCEDURES -- 3 of 4 -- CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on the review of laboratory procedures, lack of stain (QC) records, and an interview with the technical supervisor (TS), the laboratory failed to document QC for each microscopic examination in hematology each day of use, for their intended reactivity for six of twelve months (December 2024 to July 2025). Findings included: 1. Review of laboratory procedures revealed that the following tests were performed with the use of Camco Quik Stain II (Buffered Differential Wright-Giemsa Stain): a. RBC Morphology. b. WBC Differential. 2. A review of stain QC records on July 16, 2025, at 2:30 p.m. revealed that the laboratory had not documented positive and negative intended reactivity for the Wright-Giemsa stain since December 31, 2024. 3. By interview, the TS on July 16, 2025, at 4:00 pm confirmed the above findings. Key: RBC = Red Blood Cell. WBC = White Blood Cell. -- 4 of 4 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and BD Affirm VPIII Microbial Identification Test quality control record review on May 4, 2023 at 12:30 pm, the laboratory failed to include positive control materials at least once each day patient specimens were assayed. Findings included: a. It was the practice of the laboratory to test patient specimens using the BD Affirm VPIII Microbial Identification Test. According to the manufacturer, this test is intended for use in the detection and identification of Candida species, Gardnerella vaginalis, and Trichomonas vaginalis nucleic acid in vaginal fluid specimens from patients with symptoms of vaginitis /vaginosis. b. Laboratory records indicate that each day patient specimens are tested using the BD Affirm VPIII Microbial Identification Test, the laboratory also tests negative and positive control materials using this test system. However, the laboratory uses one positive control material that is known to be positive for Candida species, Gardnerella vaginalis, and Trichomonas vaginalis even though the laboratory reports patient test results for each of these organisms individually. That is, each day patient specimens are tested using the BD Affirm VPIII Microbial Identification Test, the laboratory does not test a positive control control material that includes Candida species only, a positive control material that includes Gardnerella vaginalis only, and a positive control material that includes Trichomonas vaginalis only, even though 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 -- laboratory reports patient test results for each of these organisms individually. c. According to laboratory survey records, the laboratory tests approximately 1,796 patient specimens annually using the BD Affirm VPIII Microbial Identification Test. -- 2 of 2 --

Summary Statement of Deficiencies 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 desk review of CMS proficiency testing records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a proficiency testing program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. Findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two consecutive or two out of three consecutive proficiency testing events in the subspecialty of Routine Chemistry constituting unsuccessful proficiency testing performance. (See D2096) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS proficiency testing records (CMS CASPER Report 0155D and 0153D), it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive proficiency testing events for the analyte, Total Bilirubin, resulting in a "non-initial" unsuccessful performance. Findings included: a. The laboratory failed to maintain successful performance with the proficiency testing program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive proficiency testing events for the analyte, Total Bilirubin, as follows: 2021 2022 2022 Event 2 Event 1 Event 2 Total Bilirubin 60% 40% 60% b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive proficiency testing events resulted in a subsequent unsuccessful performance for the analyte, Total Bilirubin. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that proficiency testing samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that 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 desk review of CMS proficiency testing records, it was determined the laboratory director, moderate complexity testing, failed to ensure that proficiency testing samples were tested as required under subpart H of this part. Findings included: a. For the analyte, Total Bilirubin, the laboratory repeatedly failed to -- 2 of 3 -- achieve satisfactory performance for the same analyte or test in two out of three consecutive proficiency testing events, resulting in unsuccessful proficiency testing performances. (See D2016 and D2096) -- 3 of 3 --

Summary Statement of Deficiencies 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, documentation of freezer temperatures, observation of quality control (QC) material stored in the freezer, and interview with the technical supervisor (TS) #1, the laboratory failed to follow the manufacturer's instructions for storage of control material for 18 of 18 testing days since September 1, 2021 through September 21, 2021. Findings: 1. Review of the manufacturer's instructions for Bio-Rad liquid unassayed Multiqual control showed controls must be stored at minus 20 degrees Celsius (C) to minus 70 degrees C. 2. Review of the laboratory's temperature chart showed a defined acceptable range of minus 15 degrees C to minus 30 degrees C. Review of the temperature chart from September 1-21, 2021 showed 18 of 18 days, the temperature failed to meet the required range. 3. Observation of the laboratory freezer showed three sets of Bio-Rad Multiqual unassayed control level I, II, III currently in use in the laboratory. 4. Interview with the TS#1 on September 21, 2021 at 11:00 AM confirmed the laboratory failed to properly monitor the freezer and store QC materials and supplies per manufacturer's instructions. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of Sysmex XN-L Check hematology controls, review of manufacturer insert, laboratory quality control (QC) procedure, and interview with the technical supervisor (TS) #1, the laboratory failed to use unexpired control. Findings: 1. Observation of the refrigerator located in the laboratory showed one bottle of Sysmex low control (lot #11831401), one bottle of normal control (lot #11831402) and one bottle of high control (lot #11831403) opened on August 16, 2021 and in use for complete blood cell counts. 2. Review of the Sysmex manufacturer insert showed "opened vials and vials which have been sampled by cap piercing will retain stability for 15 days if stored at 2-8 degrees C after being re-capped." 3. Review of the laboratory's quality control procedure stated "Opened-Stored at 2-8 degrees Centigrade. Stable for 15 days." 4. Interview with TS #1 on September 21, 2021 at 12: 00 PM confirmed the laboratory used control material past the expiration date. -- 2 of 2 --