Parmer Medical Center

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on October 3, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6076 - 42 C.F.R 493.1441 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 Proficiency Institute (API) Proficiency testing (PT) records, the laboratory failed to achieve successful 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 -- performance in two of three consecutive testing events in 2024 and 2025, resulting in unsuccessful performance. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory 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 Proficiency Institute (API) Proficiency testing (PT) testing records for 2024 and 2025, the laboratory failed to achieve an overall testing event score of satisfactory performance (100%) for two of three consecutive testing events for immunohematology compatibility testing. Two out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. The findings included: 1. A review of the CASPER Report 155 listed the following scores for the PT Program Immunohematology Compatibility testing: Event, Analyte/Test: Score 2025 Event 2, Compatibility Testing: 80% 2024 Event 3, Compatibility Testing: 80% 2. A desk review of API proficiency testing records for 2024 and 2025 confirmed that the laboratory received an immunohematology compatibility testing score of 80% for 2025 event 2, and 80% for 2024 event 3. 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 Proficiency Institute (API) Proficiency testing (PT) testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program in immunohematology, compatibility testing for two of three events reviewed in 2024 and 2025. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) 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 Proficiency Institute (API) Proficiency testing (PT) proficiency testing records, the laboratory director -- 2 of 3 -- failed to ensure successful participation in a HHS approved proficiency testing program for immunohematology compatibility testing for two of three reviewed in 2024 and 2025. Refer to D2181. -- 3 of 3 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 upon review of policies and procedures and interview of the general supervisor, 25 of 26 procedures found in the procedure manual had not been approved by the current laboratory director. The findings included: 1. Review of the procedure manual found 25 of 26 procedures included were approved by the previous laboratory director. 2. During interview of the general supervisor conducted March 5, 2025 at 12: 05 PM, she confirmed that policies and procedures had not yet been approved by the current laboratory director hired January 1, 2025. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: 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 -- Based upon review of policies and procedures, manufacturer's instructions, quality control records and interview of facility personnel found the laboratory failed to ensure that quality control materials were tested with each now lot of Profile- V MEDTOX Drugs of Abuse Test cards before testing 3 of 14 patient specimens tested in July 2024. The findings included: 1. Review of the laboratory's own written procedure (approved December 30, 2015) found on page 3, under the heading Quality Control: "External controls are to be performed as follows: To practice the test with a know control. When a new lot of devices is opened. Once a week. If the operator suspects that the reader is not working properly. If the operator has a repeated unexpected result. If the operator suspects that the test devices have been stored improperly." 2. Review of the Profile- V MEDTOX Drugs of Abuse Test cards instructions found on page 4 under the heading Quality Control: " "External controls are to be performed as follows: To practice the test with a know control. When a new lot of devices is opened. Once a week. If the operator suspects that the reader is not working properly. If the operator has a repeated unexpected result. If the operator suspects that the test devices have been stored improperly." 3. Review of quality control records for July 2024 found the laboratory performed weekly quality control testing using 2 lots of Med Tox Drugs of Abuse Cards as follows: 07/03/2024 - lot TM038A26 07/10/2024 - lot TM038A26 07/13/2024 - lot TM048B26 07/17/2024 - lot TM038A26 07/24/2024 - lot TM048B26 4. Review of patient test records found 3 of 14 patients tested in July 2024 were tested using Drugs of abuse cards lot TM048B26 with no documentation of external quality control materials tested between 07/13/2024 and 07/24/2024. Patient 10052895 tested 07/19/2024 Patient 10052898 tested 07/20/2024 Patient 10052913 tested 07/21/2024 4. During interview of the General Supervisor conducted March 6, 2025 at 10:25 AM she confirmed there was no documentation of external quality control materials for lot TM048B26 tested between 07/13/2024 and 07/24/2024. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 upon review of manufacturer's instructions for use, Immunohematology quality control records, patient test records and interview of facility personnel, the laboratory failed to ensure expired reagents were not used in testing 4 patients on 4 of 61 days in October and November of 2022. The findings included: 1. Review of the Ortho Reagent Red Blood Cells instructions for use found: a. 0.8% Affirmagen Reagent Red Blood Cells - under the heading Reagents: "Do not use beyond expiration date". b. 0.8% Selectogen Reagent Red Blood Cells - under the heading Reagents: "Do not use beyond expiration date". Review of the Micro Typing Systems (MTS) Anti- IgG Card instructions for use found on page 2 under the heading Precautions - " Do not use beyond expiration date." 2. Review of the Immunohematology quality control records and patient test records for October and November 2022 found the laboratory used expired Ortho reagents and MTS IgG cards to test patient specimens as follows: a. Patient 10036320 was tested October 19, 2022 using the expired Ortho 0.8% Affirmagen Reagent Red Blood Cells lot 8A485 (Expiration October 18, 2022). b. Patient 202922 was tested October 7, 2022 using the expired Ortho 0.8% Selectogen Reagent Red Blood Cells lot V5460 (Expiration October 4, 2022). c. Patient 10036320 was tested October 19, 2022 using the the expired Ortho 0.8% Selectogen Reagent Red Blood Cells lot V5460 (Expiration October 4, 2022), and the expired Ortho 0.8% Affirmagen Reagent Red Blood Cells lot 8A485 (Expiration October 18, 2022). d. Patient 10036570 was tested November 19, 2022 using the expired Micro Typing Systems (MTS) Anti- IgG Card lot 011322001-12 (expiration November 15, 2022). 3. During interview of the general supervisor listed on the CMS report 209 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 Personnel Report conducted January 19, 2023 at11:09 AM she confirmed that the laboratory used expired reagents and supplies to test patient specimens for blood typing and antibody detection. 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: Based upon review of policies and procedures, quality control records, patient test records and interview of facility personnel, the laboratory failed to test at least two levels of Hematology quality control material prior to testing patient specimens on two of thirty one days in October 2022. The findings included: 1. Review of the laboratory's own written quality control policy titled Quality Control Schedule found on page one: " Hematology - Three levels of control material (low, normal & high) are run every 24 hours. However, it is not required if there are no patients to run; for example: nights and weekends. Two of the three controls must be within performance range in order for patient results to be reported." 2. Review of Hematology quality control records for October 2022 found the laboratory failed to test quality control materials on October 12, October 15 and October 27 as written in their own policy. 3. Review of patient test records found the laboratory tested six patients on dates when quality control testing was not performed as follows: a. October 12, 2022 - patient 10036153 b. October 27, 2022 _ patients 10036352, 10036498, 10036503, 10036505, patient 10036506 4. During interview of the general supervisor listed on the CMS Report 209 conducted January 19.2023 at 12: 18 PM she confirmed patient specimens were tested without testing at least two levels of quality control material on the two dates in October 2022. -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)