Carol N Abalihi Md Pa

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 28 2022, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: 2016 - 42 C.F.R. 493.803 Condition: Successful participation D6076 - 42 C.F.R. 493.1403 Condition: Laboratory Director, high complexity 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalyst (AAB) proficiency testing (PT) records, the facility failed to achieve 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 -- successful performance in two of two consecutive testing events for Bacteriology in 2022, resulting in unsuccessful performance. Refer to 2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Association of Bioanalyst (AAB) proficiency testing (PT) records from 2022, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of two consecutive testing events for the specialty of Bacteriology. Two out of two overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A review of the CASPER Report 155 listed the following scores for the 2022 Bacteriology PT events 2 and 3: 2022 Bacteriology Event 2: 60% Bacteriology Event 3: 67% 2. A proficiency desk review of AAB proficiency testing records from 2022 confirmed that the laboratory received the following Bacteriology scores for the 2022 PT 2nd and 3rd events: 2022 Bacteriology Event 2: 60% Bacteriology Event 3: 67% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalyst (AAB) proficiency testing (PT) records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for two of two events in Bacteriology in 2022. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalyst (AAB) proficiency testing (PT) records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for Bacteriology for two of two events in 2022. Refer to D2028. -- 2 of 2 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of policies and procedures, quality control records for Thyroid Stimulating Hormone (TSH) patient test records and interview of facility personnel found the laboratory tested ten patient specimens without at least two acceptable quality control results, The findings included: 1. Review of the quality control procedure found on page 6 under the heading Quality Control Procedures: "15. The NHANES guideline declares a system "out of control" if any one of the following events occur for any one of the quality control materials: A. The mean from a single control falls outside the 99% (3SD) confidence limits. B. The means from two controls fall outside the 95% (2SD) confidence limits. C. The daily means of one control from eight successive runs lie either all above +1SD or all below -1SD. 16. PLEASE DO NOT RUN PATIENT SAMPLES UNTIL QC PASSED." 2. Reviw of quality control records found on June 13, 2022 the laboratory failed to obtain acceptable results for BIO RAD Immunoassay levels 2 and 3. a. BIO RAD Immunoassay level 2 - The laboratory obtained a value of 4.3 uIU/ml with an acceptable result 4.39- 5.72 uIU/ml. b. BIO RAD Immunoassay level 3 - The laboratory obtained a value of 27.19 uIU/ml with an acceptable result 28.28-39.65 uIU/ml. 3. Review of patient test records found the laboratory tested the following patient specimens on June 13, 2022 without at least 2 levels of acceptable quality control: Accession 24363 Accession 24746 Accession 32054 Accession 21151 Accession 45518 Accession 26401 Accession 47998 Accession 26371 Accession 23920 Accession 47979 4. Interview of testing personnel conducted August 4, 2022 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 the laboratory did not obtain at least two levels of acceptable quality control before testing patient specimens. -- 2 of 2 --

Summary Statement of Deficiencies D0000 As a result of the CLIA onsite survey conducted April 13th and 14th, 2022, the laboratory is not in compliance with the following Conditions of Participation required for certification in the CLIA program at 42 CFR part 493: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 review of personnel records, the CMS 209 Laboratory Personnel Report form, laboratory policies and procedures, and interview with facility personnel, the laboratory failed to ensure policies and procedures were established to assess competency of two of two testing personnel. Findings included: 1. Review of personnel records and the CMS 209 form revealed the laboratory employed two testing personnel and had not yet assessed competency on either testing persons. 2. During an interview on 4/13/2022 at 10:15 am, Testing Person 1 confirmed the laboratory had not established written policies and procedures for assessing competency. Key: CMS - Center for Medicaid and Medicare Services D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate 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 7 -- overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on surveyor observations, review of policies and procedures, review of quality control records, patient records, verification studies, and interview with facility personnel, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283. Refer to D5449, D5421, and D5783. 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 a review of quality control (QC) instructions for use, instrument data, and confirmed in interview, the laboratory failed to have a policy for the establishment or verification for the mean and ranges of two levels of QC for the Alfa Wasserman chemistry analyzer for 6 months since its installation in November 2021. The findings include: 1. Review of the Alfa Wassermann Chemistry control instructions for use (IFU) and instrument printouts had the following acceptable ranges for each analyte. Refer to D5469. 2. Surveyor queried 4/12/2022 at 15:30 hours, in the conference room, for a policy for the verification and establishment of QC means and ranges for the Alfa Wasserman chemistry analyzer, and none was provided. 3. In an interview on 4/12/2022 at 14:05 hours, in the conference room, testing person 2 confirmed that the laboratory did not have a policy for the establishment or verification of QC means and ranges for the Alfa Wasserman chemistry analyzer. . 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 surveyor observations, review of temperature records, and interview with facility personnel, the laboratory failed to monitor the temperature and humidity in the laboratory for three of three months between January 2022 and March 2022 and failed to ensure frozen reagents and test supplies were stored appropriately for ten of eleven days in April 2022. The findings included: 1. At 15:24 hours on 4/12/2022, the surveyor observed two LabTurbo AIO Covid-19 RNA testing kits stored in the freezer. The temperature requirements were to store at -20C. 2. Based on review of -- 2 of 7 -- the freezer temperature records, the freezer did not achieve -20C in the ten of eleven days reviewed in April 2022. 04/01/2022 -17C 04/02/2022 -18C 04/03/2022 -17C 04 /04/2022 -17C 04/05/2022 -18C 04/06/2022 -19C 04/07/2022 -19C 04/08/2022 -20C 04/09/2022 -19C 04/10/2022 -18C 04/11/2022 -17C 3. In an interview at 15:24 hours on 4/12/2022, Testing Persons 1 and 2 confirmed the freezer had not continuously provided temperatures of -20C. 4. In an interview at 10:15 hours on 4/13/2022 in the laboratory, Testing Persons 1 and 2 confirmed the laboratory had not taken temperature and humidity readings in the main laboratory space. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the manufacturer instructions for verification protocols, the laboratory's verification studies for the hematology analyzer, and interview with facility personnel, the laboratory failed to verify patient normal ranges for one of one hematology analyzer in use since January 2022. The findings included: 1. Based on review of the Sysmex document "Method Verification Protocols", under Section 3, the document stated the following: "It is the customer's responsibility to perform additional studies, following the requirements of their accrediting agency. The following protocols are provided: Reference Range Verification (See Resource Manual). Reference Range Study (for Customer Reference only) Reference ranges describe analyte levels associated with persons who are considered "healthy". Multiple factors can influence a reference range including, population selection (geography and demographics) and specimen collection and handling. Assuming the study that resulted in the current reference range. was performed correctly, that the population has not changed, and the new analyzer is determined to be comparable (correlation), a study to verify the current reference ranges with the new analyzer is appropriate. The outcome of this study either verifies the current reference range or determines whether a new reference range needs to be established. A. Sample Selection 1. Use your current reference ranges for the CBC, differential and reticulocyte parameters, if applicable, and your established criteria for "healthy" individuals to select samples. For example, normal donors may be defined as ones who: a. Have no clinical evidence of a medical disorder known to affect the CBC, differential and reticulocyte counts. b. Have had no recent episode of bleeding or infection. c. Have CBC, differential and reticulocyte counts within the current reference ranges. d. Healthy individuals selected should reflect the laboratory's patient population, including both male and female of an established age range. Separate reference ranges based on age may be necessary for pediatric or geriatric populations. 2. The sample size for this study is dependent upon your laboratory's policy and procedure for new analyzer implementation. Select at least 25 to 50 samples. A larger sampling, however, improves the confidence of the statistics generated from the study. -- 3 of 7 -- 2. Based on review of the analytic records, the accuracy, precision, and reportable range were verified in January 2022. There were not records available for verification of patient normal ranges. 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 quality control records, patient results, and interview, the laboratory failed to run quality control each day of patient testing for 29 of 29 days testing was performed between February 22, 2022 and April 6, 2022 for 142 patient specimens tested on the Quidel Triage MeterPro for TOX Drug screen testing. The findings include: 1. Review of quality control records for the Quidel Triage MeterPro for TOX Drug Screen testing had QC every day of patient testing from January 20th 2022 to February 21st 2022, after which QC was only performed on March 22 and 30th, 2022, and April 8th 2022. 2. Review of patient TOX Drug Screen results for the six weeks since February 21, 2022 had the following 142 patients ran without control procedures being run prior to testing. February 2022: 30 Patients Test Date: Patient ID 2/22/2022: GA092389 2/22/2022: DV058176 2/22/2022: ST012075 2/23/2022: CJ120547 2/23 /2022: CV062288 2/23/2022: HV030446 2/23/2022: MM072753 2/23/2022: RC122688 2/23/2022: CJ122003 2/23/2022: CM112883 2/23/2022: SM091062 2/23 /2022: SX070901 2/24/2022: DR4442 2/24/2022: BE062384 2/24/2022: GO021154 2 /24/2022: KM022555 2/24/2022: KD101957 2/24/2022: MM81861 2/24/2022: VS052296 2/24/2022: OD070260 2/24/2022: PC122462 2/25/2022: RA011402 2/25 /2022: RD4549 2/25/2022: MC080156 2/25/2022: AC092230 2/25/2022: OT020147 2 /28/2022: AM050754 2/28/2022: GJ080942 2/28/2022: LM121165 2/28/2022: PT100446 March 2022: 98 Patients Test Date: Patient ID 3/1/2022: AP71357 3/1 /2022: HC120872 3/1/2022: OM070148 3/1/2022: MM092455 3/1/2022: CT092548 3 /2/2022: MC011059 3/2/2022: ML05061974 3/2/2022: RM071547 3/2/2022: CI110752 3/2/2022: GK071702 3/3/2022: YD092391 3/3/2022: CD051357 3/3/2022: CC120954 3/3/2022: GM12145 3/3/2022: CD110554 3/4/2022: CG07091963 3/4 /2022: EC112347 3/4/2022: GL31659 3/4/2022: DR102444 3/4/2022: HJ082552 3/4 /2022: DA060301 3/7/2022: ED010314 3/7/2022: PT021647 3/7/2022: SD013152 3/7 /2022: ES6864 3/7/2022: GP51661 3/8/2022: SJ081004 3/8/2022: RD082854 3/8 /2022: PB082064 3/8/2022: MS060177 3/9/2022: MS32597 3/9/2022: MR-090363 3/9 /2022: AL-052878 3/9/2022: ML013048 3/9/2022: LJ-21557 3/9/2022: DV-020654 3 /9/2022: KP031554 3/10/2022: CV062474 3/10/2022: MO032057 3/10/2022: SD123046 3/10/2022: LL092395 3/10/2022: MR082063 3/11/2022: PG031857 3/11 /2022: CR102284 3/11/2022: FR110486 3/11/2022: CM021141 3/11/2022: LJ102989 3/11/2022: GV101049 3/11/2022: LM121165 3/14/2022: GI112678 3/14/2022: CJ112969 3/14/2022: RD101288 3/14/2022: VA112263 3/14/2022: RO052681 3/15 /2022: MR042572 3/15/2022: SC022057 3/15/2022: AP052570 3/15/2022: AKC072465 3/16/2022: LI071602 3/16/2022: MC020262 3/16/2022: VI110752 3/16 /2022: LVJ010949 3/16/2022: SP062251 3/16/2022: SN120749 3/16/2022: OSG032465 3/17/2022: GA030707 3/17/2022: BA082434 3/17/2022: PHM070461 3 /17/2022: TT100192 3/17/2022: ST72154 3/17/2022: CB090173 3/20/2022: -- 4 of 7 -- CCE060352 3/20/2022: RS011470 3/20/2022: DK090600 3/20/2022: CC010249 3/21 /2022: ST012075 3/21/2022: CV092249 3/21/2022: ST033041 3/23/2022: SM091062 3/23/2022: GE072363 3/24/2022: TJ102154 3/24/2022: GG-101751 3/24/2022: RE120957 3/24/2022: VC-062288 3/24/2022: GS091145 3/24/2022: KM032555 3/24 /2022: JA-122773 3/24/2022: LM021384 3/24/2022: CJ-091956 3/24/2022: GM- 012145 3/24/2022: AM071547 3/25/2022: VS052296 3/25/2022: AP071357 3/28 /2022: LA-041977 3/28/2022: RG022555 3/28/2022: CA030450 3/29/2022: PH062751 3/29/2022: GA-042577 April 1-6th 2022: 14 Patients Test Date: Patient ID 4/1/2022 : HMN052691 4/1/2022: BJ-101779 4/1/2022: CV092249 4/4/2022: CD110554 4/4/2022: RE012455 4/4/2022: BL-101646 4/4/2022: GR071592 4/5 /2022: GJ-103006 4/5/2022: OT-020147 4/5/2022: CC-120954 4/5/2022: CD-051357 4/6/2022: LJ100482 4/6/2022: GK071702 4/6/2022: DV020654 3. In an interview on 4/12/2022 at 09:25 hours, in the conference room, testing person 2 confirmed that QC was not performed every day of patient testing past February 21, 2022 for TOX Drug Screen testing. . 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 a review of quality control (QC) instructions for use, instrument data, and confirmed in interview, the laboratory failed to verify the means and ranges for two levels of QC for the Alfa Wasserman chemistry analyzer for 6 months since its installation on November 2021. 1. Review of the Alfa Wassermann Chemistry control instructions for use (IFU) and instrument printouts had the following acceptable ranges for each analyte: Level 1 Chemistry Control Lot 1501UNCM, Expiration 11/28 /2024 Analyte: IFU Range - Instrument Range PHOS:2.8 - 3.8 2.9 - 3.7 MG: 2.0 - 2.8 2.2 - 2.8 NA: 123.9 - 151.5 128.5 - 146.9 K: 3.55 - 4.55 3.72 - 4.38 CL: 96.1 - 117.5 99.7 - 113.9 CA: 8.6 - 10.6 9.0 - 10.2 AST: 39 - 59 42 - 56 ALP: 53 - 79 54 - 75 GLU: 88 - 108 86 - 98 TBILI:1.2 - 2.0 1.3 - 1.9 TP: 4.1 - 4.9 4.2 - 4.8 ALB: 2.5 - 3.3 2.6 - 3.2 CREAT:1.48 - 2.08 1.58 - 1.98 UA: 4.3 - 6.1 4.4 - 5.6 CHOL: 101 - 123 102 - 116 TRIG: 81 - 111 84 - 104 HDL: 35 - 47 34 - 42 ALT: 43 - 64 46 - 60 CO2: 11.9 - 17.9 11.7 -15.5 Level 2 Chemistry Control Lot 1166 UECM, Expiration 11/28/2024 Analyte : IFU Acceptable Range - Instrument Acceptable Range PHOS: 6.0 - 8.2 6.3 - 7.9 MG: 4.1 - 5.5 4.4 - 5.4 NA: 110.5 - 135.1 114.6 - 131.0 K: 7.23 - 8.23 7.40 - 8.06 CL: 72.6 - 88.8 75.3 - 86.1 CA: 10.9 - 13.3 11.3 - 12.9 AST: 171 - 257 185 - 243 ALP: 320 - 480 347 -453 GLU: 279 - 341 270 -308 TBILI: 4.3 - 6.4 4.6 - 6.0 TP: 6.9 - 8.5 7.2 - 8.2 ALB: 3.9 - 5.3 4.1 - 5.1 CREAT: 6.33 - 8.57 6.71 - 8.19 UA: 7.9 - 11.1 8.3 -10.5 CHOL: 177 - 217 177 - 203 TRIG: 154 - 212 159 - 197 HDL: 62 - 82 63 - -- 5 of 7 -- 77 ALT: 111 - 167 121 - 157 CO2: 24.4 - 36.6 23.8 - 31.8 2. Surveyor queried 4/12 /2022 at 15:30 hours, in the conference room, for a policy for the verification of QC means and ranges for the Alfa Wasserman chemistry analyzer, and none was provided. Testing person (TP) 2 stated they occasionally adjust the means and acceptable range from the QC datasheets. 3. In an interview on 4/12/2022 at 14:05 hours, in the conference room, testing person 2 confirmed that the laboratory did not verification of QC means and ranges for the Alfa Wasserman chemistry analyzer. . D5783