Silsbee Family Medicine, Pa

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). This CONDITION is not met as evidenced by: Based on surveyor observation, review of laboratory policy, and confirmed in interview, the laboratory facility administration failed to ensure safety precautions were followed to ensure the safety of personnel as observed on September 17, 2025, at 13:40 hours. Refer to D3011. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation on September 17, 2025 at 13:40, review of laboratory policy, and confirmed in interview, the laboratory failed to ensure safety precautions were followed to ensure facility personnel did not store food or drinks in a biohazard indicated area. The findings included: 1. During an unannounced revisit conducted on September 17, 2025, the surveyor opened the laboratory refrigerator, located within in the laboratory with two large biohazard stickers and a handwritten note attached to the front that stated "No Food or Drink", to check for supplies, and observed 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 3 -- following: In the door of the refrigerator, located between proficiency testing samples from American Proficiency Institute (API) and a biohazard bag holding additional API specimens, included the following food items: Two Atkins Milk Chocolate Delight Protein Shakes One Can of Dr. Pepper Diet One open jar of Vlasic pickles In the body of the refrigerator, located in the vicinity and against, proficiency testing samples, and patient samples (including fecal occult cards, strep screens, and urine drug screens) included the following food items: Two to-go containers with food in them. Two Lunchables Two yogurt cups A cardboard 12 pack of Dr. Pepper Diet, open with cans missing. In an interview on 9/17/2025 at 13:40, in the laboratory, testing personnel (TP) 1 acknowledged the food in the specimen and reagent refrigerator. 2. Review of the laboratory policy titled "Universal Precautions for Infectious Blood & Body Fluid", section "Procedure" included the following instructions: "9. Due to the biohazardous conditions within the laboratory, the following should be considered: a. No food or drink will be allowed anywhere in the biohazard area." 3. In an interview on 9/17/2025 at 1530 hours, in the office, the practice manager confirmed food and drink were not supposed to be in the laboratory biohazard refrigerator. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on an unannounced survey performed on 9/17/2025 to assess compliance with deficiencies cited on 7/1/2025, surveyor observations, manufacturer's instructions, quality control (QC) results, patient reports, and interviews, the laboratory failed to meet the analytic requirements, specified in 493.1230 through 493.1256, 493.1267, and 493.1281 through 493.1299, for chemistry testing performed on the Clinitek 100 Urine Chemistry Analyzer, for patient testing from July 2025 through September 17, 2025. The findings included: 1. Based on surveyor observation, manufacturer's instructions for use (IFU), review of laboratory quality control records, patient test worksheets, and confirmed in interview, the laboratory failed to remove expired controls from use for 63 days past expiration when testing patient specimens. Refer to D5417. 2. Based on review of laboratory QC records, laboratory patient testing, and interview, the failed to have a mechanism in place to detect immediate errors for QC on the Clinitek 100 urine chemistry analyzer from July through September 17, 2025. Refer to D5441. 3. Based on review of laboratory policy, laboratory QC documentation, patient testing, and confirmed in interview, the failed to ensure the documentation of two levels of quality control each day of patient testing for the Siemens Multisix 10G Urine Dipstick, performed on the moderate complexity Clinitek 100 Urine Chemistry Analyzer for six of six patients. Refer to D5447. 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 -- 2 of 3 -- 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: Based on surveyor observation, review of laboratory policy, laboratory demonstration, and confirmed in interview, the laboratory did not have a mechanism in place to detect immediate errors for the KOVA-Trol urine QC performed on the Clinitek 100 urine chemistry analyzer for QC performed from July 2025 to September 17, 2025. The findings included: 1. During an unannounced revisit on 9/17/2025, the surveyor noted reconstituted KOVA-Trol with a prep date of 7/7/2025 and expiration of 7/14 /2025. Surveyor asked if any additional KOVA-Trol was available for daily QC testing. Testing personnel (TP)1 confirmed the laboratory had lypholized reagent bottles available for reconstitution and use. Surveyor requested the controls be reconstituted according to the manufacturer's instructions in order to demonstrate the performance of quality control. 2. Review of the laboratory document titled "Control Log - Urine Dipstick & Microalbumin Urinalysis Test" included a space for the expected values of the following normal and abnormal quality control results: Glucose, bilirubin, ketones, specific gravity, blood, pH, protein, urobilirubin, nitrate, leukocyte esterase, microalbumin. 3. In a demonstration on 9/17/2025 at 15:00 TP1 performed normal and abnormal quality control for the following tests on the Clinitek 100 urine analyzer: Siemens Multistix 10G Urine Dipstick: for the testing of urine Glucose, Bilirubin, Ketones, Specific Gravity, pH, protein, urobilinogen, nitrate, blood, leukocytes. Microalbumin 2 Reagent Strips: for the testing of urine microalbumin and urine creatinine Surveyor asked for the QC acceptability to ensure the QC was within expected range and none could be provided. 4. Review of laboratory QC documentation for July, August, through September 16, 2025, did not include the expected acceptability for the KOVA-Trol normal and abnormal controls for the following lots: Normal Control Lot K306732 Abnormal Control Lot K306750 5. Review of patient testing in July, August, and through September 16 included 307 patients (see patient crosswalk for complete list) to include the following sampling of 10: Date of test: Patient ID, Test Performed 07/02/2025: Patient K, Urinalysis, urine albumin, urine microalbumin 07/08/2025: Patient 1I, Urinalysis, urine albumin, urine microalbumin 07/14/2025: Patient 3K, Urinalysis, urine albumin, urine microalbumin 07/24/2025: Patient 6K, Urinalysis 08/14/2025: Patient 7W, Urinalysis, urine albumin, urine microalbumin 08/18/2025: Patient 8D, Urinalysis 08/26/2025: Patient 8Q, Urinalysis, urine albumin, urine microalbumin 08/28/2025: Patient 9R, Urinalysis, urine albumin, urine microalbumin 09/04/2025: Patient 10X, Urinalysis, urine albumin, urine microalbumin 09/05/2025: Patient 10Y, Urinalysis 6. In an interview on 9/17/2025 at 15:20, in the laboratory, TP1 confirmed the laboratory did not have QC acceptability for the KOVA-Trol abnormal and normal QC available for the evaluation of daily QC and to detect immediate errors in the test system. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey on July 1, 2025. The following conditions were not met: D2000 - 42 C.F.R. 493.801 Condition: Enrollment and testing of [proficiency testing] samples; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: I. Based upon review of the CMS 116 application, proficiency testing records and interview of facility personnel, the laboratory failed to enroll in a proficiency testing program for Urinalysis in 2025. The findings included: 1. Review of the CMS 116 application found the laboratory reported an estimated annual volume of 476 urinalysis tests. 2. Review of the American Proficiency Testing (API) proficiency testing records offered for 2023, 2024 and 2025 found no Urinalysis proficiency testing records for 2025. 3. During interview of the office manager conducted July 1, 2025 at 10:52 AM, she confirmed that she had not enrolled in a proficiency testing program for Urinalysis in 2025. 45469 II. Based on review of the laboratory testing menu, laboratory proficiency testing records, and confirmed in interview, the laboratory failed to ensure enrollment for urine creatinine testing on the moderate Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- complexity Clinitek 100 Urine Chemistry Analyzer, for records reviewed in 2023, 2024, and January through July 2025. The findings included: 1. Review of the laboratory provided test menu included the following moderate complexity general chemistry performed on the Clinitek 100 Urine Chemistry Analyzer: Urine Creatinine 2. Review of laboratory proficiency testing for 2023, 2024, and January through June 2025 did not include proficiency testing for urine creatinine. Surveyor asked for documentation that proficiency testing was performed, and none was provided. 3. In an interview on 7/1/2025 at 10:53 hours, in the break room, the laboratory manager confirmed the laboratory was not enrolled in proficiency testing for urine creatinine in 2023, 2024 and from January through June 2025. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory testing menu, laboratory proficiency testing records, and confirmed in interview, the laboratory failed the twice annual accuracy for urine microalbumin testing on the moderate complexity Clinitek 100 Urine Chemistry Analyzer, for records reviewed in 2023 and 2024. The findings included: 1. Review of the laboratory provided test menu included the following moderate complexity general chemistry: Urine Microalbumin 2. Review of laboratory proficiency testing for 2023 and 2024 did not include proficiency testing for urine microalbumin. Surveyor asked for documentation of a twice annual accuracy assessment, and none was provided. 3. In an interview on 7/1/2025 at 10:53 hours, in the break room, the laboratory manager confirmed a twice annual accuracy assessment had not been performed for urine microalbumin in 2023 and 2024. 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 upon observations, review of policies and procedures, manufacturers instructions, quality control logs and interview of facility personnel, the laboratory used expired KOVA-Trol Urinalysis quality control materials levels I and III for 86 days past expiration when testing patient specimens. The findings included: 1. Observations made during the inspection found the laboratory was currently using the KOVA-Trol urinalysis controls level I (lot K306732 labeled as opened on 02/25/2025, with an expiration date of 03/25/2025) and III (lot K306750 labeled as opened on 02 /25/2025 with an expiration date of 03/2025). 2. Review of the laboratory's own written policy titled Urinalysis Routine found on page 2 under the heading CONTROLS: "KOVA-Trol III (Normal) Reconstitution: Add 60 or 15 ml of distilled water to the vial of control. Allow to sit at room temperature for 30 minutes. Swirl and invert to mix. The control is ready to use. Refrigerate after using control. Control is found to be stable for five days when kept at 2-8 C. KOVA-Trol I (Abormal) -- 2 of 6 -- Reconstitution: Add 60 or 15 ml of distilled water to the vial of control. Allow to sit at room temperature for 30 minutes. Swirl and invert to mix. The control is ready to use. Refrigerate after using control. Control is found to be stable for five days when kept at 2-8 C." 3. Review of the manufacturer's instructions for use found under the heading Stability and Storage: "The lypholyzed KOVA-Trol product is stable until the expiration date stated on the label when stored between 2 - 8C. Following reconstitution, keep the liquid KOVA-Trol stoppered and refrigerated. When KOVA- Trol is properly reconstituted and stored at 2- 8C, the constituents are stable from the date of reconstitution for a maximum of seven (7) days." 4. Review of quality control logs found the laboratory used expired control materials for 86 days after expiration of the control material reconstituted on February 25, 2025. 5. During interview of testing person one on the CMS Report 209 conducted July 1, 2025 at 12:11 PM, she confirmed that she was currently using the reconstituted controls to ensure the accuracy of urinalysis results each day of patient testing, recording the results on the urinalysis control log. She went on to say she reconstitutes new controls once every 30 days and stores them in the refrigerator for daily use. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on review of laboratory test list, laboratory policy, laboratory quality control documents, patient reports, and confirmed in interview, the laboratory failed to document two levels of quality control, each day of patient testing, for urine microalbumin and creatinine testing performed on the Clinitek 100 Urine Chemistry Analyzer for nine of nine patients tested for records reviewed from April 2025 through June 2025. The findings included: 1. Review of the laboratory test list included urine microalbumin and urine creatinine, using the Clinitek Microalbumin2 /Creatinine strips, performed on the Clinitek 100 Urine Chemistry Analyzer. 2. Review of the laboratory policy titled "Quality Control Procedures" included the following instructions: "5. Two levels (usually one Normal and one Abnormal) controls are required for each test/instrument at the beginning of each day (or time performed if not performed daily) ..." 3. Review of the laboratory urinalysis control log sheet did not include a spot for the documentation of acceptable urine creatinine testing results. Under the column labeled MALB (microalbumin) no quantitative number was recorded, only a 'check' mark. Surveyor asked if the Clinitek 100 provided quantitative results for the urine microalbumin and urine creatinine testing and for the QC documentation. Testing personnel (TP) 1 stated the results were quantitative, but the laboratory did not record them. 4. Review of patient worksheets from April 2025 to June 16, 2025, included the following nine patients (refer to patient crosswalk for identifiers) with urine microalbumin and urine creatinine testing performed on days where quality control was not documented. Date Of Testing Patient ID 04/02/2025 Patient B 05/06/2025 Patient D 05/07/2025 Patient E 05/12 /2025 Patient F 05/13/2025 Patient G 05/15/2025 Patient H 06/04/2025 Patient I 06/12 /2025 Patient J 06/16/2025 Patient K 5. In an interview on 7/1/2025 at 11:35 hours, in the laboratory, TP 1 confirmed urine microalbumin and urine creatinine had not been documented for the above days before patient testing occurred. D5807 TEST REPORT -- 3 of 6 -- CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of laboratory testing, laboratory policy, patient test results, and confirmed in interview, the laboratory failed to ensure pertinent reference intervals were included on the patient final report for two of two tests being performed on moderate complexity Clinitek 100 Urine Chemistry Analyzer, for 14 of 14 patients reviewed. The findings included: 1. Review of the laboratory provided test list included urine testing on the Clinitek 100 urine analyzer for the following: Siemens Multistix 10G Urine Dipstick: for the testing of urine Glucose, Bilirubin, Ketones, Specific Gravity, pH, protein, urobilinogen, nitrate, blood, leukocytes. Microalbumin 2 Reagent Strips: for the testing of urine microalbumin and urine creatinine 2. Review of the laboratory policy titled "Normal Reference Ranges, Laboratory Test Results" included the following normal reference ranges established for patient testing: "Urinalysis: Parameter Normal Color Straw to yellow Appearance Clear to slightly hazy Leukocytes Negative Nitrite Negative Urobilinogen Negative Protein Negative pH 4.6 - 8.0 Blood Negative Sp. Gravity 1.003 - 1.030 Ketone Negative Bilirubin Negative Glucose Negative" Surveyor asked for the reference range for the Urine Microalbumin and Urine Creatinine tests, and none could be provided. 3. Review of the following 14 patient final test reports (refer to patient crosswalk for identifiers) did not include normal patient reference ranges: Date Of Testing, Patient ID: Test 12/03 /2024, Patient A: Urinalysis 04/02/2025, Patient B: Urinalysis, urine microalbumin, urine creatinine 04/09/2025, Patient C: Urinalysis 05/06/2025, Patient D: Urinalysis, urine microalbumin, urine creatinine 05/07/2025, Patient E: Urinalysis, urine microalbumin, urine creatinine 05/12/2025, Patient F: Urinalysis, urine microalbumin, urine creatinine 05/13/2025, Patient G: Urinalysis, urine microalbumin, urine creatinine 05/15/2025, Patient H: Urinalysis, urine microalbumin, urine creatinine 06 /04/2025, Patient I: Urinalysis, urine microalbumin, urine creatinine 06/12/2025, Patient J: Urinalysis, urine microalbumin, urine creatinine 06/16/2025, Patient K: Urinalysis, urine microalbumin, urine creatinine 06/30/2025, Patient L: Urinalysis 07 /01/2025, Patient M: Urinalysis 07/01/2025, Patient N: Urinalysis 4. In an interview on 7/1/2025 at 11:11 hours, in the laboratory, testing personnel (TP) 1 confirmed normal patient ranges for urinalysis, urine microalbumin, and urine creatinine, were not available on the patient final reports. 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 review of direct observation, laboratory policy, laboratory proficiency testing, laboratory quality control, and laboratory quality assurance documents, the laboratory director failed to ensure testing personnel followed the procedure for use of the KOVA-Trol urinalysis quality controls in 2023, 2024 and 2025 (See D 6014), the -- 4 of 6 -- laboratory director failed to ensure the laboratory was enrolled in a proficiency testing program for non-waived urinalysis testing in 2025 (See D 6015), the laboratory director failed to ensure the QC and QA programs intended to identified failures as they occurred for records reviewed from 2023 through June 2025 (see D6020). D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: The laboratory director failed to ensure testing personnel followed the procedure for use of the KOVA-Trol urinalysis quality controls in 2023, 2024 and 2025. (See D 5417) D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: The laboratory director failed to ensure the laboratory was enrolled in a proficiency testing program for non-waived urinalysis testing in 2025. (See D2000 I and II) D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of laboratory quality assessment policy, laboratory patient results, laboratory quality control records, laboratory proficiency testing, and confirmed in interview, the laboratory director failed to ensure the QC and QA programs intended for the monthly review of laboratory compliance, identified failures as they occurred for records reviewed from 2023 through June 2025. The findings included: 1. Review of the laboratory policy titled "Quality Assurance Program Guildlines" included the following areas of review: "Analytical Guidelines" Annual Review Goal: 90% compliance 1) Test Requisition/Report a) Does the test requisition/report contain the following: ... Reference range? ... 2) Quality control Monthly Monitoring Goal: 100% compliance a) Are at least two levels of control run each day of testing for every test? ... g) Are two levels of quality control within acceptable ranges prior to testing and reporting patient values? 3) Proficiency Testing Three Cycle Per Year, Goal: 100% Compliance, Goal 80% of sample results a) is the lab enrolled in an approved proficiency testing program for each specialty and subspecialty for which it seeks certification? ..." 2. Based review of laboratory patient results the laboratory failed to ensure pertinent reference intervals were included on the patient final report for two of -- 5 of 6 -- two tests being performed on moderate complexity Clinitek 100 Urine Chemistry Analyzer, for 14 of 14 patients reviewed. Refer to D5807. 3. Based on review of the laboratory quality control documents the laboratory failed to document two levels of quality control, each day of patient testing, for urine microalbumin and creatinine testing performed on the Clinitek 100 Urine Chemistry Analyzer for nine of nine patients tested for records reviewed from April 2025 through June 2025. D5447. 4. Based on review of the laboratory proficiency testing records the laboratory failed to ensure enrollment for urine creatinine testing on the moderate complexity Clinitek 100 Urine Chemistry Analyzer, for records reviewed in 2023, 2024, and January through July 2025. (D2000 II) 5. In an interview on 7/1/2025 at 12:30 hours, in the break room, the office manager confirmed the quality assurance program and checklists had not been successful in identifying the above failures as they occurred. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) (b) Each individual performing moderate complexity testing must-- (b)(1) Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results; This STANDARD is not met as evidenced by: Based upon observations, review of policies and procedures, manufacturers instructions and interview of facility personnel, testing personnel failed to follow the laboratory's own written policy for the use of urinalysis controls beyond the reconstituted expiration date. (See D5417) -- 6 of 6 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, laboratory policy, and confirmed in interview, the laboratory failed to test PT samples the same number of times that it routinely tests patient samples for infectious mononucleosis for one of two Immunology/Immunohematology PT events reviewed in 2022. The findings include: 1. Review of the 2022 Immunology/Immunohematology proficiency testing records for events one had a sticky note attached to the result page with the following information: Mono - 3/29/22 1 + 1 + 2 - 2 - 3 + 3 + 4 - 4 - 5 - 5 - 2. Review of the laboratory policy titled "proficiency testing program" Section "Procedure" had the following statement: "No special (multiple) analysis should be performed on the survey material." Surveyor queried testing person (TP) 1 if repeat testing, as indicated by the sticky note, was how routine patients were tested. TP 1 indicated that the laboratory did not repeat mono testing on patients. 3. In an interview on 1/19/2023 at 11:15 hours, in the laboratory, TP 1 confirmed that the laboratory had not tested PT samples in the same manner as it tested patients. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of laboratory policy, review of proficiency testing (PT) records, and confirmed in interview, the laboratory failed to follow its own policy for the documentation of review of results for PT evaluation reports for two of four PT performance reviews reviewed in 2022. The findings include: 1. Review of the laboratory policy "Assignment of Responsibility of Laboratory Duties" had the following statement: "Laboratory Director must review, sign, and date all proficiency test results." 2. Review of PT "Performance Review and

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