Sun Wellness Llc

Summary Statement of 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: A) Based on surveyor review of the Procedure Manual (PM), and interview with the Laboratory Director (LD), the laboratory failed to follow all procedures written for "Procedure Manual Review" from 2/19/19 to the date of the survey. The findings include: 1. The procedure "Procedure Manual Review" stated "Annually, the Lab Director will review all policies and procedures and ensure that all lab staff has reviewed all policies and procedures. These reviews will be documented by signature and date on an attestation page at the front of the Procedure Manual." 2. There was no documented evidence the above mentioned procedure was performed. 3. The LD confirmed on 6/29/23 at 11:00 am that the PM was not followed. B) Based on surveyor review of the Procedure Manual (PM), and interview with the Laboratory Director (LD), the procedures in the PM did not reflect the current instrumentation in use. The findings include: 1. The laboratory is currently using the Tosoh AIA 900 but all procedures in the PM were specified for the Tosoh AIA 600 II. 2. The LD The LD confirmed on 6/29/23 at 11:00 am that the PM does not reflect the current instrumentation in use. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Laboratory Director (LD), the laboratory failed to record discontinuance dates for procedures not performed in the laboratory on the date of survey. The finding includes: 1. There were no discontinuance dates for the Vitamin B12 and Folate procedures in the PM. 2. There were no discontinuance dates for procedures for the Tosoh AIA 600 II analyzer in the PM. 3. The LD confirmed on 6/29/23 at 11:30am the laboratory failed to record discontinuance dates on the above mentioned procedures in the PM. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 surveyor observation of the quality controls (QC) in use, review of the Manufacturers Package Insert (MPI) and interview with the Laboratory Director (LD), the laboratory failed to follow the QC MPI at the time of the survey. The finding includes: 1. Controls in use did not have an open or expiration date documented as per the MPI. QC in use were Biorad Lyphocheck Specialty Immunoassay lot numbers 88733 and 88731 and Biorad Liquichek lot numbers 85331 and 85333. 2. The LD confirmed on 10/14/21 at 11:30 am the laboratory failed to follow the MPI for the above mentioned QC in use. Note: This is a repeat citation. It was previously cited on 8/9/18 and 10/14/21.

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Director (LD) the laboratory failed to review and evaluate results when they received an unacceptable score in FreeTriiodothyronine (T3) performed with the American Proficiency Institute (API) for the 2021 Chemistry Core Third Event. The findings include: 1. The laboratory received an 50% Grade for Free T3. 2. There was no documented evidence that the laboratory investigated the failure. 3. The LD confirmed on 10/14/21 at 10:30 am that the laboratory did not review and document an evaluation of unacceptable PT results. D5407 PROCEDURE MANUAL CFR(s): 493.1251(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 on surveyor review of the Procedure Manual (PM) and interview with the Laboratory Director (LD) , the laboratory failed to have an approved, signed and dated PM by the LD from January 2020 to the date of the survey. The LD confirmed on 10/14/21 at 12:30 pm a PM signed by the LD was not available. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) 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 -- 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 surveyor observation of the controls in use, review of the Manufacturers Package Insert (MPI) and interview with the Laboratory Director (LD), the laboratory failed to follow MPI for controls at the time of the survey. The finding includes: 1. Controls in use did not have an open or expiration date documented as per MPI. Controls in use were Biorad Lyphocheck Specialty Immunoassay lot numbers 25301 and 25303. (expiration date 1/31/2023) 2. The LD confirmed on 10/14/21 at 11:30 am that MPI was not followed. Note: This is a repeat citation. It was previously cited on 8 /9/18.

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to review and evaluate Chemistry PT results obtained from the American Proficiency Institute (API) performed in the calendar years 2017 and 2018. The finding includes: 1. There was no review or evaluation documented for Chemistry Core events 1 and 3-2017 and 2-2018. 2. There was no review or evaluation documented for Chemistry Miscellaneous events 1-2017 and 1-2018. 3. The LD confirmed on 8/9/18 at 12:40 pm the laboratory did not review all PT results. . D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 surveyors observation of the Manufacturers Instruction (MI) for controls in use and interview with the Laboratory Director (LD), the laboratory failed to follow Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- MI for controls at the time of the survey. The finding includes: 1. Controls in use did not have an open or expiration date documented as per MI. 2. The LD confirmed on 8 /9/18 at 1:15 pm that MI were not followed. 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 review of Temperature Records (TR) and interview with the Laboratory Director (LD), the laboratory failed to monitor and record the temperature of the refrigerator and room where Tosoh A1A reagents, controls and calibrators were stored from 7/20/17 to the date of the survey. The finding includes: 1. A review of the TR revealed temperature was taken twice a month when testing was performed. 2. The LD confirmed on 8/9/18 at 12:50 pm that room and refrigerator temperature was not monitored and recorded. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: a) Based on surveyor observation of reagents, solutions and interview with the Laboratory Director (LD), the laboratory failed to put prepared and expiration dates on the reagents and solutions used to perform Chemistry and Endocrinoloy tests at the time of the of survey. The findings include: 1. The Tosoh AIA 600 II Manufacturers Package Insert stated that the working diluent and wash solution were stable for 30 days at Room Temperature. 2. The laboratory did not put a prepared and expiration date on the working diluent and wash solution in use. 3. The LD confirmed on 8/9/18 at 12:30 pm the laboratory failed to label the working diluent and wash solution. b) Based on surveyor observation of the refrigerated reagents and interview with the LD, the laboratory failed to label all the reagents used to perform Chemistry and Endocrinology tests with pertinant information at the time of the survey. The finding includes: 1. A 50 ml reagent vial found in the refrigerator was not labeled with its idenity, strength or concetration, storage requirements, preparation and expiration date. 2. The LD confirmed on 8/9/18 at 1:45 pm the reagent vial was not labeled. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) -- 2 of 5 -- 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 surveyor review of the reagents, calibrators and interview with the Laboratory Director, the laboratory had expired material for Routine Chemistry and Endocrinology tests performed on the Tosoh A1A analyzer from January 2017 to the date of survey. The findings include: 1. Calibrators and Reagents were expired as follows: a. Sex Hormone-Binding Globulin (SHBG) Sample Diluent - Lot F85C405 expired August 2016 b. ST A1A Pack Program II - Lot H83C718 expired 7/31/18 c. A1A Pack Prostate Specific Antigen (PA) Calibrator - Lot H831222 expired 7/31/18 d. A1A Pack Prolactin (PRL) Calibrator - Lot H833124 expired 7/31/18 e. A1A Pack Progesterone (PR-2) Calibrator - Lot F15C701 expired January 2016 f. Ferritin Cal Verification Lot G300386 expired March 2017 g. PA Cal Verification Lot G301290 expired 3/31/17 h. PRL Cal Verification Lot G103181 expired January 2017 i. Follicle Stimulating Hormone (FSH) Cal Verification Lot G103384 expired January 2017 2. Approximately 15 patients were run twice a month. 3. The LD confirmed on 8/9/18 at 1:00 pm that the laboratory had expired reagents and calibrator material. 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 surveyor review of the Final Reports (FR) and interview with the Laboratory Director (LD), the laboratory failed to have verification for the Reference Intervals (RI) used for 13 out of 15 tests performed on Tosoh A1A analyzer from 7/20 /17 to the date of the survey. The LD confirmed on 8/9/18 at 2:25 pm that she did not have verification of RI. 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 -- 3 of 5 -- 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 surveyor review of the Quality Control (QC) records and interview with the Laboratory Director (LD), the laboratory failed to verify that assayed QC materials were within the acceptable ranges before they were put into use for Chemistry and Endocrinology Testing on the Tosoh A1A 600 II analyzer from 7/20/17 to the date of survey. The findings include: 1. This was cited on the previous survey performed on 7 /20/17. 2. The